chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Colitis microscopic, Limb discomfort, Migraine
Clinical narrative: collagenos colitis; arm started hurting again; migraine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COLITIS MICROSCOPIC (collagenos colitis) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Cancer on 20-Oct-2011 and Mastectomy bilateral on 20-Oct-2011. Concurrent medical conditions included Allergic reaction to food since January 2021, Iodine allergy since January 2021, Pain in arm (Pain returned) since January 2021, Headache aggravated (Got much worse) since January 2021 and Colitis collagenous (went away and now has returned) since January 2021. Concomitant products included CICLOSPORIN (RESTASIS) for Dry eyes, LORAZEPAM for Sleep disorder, VITAMIN D NOS for an unknown indication.  On 18-Jan-2021 at 3:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 03-Mar-2021, the patient experienced MIGRAINE (migraine). On an unknown date, the patient experienced COLITIS MICROSCOPIC (collagenos colitis) (seriousness criterion medically significant) and LIMB DISCOMFORT (arm started hurting again). At the time of the report, COLITIS MICROSCOPIC (collagenos colitis) and LIMB DISCOMFORT (arm started hurting again) outcome was unknown and MIGRAINE (migraine) had not resolved.  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.   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.   This case was linked to MOD-2021-075934 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest pain, Dizziness, Electrocardiogram, Gastrooesophageal reflux disease
Clinical narrative: chest pain; left arm went numb; GERD; light headed/dizzy; increased in smell; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (light headed/dizzy) and PAROSMIA (increased in smell). On 10-Apr-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged), HYPOAESTHESIA (left arm went numb) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD). On 28-Mar-2021, PAROSMIA (increased in smell) had resolved. On 12-Apr-2021, CHEST PAIN (chest pain), DIZZINESS (light headed/dizzy), HYPOAESTHESIA (left arm went numb) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       They did a EKG and chemical test, everything normal. More tests were run and everything came back normal. Patient spent two nights in the hospital.  Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Parosmia
Clinical narrative: chest pain; left arm went numb; GERD; light headed/dizzy; increased in smell; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (light headed/dizzy) and PAROSMIA (increased in smell). On 10-Apr-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged), HYPOAESTHESIA (left arm went numb) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD). On 28-Mar-2021, PAROSMIA (increased in smell) had resolved. On 12-Apr-2021, CHEST PAIN (chest pain), DIZZINESS (light headed/dizzy), HYPOAESTHESIA (left arm went numb) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       They did a EKG and chemical test, everything normal. More tests were run and everything came back normal. Patient spent two nights in the hospital.  Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis microscopic, Migraine, Pain in extremity
Clinical narrative: collagenos colitis; Migraine; the arm starting hurting; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COLITIS MICROSCOPIC (collagenos colitis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer, Chronic pain (left arm), Colitis collagenous and Mastectomy bilateral on 20-Oct-2011. Concurrent medical conditions included Headache. Concomitant products included CICLOSPORIN (RESTASIS) for Dry eye, COLECALCIFEROL (VITAMIN D 3) for Nutritional supplement, LORAZEPAM for Sleep disorder NOS.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced COLITIS MICROSCOPIC (collagenos colitis) (seriousness criterion medically significant), MIGRAINE (Migraine) and PAIN IN EXTREMITY (the arm starting hurting). At the time of the report, COLITIS MICROSCOPIC (collagenos colitis), MIGRAINE (Migraine) and PAIN IN EXTREMITY (the arm starting hurting) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had previous health issues and these problems returned with vengeance. The patient had a history of headaches but mild she started having migraines. The patient had breast surgery and had previously had problems in her left arm because of infections and had 12 surgeries. The arm got better and haven't had any pain in years. The arm was started hurting again. The patient was diagnosed with collagenous colitis. It hasn't bothered her in many years. It was back and worse than ever. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: This case concerns a 78-year-old female with PMH of collagenous colitis, had a serious unexpected event of colitis microscopic, and non-serious unexpected migraine and pain in extremity. Event onset 12 days after second dose mRNA-1273. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-075459 (Patient Link).; Sender's Comments: This case concerns a 78-year-old female with PMH of collagenous colitis, had a serious unexpected event of colitis microscopic, and nonserious unexpected migraine and pain in extremity. Event onset 12 days after second dose mRNA-1273. Event ongoing. 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Confusional state, Lethargy, Loss of consciousness, Malaise
Clinical narrative: Passed out; Strain on heart; Confusion; Lethargic; Not feeling well; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 55-year-old female 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.     Concurrent medical conditions included Drug hypersensitivity, Hypertension and Anxiety. Concomitant products included AMLODIPINE BESILATE (NORVASC), CLONIDINE HYDROCHLORIDE (CLONIDIN), BUPROPION HYDROCHLORIDE (WELLBUTRIN), LEVOTHYROXINE and CEFIXIME (FLEXERIL [CEFIXIME]).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), CARDIAC DISCOMFORT (Strain on heart), CONFUSIONAL STATE (Confusion), LETHARGY (Lethargic) and MALAISE (Not feeling well). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), CARDIAC DISCOMFORT (Strain on heart), CONFUSIONAL STATE (Confusion), LETHARGY (Lethargic) and MALAISE (Not feeling well) 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.   The patient followed up with doctor on 03/26/2021.  No treatment medication was provided by the reporter.  Patient reports after she left the site and drove about thirty minutes away, she had to pull into parking lot because she felt bad and confused. States she has passed out x2 that same day. Reported feeling lethargic and a strain on her heart.; 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. The patient's medical history of drug hypersensitivity, and anxiety remain as confounders.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac output increased, Confusional state, Vision blurred, Vomiting
Clinical narrative: confusion/was not coherent; blurry vision; vomited; cardiac outcomes went up, from the lab results they were elevated; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (confusion/was not coherent), VISION BLURRED (blurry vision), VOMITING (vomited) and CARDIAC OUTPUT INCREASED (cardiac outcomes went up, from the lab results they were elevated) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced CONFUSIONAL STATE (confusion/was not coherent) (seriousness criterion hospitalization), VISION BLURRED (blurry vision) (seriousness criterion hospitalization), VOMITING (vomited) (seriousness criterion hospitalization) and CARDIAC OUTPUT INCREASED (cardiac outcomes went up, from the lab results they were elevated) (seriousness criterion hospitalization). At the time of the report, CONFUSIONAL STATE (confusion/was not coherent), VISION BLURRED (blurry vision), VOMITING (vomited) and CARDIAC OUTPUT INCREASED (cardiac outcomes went up, from the lab results they were elevated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had his first dose of the Moderna COVID-19 vaccine yesterday and immediately felt the vaccine go to his chest and down to the toes; 30-40 minutes after had confusion, blurry vision; he made it to a hospital in Dallas where he vomited, he could not read at the moment, could not call 911, did not know how to send his location, how to call or text, he was not coherent. Was admitted in the ER with altered mental state, he was not responsive when she went to see him. He stayed overnight, his cardiac outcomes went up, from the lab results they were elevated. They performed CT scans, neurological checks, a holter monitor, MRI, multiple blood works and everything was clear.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Short of breath; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Short of breath) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID-19). On 10-Apr-2021, the patient experienced DYSPNOEA (Short of breath) (seriousness criterion hospitalization). The patient was hospitalized on 10-Apr-2021 due to DYSPNOEA. At the time of the report, DYSPNOEA (Short of breath) and COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Two weeks after her first dose she got tested at the hospital and tested positive for COVID. Patient was short of breath and went to the emergency room on 10APR2021.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness transient, Cerebrovascular accident, Fatigue, Migraine, Nausea
Clinical narrative: stroke; Completely lost vision in right eye which came back; migraine; fatigued kicked in, very tired,exhausted; nauseated; throwing up; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Stroke. Concomitant products included METFORMIN, LISINOPRIL, GLIMEPIRIDE, ROSUVASTATIN CALCIUM (CRESTOR), PIOGLITAZONE HYDROCHLORIDE (ACTOS) and CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MIGRAINE (migraine), FATIGUE (fatigued kicked in, very tired,exhausted), NAUSEA (nauseated) and VOMITING (throwing up). On 06-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion hospitalization) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) (seriousness criterion medically significant). The patient was hospitalized from 06-Apr-2021 to 09-Apr-2021 due to CEREBROVASCULAR ACCIDENT. On 01-Apr-2021, MIGRAINE (migraine), FATIGUE (fatigued kicked in, very tired,exhausted), NAUSEA (nauseated) and VOMITING (throwing up) had resolved. On 09-Apr-2021, CEREBROVASCULAR ACCIDENT (stroke) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment reported during hospital included IV blood thinner ,Xarelto 20mg. Metoprolol Tartrate 25mg, Amiodarone 200mg, after second dose.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-076248 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.  .
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: stroke; Completely lost vision in right eye which came back; migraine; fatigued kicked in, very tired,exhausted; nauseated; throwing up; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Stroke. Concomitant products included METFORMIN, LISINOPRIL, GLIMEPIRIDE, ROSUVASTATIN CALCIUM (CRESTOR), PIOGLITAZONE HYDROCHLORIDE (ACTOS) and CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MIGRAINE (migraine), FATIGUE (fatigued kicked in, very tired,exhausted), NAUSEA (nauseated) and VOMITING (throwing up). On 06-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion hospitalization) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) (seriousness criterion medically significant). The patient was hospitalized from 06-Apr-2021 to 09-Apr-2021 due to CEREBROVASCULAR ACCIDENT. On 01-Apr-2021, MIGRAINE (migraine), FATIGUE (fatigued kicked in, very tired,exhausted), NAUSEA (nauseated) and VOMITING (throwing up) had resolved. On 09-Apr-2021, CEREBROVASCULAR ACCIDENT (stroke) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment reported during hospital included IV blood thinner ,Xarelto 20mg. Metoprolol Tartrate 25mg, Amiodarone 200mg, after second dose.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-076248 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.  .
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Computerised tomogram, Nausea, Pain in extremity
Clinical narrative: Acute pulmonary embolism/two blood clots in lung; Chest pain; Pain over left arm; pain all over joints; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Acute pulmonary embolism/two blood clots in lung) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain over left arm), ARTHRALGIA (pain all over joints) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced CHEST PAIN (Chest pain). On 13-Apr-2021, the patient experienced PULMONARY EMBOLISM (Acute pulmonary embolism/two blood clots in lung) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Acute pulmonary embolism/two blood clots in lung), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Pain over left arm), ARTHRALGIA (pain all over joints) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Computerised tomogram: abnormal (abnormal) diagnosed acute pulmonary embolism.. Two blood clots in lung.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Description: The patient experienced pain over left arm, pain all over joints, nausea after vaccine administration. On 12 Apr2 021, the patient experienced chest pain and went to Emergency. Room where blood test and D-dimer was done. The treatment information included apixaban.  Company Comment:  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Acute pulmonary embolism/two blood clots in lung; Chest pain; Pain over left arm; pain all over joints; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Acute pulmonary embolism/two blood clots in lung) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain over left arm), ARTHRALGIA (pain all over joints) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced CHEST PAIN (Chest pain). On 13-Apr-2021, the patient experienced PULMONARY EMBOLISM (Acute pulmonary embolism/two blood clots in lung) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Acute pulmonary embolism/two blood clots in lung), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Pain over left arm), ARTHRALGIA (pain all over joints) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Computerised tomogram: abnormal (abnormal) diagnosed acute pulmonary embolism.. Two blood clots in lung.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Description: The patient experienced pain over left arm, pain all over joints, nausea after vaccine administration. On 12 Apr2 021, the patient experienced chest pain and went to Emergency. Room where blood test and D-dimer was done. The treatment information included apixaban.  Company Comment:  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Eye inflammation, Influenza like illness, Uveitis
Clinical narrative: Uveitis; Inflammatory eye condition flared up; Flu like symptoms; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of UVEITIS (Uveitis) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 11-Apr-2021, the patient experienced UVEITIS (Uveitis) (seriousness criterion medically significant) and EYE INFLAMMATION (Inflammatory eye condition flared up). At the time of the report, UVEITIS (Uveitis), INFLUENZA LIKE ILLNESS (Flu like symptoms) and EYE INFLAMMATION (Inflammatory eye condition flared up) had not resolved.        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 went to Ophthalmologist and confirmed her condition as Uveitis.   Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Feeling hot, Induration, Pruritus, Rash
Clinical narrative: skin cellulitis; feeing warm; hard; a big red blotch on arm; arm got really itchy; This spontaneous case was reported by a non-health professional and describes the occurrence of CELLULITIS (skin cellulitis) in a 67-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 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PRURITUS (arm got really itchy). On 09-Apr-2021, the patient experienced CELLULITIS (skin cellulitis) (seriousness criterion medically significant), FEELING HOT (feeing warm), INDURATION (hard) and RASH (a big red blotch on arm). At the time of the report, CELLULITIS (skin cellulitis), FEELING HOT (feeing warm), INDURATION (hard), RASH (a big red blotch on arm) and PRURITUS (arm got really itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. 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. 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, a causal relationship cannot be excluded. Further information has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Suffered an anaphylactic reaction and I was taken by ambulance to the Emergency Room; Diarrhea; Nausea; Headache; Myalgia; Fever; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Suffered an anaphylactic reaction and I was taken by ambulance to the Emergency Room) in a 67-year-old male patient who received mRNA-1273 (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Was hospitalized with Covid in February 2021) on 01-Feb-2021, Deep venous thrombosis NOS (Ended up with Deep Venous Thrombosis in the hospital) and Thrombophlebitis.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced HEADACHE (Headache), MYALGIA (Myalgia), PYREXIA (Fever) and FATIGUE (Fatigue). On 07-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nausea). On 13-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Suffered an anaphylactic reaction and I was taken by ambulance to the Emergency Room) (seriousness criteria medically significant and life threatening). On 01-Apr-2021, PYREXIA (Fever) had resolved. On 12-Apr-2021, NAUSEA (Nausea) had resolved. At the time of the report, ANAPHYLACTIC REACTION (Suffered an anaphylactic reaction and I was taken by ambulance to the Emergency Room), DIARRHOEA (Diarrhea), HEADACHE (Headache), MYALGIA (Myalgia) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  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 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Suffered an anaphylactic reaction and I was taken by ambulance to the Emergency Room; Diarrhea; Nausea; Headache; Myalgia; Fever; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Suffered an anaphylactic reaction and I was taken by ambulance to the Emergency Room) in a 67-year-old male patient who received mRNA-1273 (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Was hospitalized with Covid in February 2021) on 01-Feb-2021, Deep venous thrombosis NOS (Ended up with Deep Venous Thrombosis in the hospital) and Thrombophlebitis.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced HEADACHE (Headache), MYALGIA (Myalgia), PYREXIA (Fever) and FATIGUE (Fatigue). On 07-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nausea). On 13-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Suffered an anaphylactic reaction and I was taken by ambulance to the Emergency Room) (seriousness criteria medically significant and life threatening). On 01-Apr-2021, PYREXIA (Fever) had resolved. On 12-Apr-2021, NAUSEA (Nausea) had resolved. At the time of the report, ANAPHYLACTIC REACTION (Suffered an anaphylactic reaction and I was taken by ambulance to the Emergency Room), DIARRHOEA (Diarrhea), HEADACHE (Headache), MYALGIA (Myalgia) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  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 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Oral herpes, Pain in extremity
Clinical narrative: Bel's palsy (L side); Fever bolsters in her lips; Real sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bel's palsy (L side)) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bell's palsy (Right side, 12 or 15 years ago). Concurrent medical conditions included Overactive bladder. Concomitant products included OXYBUTYNIN for Overactive bladder.    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 PAIN IN EXTREMITY (Real sore arm). On 10-Apr-2021, the patient experienced FACIAL PARALYSIS (Bel's palsy (L side)) (seriousness criterion medically significant) and ORAL HERPES (Fever bolsters in her lips). On 11-Mar-2021, PAIN IN EXTREMITY (Real sore arm) had resolved. At the time of the report, FACIAL PARALYSIS (Bel's palsy (L side)) and ORAL HERPES (Fever bolsters in her lips) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient has her second dose scheduled for 16-Apr-2021.  She developed "bel's palsy" on 10-Apr-2021.  She started to notice it on 09-Apr-2021 but received confirmation on 10-Apr-2021.  She reported a real sore arm for two days after the vaccination.  The patient also developed "fever bolsters" in her lips.  She doesn't know if it is side effects from the vaccine.  The patient had a virtual appointment with her physician, and he recommended that she not receive the second vaccine and to visit a neurologist. Treatment medications included steroid and antiviral medications. Valtrex 1 gr table as needed (3 times a day).  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: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Emotional disorder, Fatigue, Feeling of despair
Clinical narrative: I woke up in the middle of the first night after receiving 2nd dose of Moderna.  I had a fever, chills and muscle aches, and extreme fatigue.  Those symptoms lasted approx 3 days.  Two days after the vaccination I also became extremely nauseous.  I was anticipating all of these symptoms.  On the 3rd and 4th days after the vaccine most of the symptoms disappeared but I received some new ones that I was not expecting.  I suddenly felt a large amount of despair and hopelessness.  I had suicidal thoughts.  I had panic attacks and anxiety.  I had paranoia.  I did not feel like I had long to live, or anything to live for.  By 20 Apr all of these emotional and mental side effects were completely gone.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Mental status changes, Myalgia, Nausea, Panic attack, Paranoia
Clinical narrative: I woke up in the middle of the first night after receiving 2nd dose of Moderna.  I had a fever, chills and muscle aches, and extreme fatigue.  Those symptoms lasted approx 3 days.  Two days after the vaccination I also became extremely nauseous.  I was anticipating all of these symptoms.  On the 3rd and 4th days after the vaccine most of the symptoms disappeared but I received some new ones that I was not expecting.  I suddenly felt a large amount of despair and hopelessness.  I had suicidal thoughts.  I had panic attacks and anxiety.  I had paranoia.  I did not feel like I had long to live, or anything to live for.  By 20 Apr all of these emotional and mental side effects were completely gone.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Suicidal ideation
Clinical narrative: I woke up in the middle of the first night after receiving 2nd dose of Moderna.  I had a fever, chills and muscle aches, and extreme fatigue.  Those symptoms lasted approx 3 days.  Two days after the vaccination I also became extremely nauseous.  I was anticipating all of these symptoms.  On the 3rd and 4th days after the vaccine most of the symptoms disappeared but I received some new ones that I was not expecting.  I suddenly felt a large amount of despair and hopelessness.  I had suicidal thoughts.  I had panic attacks and anxiety.  I had paranoia.  I did not feel like I had long to live, or anything to live for.  By 20 Apr all of these emotional and mental side effects were completely gone.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site rash
Clinical narrative: Rash/redness at injection site. Itching. Feels like a lump under the skin that wasn't there before. Just started this evening. Will put ice on it and perhaps take an anti histamine tomorrow if it still itches.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles - confirmed diagnosis by doctor. Bad case of them.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Vertigo
Clinical narrative: Anaphylactic reaction; Vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) and VERTIGO (Vertigo) outcome was unknown.            Patient had an anaphylactic reaction within 10 minutes of administration and was administered an Epi Pen and Benadryl. Patient went to the ER and was discharged the same day. Since then, the patient has been experiencing vertigo intermittently.no history for the treatment of Vertigo was provided  Concomitant medications were not reported.  Action taken with mRNA-1273 in response to the events was not Applicable.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, the previous history of Vertigo is a confounder.   This case was linked to MOD-2021-076365 (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 these events, a causal relationship cannot be excluded. However, the previous history of Vertigo is a confounder. MOD-2021-076365:1st dose of vaccine
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, C-reactive protein increased, Hypoaesthesia oral, Platelet count decreased, Rash papular
Clinical narrative: Patient experienced self-limited angioedema of the lips resulting in perioral numbness that persisted for 2 weeks before resolving.  Errythematous papulovesicular rash on dorsum of both great toes. Thrombocytopenia with platelet count of 129,000.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate normal, Thrombocytopenia
Clinical narrative: Patient experienced self-limited angioedema of the lips resulting in perioral numbness that persisted for 2 weeks before resolving.  Errythematous papulovesicular rash on dorsum of both great toes. Thrombocytopenia with platelet count of 129,000.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Maternal exposure during breast feeding, Menstruation irregular, Pelvic discomfort, Sensory disturbance
Clinical narrative: I am 3 months post partum. The day after  I received my shot, my pelvic area had a odd feeling. Almost like my uterus felt a dull very very mild pressure. Day 2 after receiving my shot, I started to bleed. I am exclusively breastfeeding and I have never had a period start this early with all of my other children. Normal is 7 plus months for me. This period was also not a normal period. I had zero cramps. I felt nothing. I never have had a period with zero cramps. Lasted for 7 days.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: I am 3 months post partum. The day after  I received my shot, my pelvic area had a odd feeling. Almost like my uterus felt a dull very very mild pressure. Day 2 after receiving my shot, I started to bleed. I am exclusively breastfeeding and I have never had a period start this early with all of my other children. Normal is 7 plus months for me. This period was also not a normal period. I had zero cramps. I felt nothing. I never have had a period with zero cramps. Lasted for 7 days.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vital signs measurement
Clinical narrative: Patient got vaccinated at 10:32 AM.   He called at 2:24 PM and said that his hand has been shaking "since 2 hours ago".  He said it's been like that for 1 hour.   He self-reports that he checked his blood glucose & blood pressure and they're all within  normal.  I told him to see MD ASAP.  Last I heard from him was that he's going to call an ambulance.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Dizziness, Ear discomfort, Tinnitus
Clinical narrative: On April 5th I was sitting, watching TV. Suddenly, it felt as though I needed to pop my left ear and I couldn't. I also couldn't hear out of that ear It was a roaring sound like the ocean and intermittent buzzing and ringing in my ear. The next day was no better and I started getting dizzy. By April 5th I had a very bad case of Vertigo and had to go to the hospital. I was given an IV with motion sickness meds and nausea meds, as well as antibiotics and I think a steroid shot. I still couldn't hear. I was sent home with prescriptions. The vertigo gradually got better over the following days, but I never regained my hearing. On the 12th of April, still feeling the affects of the vertigo, and out of nausea meds, I went to my primary doctor. I received another steroid shot and more meds. On the 19th I went again and got a hearing test. I am deaf in my left ear and will see a specialist.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: On April 5th I was sitting, watching TV. Suddenly, it felt as though I needed to pop my left ear and I couldn't. I also couldn't hear out of that ear It was a roaring sound like the ocean and intermittent buzzing and ringing in my ear. The next day was no better and I started getting dizzy. By April 5th I had a very bad case of Vertigo and had to go to the hospital. I was given an IV with motion sickness meds and nausea meds, as well as antibiotics and I think a steroid shot. I still couldn't hear. I was sent home with prescriptions. The vertigo gradually got better over the following days, but I never regained my hearing. On the 12th of April, still feeling the affects of the vertigo, and out of nausea meds, I went to my primary doctor. I received another steroid shot and more meds. On the 19th I went again and got a hearing test. I am deaf in my left ear and will see a specialist.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Dizziness, Eye pain
Clinical narrative: April 8th at 11pm I started to have slight body aches. I woke up at 3am with intense body aches/ chills/sweats, felt like I had a cabin fever for the entire day of April 9th. I felt dizzy,  had a headache, my eyes aches and very very fatigued and couldn?t eat. Night of April 9th I started to not feel so dizzy but I was very very hot and could not cool down. Ever since April 10th I?ve have runny/stuffy nose/ body aches, sore throat, I developed a cough week of April 12th, eyes ached and very very fatigued. Today, April 21st, I am still a little fatigued, little soar throat, but runny/stuff nose still, and body soreness/aches.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Hyperhidrosis, Nasal congestion
Clinical narrative: April 8th at 11pm I started to have slight body aches. I woke up at 3am with intense body aches/ chills/sweats, felt like I had a cabin fever for the entire day of April 9th. I felt dizzy,  had a headache, my eyes aches and very very fatigued and couldn?t eat. Night of April 9th I started to not feel so dizzy but I was very very hot and could not cool down. Ever since April 10th I?ve have runny/stuffy nose/ body aches, sore throat, I developed a cough week of April 12th, eyes ached and very very fatigued. Today, April 21st, I am still a little fatigued, little soar throat, but runny/stuff nose still, and body soreness/aches.