chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea
Clinical narrative: mild anaphylactic shock; nauseated; about to pass out; bolt of tightness in her chest and across from her shoulder; pain in her chest; shortness of breath; dizzy/lightheadness; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (mild anaphylactic shock) and LOSS OF CONSCIOUSNESS (about to pass out) in a 73-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 No adverse event (no medical history reported ).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (about to pass out) (seriousness criterion medically significant), CHEST DISCOMFORT (bolt of tightness in her chest and across from her shoulder), CHEST PAIN (pain in her chest), DYSPNOEA (shortness of breath) and DIZZINESS (dizzy/lightheadness). On an unknown date, the patient experienced ANAPHYLACTIC SHOCK (mild anaphylactic shock) (seriousness criterion medically significant) and NAUSEA (nauseated). On 13-Feb-2021, LOSS OF CONSCIOUSNESS (about to pass out), CHEST DISCOMFORT (bolt of tightness in her chest and across from her shoulder), CHEST PAIN (pain in her chest), DYSPNOEA (shortness of breath) and DIZZINESS (dizzy/lightheadness) had resolved. At the time of the report, ANAPHYLACTIC SHOCK (mild anaphylactic shock) and NAUSEA (nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No other relevant medication was reported. No treatment information was reported.  This case concerns a 73-year-old female with serious unexpected events of anaphylactic shock and loss of consciousness, and nonserious unexpected chest pain, chest discomfort, dyspnea, dizziness, and expected nausea. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 73-year-old female with serious unexpected events of anaphylactic shock and loss of consciousness, and nonserious unexpected chest pain, chest discomfort, dyspnea, dizziness, and expected nausea. 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chest discomfort, Chest pain, Chills, Erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Tightness), LIP SWELLING (Swollen Lips) and ADVERSE REACTION (allergic reaction to the vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) 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 LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (Body Aches) and PYREXIA (fever). On 06-Mar-2021, the patient experienced CHILLS (Chills). On 15-Mar-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness) and URTICARIA (Hives). On 20-Mar-2021, the patient experienced CHEST PAIN (Chest Pain) (seriousness criterion hospitalization), CHEST DISCOMFORT (Chest Tightness) (seriousness criterion hospitalization) and LIP SWELLING (Swollen Lips) (seriousness criterion hospitalization). On an unknown date, the patient experienced ADVERSE REACTION (allergic reaction to the vaccine) (seriousness criterion hospitalization). The patient was hospitalized on 20-Mar-2021 due to ADVERSE REACTION, CHEST DISCOMFORT, CHEST PAIN and LIP SWELLING. At the time of the report, CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Tightness), LIP SWELLING (Swollen Lips), PAIN (Body Aches), PRURITUS (Itchiness), ERYTHEMA (Redness), URTICARIA (Hives), ADVERSE REACTION (allergic reaction to the vaccine), PYREXIA (fever) and CHILLS (Chills) outcome was unknown. Following the first dose of the vaccine, the patient experienced fever, chills and body aches that lasted for 24-36 hours and then subsided. Following the second dose of the vaccine, the patient initially experienced the similar side effects of fever, chills and body aches that lasted for a similar time frame. Then, on 15 Mar 2021, the patient began to have full body itchiness. No rash was present, but wherever she would itch would turn red and break out into hives. This continued and then on 20 Mar 2021, the patient was taken to the Emergency Room because she experienced tightness in her chest, chest pains and swelling in her lips. There she was treated for an allergic reaction to the vaccine. Some symptoms have improved but all are still present at the time of the report. Treatment details included Pepcid, Claritin D, Mailax, Prednisone, and Benadryl.; 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Myalgia, Pruritus, Pyrexia, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Tightness), LIP SWELLING (Swollen Lips) and ADVERSE REACTION (allergic reaction to the vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) 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 LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (Body Aches) and PYREXIA (fever). On 06-Mar-2021, the patient experienced CHILLS (Chills). On 15-Mar-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness) and URTICARIA (Hives). On 20-Mar-2021, the patient experienced CHEST PAIN (Chest Pain) (seriousness criterion hospitalization), CHEST DISCOMFORT (Chest Tightness) (seriousness criterion hospitalization) and LIP SWELLING (Swollen Lips) (seriousness criterion hospitalization). On an unknown date, the patient experienced ADVERSE REACTION (allergic reaction to the vaccine) (seriousness criterion hospitalization). The patient was hospitalized on 20-Mar-2021 due to ADVERSE REACTION, CHEST DISCOMFORT, CHEST PAIN and LIP SWELLING. At the time of the report, CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Tightness), LIP SWELLING (Swollen Lips), PAIN (Body Aches), PRURITUS (Itchiness), ERYTHEMA (Redness), URTICARIA (Hives), ADVERSE REACTION (allergic reaction to the vaccine), PYREXIA (fever) and CHILLS (Chills) outcome was unknown. Following the first dose of the vaccine, the patient experienced fever, chills and body aches that lasted for 24-36 hours and then subsided. Following the second dose of the vaccine, the patient initially experienced the similar side effects of fever, chills and body aches that lasted for a similar time frame. Then, on 15 Mar 2021, the patient began to have full body itchiness. No rash was present, but wherever she would itch would turn red and break out into hives. This continued and then on 20 Mar 2021, the patient was taken to the Emergency Room because she experienced tightness in her chest, chest pains and swelling in her lips. There she was treated for an allergic reaction to the vaccine. Some symptoms have improved but all are still present at the time of the report. Treatment details included Pepcid, Claritin D, Mailax, Prednisone, and Benadryl.; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Presbyacusis
Clinical narrative: hearing loss from right ear; muffled hearing on right ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (hearing loss from right ear) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Renal impairment NOS.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DEAFNESS UNILATERAL (hearing loss from right ear) (seriousness criterion medically significant) and PRESBYACUSIS (muffled hearing on right ear). At the time of the report, DEAFNESS UNILATERAL (hearing loss from right ear) and PRESBYACUSIS (muffled hearing on right ear) 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.   Concomitant medications were not reported.   The patient was evaluated at the urgent care and found a wax plug in her ear. The patient was told it was a coincidence that it started at the same time after getting a shot and is not related to vaccine.   Treatment for the events was not reported.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chills, Dyspnoea, Liver function test, Liver function test increased
Clinical narrative: Fever; chills; Hyperexpanded lungs; Inflamed lungs; Pleural Effusion; Trouble breathing; Pain in her chest when taking deep breath; Liver numbers elevated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LUNG HYPERINFLATION (Hyperexpanded lungs), PNEUMONITIS (Inflamed lungs), PLEURAL EFFUSION (Pleural Effusion), DYSPNOEA (Trouble breathing) and NON-CARDIAC CHEST PAIN (Pain in her chest when taking deep breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included Hypertension and Cholesterol (Takes cholesterol medicine.).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced LUNG HYPERINFLATION (Hyperexpanded lungs) (seriousness criterion medically significant), PNEUMONITIS (Inflamed lungs) (seriousness criterion medically significant), PLEURAL EFFUSION (Pleural Effusion) (seriousness criterion medically significant), DYSPNOEA (Trouble breathing) (seriousness criterion medically significant), NON-CARDIAC CHEST PAIN (Pain in her chest when taking deep breath) (seriousness criterion medically significant) and LIVER FUNCTION TEST INCREASED (Liver numbers elevated). On 18-Mar-2021, the patient experienced PYREXIA (Fever) and CHILLS (chills). On 20-Mar-2021, PYREXIA (Fever) and CHILLS (chills) had resolved. At the time of the report, LUNG HYPERINFLATION (Hyperexpanded lungs), PNEUMONITIS (Inflamed lungs), PLEURAL EFFUSION (Pleural Effusion) and NON-CARDIAC CHEST PAIN (Pain in her chest when taking deep breath) had resolved and DYSPNOEA (Trouble breathing) and LIVER FUNCTION TEST INCREASED (Liver numbers elevated) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Chest X-ray: pleural effusion, inflamed and hyperexpanded lungs (abnormal) Pleural effusion, inflamed and hyperexpanded lungs. In March 2021, Liver function test: increased (Inconclusive) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products known to have been used by the patient, within two weeks prior to the event included high blood pressure medication and cholesterol medication.  Treatment for the events included acetaminophen.  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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lung hyperinflation, Non-cardiac chest pain, Pleural effusion, Pneumonitis, Pyrexia
Clinical narrative: Fever; chills; Hyperexpanded lungs; Inflamed lungs; Pleural Effusion; Trouble breathing; Pain in her chest when taking deep breath; Liver numbers elevated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LUNG HYPERINFLATION (Hyperexpanded lungs), PNEUMONITIS (Inflamed lungs), PLEURAL EFFUSION (Pleural Effusion), DYSPNOEA (Trouble breathing) and NON-CARDIAC CHEST PAIN (Pain in her chest when taking deep breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included Hypertension and Cholesterol (Takes cholesterol medicine.).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced LUNG HYPERINFLATION (Hyperexpanded lungs) (seriousness criterion medically significant), PNEUMONITIS (Inflamed lungs) (seriousness criterion medically significant), PLEURAL EFFUSION (Pleural Effusion) (seriousness criterion medically significant), DYSPNOEA (Trouble breathing) (seriousness criterion medically significant), NON-CARDIAC CHEST PAIN (Pain in her chest when taking deep breath) (seriousness criterion medically significant) and LIVER FUNCTION TEST INCREASED (Liver numbers elevated). On 18-Mar-2021, the patient experienced PYREXIA (Fever) and CHILLS (chills). On 20-Mar-2021, PYREXIA (Fever) and CHILLS (chills) had resolved. At the time of the report, LUNG HYPERINFLATION (Hyperexpanded lungs), PNEUMONITIS (Inflamed lungs), PLEURAL EFFUSION (Pleural Effusion) and NON-CARDIAC CHEST PAIN (Pain in her chest when taking deep breath) had resolved and DYSPNOEA (Trouble breathing) and LIVER FUNCTION TEST INCREASED (Liver numbers elevated) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Chest X-ray: pleural effusion, inflamed and hyperexpanded lungs (abnormal) Pleural effusion, inflamed and hyperexpanded lungs. In March 2021, Liver function test: increased (Inconclusive) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products known to have been used by the patient, within two weeks prior to the event included high blood pressure medication and cholesterol medication.  Treatment for the events included acetaminophen.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Haematoma, Haemorrhage, Rash
Clinical narrative: Bled down her leg; Hematoma on lower leg; Creepy; Rash on legs, hands, wrists, fingers; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (Bled down her leg), HAEMATOMA (Hematoma on lower leg), FEELING ABNORMAL (Creepy) and RASH (Rash on legs, hands, wrists, fingers) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bled down her leg), HAEMATOMA (Hematoma on lower leg), FEELING ABNORMAL (Creepy) and RASH (Rash on legs, hands, wrists, fingers). At the time of the report, HAEMORRHAGE (Bled down her leg), HAEMATOMA (Hematoma on lower leg), FEELING ABNORMAL (Creepy) and RASH (Rash on legs, hands, wrists, fingers) 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.   This case was linked to MOD-2021-059458 (Patient Link).; Sender's Comments: This case concerns a 62-year-old female with a serious unexpected event of hemorrhage, and nonserious unexpected hematoma, feeling abnormal and expected rash. Event onset with unknown latency after first dose mRNA-1273. Events 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: Chest X-ray, Computerised tomogram head, Dizziness, Electrocardiogram, Loss of consciousness
Clinical narrative: An episode of seizure; Syncope; Unconscious; Dizziness; Fever; Nausea; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (An episode of seizure), SYNCOPE (Syncope) and LOSS OF CONSCIOUSNESS (Unconscious) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced SEIZURE (An episode of seizure) (seriousness criterion medically significant), SYNCOPE (Syncope) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Unconscious) (seriousness criterion medically significant), DIZZINESS (Dizziness), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle aches). On 23-Mar-2021, SEIZURE (An episode of seizure) and LOSS OF CONSCIOUSNESS (Unconscious) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Chest X-ray: normal (normal) normal. On 23-Mar-2021, Computerised tomogram head: normal (normal) normal. On 23-Mar-2021, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient was taken to the emergency room (ER).   Treatment included intravenous fluids.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Seizure, Syncope
Clinical narrative: An episode of seizure; Syncope; Unconscious; Dizziness; Fever; Nausea; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (An episode of seizure), SYNCOPE (Syncope) and LOSS OF CONSCIOUSNESS (Unconscious) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced SEIZURE (An episode of seizure) (seriousness criterion medically significant), SYNCOPE (Syncope) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Unconscious) (seriousness criterion medically significant), DIZZINESS (Dizziness), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle aches). On 23-Mar-2021, SEIZURE (An episode of seizure) and LOSS OF CONSCIOUSNESS (Unconscious) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Chest X-ray: normal (normal) normal. On 23-Mar-2021, Computerised tomogram head: normal (normal) normal. On 23-Mar-2021, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient was taken to the emergency room (ER).   Treatment included intravenous fluids.; 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation; A spontaneous report was received from a consumer concerning a 81-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced atrial fibrillation.  The patient's medical history includes hypertension, cholesterol, and tachycardia. Concomitant product use provided was amiodarone for tachycardia and diltiazem.  On 06-MAR-2021, approximately 3 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:032M20A) via unknown route in an unspecified arm for prophylaxis of COVID-19 infection. Treatment details were not reported.  On 09-MAR2-021 patient report she had she had an atrial fibrillation, resulting in hospitalization for 6 days.  Action taken with mRNA-1273 in response to the event(s) was unknown.  The outcome of the events, atrial fibrillation was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain in extremity, Pyrexia
Clinical narrative: Passed out; Arm is still sore; 102°F fever; This spontaneous case was reported by a health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID-19 in November.) in November 2020.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm is still sore) and PYREXIA (102°F fever). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), PAIN IN EXTREMITY (Arm is still sore) and PYREXIA (102°F fever) 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.   No treatment information was provided. Concomitant medications was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood pressure measurement, Concussion, Fall, Head injury
Clinical narrative: fell down the stairs; hit his head; Patient was reported to have low BP; lost his balance, which has been off lately; minor concussion; 47 days since patient received 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (lost his balance, which has been off lately), CONCUSSION (minor concussion), FALL (fell down the stairs), HEAD INJURY (hit his head) and HYPOTENSION (Patient was reported to have low BP) in an 82-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.     Concurrent medical conditions included No adverse event (No reported medical history). Concomitant products included HYDROCHLOROTHIAZIDE, PARACETAMOL (TYLENOL), NAPROXEN, DIPHENHYDRAMINE and SIMVASTATIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced BALANCE DISORDER (lost his balance, which has been off lately) (seriousness criterion hospitalization), FALL (fell down the stairs) (seriousness criterion hospitalization), HEAD INJURY (hit his head) (seriousness criterion hospitalization) and HYPOTENSION (Patient was reported to have low BP) (seriousness criterion hospitalization). On an unknown date, the patient experienced CONCUSSION (minor concussion) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (47 days since patient received 1st dose). The patient was hospitalized for 5 days due to BALANCE DISORDER and CONCUSSION. At the time of the report, BALANCE DISORDER (lost his balance, which has been off lately), CONCUSSION (minor concussion), FALL (fell down the stairs), HEAD INJURY (hit his head), HYPOTENSION (Patient was reported to have low BP) and PRODUCT DOSE OMISSION ISSUE (47 days since patient received 1st dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood pressure measurement: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.  This report also refers to an event PT Product dose omission issue, lot # unknown.  There were no AEs specifically associated with this medication error; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.  This report also refers to an event PT Product dose omission issue, lot # unknown.  There were no AEs specifically associated with this medication error
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Product dose omission issue
Clinical narrative: fell down the stairs; hit his head; Patient was reported to have low BP; lost his balance, which has been off lately; minor concussion; 47 days since patient received 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (lost his balance, which has been off lately), CONCUSSION (minor concussion), FALL (fell down the stairs), HEAD INJURY (hit his head) and HYPOTENSION (Patient was reported to have low BP) in an 82-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.     Concurrent medical conditions included No adverse event (No reported medical history). Concomitant products included HYDROCHLOROTHIAZIDE, PARACETAMOL (TYLENOL), NAPROXEN, DIPHENHYDRAMINE and SIMVASTATIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced BALANCE DISORDER (lost his balance, which has been off lately) (seriousness criterion hospitalization), FALL (fell down the stairs) (seriousness criterion hospitalization), HEAD INJURY (hit his head) (seriousness criterion hospitalization) and HYPOTENSION (Patient was reported to have low BP) (seriousness criterion hospitalization). On an unknown date, the patient experienced CONCUSSION (minor concussion) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (47 days since patient received 1st dose). The patient was hospitalized for 5 days due to BALANCE DISORDER and CONCUSSION. At the time of the report, BALANCE DISORDER (lost his balance, which has been off lately), CONCUSSION (minor concussion), FALL (fell down the stairs), HEAD INJURY (hit his head), HYPOTENSION (Patient was reported to have low BP) and PRODUCT DOSE OMISSION ISSUE (47 days since patient received 1st dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood pressure measurement: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.  This report also refers to an event PT Product dose omission issue, lot # unknown.  There were no AEs specifically associated with this medication error; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.  This report also refers to an event PT Product dose omission issue, lot # unknown.  There were no AEs specifically associated with this medication error
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Chills, Dysphonia, Headache, Heart rate
Clinical narrative: Anaphylactic shock after 10-15 minutes of the injection; Rapid heart rate of 166; shaking - mostly left arm and leg; super pale  lost all her color; voice was off; itching; Rash from the top of the neck, all the way down to her back; teeth were majorly chattering; bad headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock after 10-15 minutes of the injection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03M20A and 018A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction (anaphylactic reaction to sea food 15 years ago so) in 2006.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock after 10-15 minutes of the injection) (seriousness criteria hospitalization and medically significant), TACHYCARDIA (Rapid heart rate of 166), TREMOR (shaking - mostly left arm and leg), SKIN DISCOLOURATION (super pale  lost all her color), DYSPHONIA (voice was off), PRURITUS (itching), RASH (Rash from the top of the neck, all the way down to her back), CHILLS (teeth were majorly chattering) and HEADACHE (bad headache). The patient was hospitalized for 1 day due to ANAPHYLACTIC SHOCK. On 24-Mar-2021, ANAPHYLACTIC SHOCK (Anaphylactic shock after 10-15 minutes of the injection), TACHYCARDIA (Rapid heart rate of 166), TREMOR (shaking - mostly left arm and leg), SKIN DISCOLOURATION (super pale  lost all her color), DYSPHONIA (voice was off), RASH (Rash from the top of the neck, all the way down to her back) and CHILLS (teeth were majorly chattering) had resolved. At the time of the report, PRURITUS (itching) outcome was unknown and HEADACHE (bad headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Heart rate: 166 (High) tachycardia.         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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin discolouration, Tachycardia, Tremor
Clinical narrative: Anaphylactic shock after 10-15 minutes of the injection; Rapid heart rate of 166; shaking - mostly left arm and leg; super pale  lost all her color; voice was off; itching; Rash from the top of the neck, all the way down to her back; teeth were majorly chattering; bad headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock after 10-15 minutes of the injection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03M20A and 018A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction (anaphylactic reaction to sea food 15 years ago so) in 2006.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock after 10-15 minutes of the injection) (seriousness criteria hospitalization and medically significant), TACHYCARDIA (Rapid heart rate of 166), TREMOR (shaking - mostly left arm and leg), SKIN DISCOLOURATION (super pale  lost all her color), DYSPHONIA (voice was off), PRURITUS (itching), RASH (Rash from the top of the neck, all the way down to her back), CHILLS (teeth were majorly chattering) and HEADACHE (bad headache). The patient was hospitalized for 1 day due to ANAPHYLACTIC SHOCK. On 24-Mar-2021, ANAPHYLACTIC SHOCK (Anaphylactic shock after 10-15 minutes of the injection), TACHYCARDIA (Rapid heart rate of 166), TREMOR (shaking - mostly left arm and leg), SKIN DISCOLOURATION (super pale  lost all her color), DYSPHONIA (voice was off), RASH (Rash from the top of the neck, all the way down to her back) and CHILLS (teeth were majorly chattering) had resolved. At the time of the report, PRURITUS (itching) outcome was unknown and HEADACHE (bad headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Heart rate: 166 (High) tachycardia.         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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Skin cancer
Clinical narrative: Skin cancer; received his 2nd dose today, 29Mar2021; A spontaneous report was received from a consumer concerning an 80-year old male patient, who received the first dose of the Moderna's COVID-19 vaccine (mRNA-1273) and experienced skin cancer and received his 2nd dose today, 29 Mar 2021.  The patient's medical history was not provided. Concomitant medications included atorvastatin, metoprolol for blood pressure and acetylsalicylic acid.  On 30 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (Batch Number: 006B21A) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, after receiving vaccine, the patient was made aware of his skin cancer and had to get the stitches removed and had his surgical appointment o the day his second dose was scheduled.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event Skin cancer was unknown. The event received his 2nd dose today, 29Mar2021 was considered to be reslved on 29 Mar 2021.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # 027L20A with no associated AEs. 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Malaise
Clinical narrative: so close to having pneumonia; got sick after the shot; hacking cough; choking; missed the 42 day window; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (so close to having pneumonia) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) 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 medications were not provided.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (so close to having pneumonia) (seriousness criterion medically significant), MALAISE (got sick after the shot), COUGH (hacking cough), CHOKING (choking) and PRODUCT DOSE OMISSION ISSUE (missed the 42 day window). At the time of the report, PNEUMONIA (so close to having pneumonia), ILLNESS (got sick after the shot), COUGH (hacking cough), CHOKING (choking) and PRODUCT DOSE OMISSION ISSUE (missed the 42 day window) had not resolved.      Treatment information was 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.; 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) lot # unknown with no associated AEs.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: flares with autoimmune condition; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (flares with autoimmune condition) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012AUA and 017BUA) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (flares with autoimmune condition) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (flares with autoimmune condition) outcome was unknown.            Concomitant medication not provided. Treatment not provided.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Dizziness, Magnetic resonance imaging, Nausea, Tinnitus
Clinical narrative: dizzy; pukey; deaf in her left ear; water sounds in her ear; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS (deaf in her left ear) in a 55-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 reported medical history).    On 18-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 DEAFNESS (deaf in her left ear) (seriousness criterion medically significant) and TINNITUS (water sounds in her ear). On an unknown date, the patient experienced DIZZINESS (dizzy) and NAUSEA (pukey). At the time of the report, DEAFNESS (deaf in her left ear), TINNITUS (water sounds in her ear), DIZZINESS (dizzy) and NAUSEA (pukey) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: not provided (Inconclusive) Not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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 US-MODERNATX, INC.-MOD-2021-062183 (E2B Linked Report). This case was linked to MOD-2021-062183 (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. US-MODERNATX, INC.-MOD-2021-062183:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Nasal congestion
Clinical narrative: trouble in breathing; congestion; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble in breathing) and NASAL CONGESTION (congestion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Bronchitis and Shortness of breath (SOB). Concurrent medical conditions included Chronic obstructive pulmonary disease (COPD) and Smoker.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date (reported as few days after vaccination), the patient experienced DYSPNOEA (trouble in breathing) (seriousness criterion medically significant) and NASAL CONGESTION (congestion) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (trouble in breathing) and NASAL CONGESTION (congestion) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The treatment information included inhaler.   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 onset date of the reported events, a causal relationship cannot be excluded.  However, patient's prior SOB, being a smoker and underlying bronchitis and COPD may have been contributory.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nausea, Pain, Pyrexia
Clinical narrative: Experience exact symptoms of Covid19 virus as when I had it in Dec/2020. nausea, fever, cough, and body aches. It lasted 24 hours.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: 4 hours after the vaccine shot on my left arm, my left eye started twitching.  It happened a lot at first, and happened multiple times a day for 10-20 minutes at a time.  After a couple weeks it slowed down to the point where it only happens every couple days.  This absolutely did not happen before that exact day so I am relatively sure it was caused by the vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Neck pain, Swelling
Clinical narrative: Pain Lump/swelling on neck (left side) Lump/swelling on Armpit (left hand) Constant pain
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hypoaesthesia, Influenza like illness
Clinical narrative: Flu like symptoms,  SEVERE  muscle cramps. Loss of feeling in limbs. Headache and nausea. Lightheaded. Chills and shaking.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Tremor
Clinical narrative: Flu like symptoms,  SEVERE  muscle cramps. Loss of feeling in limbs. Headache and nausea. Lightheaded. Chills and shaking.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Epistaxis, Fatigue, Intensive care
Clinical narrative: currently in hospital (ICU). Fainting, lightheadedness, extreme fatigue, petechiae, extremely low platelet count, possibly kidney damage, nose bleed, weakness,
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae, Platelet count decreased, Syncope
Clinical narrative: currently in hospital (ICU). Fainting, lightheadedness, extreme fatigue, petechiae, extremely low platelet count, possibly kidney damage, nose bleed, weakness,
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood test, Decreased appetite, Dizziness
Clinical narrative: Went to get up to get ready for work and instantly collapsed-scraping up knee. Became extremely nauseous, weak, excruciating headache and dizzy. Unable to stand, had to crawl to nearby chair and call for wife. Thought might be dehydrated, extremely pale, tried to drink water, but began vomiting. BP was elevated, but no temperature. Tried to eat crackers and drink more water, but continued to violently vomit. Never felt so badly in entire life. No strength to stand or get up the stairs to be taken to ER, so had to call paramedics. When they arrived, BP had come down, but they felt needed to be transported to ER, so they took to healthcare facility at about 1:30 pm.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Electrocardiogram, Fall, Fatigue, Headache
Clinical narrative: Went to get up to get ready for work and instantly collapsed-scraping up knee. Became extremely nauseous, weak, excruciating headache and dizzy. Unable to stand, had to crawl to nearby chair and call for wife. Thought might be dehydrated, extremely pale, tried to drink water, but began vomiting. BP was elevated, but no temperature. Tried to eat crackers and drink more water, but continued to violently vomit. Never felt so badly in entire life. No strength to stand or get up the stairs to be taken to ER, so had to call paramedics. When they arrived, BP had come down, but they felt needed to be transported to ER, so they took to healthcare facility at about 1:30 pm.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pallor, Skin abrasion, Urine analysis, Vomiting
Clinical narrative: Went to get up to get ready for work and instantly collapsed-scraping up knee. Became extremely nauseous, weak, excruciating headache and dizzy. Unable to stand, had to crawl to nearby chair and call for wife. Thought might be dehydrated, extremely pale, tried to drink water, but began vomiting. BP was elevated, but no temperature. Tried to eat crackers and drink more water, but continued to violently vomit. Never felt so badly in entire life. No strength to stand or get up the stairs to be taken to ER, so had to call paramedics. When they arrived, BP had come down, but they felt needed to be transported to ER, so they took to healthcare facility at about 1:30 pm.