chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Deafness unilateral, Ear discomfort, Headache
Clinical narrative: Loss of hearing in the left ear; Sore throat; Ears clogged; SEVERE muscle spasms; All of my muscles in my arms, legs, and cheeks were trembling constantly; One hard, tiny, tiny mucous ball from each cough; Tremendous sweats; I slept for 1 day; Headache; SEVERE chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Loss of hearing in the left ear) in a 73-year-old patient of an unknown gender 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 Asthma and Hypoglycemia.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (Loss of hearing in the left ear) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat), EAR DISCOMFORT (Ears clogged), MUSCLE SPASMS (SEVERE muscle spasms), TREMOR (All of my muscles in my arms, legs, and cheeks were trembling constantly), PRODUCTIVE COUGH (One hard, tiny, tiny mucous ball from each cough), HYPERHIDROSIS (Tremendous sweats), HYPERSOMNIA (I slept for 1 day), HEADACHE (Headache), CHILLS (SEVERE chills) and PYREXIA (Fever). At the time of the report, DEAFNESS UNILATERAL (Loss of hearing in the left ear), OROPHARYNGEAL PAIN (Sore throat), EAR DISCOMFORT (Ears clogged), MUSCLE SPASMS (SEVERE muscle spasms), TREMOR (All of my muscles in my arms, legs, and cheeks were trembling constantly), PRODUCTIVE COUGH (One hard, tiny, tiny mucous ball from each cough), HYPERHIDROSIS (Tremendous sweats), HYPERSOMNIA (I slept for 1 day), HEADACHE (Headache), CHILLS (SEVERE chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.3 (High) 103.3.         Very limited information regarding these events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-072199 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypersomnia, Muscle spasms, Oropharyngeal pain, Productive cough
Clinical narrative: Loss of hearing in the left ear; Sore throat; Ears clogged; SEVERE muscle spasms; All of my muscles in my arms, legs, and cheeks were trembling constantly; One hard, tiny, tiny mucous ball from each cough; Tremendous sweats; I slept for 1 day; Headache; SEVERE chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Loss of hearing in the left ear) in a 73-year-old patient of an unknown gender 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 Asthma and Hypoglycemia.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (Loss of hearing in the left ear) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat), EAR DISCOMFORT (Ears clogged), MUSCLE SPASMS (SEVERE muscle spasms), TREMOR (All of my muscles in my arms, legs, and cheeks were trembling constantly), PRODUCTIVE COUGH (One hard, tiny, tiny mucous ball from each cough), HYPERHIDROSIS (Tremendous sweats), HYPERSOMNIA (I slept for 1 day), HEADACHE (Headache), CHILLS (SEVERE chills) and PYREXIA (Fever). At the time of the report, DEAFNESS UNILATERAL (Loss of hearing in the left ear), OROPHARYNGEAL PAIN (Sore throat), EAR DISCOMFORT (Ears clogged), MUSCLE SPASMS (SEVERE muscle spasms), TREMOR (All of my muscles in my arms, legs, and cheeks were trembling constantly), PRODUCTIVE COUGH (One hard, tiny, tiny mucous ball from each cough), HYPERHIDROSIS (Tremendous sweats), HYPERSOMNIA (I slept for 1 day), HEADACHE (Headache), CHILLS (SEVERE chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.3 (High) 103.3.         Very limited information regarding these events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-072199 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Loss of hearing in the left ear; Sore throat; Ears clogged; SEVERE muscle spasms; All of my muscles in my arms, legs, and cheeks were trembling constantly; One hard, tiny, tiny mucous ball from each cough; Tremendous sweats; I slept for 1 day; Headache; SEVERE chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Loss of hearing in the left ear) in a 73-year-old patient of an unknown gender 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 Asthma and Hypoglycemia.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (Loss of hearing in the left ear) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat), EAR DISCOMFORT (Ears clogged), MUSCLE SPASMS (SEVERE muscle spasms), TREMOR (All of my muscles in my arms, legs, and cheeks were trembling constantly), PRODUCTIVE COUGH (One hard, tiny, tiny mucous ball from each cough), HYPERHIDROSIS (Tremendous sweats), HYPERSOMNIA (I slept for 1 day), HEADACHE (Headache), CHILLS (SEVERE chills) and PYREXIA (Fever). At the time of the report, DEAFNESS UNILATERAL (Loss of hearing in the left ear), OROPHARYNGEAL PAIN (Sore throat), EAR DISCOMFORT (Ears clogged), MUSCLE SPASMS (SEVERE muscle spasms), TREMOR (All of my muscles in my arms, legs, and cheeks were trembling constantly), PRODUCTIVE COUGH (One hard, tiny, tiny mucous ball from each cough), HYPERHIDROSIS (Tremendous sweats), HYPERSOMNIA (I slept for 1 day), HEADACHE (Headache), CHILLS (SEVERE chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.3 (High) 103.3.         Very limited information regarding these events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-072199 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hallucination, Rash, Vomiting
Clinical narrative: Violent hallucination; Diarrhea; Rash; vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HALLUCINATION (Violent hallucination) 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 reported medical history). Concomitant products included ALPHA-1-ANTITRYPSIN (ZEMAIRA) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravascular) 1 dosage form. On 23-Mar-2021, the patient experienced HALLUCINATION (Violent hallucination) (seriousness criterion medically significant). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), RASH (Rash) and VOMITING (vomiting). On 28-Mar-2021, HALLUCINATION (Violent hallucination) had resolved. At the time of the report, DIARRHOEA (Diarrhea), RASH (Rash) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravascular) was unknown.       Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. Rash and vomiting are consistent with the product known safety profile.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. Rash and vomiting are consistent with the product known safety profile.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pharyngeal swelling
Clinical narrative: extreme weakness; fatigue; Throat swelling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Apr-2021 and was forwarded to Moderna on 10-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (extreme weakness) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ATORVASTATIN and MULTIVITAMIN [ASCORBIC ACID;BIOTIN;FOLIC ACID;NICOTINIC ACID;PANTOTHENIC ACID;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHEROL;VITAMIN B12 NOS;VITAMIN D NOS;VITAMIN K NOS] for an unknown indication.    On 25-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ASTHENIA (extreme weakness) (seriousness criterion hospitalization) and FATIGUE (fatigue) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Throat swelling). At the time of the report, ASTHENIA (extreme weakness), PHARYNGEAL SWELLING (Throat swelling) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received his vaccination at 12pm 25Mar2021 and reported no symptoms until 27Mar2021 when he reports "feeling weak. I couldn't hold myself up." This symptom continued until this past Tuesday 6Apr2021 patient presented to the hospital where he was admitted for a day and a half. Patient reported no treatments information. He reports currently experiencing symptoms of swelling around his throat and fatigue similar to his last hospitalization. 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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015N2OA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL, TRIMEBUTINE (BUMETIN [TRIMEBUTINE]), EZETIMIBE (EZETIMIB ALKEM), FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), LOSARTAN, ATORVASTATIN CALCIUM (LIPITOR), MONTELUKAST, ALBUTEROL [SALBUTAMOL], AZELASTIN [AZELASTINE] and GLYCERYL TRINITRATE (NITROLINGUAL) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included 7 days of oral antibiotic treatment as outpatient.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Myocardial infarction
Clinical narrative: Heart attack; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion hospitalization). The patient was hospitalized on 30-Mar-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Heart rate: 209 (High) beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.; Sender's Comments: Based on the current information available and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pyrexia, Vomiting
Clinical narrative: Was out of it for 36 hours; Was throwing up; Had a fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was out of it for 36 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Was out of it for 36 hours) (seriousness criterion medically significant), VOMITING (Was throwing up) and PYREXIA (Had a fever). At the time of the report, LOSS OF CONSCIOUSNESS (Was out of it for 36 hours), VOMITING (Was throwing up) and PYREXIA (Had a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; 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
Symptoms: Dysphagia, Epstein-Barr virus infection reactivation, Eye discharge, Fatigue, Glossodynia
Clinical narrative: Reactivation Of Epstein Barr Virus; Trouble swallowing; Tongue Painful; Eyes running; Eyes yellow matter; Extremely Fatigue; Low grade Fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EPSTEIN-BARR VIRUS INFECTION REACTIVATION (Reactivation Of Epstein Barr Virus) in a 44-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 Infectious mononucleosis (has history of Infectious Mononucleosis 2 times).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EPSTEIN-BARR VIRUS INFECTION REACTIVATION (Reactivation Of Epstein Barr Virus) (seriousness criterion medically significant), DYSPHAGIA (Trouble swallowing), GLOSSODYNIA (Tongue Painful), LACRIMATION INCREASED (Eyes running), EYE DISCHARGE (Eyes yellow matter), FATIGUE (Extremely Fatigue) and PYREXIA (Low grade Fever). At the time of the report, EPSTEIN-BARR VIRUS INFECTION REACTIVATION (Reactivation Of Epstein Barr Virus), DYSPHAGIA (Trouble swallowing), GLOSSODYNIA (Tongue Painful), LACRIMATION INCREASED (Eyes running), EYE DISCHARGE (Eyes yellow matter), FATIGUE (Extremely Fatigue) and PYREXIA (Low grade Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Streptococcus test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included antibiotics and eye drops.  EBV can be reactivated as a result of with weakened immune systems manifesting in patients developing symptoms.  Hence, based on the information provided and the onsets of the reported events, a causal association cannot be excluded. Fatigue and fever are consistent with the known safety profile of mRNA-1273; Sender's Comments: EBV can be reactivated as a result of with weakened immune systems manifesting in patients developing symptoms.  Hence, based on the information provided and the onsets of the reported events, a causal association cannot be excluded. Fatigue and fever are consistent with the known safety profile of mRNA-1273
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Pyrexia, SARS-CoV-2 test, Streptococcus test
Clinical narrative: Reactivation Of Epstein Barr Virus; Trouble swallowing; Tongue Painful; Eyes running; Eyes yellow matter; Extremely Fatigue; Low grade Fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EPSTEIN-BARR VIRUS INFECTION REACTIVATION (Reactivation Of Epstein Barr Virus) in a 44-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 Infectious mononucleosis (has history of Infectious Mononucleosis 2 times).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EPSTEIN-BARR VIRUS INFECTION REACTIVATION (Reactivation Of Epstein Barr Virus) (seriousness criterion medically significant), DYSPHAGIA (Trouble swallowing), GLOSSODYNIA (Tongue Painful), LACRIMATION INCREASED (Eyes running), EYE DISCHARGE (Eyes yellow matter), FATIGUE (Extremely Fatigue) and PYREXIA (Low grade Fever). At the time of the report, EPSTEIN-BARR VIRUS INFECTION REACTIVATION (Reactivation Of Epstein Barr Virus), DYSPHAGIA (Trouble swallowing), GLOSSODYNIA (Tongue Painful), LACRIMATION INCREASED (Eyes running), EYE DISCHARGE (Eyes yellow matter), FATIGUE (Extremely Fatigue) and PYREXIA (Low grade Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Streptococcus test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included antibiotics and eye drops.  EBV can be reactivated as a result of with weakened immune systems manifesting in patients developing symptoms.  Hence, based on the information provided and the onsets of the reported events, a causal association cannot be excluded. Fatigue and fever are consistent with the known safety profile of mRNA-1273; Sender's Comments: EBV can be reactivated as a result of with weakened immune systems manifesting in patients developing symptoms.  Hence, based on the information provided and the onsets of the reported events, a causal association cannot be excluded. Fatigue and fever are consistent with the known safety profile of mRNA-1273
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Heart rate increased, Hypotension
Clinical narrative: Fever at 103; Heart rate at 140; Blood pressure at 81/41; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever at 103), HEART RATE INCREASED (Heart rate at 140) and HYPOTENSION (Blood pressure at 81/41) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (Fever at 103) (seriousness criterion hospitalization), HEART RATE INCREASED (Heart rate at 140) (seriousness criterion hospitalization) and HYPOTENSION (Blood pressure at 81/41) (seriousness criterion hospitalization). At the time of the report, PYREXIA (Fever at 103), HEART RATE INCREASED (Heart rate at 140) and HYPOTENSION (Blood pressure at 81/41) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Blood pressure measurement: 81/41 (Low) 81/41. On 10-Apr-2021, Body temperature: 103 (High) 103. On 10-Apr-2021, Heart rate: 140 (High) 140.     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 product use was not provided by the reporter. The patient was currently in the ICU receiving 2 vasopressor Norepinephrine and Neosynephrine.  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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever at 103; Heart rate at 140; Blood pressure at 81/41; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever at 103), HEART RATE INCREASED (Heart rate at 140) and HYPOTENSION (Blood pressure at 81/41) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (Fever at 103) (seriousness criterion hospitalization), HEART RATE INCREASED (Heart rate at 140) (seriousness criterion hospitalization) and HYPOTENSION (Blood pressure at 81/41) (seriousness criterion hospitalization). At the time of the report, PYREXIA (Fever at 103), HEART RATE INCREASED (Heart rate at 140) and HYPOTENSION (Blood pressure at 81/41) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Blood pressure measurement: 81/41 (Low) 81/41. On 10-Apr-2021, Body temperature: 103 (High) 103. On 10-Apr-2021, Heart rate: 140 (High) 140.     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 product use was not provided by the reporter. The patient was currently in the ICU receiving 2 vasopressor Norepinephrine and Neosynephrine.  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: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Pyrexia, Seizure
Clinical narrative: Passed out; Seizure; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and SEIZURE (Seizure) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) 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).  No concomitant medication were reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form Lot # 040A21A..  On 10-Mar-2021, the patient experienced had a fever, passed out and had a seizure  On 07 Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form Lot # 045A21A. After 12 hours he passed out and had a seizure.  The patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), SEIZURE (Seizure) (seriousness criterion medically significant) and PYREXIA (Fever).   The outcome of passed out, seizure and fever is resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) is not applicable as both vaccines had been administered.   Description: On 10 Mar 2021, the patient had a fever, passed out (medically significant) and had a seizure (medically significant).  No treatment information was provided.   This case was linked to (E2B Linked Report).; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. Fever is consistent with the known safety profile of mRNA-1273. MOD-2021-072699:2nd dose case
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Vision blurred
Clinical narrative: unconscious 3 times only for a second, kind of freak out, this is like immediately everything close and her vision turned black; like vision going blurring, blurred vision with spots, very vague even when lying down, had this 25-30 times and 5 time so far; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (unconscious 3 times only for a second, kind of freak out, this is like immediately everything close and her vision turned black) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) 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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (unconscious 3 times only for a second, kind of freak out, this is like immediately everything close and her vision turned black) (seriousness criterion medically significant) and VISION BLURRED (like vision going blurring, blurred vision with spots, very vague even when lying down, had this 25-30 times and 5 time so far). At the time of the report, LOSS OF CONSCIOUSNESS (unconscious 3 times only for a second, kind of freak out, this is like immediately everything close and her vision turned black) and VISION BLURRED (like vision going blurring, blurred vision with spots, very vague even when lying down, had this 25-30 times and 5 time so far) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.  Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Vasodilatation
Clinical narrative: Thrombosis on left arm and chest; "you can see all of the veins"; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Thrombosis on left arm and chest) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neuralgia.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced THROMBOSIS (Thrombosis on left arm and chest) (seriousness criterion medically significant) and VASODILATATION ("you can see all of the veins"). At the time of the report, THROMBOSIS (Thrombosis on left arm and chest) and VASODILATATION ("you can see all of the veins") had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product include an unspecified neuralgia medication.  No treatment information was reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest X-ray, Electrocardiogram
Clinical narrative: A fib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (A fib) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 029A21A) for COVID-19 vaccination.     The patient's past medical history included AFib (Takes Flecainide for Heart Rate control) since an unknown date and Cardioversion in 2019. Concomitant products included FLECAINIDE for AFib, LOSARTAN, ATORVASTATIN, FUROSEMIDE (LASIX [FUROSEMIDE]) and POTASSIUM for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced ATRIAL FIBRILLATION (A fib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (A fib) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: unknown (Inconclusive) Results not provided. On an unknown date, Electrocardiogram: unknown (Inconclusive) Results not provided.         Patient was taken to ER (Emergency Room) where an EKG and a chest X-RAY were done. The results of the EKG and chest X-ray were not provided. Patient reported that she takes Flecainide for Heart Rate control.  No other treatment information was provided.  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.   This case was linked to MOD21-072680 (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 this event, a causal relationship cannot be excluded. MOD21-072680:MOD-2021-072836 1st dose case
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Magnetic resonance imaging
Clinical narrative: Brain stroke; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Brain stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE, SIMVASTATIN, LISINOPRIL, OMEPRAZOLE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Brain stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Brain stroke) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) medial occipital and temporal lobes affected..     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.
Sex: F
Vaccine: COVID19
Symptoms: Bronchospasm, Illness, Pneumonia
Clinical narrative: pneumonia; bronchospasm; Sick; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21) 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ILLNESS (Sick). On 25-Mar-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and BRONCHOSPASM (bronchospasm). At the time of the report, PNEUMONIA (pneumonia), BRONCHOSPASM (bronchospasm) and ILLNESS (Sick) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.  Although a temporal association exist, based on the known etiology of pneumonia being of an infective etiology, a  causal relationship between the event and the administration of mRNA-1273 is unlikely.  However, the relationship between the other events and mRNA-1273 cannot be excluded.; Sender's Comments: Although a temporal association exist, based on the known etiology of pneumonia being of an infective etiology, a  causal relationship between the event and the administration of mRNA-1273 is unlikely.  However, the relationship between the other events and mRNA-1273 cannot be excluded
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vasculitis
Clinical narrative: Vasculitis; Urticaria both hands; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VASCULITIS (Vasculitis) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VASCULITIS (Vasculitis) (seriousness criterion hospitalization) and URTICARIA (Urticaria both hands). The patient was hospitalized on 05-Apr-2021 due to VASCULITIS. At the time of the report, VASCULITIS (Vasculitis) and URTICARIA (Urticaria both hands) 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.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate decreased, Lung disorder, SARS-CoV-2 test
Clinical narrative: Lungs are not processing oxygen; Shortness of breath; Pulse dropping; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LUNG DISORDER (Lungs are not processing oxygen), DYSPNOEA (Shortness of breath) and HEART RATE DECREASED (Pulse dropping) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Smoker.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LUNG DISORDER (Lungs are not processing oxygen) (seriousness criterion hospitalization), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization) and HEART RATE DECREASED (Pulse dropping) (seriousness criterion hospitalization). At the time of the report, LUNG DISORDER (Lungs are not processing oxygen), DYSPNOEA (Shortness of breath) and HEART RATE DECREASED (Pulse dropping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: negative (Negative) negative.         No concomitant medications were reported. Treatment of these events included hospitalization with helium therapy, oxygen therapy and steroid therapy.  Action taken with mRNA-1273 was not applicable.   Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: fluttering sensation in the chest which was on and off/symptom came again and it was little more intense; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (fluttering sensation in the chest which was on and off/symptom came again and it was little more intense) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No medical history reported).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC FLUTTER (fluttering sensation in the chest which was on and off/symptom came again and it was little more intense) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (fluttering sensation in the chest which was on and off/symptom came again and it was little more intense) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Description: The patient started experiencing fluttering sensation in the chest (medically significant) which was on and off and it was persisting for more than two weeks. The patient reported that last night the symptom came again and it was little more intense.  The treatment information included antacid medications thinking it could be acid reflux issue.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Seizure
Clinical narrative: Was driving and had a seizure; Banged her head; This spontaneous case was reported by an other and describes the occurrence of SEIZURE (Was driving and had a seizure) in a 54-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Was driving and had a seizure) (seriousness criterion medically significant) and HEAD INJURY (Banged her head). At the time of the report, SEIZURE (Was driving and had a seizure) and HEAD INJURY (Banged her head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy, Arthralgia, Back pain, Seizure
Clinical narrative: Grand seizure; Circulation of left side was dead; upper back and shoulders and arm aches; upper back and shoulders and arm aches; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Grand seizure) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epileptic seizure. Concomitant products included TIAGABINE HYDROCHLORIDE (GABITRIL) for Epileptic seizure.   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 25-Mar-2021, the patient experienced SEIZURE (Grand seizure) (seriousness criterion medically significant), ANGIOPATHY (Circulation of left side was dead), PAIN (strong body pain), BACK PAIN (upper back and shoulders and arm aches), PAIN IN EXTREMITY (upper back and shoulders and arm aches) and ARTHRALGIA (upper back and shoulders and arm aches). At the time of the report, SEIZURE (Grand seizure), ANGIOPATHY (Circulation of left side was dead), PAIN (strong body pain), BACK PAIN (upper back and shoulders and arm aches), PAIN IN EXTREMITY (upper back and shoulders and arm aches) and ARTHRALGIA (upper back and shoulders and arm aches) outcome was unknown.            Other concomitant medication included: cardatril.  Description: The patient experienced on 25 Mar2021, around 15 hours after vaccination grand seizure (medically significant), circulation of left side was dead. The patient also experienced on 25 Mar 2021, strong body pain, upper back and shoulders and arm aches.  Treatment information included  lorazepam  at home.  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.   This case was linked to MOD-2021-073130 (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. Patient has a Hx of seizure
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Headache, Hyposmia, Loss of consciousness
Clinical narrative: Partially lost smell; Partially lost taste; Headache; Short time "everything come black"/ short time "black down"; Sore arm; Night time sweat; Short time "lost control of muscle of neck"; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Short time "everything come black"/ short time "black down") in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) 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 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Short time "everything come black"/ short time "black down") (seriousness criterion medically significant), PAIN IN EXTREMITY (Sore arm), NIGHT SWEATS (Night time sweat), MUSCLE DISCOMFORT (Short time "lost control of muscle of neck"), DIZZINESS (Dizziness) and HEADACHE (Headache). On 11-Apr-2021, the patient experienced HYPOSMIA (Partially lost smell) and DYSGEUSIA (Partially lost taste). On 10-Apr-2021, LOSS OF CONSCIOUSNESS (Short time "everything come black"/ short time "black down") had resolved. On 11-Apr-2021, NIGHT SWEATS (Night time sweat), MUSCLE DISCOMFORT (Short time "lost control of muscle of neck"), DIZZINESS (Dizziness) and HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), HYPOSMIA (Partially lost smell) and DYSGEUSIA (Partially lost taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications use 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 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.