chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Hypotension, Pain in extremity, Thrombosis
Clinical narrative: blood clots; his arm felt sore, almost like he had just received the vaccine; doctor thinks it has something to do with the heart; low blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots) in a 64-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 reported medical history).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced THROMBOSIS (blood clots) (seriousness criterion hospitalization), PAIN IN EXTREMITY (his arm felt sore, almost like he had just received the vaccine), CARDIAC DISORDER (doctor thinks it has something to do with the heart) and HYPOTENSION (low blood pressure). The patient was hospitalized on 08-Apr-2021 due to THROMBOSIS. At the time of the report, THROMBOSIS (blood clots), PAIN IN EXTREMITY (his arm felt sore, almost like he had just received the vaccine) and CARDIAC DISORDER (doctor thinks it has something to do with the heart) had not resolved and HYPOTENSION (low blood pressure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. On 08 Apr 2021, the patient's arm felt sore, "almost like he had just received the vaccine".  He went to urgent care, and they sent him to the hospital and he was admitted.  The patient said his doctor thinks the blood clots had something to do with the heart.  The patient thought it had to do with the vaccine because he has "always been healthy" and never had any heart problems.  The patient was still in the hospital at the time of this report. Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Doctor thinks "thrombosis" has something to do with the heart
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Chills, Cyanosis, Diarrhoea, Hypothermia
Clinical narrative: Temperature of 95F, hypothermia; Diarrhea; left eye was twitching; Finger in the left and right hand where blue; Vomiting; Chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (Temperature of 95F, hypothermia) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Relevant medical history was not reported).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LIMB DISCOMFORT (sore arm). On 10-Apr-2021, the patient experienced CHILLS (Chills). On 11-Apr-2021, the patient experienced HYPOTHERMIA (Temperature of 95F, hypothermia) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), BLEPHAROSPASM (left eye was twitching), CYANOSIS (Finger in the left and right hand where blue) and VOMITING (Vomiting). At the time of the report, HYPOTHERMIA (Temperature of 95F, hypothermia), DIARRHOEA (Diarrhea), BLEPHAROSPASM (left eye was twitching), CYANOSIS (Finger in the left and right hand where blue), LIMB DISCOMFORT (sore arm), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.   Treatment for the events included acetaminophen and naproxen.   It was noted that the patient's HCP was aware of her symptoms.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vomiting
Clinical narrative: Temperature of 95F, hypothermia; Diarrhea; left eye was twitching; Finger in the left and right hand where blue; Vomiting; Chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (Temperature of 95F, hypothermia) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Relevant medical history was not reported).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LIMB DISCOMFORT (sore arm). On 10-Apr-2021, the patient experienced CHILLS (Chills). On 11-Apr-2021, the patient experienced HYPOTHERMIA (Temperature of 95F, hypothermia) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), BLEPHAROSPASM (left eye was twitching), CYANOSIS (Finger in the left and right hand where blue) and VOMITING (Vomiting). At the time of the report, HYPOTHERMIA (Temperature of 95F, hypothermia), DIARRHOEA (Diarrhea), BLEPHAROSPASM (left eye was twitching), CYANOSIS (Finger in the left and right hand where blue), LIMB DISCOMFORT (sore arm), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.   Treatment for the events included acetaminophen and naproxen.   It was noted that the patient's HCP was aware of her symptoms.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) outcome was unknown. Not Provided      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 concomitant medications were reported. Treatment information 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 this event, a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Headache, Hypertension, Oedema peripheral, Ultrasound Doppler abnormal
Clinical narrative: extremly high blood pressure; severe headache; DVT to right leg starting at the groin and going down to the foot; worsen edema with 4+and 5+ pitting edema in right leg; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (DVT to right leg starting at the groin and going down to the foot) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included DUPILUMAB (DUPIXENT) from 09-Mar-2021 to 06-Apr-2021 and DULOXETINE HYDROCHLORIDE (CYMBALTA) 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 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT to right leg starting at the groin and going down to the foot) (seriousness criterion medically significant) and OEDEMA PERIPHERAL (worsen edema with 4+and 5+ pitting edema in right leg). On an unknown date, the patient experienced HYPERTENSION (extremly high blood pressure) and HEADACHE (severe headache). At the time of the report, DEEP VEIN THROMBOSIS (DVT to right leg starting at the groin and going down to the foot), OEDEMA PERIPHERAL (worsen edema with 4+and 5+ pitting edema in right leg), HYPERTENSION (extremly high blood pressure) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Ultrasound Doppler abnormal: abnormal (abnormal) Causative extensive occlusive thrombus", DVT in the right leg starting from the groin going down to the foot.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had an ultrasound of the leg performed. The diagnosis showed "causative extensive occlusive thrombus". Patient reported taking heparin and acetaminophen(Tylenol) ad treatment for the symptoms.   This case was linked to (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD-2021-079102:1st dose
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Breast mass
Clinical narrative: two large lumps in his right breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (two large lumps in his right breast) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced BREAST MASS (two large lumps in his right breast) (seriousness criterion medically significant). At the time of the report, BREAST MASS (two large lumps in his right breast) outcome was unknown.            he noticed "two large lumps in his right breast" and he is "getting surgically removed" No concomitant medications were provided. Treatment medications was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Migraine
Clinical narrative: Stroke; Complex migraine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and MIGRAINE (Complex migraine) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A.) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant) and MIGRAINE (Complex migraine) (seriousness criterion medically significant). The patient was hospitalized on sometime in 2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and MIGRAINE (Complex migraine) outcome was unknown.            Company comment:Very limited information regarding these events has been provided at this time.  Further information has been requested.  Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Strong arm pains 48 hours after the shot , in the opposite arm of the COVID-19 vaccine (in that arm had a shingles vaccination a month before); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Strong arm pains 48 hours after the shot , in the opposite arm of the COVID-19 vaccine (in that arm had a shingles vaccination a month before)) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     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 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Strong arm pains 48 hours after the shot , in the opposite arm of the COVID-19 vaccine (in that arm had a shingles vaccination a month before)) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Strong arm pains 48 hours after the shot , in the opposite arm of the COVID-19 vaccine (in that arm had a shingles vaccination a month before)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication administered included shingles injection. Treatment information included paracetamol (Tylenol).  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.; 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Dysarthria, Dyskinesia, Transient ischaemic attack
Clinical narrative: had another stroke; blood clots in brain; Difficult to control right hand; difficult to speak; had a stroke and went to the hospital; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (had another stroke), CEREBRAL THROMBOSIS (blood clots in brain), TRANSIENT ISCHAEMIC ATTACK (had a stroke and went to the hospital), DYSKINESIA (Difficult to control right hand) and DYSARTHRIA (difficult to speak) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 039A20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 12-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 21-Feb-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (had a stroke and went to the hospital) (seriousness criterion medically significant).  On 23-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (had another stroke) (seriousness criteria hospitalization and medically significant), CEREBRAL THROMBOSIS (blood clots in brain) (seriousness criterion hospitalization), DYSKINESIA (Difficult to control right hand) (seriousness criterion hospitalization) and DYSARTHRIA (difficult to speak) (seriousness criterion hospitalization).   The patient was hospitalized from 23-Feb-2021 to 26-Feb-2021 due to CEREBRAL THROMBOSIS, CEREBROVASCULAR ACCIDENT, DYSARTHRIA and DYSKINESIA.   At the time of the report, CEREBROVASCULAR ACCIDENT (had another stroke), CEREBRAL THROMBOSIS (blood clots in brain), TRANSIENT ISCHAEMIC ATTACK (had a stroke and went to the hospital), DYSKINESIA (Difficult to control right hand) and DYSARTHRIA (difficult to speak) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was not reported.   Treatment for the events included Plavix.; Sender's Comments: Although a temporal association exist,  critical details such as the patient's medical history, list of concomitant medication are lacking .  Pending additional information, causality with mRNA-1273  administration cannot be confirmed for all events.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Haematochezia, Headache
Clinical narrative: Blood in the stool; Diarrhoea; Stomach cramping; Head ache; Little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in the stool) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported adverse event.). Concomitant products included METOPROLOL and LOSARTAN for Blood pressure.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Little dizzy). On 16-Apr-2021, the patient experienced HAEMATOCHEZIA (Blood in the stool) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (Stomach cramping) and HEADACHE (Head ache). At the time of the report, HAEMATOCHEZIA (Blood in the stool), DIZZINESS (Little dizzy), DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (Stomach cramping) and HEADACHE (Head ache) outcome was unknown.            Patient stated that he has discharged blood 3 or 4 times more but said it is just a splatter on top of the water and on the paper when clean itself. The patient has no history of gastrointestinal issues or bleeding. Patient had taken 2 Aleve.  This case concerns a 56-year-old male with a serious unexpected event of hematochezia, and nonserious unexpected abdominal pain upper, dizziness, diarrhea, and expected headache. Event onset 2 days after second dose mRNA-1273. Event outcomes unknown. 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 56-year-old male with a serious unexpected event of hematochezia, and nonserious unexpected abdominal pain upper, dizziness, diarrhea, and expected headache. Event onset 2 days after second dose mRNA-1273. Event outcomes unknown. 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: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Facial paralysis, Vaccination site pain
Clinical narrative: left side of face drooped; Chills; Mild Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (left side of face drooped) in a 71-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 reported medical history).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Mild Sore left arm). On 03-Apr-2021, the patient experienced FACIAL PARALYSIS (left side of face drooped) (seriousness criterion medically significant) and CHILLS (Chills). On 04-Apr-2021, CHILLS (Chills) had resolved. At the time of the report, FACIAL PARALYSIS (left side of face drooped) and PAIN IN EXTREMITY (Mild Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   This case was linked to US-MODERNATX, INC.-MOD-2021-079339 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-079339:Case for dose 2
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Chills
Clinical narrative: left side of face drooped; Chills; Mild Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (left side of face drooped) in a 71-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 reported medical history).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Mild Sore left arm). On 03-Apr-2021, the patient experienced FACIAL PARALYSIS (left side of face drooped) (seriousness criterion medically significant) and CHILLS (Chills). On 04-Apr-2021, CHILLS (Chills) had resolved. At the time of the report, FACIAL PARALYSIS (left side of face drooped) and PAIN IN EXTREMITY (Mild Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   This case was linked to US-MODERNATX, INC.-MOD-2021-079339 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-079339:Case for dose 2
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Facial paralysis, Vaccination site pain
Clinical narrative: Felt left side of face drooped, unable to close left eye, and could not control left side of face; patient woke up with 5-seconds chills and went away quickly, happened 3 times during the day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Felt left side of face drooped, unable to close left eye, and could not control left side of face) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bladder disorder. Concomitant products included OXYBUTYNIN HYDROCHLORIDE (OXYBUTININ ACCORD) for Bladder disorder NOS.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced FACIAL PARALYSIS (Felt left side of face drooped, unable to close left eye, and could not control left side of face) (seriousness criterion medically significant) and CHILLS (patient woke up with 5-seconds chills and went away quickly, happened 3 times during the day). On 04-Apr-2021, CHILLS (patient woke up with 5-seconds chills and went away quickly, happened 3 times during the day) had resolved. At the time of the report, FACIAL PARALYSIS (Felt left side of face drooped, unable to close left eye, and could not control left side of face) outcome was unknown.            Treatment Medications included prednisone 20mg 3 times daily for 4 days, valacyclovir 1 gm tablet 3 times daily for 7 days and artificial tears drops with directions instill 1 to 2 drops every 4 hours to left eye. On 04Apr2021, Emergency room and primary care doctors confirmed that it is Bell's Palsy. As up 16Apr2021, the neurologist assessed and confirmed of Bell's Palsy (severe facial paralysis).  Based on current available information and the temporal relationship between product use and the start date of the events a causal relationship cannot be excluded.  Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to MODERNATX, INC.-MOD-2021-079332 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal relationship between product use and the start date of the events a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-079332:Case for dose 1
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Chills
Clinical narrative: Felt left side of face drooped, unable to close left eye, and could not control left side of face; patient woke up with 5-seconds chills and went away quickly, happened 3 times during the day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Felt left side of face drooped, unable to close left eye, and could not control left side of face) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bladder disorder. Concomitant products included OXYBUTYNIN HYDROCHLORIDE (OXYBUTININ ACCORD) for Bladder disorder NOS.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced FACIAL PARALYSIS (Felt left side of face drooped, unable to close left eye, and could not control left side of face) (seriousness criterion medically significant) and CHILLS (patient woke up with 5-seconds chills and went away quickly, happened 3 times during the day). On 04-Apr-2021, CHILLS (patient woke up with 5-seconds chills and went away quickly, happened 3 times during the day) had resolved. At the time of the report, FACIAL PARALYSIS (Felt left side of face drooped, unable to close left eye, and could not control left side of face) outcome was unknown.            Treatment Medications included prednisone 20mg 3 times daily for 4 days, valacyclovir 1 gm tablet 3 times daily for 7 days and artificial tears drops with directions instill 1 to 2 drops every 4 hours to left eye. On 04Apr2021, Emergency room and primary care doctors confirmed that it is Bell's Palsy. As up 16Apr2021, the neurologist assessed and confirmed of Bell's Palsy (severe facial paralysis).  Based on current available information and the temporal relationship between product use and the start date of the events a causal relationship cannot be excluded.  Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to MODERNATX, INC.-MOD-2021-079332 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal relationship between product use and the start date of the events a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-079332:Case for dose 1
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphagia, Lethargy, Movement disorder, Pyrexia
Clinical narrative: couldn't move; throat closed; couldn't swallow; lethargic; chills; fever; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of MOVEMENT DISORDER (couldn't move), THROAT TIGHTNESS (throat closed) and DYSPHAGIA (couldn't swallow) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Caller stated that she had COVID19 last April and she was hospitalized two times because she needed oxygen.) in April 2020 and Cancer (She is recovering from cancer, so she was reluctant to go to the hospital or call her doctor for her side effects.) since an unknown date.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MOVEMENT DISORDER (couldn't move) (seriousness criterion hospitalization), THROAT TIGHTNESS (throat closed) (seriousness criterion hospitalization) and DYSPHAGIA (couldn't swallow) (seriousness criterion hospitalization). On an unknown date, the patient experienced LETHARGY (lethargic), CHILLS (chills) and PYREXIA (fever). The patient was hospitalized on 01-Apr-2021 due to MOVEMENT DISORDER, then for 4 days due to DYSPHAGIA and THROAT TIGHTNESS. At the time of the report, MOVEMENT DISORDER (couldn't move), THROAT TIGHTNESS (throat closed), DYSPHAGIA (couldn't swallow), LETHARGY (lethargic), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. 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 the events, a causal relationship cannot be excluded. Additional 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. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: couldn't move; throat closed; couldn't swallow; lethargic; chills; fever; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of MOVEMENT DISORDER (couldn't move), THROAT TIGHTNESS (throat closed) and DYSPHAGIA (couldn't swallow) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Caller stated that she had COVID19 last April and she was hospitalized two times because she needed oxygen.) in April 2020 and Cancer (She is recovering from cancer, so she was reluctant to go to the hospital or call her doctor for her side effects.) since an unknown date.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MOVEMENT DISORDER (couldn't move) (seriousness criterion hospitalization), THROAT TIGHTNESS (throat closed) (seriousness criterion hospitalization) and DYSPHAGIA (couldn't swallow) (seriousness criterion hospitalization). On an unknown date, the patient experienced LETHARGY (lethargic), CHILLS (chills) and PYREXIA (fever). The patient was hospitalized on 01-Apr-2021 due to MOVEMENT DISORDER, then for 4 days due to DYSPHAGIA and THROAT TIGHTNESS. At the time of the report, MOVEMENT DISORDER (couldn't move), THROAT TIGHTNESS (throat closed), DYSPHAGIA (couldn't swallow), LETHARGY (lethargic), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. 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 the events, a causal relationship cannot be excluded. Additional 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. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood thyroid stimulating hormone, Electrocardiogram, Stress echocardiogram, Thyroid hormones decreased
Clinical narrative: Atrial fibrillation; Thyroid hormone (TSH) goes down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant) and THYROID HORMONES DECREASED (Thyroid hormone (TSH) goes down). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) and THYROID HORMONES DECREASED (Thyroid hormone (TSH) goes down) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood thyroid stimulating hormone: low (Low) Low. On 21-Mar-2021, Electrocardiogram: atrial fibrillation (abnormal) Atrial fibrillation. On 21-Mar-2021, Stress echocardiogram: atrial fibrillation (abnormal) Atrial fibrillation.     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 provided. The patient was in emergency room for few hours and was given 3 doses of apixaban (Eliquis) for treatment for the events. The patient was on holter monitor for 3 days.  The patient reported, his thyroid level comes near normal after one and half weeks.  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. He is pilot and kept off the duty for Atrial fibrillation.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Transient global amnesia
Clinical narrative: Transient global amnesia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT GLOBAL AMNESIA (Transient global amnesia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TRANSIENT GLOBAL AMNESIA (Transient global amnesia) (seriousness criteria hospitalization and disability). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to TRANSIENT GLOBAL AMNESIA. At the time of the report, TRANSIENT GLOBAL AMNESIA (Transient global amnesia) was resolving. Not Provided          No concomitant medications were reported. Treatment information was not provided.  The patient was fine after first dose, but after second dose, the patient was hospitalized for 3 days and diagnosed with transient global amnesia. It was reported that patient was feeling better.  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. 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 event, a causal relationship cannot be excluded. Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Gait disturbance
Clinical narrative: Atrial fibrillation for 4 days; condition aggravated; Couldn't stand up straight or walk in a straight line during the atrial fibrillation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation for 4 days) and CONDITION AGGRAVATED (condition aggravated) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) 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 WARFARIN, ATENOLOL and ATORVASTATIN for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation for 4 days) (seriousness criterion medically significant), CONDITION AGGRAVATED (condition aggravated) (seriousness criterion medically significant) and GAIT DISTURBANCE (Couldn't stand up straight or walk in a straight line during the atrial fibrillation). On 16-Apr-2021, GAIT DISTURBANCE (Couldn't stand up straight or walk in a straight line during the atrial fibrillation) outcome was unknown. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation for 4 days) and CONDITION AGGRAVATED (condition aggravated) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was treated with Cartia (diltiazem) as advised by their health care professional to try to alleviate the symptoms.  Action taken with mRNA-1273 in response to events was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked; 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. cross linked case
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Delirium, Loss of consciousness, Myocardial infarction, Pneumonia
Clinical narrative: Double pneumonia; Urinary tract infection; Silent heart attack; Delirious; Passed out; Very weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DELIRIUM (Delirious), LOSS OF CONSCIOUSNESS (Passed out), PNEUMONIA (Double pneumonia), URINARY TRACT INFECTION (Urinary tract infection) and MYOCARDIAL INFARCTION (Silent heart attack) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history was reported).    On 26-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 DELIRIUM (Delirious) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion hospitalization), PNEUMONIA (Double pneumonia) (seriousness criterion hospitalization), URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion hospitalization), MYOCARDIAL INFARCTION (Silent heart attack) (seriousness criterion hospitalization) and ASTHENIA (Very weak). At the time of the report, DELIRIUM (Delirious), PNEUMONIA (Double pneumonia), URINARY TRACT INFECTION (Urinary tract infection), MYOCARDIAL INFARCTION (Silent heart attack) and ASTHENIA (Very weak) outcome was unknown and LOSS OF CONSCIOUSNESS (Passed out) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and medical history were not reported. The treatment received in response to the events was unknown.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Double pneumonia; Urinary tract infection; Silent heart attack; Delirious; Passed out; Very weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DELIRIUM (Delirious), LOSS OF CONSCIOUSNESS (Passed out), PNEUMONIA (Double pneumonia), URINARY TRACT INFECTION (Urinary tract infection) and MYOCARDIAL INFARCTION (Silent heart attack) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history was reported).    On 26-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 DELIRIUM (Delirious) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion hospitalization), PNEUMONIA (Double pneumonia) (seriousness criterion hospitalization), URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion hospitalization), MYOCARDIAL INFARCTION (Silent heart attack) (seriousness criterion hospitalization) and ASTHENIA (Very weak). At the time of the report, DELIRIUM (Delirious), PNEUMONIA (Double pneumonia), URINARY TRACT INFECTION (Urinary tract infection), MYOCARDIAL INFARCTION (Silent heart attack) and ASTHENIA (Very weak) outcome was unknown and LOSS OF CONSCIOUSNESS (Passed out) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and medical history were not reported. The treatment received in response to the events was unknown.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Inappropriate schedule of product administration, Oral mucosal blistering, Pain, Rash
Clinical narrative: blisters form after she eats and when they pop they bleed for a while; blood blisters in mouth worse; blisters pop and it hurts; rash gotten worse; 45 days between the administration of the 1st dose and 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while) in an 87-year-old female patient who received mRNA-1273 (batch nos. 032M20A and 030L20A) 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 previous medical history was provided).   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (45 days between the administration of the 1st dose and 2nd dose). On an unknown date, the patient experienced HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while) (seriousness criterion medically significant), ORAL MUCOSAL BLISTERING (blood blisters in mouth worse), PAIN (blisters pop and it hurts) and RASH (rash gotten worse). At the time of the report, HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while), PAIN (blisters pop and it hurts) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (45 days between the administration of the 1st dose and 2nd dose) outcome was unknown and ORAL MUCOSAL BLISTERING (blood blisters in mouth worse) and RASH (rash gotten worse) had not resolved.            No concomitant medications were reported. No treatment information was provided.  Company Comment: This case concerns an 87-year-old female who had inappropriate schedule of product administration (Lot # 030L20A), with adverse events of serious unexpected hemorrhage, and nonserious unexpected oral mucosal blistering, pain, and expected rash. Event onset after 1st dose with worsening after 2nd dose mRNA-1273. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-079482 (Patient Link).; Sender's Comments: This case concerns an 87-year-old female who had inappropriate schedule of product administration (Lot # 030L20A), with adverse events of serious unexpected hemorrhage, and nonserious unexpected oral mucosal blistering, pain, and expected rash. Event onset after 1st dose with worsening after 2nd dose mRNA-1273. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.