chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure increased, Blood pressure measurement, Bradycardia, Dizziness
Clinical narrative: Very dizzy; Blood pressure inreased to 190; Felt like she was dying; Heartbeat goes down, and goes up; Heartbeat dropped to 44; Suddenly her blood pressure goes down and up; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    This spontaneous case was reported by a patient and describes the occurrence of BRADYCARDIA (Heartbeat dropped to 44) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for Hypertension, HYDROCHLOROTHIAZIDE for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Suddenly her blood pressure goes down and up). On 21-Mar-2021, the patient experienced BRADYCARDIA (Heartbeat dropped to 44) (seriousness criterion medically significant), DIZZINESS (Very dizzy), BLOOD PRESSURE INCREASED (Blood pressure inreased to 190), FEELING ABNORMAL (Felt like she was dying) and HEART RATE IRREGULAR (Heartbeat goes down, and goes up). The patient was treated with ATENOLOL (ATENOL) ongoing since an unknown date for Heart disorder, at a dose of 50 milligram. At the time of the report, BRADYCARDIA (Heartbeat dropped to 44), BLOOD PRESSURE FLUCTUATION (Suddenly her blood pressure goes down and up), DIZZINESS (Very dizzy), BLOOD PRESSURE INCREASED (Blood pressure inreased to 190), FEELING ABNORMAL (Felt like she was dying) and HEART RATE IRREGULAR (Heartbeat goes down, and goes up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Blood pressure measurement: high (High) Reported as 190. On 21-Feb-2021, Heart rate: low (Low) 44. On 24-Mar-2021, Blood pressure measurement: high (High) 173/92. On 24-Mar-2021, Heart rate: normal (normal) 72.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient  suffers from high blood pressure, takes medicines. Since the first dose of vaccine she felt a abrupt changes in her blood pressure and heartbeat. She doesn't know if this could be a side effect, she even thought she made a mistake and took 2 doses of her medication.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Heart rate irregular
Clinical narrative: Very dizzy; Blood pressure inreased to 190; Felt like she was dying; Heartbeat goes down, and goes up; Heartbeat dropped to 44; Suddenly her blood pressure goes down and up; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    This spontaneous case was reported by a patient and describes the occurrence of BRADYCARDIA (Heartbeat dropped to 44) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for Hypertension, HYDROCHLOROTHIAZIDE for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Suddenly her blood pressure goes down and up). On 21-Mar-2021, the patient experienced BRADYCARDIA (Heartbeat dropped to 44) (seriousness criterion medically significant), DIZZINESS (Very dizzy), BLOOD PRESSURE INCREASED (Blood pressure inreased to 190), FEELING ABNORMAL (Felt like she was dying) and HEART RATE IRREGULAR (Heartbeat goes down, and goes up). The patient was treated with ATENOLOL (ATENOL) ongoing since an unknown date for Heart disorder, at a dose of 50 milligram. At the time of the report, BRADYCARDIA (Heartbeat dropped to 44), BLOOD PRESSURE FLUCTUATION (Suddenly her blood pressure goes down and up), DIZZINESS (Very dizzy), BLOOD PRESSURE INCREASED (Blood pressure inreased to 190), FEELING ABNORMAL (Felt like she was dying) and HEART RATE IRREGULAR (Heartbeat goes down, and goes up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Blood pressure measurement: high (High) Reported as 190. On 21-Feb-2021, Heart rate: low (Low) 44. On 24-Mar-2021, Blood pressure measurement: high (High) 173/92. On 24-Mar-2021, Heart rate: normal (normal) 72.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient  suffers from high blood pressure, takes medicines. Since the first dose of vaccine she felt a abrupt changes in her blood pressure and heartbeat. She doesn't know if this could be a side effect, she even thought she made a mistake and took 2 doses of her medication.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: left side of his face is numb and droopy; left side of his face is numb; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (left side of his face is numb and droopy) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE) for an unknown indication.    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 FACIAL PARALYSIS (left side of his face is numb and droopy) (seriousness criterion medically significant) and HYPOAESTHESIA (left side of his face is numb). At the time of the report, FACIAL PARALYSIS (left side of his face is numb and droopy) and HYPOAESTHESIA (left side of his face is numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of these events were not provided.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac dysfunction, Decreased appetite, Dyspnoea, Heart rate increased, Malaise
Clinical narrative: One side of heart was not pumping right; Nauseous; Patient was not feeling well; Loss of appetite; Increased heart rate; Pale; hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DYSFUNCTION (One side of heart was not pumping right) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. 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-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CARDIAC DYSFUNCTION (One side of heart was not pumping right) (seriousness criterion hospitalization). On an unknown date, the patient experienced NAUSEA (Nauseous), MALAISE (Patient was not feeling well), DECREASED APPETITE (Loss of appetite), HEART RATE INCREASED (Increased heart rate), PALLOR (Pale) and DYSPNOEA (hard time breathing). The patient was hospitalized from 09-Mar-2021 to 19-Mar-2021 due to CARDIAC DYSFUNCTION. At the time of the report, CARDIAC DYSFUNCTION (One side of heart was not pumping right), NAUSEA (Nauseous), MALAISE (Patient was not feeling well), DECREASED APPETITE (Loss of appetite), HEART RATE INCREASED (Increased heart rate), PALLOR (Pale) and DYSPNOEA (hard time breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the events included diuretic medications.  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: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pallor
Clinical narrative: One side of heart was not pumping right; Nauseous; Patient was not feeling well; Loss of appetite; Increased heart rate; Pale; hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DYSFUNCTION (One side of heart was not pumping right) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. 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-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CARDIAC DYSFUNCTION (One side of heart was not pumping right) (seriousness criterion hospitalization). On an unknown date, the patient experienced NAUSEA (Nauseous), MALAISE (Patient was not feeling well), DECREASED APPETITE (Loss of appetite), HEART RATE INCREASED (Increased heart rate), PALLOR (Pale) and DYSPNOEA (hard time breathing). The patient was hospitalized from 09-Mar-2021 to 19-Mar-2021 due to CARDIAC DYSFUNCTION. At the time of the report, CARDIAC DYSFUNCTION (One side of heart was not pumping right), NAUSEA (Nauseous), MALAISE (Patient was not feeling well), DECREASED APPETITE (Loss of appetite), HEART RATE INCREASED (Increased heart rate), PALLOR (Pale) and DYSPNOEA (hard time breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the events included diuretic medications.  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.
Sex: F
Vaccine: COVID19
Symptoms: Breast engorgement, Burning sensation, Dizziness, Headache, Paraesthesia
Clinical narrative: Lightheaded; feeling of fullness or engorgement in the left breast; a tingling pain; burning; subarachnoid bleed; mild headache, worst headache, throbbing headache with a pain level she said felt like a 20; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SUBARACHNOID HAEMORRHAGE (subarachnoid bleed) 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 (No reported medical history.).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (mild headache, worst headache, throbbing headache with a pain level she said felt like a 20). On 14-Feb-2021, the patient experienced SUBARACHNOID HAEMORRHAGE (subarachnoid bleed) (seriousness criteria medically significant and life threatening), BREAST ENGORGEMENT (feeling of fullness or engorgement in the left breast), PARAESTHESIA (a tingling pain) and BURNING SENSATION (burning). On an unknown date, the patient experienced DIZZINESS (Lightheaded). On 23-Feb-2021, HEADACHE (mild headache, worst headache, throbbing headache with a pain level she said felt like a 20) had resolved. At the time of the report, SUBARACHNOID HAEMORRHAGE (subarachnoid bleed), BREAST ENGORGEMENT (feeling of fullness or engorgement in the left breast), PARAESTHESIA (a tingling pain) and BURNING SENSATION (burning) outcome was unknown and DIZZINESS (Lightheaded) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Subarachnoid haemorrhage
Clinical narrative: Lightheaded; feeling of fullness or engorgement in the left breast; a tingling pain; burning; subarachnoid bleed; mild headache, worst headache, throbbing headache with a pain level she said felt like a 20; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SUBARACHNOID HAEMORRHAGE (subarachnoid bleed) 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 (No reported medical history.).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (mild headache, worst headache, throbbing headache with a pain level she said felt like a 20). On 14-Feb-2021, the patient experienced SUBARACHNOID HAEMORRHAGE (subarachnoid bleed) (seriousness criteria medically significant and life threatening), BREAST ENGORGEMENT (feeling of fullness or engorgement in the left breast), PARAESTHESIA (a tingling pain) and BURNING SENSATION (burning). On an unknown date, the patient experienced DIZZINESS (Lightheaded). On 23-Feb-2021, HEADACHE (mild headache, worst headache, throbbing headache with a pain level she said felt like a 20) had resolved. At the time of the report, SUBARACHNOID HAEMORRHAGE (subarachnoid bleed), BREAST ENGORGEMENT (feeling of fullness or engorgement in the left breast), PARAESTHESIA (a tingling pain) and BURNING SENSATION (burning) outcome was unknown and DIZZINESS (Lightheaded) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: bleeding(spotting); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (bleeding(spotting)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Menopause (went to menopause 3years ago) in 2018.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (bleeding(spotting)) (seriousness criterion medically significant). On 10-Mar-2021, POSTMENOPAUSAL HAEMORRHAGE (bleeding(spotting)) had resolved. Not 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.; 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cerebrovascular accident, Vaccination site pain, Visual impairment
Clinical narrative: small stroke; heart went to into a-fib; light and dark spots; hurting badly at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (heart went to into a-fib) and CEREBROVASCULAR ACCIDENT (small stroke) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation since an unknown date. Concurrent medical conditions included Drug allergy (Eliquis). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 01-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 ATRIAL FIBRILLATION (heart went to into a-fib) (seriousness criteria hospitalization and medically significant) and VACCINATION SITE PAIN (hurting badly at injection site). On 07-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (small stroke) (seriousness criteria hospitalization and medically significant) and VISUAL IMPAIRMENT (light and dark spots). The patient was hospitalized for 4 days due to ATRIAL FIBRILLATION and CEREBROVASCULAR ACCIDENT. At the time of the report, ATRIAL FIBRILLATION (heart went to into a-fib) and CEREBROVASCULAR ACCIDENT (small stroke) outcome was unknown, VISUAL IMPAIRMENT (light and dark spots) had resolved and VACCINATION SITE PAIN (hurting badly at injection site) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       This case was linked to US-MODERNATX, INC.-MOD-2021-060976 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060976:MOD-2021-060528 (Wife case)
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Headache, Rhinorrhoea
Clinical narrative: Chest pain; Dizzy-headed; Runny nose; Slight headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain), DIZZINESS (Dizzy-headed), RHINORRHOEA (Runny nose) and HEADACHE (Slight headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome and Heart disorder (slight heart condition.). Concomitant products included CLONAZEPAM (KLONOPIN) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization), DIZZINESS (Dizzy-headed) (seriousness criterion hospitalization), RHINORRHOEA (Runny nose) (seriousness criterion hospitalization) and HEADACHE (Slight headache) (seriousness criterion hospitalization). The patient was hospitalized on sometime in February 2021 due to CHEST PAIN, DIZZINESS, HEADACHE and RHINORRHOEA. At the time of the report, CHEST PAIN (Chest pain), DIZZINESS (Dizzy-headed), RHINORRHOEA (Runny nose) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-060612 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyskinesia, Eye colour change, Fatigue, Loss of control of legs
Clinical narrative: she is jerking; her leg was jumping out of control; whiteness in her eyes; shaking; she had fatigue; teeth chattering/body chills; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of LOSS OF CONTROL OF LEGS (her leg was jumping out of control) and DYSKINESIA (she is jerking) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) 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 VITAMIN 15 for an unknown indication.    On 12-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 LOSS OF CONTROL OF LEGS (her leg was jumping out of control) (seriousness criterion medically significant), DYSKINESIA (she is jerking) (seriousness criterion medically significant), EYE COLOUR CHANGE (whiteness in her eyes), TREMOR (shaking), CHILLS (teeth chattering) and FATIGUE (she had fatigue). At the time of the report, LOSS OF CONTROL OF LEGS (her leg was jumping out of control), DYSKINESIA (she is jerking), EYE COLOUR CHANGE (whiteness in her eyes), TREMOR (shaking), CHILLS (teeth chattering) and FATIGUE (she had fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to emergency room and doctor did not tell her anything. The patient was treated with Tylenol (acetaminophen) and ibuprofen.; 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: she is jerking; her leg was jumping out of control; whiteness in her eyes; shaking; she had fatigue; teeth chattering/body chills; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of LOSS OF CONTROL OF LEGS (her leg was jumping out of control) and DYSKINESIA (she is jerking) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) 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 VITAMIN 15 for an unknown indication.    On 12-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 LOSS OF CONTROL OF LEGS (her leg was jumping out of control) (seriousness criterion medically significant), DYSKINESIA (she is jerking) (seriousness criterion medically significant), EYE COLOUR CHANGE (whiteness in her eyes), TREMOR (shaking), CHILLS (teeth chattering) and FATIGUE (she had fatigue). At the time of the report, LOSS OF CONTROL OF LEGS (her leg was jumping out of control), DYSKINESIA (she is jerking), EYE COLOUR CHANGE (whiteness in her eyes), TREMOR (shaking), CHILLS (teeth chattering) and FATIGUE (she had fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to emergency room and doctor did not tell her anything. The patient was treated with Tylenol (acetaminophen) and ibuprofen.; 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: F
Vaccine: COVID19
Symptoms: Blindness transient, Migraine with aura, Nausea
Clinical narrative: temporary vision loss; Migraine aura/migraine headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS TRANSIENT (temporary vision loss) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine headache.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2020, the patient experienced BLINDNESS TRANSIENT (temporary vision loss) (seriousness criterion medically significant), MIGRAINE WITH AURA (Migraine aura/migraine headache) and NAUSEA (nausea). On 30-Mar-2020, BLINDNESS TRANSIENT (temporary vision loss), MIGRAINE WITH AURA (Migraine aura/migraine headache) and NAUSEA (nausea) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Dyspnoea, Pain in jaw, Vaccination site movement impairment
Clinical narrative: excruciating joint pain/ had arthritic pain, on thumb, like he broke his thumb then went to toes on left side, it was his whole body, both elbows/ pain in his shoulder; can't lift my left arm for 4 days (injection arm); pain in the joints, even up in jaw bone/ It hurt so bad couldn't eat soup; had a hard time getting around with oxygen.; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old male patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm on 14Jan2021 (Lot Number: EK9231) as single dose for prevention. Medical history included pulmonary fibrosis and dyslexia. There were no concomitant medications. Patient reported "excruciating joint pain after receiving 1st dose Pfizer vaccine. Second dose was scheduled for 04Feb2021. Patient stated that three days after receiving the first dose he had arthritic pain, on thumb - like he broke his thumb (he put on aspercreme and took Advil) but night it went away. The next day my left foot (he put on aspercreme and took Advil), then moved up to his right wrist. same thing. excruciating joint pain and it would move around, it started on his thumb one his right side, then went to toes on left side, it was his whole body, both elbows, now he can't lift his left arm (injection arm) for 4 days. There is pain in his shoulder, he can move his shoulder, but to do the chicken wing with his arm, he cannot do it. Got the shot on 14Jan2021, this started 3 days later. To switch positions, from his toes to his knee joints, and it is both sides of his body. His little joints are there one day and gone, he puts Aspercreme on and took Advil, and by night time the pain was gone, but the next day it was somewhere else. The smaller joints, like in his toes and knuckles on his hands, lasted one day, but his knees, bigger joints, was 2 days, his wrists were a day, it even went up to his jawbone, he couldn't suck soup, so it's pretty bad when you can't drink soup. His left arm had been going on for 4 days. He went to his rheumatologist, and the doctor he took 9 vials of blood, because caller's next shot is supposed to be on 04Feb2021, and he was up in the air about getting it with all the pain going on, so the doctor took a look, did 9 vials of blood, and said right now he would not advise getting it until he looked at the bloodwork to see if there was compatible, and the doctor said he would be in touch by the 4thFeb2021. Patient stated he was dyslexic. He also stated he had a hard time getting around with oxygen. Patient stated that he sees a lung specialist for the last 5 years, he has pulmonary fibrosis. Seriousness of the event was reported as non-serious. The patient underwent lab test that includes bloodwork: unknown results on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Eating disorder, Movement disorder, Pain
Clinical narrative: excruciating joint pain/ had arthritic pain, on thumb, like he broke his thumb then went to toes on left side, it was his whole body, both elbows/ pain in his shoulder; can't lift my left arm for 4 days (injection arm); pain in the joints, even up in jaw bone/ It hurt so bad couldn't eat soup; had a hard time getting around with oxygen.; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old male patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm on 14Jan2021 (Lot Number: EK9231) as single dose for prevention. Medical history included pulmonary fibrosis and dyslexia. There were no concomitant medications. Patient reported "excruciating joint pain after receiving 1st dose Pfizer vaccine. Second dose was scheduled for 04Feb2021. Patient stated that three days after receiving the first dose he had arthritic pain, on thumb - like he broke his thumb (he put on aspercreme and took Advil) but night it went away. The next day my left foot (he put on aspercreme and took Advil), then moved up to his right wrist. same thing. excruciating joint pain and it would move around, it started on his thumb one his right side, then went to toes on left side, it was his whole body, both elbows, now he can't lift his left arm (injection arm) for 4 days. There is pain in his shoulder, he can move his shoulder, but to do the chicken wing with his arm, he cannot do it. Got the shot on 14Jan2021, this started 3 days later. To switch positions, from his toes to his knee joints, and it is both sides of his body. His little joints are there one day and gone, he puts Aspercreme on and took Advil, and by night time the pain was gone, but the next day it was somewhere else. The smaller joints, like in his toes and knuckles on his hands, lasted one day, but his knees, bigger joints, was 2 days, his wrists were a day, it even went up to his jawbone, he couldn't suck soup, so it's pretty bad when you can't drink soup. His left arm had been going on for 4 days. He went to his rheumatologist, and the doctor he took 9 vials of blood, because caller's next shot is supposed to be on 04Feb2021, and he was up in the air about getting it with all the pain going on, so the doctor took a look, did 9 vials of blood, and said right now he would not advise getting it until he looked at the bloodwork to see if there was compatible, and the doctor said he would be in touch by the 4thFeb2021. Patient stated he was dyslexic. He also stated he had a hard time getting around with oxygen. Patient stated that he sees a lung specialist for the last 5 years, he has pulmonary fibrosis. Seriousness of the event was reported as non-serious. The patient underwent lab test that includes bloodwork: unknown results on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pain in jaw
Clinical narrative: excruciating joint pain/ had arthritic pain, on thumb, like he broke his thumb then went to toes on left side, it was his whole body, both elbows/ pain in his shoulder; can't lift my left arm for 4 days (injection arm); pain in the joints, even up in jaw bone/ It hurt so bad couldn't eat soup; had a hard time getting around with oxygen.; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old male patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm on 14Jan2021 (Lot Number: EK9231) as single dose for prevention. Medical history included pulmonary fibrosis and dyslexia. There were no concomitant medications. Patient reported "excruciating joint pain after receiving 1st dose Pfizer vaccine. Second dose was scheduled for 04Feb2021. Patient stated that three days after receiving the first dose he had arthritic pain, on thumb - like he broke his thumb (he put on aspercreme and took Advil) but night it went away. The next day my left foot (he put on aspercreme and took Advil), then moved up to his right wrist. same thing. excruciating joint pain and it would move around, it started on his thumb one his right side, then went to toes on left side, it was his whole body, both elbows, now he can't lift his left arm (injection arm) for 4 days. There is pain in his shoulder, he can move his shoulder, but to do the chicken wing with his arm, he cannot do it. Got the shot on 14Jan2021, this started 3 days later. To switch positions, from his toes to his knee joints, and it is both sides of his body. His little joints are there one day and gone, he puts Aspercreme on and took Advil, and by night time the pain was gone, but the next day it was somewhere else. The smaller joints, like in his toes and knuckles on his hands, lasted one day, but his knees, bigger joints, was 2 days, his wrists were a day, it even went up to his jawbone, he couldn't suck soup, so it's pretty bad when you can't drink soup. His left arm had been going on for 4 days. He went to his rheumatologist, and the doctor he took 9 vials of blood, because caller's next shot is supposed to be on 04Feb2021, and he was up in the air about getting it with all the pain going on, so the doctor took a look, did 9 vials of blood, and said right now he would not advise getting it until he looked at the bloodwork to see if there was compatible, and the doctor said he would be in touch by the 4thFeb2021. Patient stated he was dyslexic. He also stated he had a hard time getting around with oxygen. Patient stated that he sees a lung specialist for the last 5 years, he has pulmonary fibrosis. Seriousness of the event was reported as non-serious. The patient underwent lab test that includes bloodwork: unknown results on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness
Clinical narrative: dizziness; slight stomach pain/stomach pain under her breast that moved to her abdomen and belly button; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that she is a recipient of the Pfizer vaccine and got her last dose on Saturday. Stated that yesterday she noticed stomach pain under her breast that moved to her abdomen and belly button. Stated that she drank tea and rubbed with rubbing alcohol each time and it went away. Stated that it started up again this morning but is not as severe as yesterday. Stated that she thinks that it is gas pain because it moved. Wanted to know if this is a side effect because she had the vaccine or if she should go to the emergency room or doctor. Clarified that it is for the Pfizer Covid vaccine. tHe outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Vaccination site pain
Clinical narrative: pain at the injection site (I couldn't raise my arm over my head between hours 5 and 30); pain at the injection site (I couldn't raise my arm over my head between hours 5 and 30); This is a spontaneous report from a contactable consumer (patient) reported for herself (Internet Source). A female patient of unspecified age had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not provided), via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant was not reported. The patient reported that, my only side effect so far has been an unusual amount of pain at the injection site (I couldn't raise my arm over my head between hours 5 and 30) in Jan2021, but it's much better today and the rest of me feels fine. The events were reported as non-serious. Facility where the most recent COVID-19 vaccine was administered was hospital. I was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient diagnosed with COVID-19 prior to vaccination and Since the vaccination, has the patient been tested for COVID-19. Outcome of the events was recovered in Jan2021.   Information on the lot/batch number has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Application site erythema, Application site swelling, Blood pressure measurement, Erythema, Pain in extremity
Clinical narrative: have a lot of redness on site and a little bit of swelling; have a lot of redness on site and a little bit of swelling; arm became sore and a redness appeared that grew to 3 inches little by little accompanied by itching; arm became sore and a redness appeared that grew to 3 inches little by little accompanied by itching; arm became sore and a redness appeared that grew to 3 inches little by little accompanied by itching; This is a spontaneous report from a contactable consumer or other non hcp.  A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9269), administered in Arm Left single dose, via intramuscular route on 03Feb2021 for COVID-19 immunization. Medical history included hypertension. The concomitant medications were not reported. In the morning after her shot, her arm became sore and a redness appeared that grew to 3 inches little by little accompanied by itching. It has been going for 3 days now as of the moment. The patient stated that she still have a lot of redness on site and a little bit of swelling. Patient asked it was considered normal and this was like the third day. The patient was just put on a wet compress for the events. The patient stated that she received the 1st dose on 03Feb2021 (Wednesday) and 2nd dose scheduled after 18 days and she was asking is the timing of the 2nd dose of vaccine. At the time of this report event application site swelling and application site erythema were not recovered and other event outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: have a lot of redness on site and a little bit of swelling; have a lot of redness on site and a little bit of swelling; arm became sore and a redness appeared that grew to 3 inches little by little accompanied by itching; arm became sore and a redness appeared that grew to 3 inches little by little accompanied by itching; arm became sore and a redness appeared that grew to 3 inches little by little accompanied by itching; This is a spontaneous report from a contactable consumer or other non hcp.  A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9269), administered in Arm Left single dose, via intramuscular route on 03Feb2021 for COVID-19 immunization. Medical history included hypertension. The concomitant medications were not reported. In the morning after her shot, her arm became sore and a redness appeared that grew to 3 inches little by little accompanied by itching. It has been going for 3 days now as of the moment. The patient stated that she still have a lot of redness on site and a little bit of swelling. Patient asked it was considered normal and this was like the third day. The patient was just put on a wet compress for the events. The patient stated that she received the 1st dose on 03Feb2021 (Wednesday) and 2nd dose scheduled after 18 days and she was asking is the timing of the 2nd dose of vaccine. At the time of this report event application site swelling and application site erythema were not recovered and other event outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Decreased appetite, Headache, Malaise
Clinical narrative: mild fever; loss of appetite; malaise; the pain was excruciating and extended to both sides of neck up into occipital area of my head and to both shoulders; the pain was excruciating and extended to both sides of neck up into occipital area of my head and to both shoulders; severe left sided ache in my neck/This worsened throughout the day; severe left sided ache in my neck/This worsened throughout the day; This is a spontaneous report from a contactable nurse reported for herself. An adult non-pregnant female patient of an unknown age received BNT162B2 (Solution for injection, Lot number: EM9810) via an unknown route of administration (second dose) on 05Feb2021 at 8.45 AM at left arm for COVID-19 immunization. Relevant medical history included bee venom allergy and clostridium difficile (treated with Vancomycin 125 every 6 hours). Historical vaccine included (first dose) BNT162B2 with lot number EL3249 on 15Jan2021 at 9.45 AM at left arm. The concomitant medication included vancomycin from an unknown date at 125 mg, every 6 hours for Clostridium Difficile. Within 2 hours of vaccine administration at 10.15 AM, patient started to experience severe left sided ache in her neck. This worsened throughout the day 05Feb2021. On 06Feb2021, the pain was excruciating and extended to both sides of neck up into occipital area of my head and to both shoulders. I could not turn my head in a full range of motion. Today on 08Feb2021, the pain is lessened, but range of motion remains limited. Additionally, patient had mild fever, loss of appetite and malaise. The patient treatments included massage, heat and ice for reported events. The outcome of all the events were recovering.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia
Clinical narrative: mild fever; loss of appetite; malaise; the pain was excruciating and extended to both sides of neck up into occipital area of my head and to both shoulders; the pain was excruciating and extended to both sides of neck up into occipital area of my head and to both shoulders; severe left sided ache in my neck/This worsened throughout the day; severe left sided ache in my neck/This worsened throughout the day; This is a spontaneous report from a contactable nurse reported for herself. An adult non-pregnant female patient of an unknown age received BNT162B2 (Solution for injection, Lot number: EM9810) via an unknown route of administration (second dose) on 05Feb2021 at 8.45 AM at left arm for COVID-19 immunization. Relevant medical history included bee venom allergy and clostridium difficile (treated with Vancomycin 125 every 6 hours). Historical vaccine included (first dose) BNT162B2 with lot number EL3249 on 15Jan2021 at 9.45 AM at left arm. The concomitant medication included vancomycin from an unknown date at 125 mg, every 6 hours for Clostridium Difficile. Within 2 hours of vaccine administration at 10.15 AM, patient started to experience severe left sided ache in her neck. This worsened throughout the day 05Feb2021. On 06Feb2021, the pain was excruciating and extended to both sides of neck up into occipital area of my head and to both shoulders. I could not turn my head in a full range of motion. Today on 08Feb2021, the pain is lessened, but range of motion remains limited. Additionally, patient had mild fever, loss of appetite and malaise. The patient treatments included massage, heat and ice for reported events. The outcome of all the events were recovering.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a contactable consumer (patient reported herself). A 67-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number/NDC number/Expiry Date: Not Provided) via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient also took carbamazepine (TEGRETOL, Batch/lot number/NDC number/Expiry Date: Unknown) via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash. It was reported that, "caller scheduled for first dose of vaccine at the end of this month. Previous allergic reaction to Tegretol, contains polyethylene glycol. Reaction 2002/2003 painful rash. Potential adverse event". Caller was a consumer that was calling about the Covid-19 Vaccine and reported that she had an appointment on 25Feb2021 to get her first injection. Caller said that she had been looking at the information online concerning the vaccine. A while back she took Tegretol and reacted from it. Caller did not have a NDC, Lot, or expiration date for the Tegretol. Caller said that it had been a long time since she took it. She took Tegretol for 4-6 months and she got a terrible, terrible rash from it. This was in 2002-2003. She said that it took a year to get rid of the rash. Caller said that the Covid-19 Vaccine and the Tegretol both contain Polyethylene Glycol and when you look at the information online, it said not to get a mRNA vaccine if you are allergic to Polyethylene Glycol. Caller said that she wanted to make sure that this was still the up to date information. Outcome of the event was unknown.  Information about lot/batch has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache, X-ray dental
Clinical narrative: toothache; This is a spontaneous report from a contactable consumer, the patient. An 84-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3302) via unspecified route of administration in the left arm on 28Jan2021 09:00 AM as a single dose for covid-19 immunization. The patients medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications included metoprolol succinate at 25 mg with unknown frequency, calcium and multi-vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 in the left arm on 07Jan2021 10:30 AM as a single dose for Covid-19 immunization (Lot number: EJ1686). In 2 days patient started having a toothache. It kept getting worse. Monday morning patient called the dentist and saw him on thursday, he took X-rays for abscess with unknown results, on an unknown date. There was none. Could be bite, no that wasn't it either. Then she figured it out. It was still sore to the touch then go back in 2 was. Will see what he says. There was a program with dentists talking about a side effect of shot and then patient knew that was the problem. Patient elbow was the same way, couldn't touch it for a couple of day it was so sore. The patient received treatment for the event. The outcome of the event was recovering.