chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Missed second dose of the Moderna COVID-19 vaccine; Spontaneous abortion; Lot of pain in my whole arm; Exposure during pregnancy; Strong headache; Pain in the muscle where I got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous abortion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine). On 08-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Spontaneous abortion) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine). The patient was treated with IBUPROFEN (oral) at a dose of 500 mg. At the time of the report, ABORTION SPONTANEOUS (Spontaneous abortion), PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine), PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followup received contains NNI; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Physical disability, Thrombosis
Clinical narrative: Blood clots in lungs, legs and brain; She cant speak or stand on her own/in diaper; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clots in lungs, legs and brain) and PHYSICAL DISABILITY (She cant speak or stand on her own/in diaper) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced THROMBOSIS (Blood clots in lungs, legs and brain) (seriousness criteria hospitalization prolonged and medically significant) and PHYSICAL DISABILITY (She cant speak or stand on her own/in diaper) (seriousness criterion hospitalization prolonged). The patient was treated with HEPARIN (intravenous) at a dose of UNK dosage form. At the time of the report, THROMBOSIS (Blood clots in lungs, legs and brain) and PHYSICAL DISABILITY (She cant speak or stand on her own/in diaper) outcome was unknown.            Concomitant medications were not provided. Reporter stated that hospital is trying to send the patient to a nursing home. No further treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Syncope
Clinical narrative: Fainted; Anxiety; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 SYNCOPE (Fainted) (seriousness criterion medically significant) and ANXIETY (Anxiety). At the time of the report, SYNCOPE (Fainted) and ANXIETY (Anxiety) outcome was unknown.            No relevant concomitant medications were provided the reporter.   Patient had anxiety and fainted. Patient had received the second dose and was fine. No treatment information was 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.   This case was linked to Patient Link.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Rheumatoid arthritis
Clinical narrative: flare up of rheumatoid arthritis in shoulders; right arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (flare up of rheumatoid arthritis in shoulders) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (flare up of rheumatoid arthritis in shoulders) (seriousness criterion medically significant) and PAIN IN EXTREMITY (right arm soreness). At the time of the report, RHEUMATOID ARTHRITIS (flare up of rheumatoid arthritis in shoulders) had not resolved and PAIN IN EXTREMITY (right arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported.  No treatment information was provided.  Very limited information regarding these events has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia, SARS-CoV-2 antibody test, Syncope
Clinical narrative: Faint; Weak; Chills; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0402B1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced CHILLS (Chills) and PYREXIA (Feverish). On 27-Apr-2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant) and ASTHENIA (Weak). At the time of the report, SYNCOPE (Faint), ASTHENIA (Weak), CHILLS (Chills) and PYREXIA (Feverish) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 antibody test: positive (Positive) Positive. In March 2021, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient included thyroid medications and cholesterol medications. 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.; 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Ear congestion, Ear pain, Pain in extremity, Productive cough
Clinical narrative: R ear hurt,is not listening, it is as if covered; L ear plugged; cough/ alot of phlegm; nose is stuffed with mucus; L ear hurt for 2 days, then right ear hurt, today left ear plugged and it hurts; arm pain for 3 days; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (R ear hurt,is not listening, it is as if covered) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PAIN IN EXTREMITY (arm pain for 3 days) and PYREXIA (fever). On 15-May-2021, the patient experienced PRODUCTIVE COUGH (cough/ alot of phlegm), RHINORRHOEA (nose is stuffed with mucus) and EAR PAIN (L ear hurt for 2 days, then right ear hurt, today left ear plugged and it hurts). On 17-May-2021, the patient experienced DEAFNESS UNILATERAL (R ear hurt,is not listening, it is as if covered) (seriousness criterion medically significant) and EAR CONGESTION (L ear plugged). The patient was treated with IBUPROFEN at an unspecified dose and frequency; BENZATHINE BENZYLPENICILLIN (MEGACILLIN [BENZATHINE BENZYLPENICILLIN]) 15-May-2021 at a dose of 1 UNK; BENZATHINE BENZYLPENICILLIN (MEGACILLIN [BENZATHINE BENZYLPENICILLIN]) 24-May-2021 at a dose of 1 dosage form; AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AUGMENTIN S) at a dose of 875 mg and FLUCONAZOLE at a dose of 1 dosage form. On 13-May-2021, PAIN IN EXTREMITY (arm pain for 3 days) and PYREXIA (fever) had resolved. At the time of the report, DEAFNESS UNILATERAL (R ear hurt,is not listening, it is as if covered), PRODUCTIVE COUGH (cough/ alot of phlegm), RHINORRHOEA (nose is stuffed with mucus), EAR PAIN (L ear hurt for 2 days, then right ear hurt, today left ear plugged and it hurts) and EAR CONGESTION (L ear plugged) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were 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.; 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: R ear hurt,is not listening, it is as if covered; L ear plugged; cough/ alot of phlegm; nose is stuffed with mucus; L ear hurt for 2 days, then right ear hurt, today left ear plugged and it hurts; arm pain for 3 days; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (R ear hurt,is not listening, it is as if covered) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PAIN IN EXTREMITY (arm pain for 3 days) and PYREXIA (fever). On 15-May-2021, the patient experienced PRODUCTIVE COUGH (cough/ alot of phlegm), RHINORRHOEA (nose is stuffed with mucus) and EAR PAIN (L ear hurt for 2 days, then right ear hurt, today left ear plugged and it hurts). On 17-May-2021, the patient experienced DEAFNESS UNILATERAL (R ear hurt,is not listening, it is as if covered) (seriousness criterion medically significant) and EAR CONGESTION (L ear plugged). The patient was treated with IBUPROFEN at an unspecified dose and frequency; BENZATHINE BENZYLPENICILLIN (MEGACILLIN [BENZATHINE BENZYLPENICILLIN]) 15-May-2021 at a dose of 1 UNK; BENZATHINE BENZYLPENICILLIN (MEGACILLIN [BENZATHINE BENZYLPENICILLIN]) 24-May-2021 at a dose of 1 dosage form; AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AUGMENTIN S) at a dose of 875 mg and FLUCONAZOLE at a dose of 1 dosage form. On 13-May-2021, PAIN IN EXTREMITY (arm pain for 3 days) and PYREXIA (fever) had resolved. At the time of the report, DEAFNESS UNILATERAL (R ear hurt,is not listening, it is as if covered), PRODUCTIVE COUGH (cough/ alot of phlegm), RHINORRHOEA (nose is stuffed with mucus), EAR PAIN (L ear hurt for 2 days, then right ear hurt, today left ear plugged and it hurts) and EAR CONGESTION (L ear plugged) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were 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.; 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: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERICARDITIS (Pericarditis) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). The patient was treated with IBUPROFEN on 25-May-2021 for Pericarditis, at an unspecified dose and frequency. On 27-May-2021, PERICARDITIS (Pericarditis) had resolved.            Concomitant product use was not provided. The patient experienced chest pain on 25 May 2021, went to the ER , and was diagnosed with pericarditis; stayed in the ER for 3 hours and was prescribed Ibuprofen. No history of heart related problem was reported by the patient.  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. Very limited information regarding this event has been provided at this time. No further information is expected at this time.   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 the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Loss of personal independence in daily activities, Nervous system disorder, Pain, X-ray
Clinical narrative: Could not stand up his own; Can not perform his routine activities; Nerve problem in his neck then to Spine/Become worst; Constant pain; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of DYSSTASIA (Could not stand up his own), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not perform his routine activities), NERVOUS SYSTEM DISORDER (Nerve problem in his neck then to Spine/Become worst) and PAIN (Constant pain) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced DYSSTASIA (Could not stand up his own) (seriousness criterion disability), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not perform his routine activities) (seriousness criterion disability), NERVOUS SYSTEM DISORDER (Nerve problem in his neck then to Spine/Become worst) (seriousness criterion disability) and PAIN (Constant pain) (seriousness criterion disability). At the time of the report, DYSSTASIA (Could not stand up his own), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not perform his routine activities), NERVOUS SYSTEM DISORDER (Nerve problem in his neck then to Spine/Become worst) and PAIN (Constant pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: unknown (Inconclusive) physician said this is coincidence..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       His father has to help him to put on wheelchair. Patient was having constant pain for that he was taking pain medicine.  MRI was scheduled for 05-Jun-2021.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Dyskinesia, Feeling abnormal, Insomnia
Clinical narrative: not getting any sleep; Involuntary movement of her arms and legs/body is just jerking; Felt like she was having an alien pop-out/felt like something in her body was squeezing her inside; Cataracts; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (Cataracts) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cataract extraction (on her right eye ) on 21-May-2021 and Cataract extraction (on the left eye ) on 06-May-2021. Concomitant products included MAGNESIUM and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced CATARACT (Cataracts) (seriousness criterion medically significant). On an unknown date, the patient experienced INSOMNIA (not getting any sleep), DYSKINESIA (Involuntary movement of her arms and legs/body is just jerking) and FEELING ABNORMAL (Felt like she was having an alien pop-out/felt like something in her body was squeezing her inside). The patient was treated with Surgery (Cataract surgery of right eye on 21MAY2021 and of left eye on 06MAY2021) for Cataract. At the time of the report, CATARACT (Cataracts) outcome was unknown and INSOMNIA (not getting any sleep), DYSKINESIA (Involuntary movement of her arms and legs/body is just jerking) and FEELING ABNORMAL (Felt like she was having an alien pop-out/felt like something in her body was squeezing her inside) had not resolved.            Treatment information was not provided.  The patient was scheduled to a neurologist.  Company comment: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. However the patient's increased aged is also a risk factor for cataracts.   This case was linked to MOD-2021-185661 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However the patient's increased aged is also a risk factor for cataracts.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: went through menopause 2+ years ago Two weeks later I menstruated, which I haven't done is over 2 year; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (went through menopause 2+ years ago Two weeks later I menstruated, which I haven't done is over 2 year) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Postmenopause.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POSTMENOPAUSAL HAEMORRHAGE (went through menopause 2+ years ago Two weeks later I menstruated, which I haven't done is over 2 year) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (went through menopause 2+ years ago Two weeks later I menstruated, which I haven't done is over 2 year) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment medication was not reported.  Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune disorder, Laboratory test, Pain in extremity, Raynaud's phenomenon
Clinical narrative: Auto immune condition similar to lupus; Episodes of Raynaud's syndrome; pain in her fingers; Pain in her wrist/knee pain/ankle pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of AUTOIMMUNE DISORDER (Auto immune condition similar to lupus) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in her fingers) and ARTHRALGIA (Pain in her wrist/knee pain/ankle pain). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Auto immune condition similar to lupus) (seriousness criterion medically significant) and RAYNAUD'S PHENOMENON (Episodes of Raynaud's syndrome). At the time of the report, AUTOIMMUNE DISORDER (Auto immune condition similar to lupus), RAYNAUD'S PHENOMENON (Episodes of Raynaud's syndrome), PAIN IN EXTREMITY (pain in her fingers) and ARTHRALGIA (Pain in her wrist/knee pain/ankle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: high (High) inflammatory markers were high in the 1000's.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The patient started having pain in her wrist, fingers, ankle and knees two weeks after receiving her second dose of the Moderna COVID-19 vaccine. The patient had daily episodes of Raynaud's syndrome and went to talk to her doctors, and they performed lab test. The lab result came out showed that her inflammatory markers were very higher. She said the marker were in the 1000's and the doctors diagnosed her with autoimmune condition like lupus. Two doctors on this case, one of the doctors thought her condition was related to the vaccine and did not recommend treatment, but to monitor her. The other doctor thought her condition should be treated with Plaquenil (hydroxychloroquine) before it gets worse. Action taken with mRNA-1273 in response to events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: My first moderna vaccine about 3 weeks later I had a stroke; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (My first moderna vaccine about 3 weeks later I had a stroke) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (My first moderna vaccine about 3 weeks later I had a stroke) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, CEREBROVASCULAR ACCIDENT (My first moderna vaccine about 3 weeks later I had a stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       About 3 weeks after receiving the first dose of vaccine, the patient had a stroke. The patient's concomitant medication was not reported. No treatment information was provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Headache, Influenza like illness, Malaise
Clinical narrative: Muscle close to hip that gave me a lot of pain; I had a short heart attack. It was a pretty severe pain.; mid chest, left side pain; Felt lousy; Had flu-like symptoms; Cough; Sore throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (I had a short heart attack. It was a pretty severe pain.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Scarlet fever (Patient had as a child, about 13 or 14 yrs old.) since an unknown date.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced MALAISE (Felt lousy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache). On 24-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (I had a short heart attack. It was a pretty severe pain.) (seriousness criterion medically significant) and CHEST PAIN (mid chest, left side pain). On 27-May-2021, the patient experienced MYALGIA (Muscle close to hip that gave me a lot of pain). At the time of the report, MYOCARDIAL INFARCTION (I had a short heart attack. It was a pretty severe pain.), CHEST PAIN (mid chest, left side pain), MALAISE (Felt lousy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) outcome was unknown and MYALGIA (Muscle close to hip that gave me a lot of pain) had resolved.            Concomitant medications were not provided.Treatment information was not reported.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Myocardial infarction, Oropharyngeal pain
Clinical narrative: Muscle close to hip that gave me a lot of pain; I had a short heart attack. It was a pretty severe pain.; mid chest, left side pain; Felt lousy; Had flu-like symptoms; Cough; Sore throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (I had a short heart attack. It was a pretty severe pain.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Scarlet fever (Patient had as a child, about 13 or 14 yrs old.) since an unknown date.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced MALAISE (Felt lousy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache). On 24-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (I had a short heart attack. It was a pretty severe pain.) (seriousness criterion medically significant) and CHEST PAIN (mid chest, left side pain). On 27-May-2021, the patient experienced MYALGIA (Muscle close to hip that gave me a lot of pain). At the time of the report, MYOCARDIAL INFARCTION (I had a short heart attack. It was a pretty severe pain.), CHEST PAIN (mid chest, left side pain), MALAISE (Felt lousy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) outcome was unknown and MYALGIA (Muscle close to hip that gave me a lot of pain) had resolved.            Concomitant medications were not provided.Treatment information was not reported.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: peripheral neuropathy, could not walk, feet hurt a lot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (peripheral neuropathy, could not walk, feet hurt a lot) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NEUROPATHY PERIPHERAL (peripheral neuropathy, could not walk, feet hurt a lot) (seriousness criterion medically significant). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form and GABAPENTIN ongoing since an unknown date at a dose of 300 mg three times a day. At the time of the report, NEUROPATHY PERIPHERAL (peripheral neuropathy, could not walk, feet hurt a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient said that she still cannot walk as much as she used to and is still having some troubles. Patient's neurologist recommended for her to increase her Gabapentin 300mg from 2 tablets to 3 tablets.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea, Lymphadenopathy
Clinical narrative: Heart problems; Breathing problems; Lymph nodes swollen; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart problems), DYSPNOEA (Breathing problems) and LYMPHADENOPATHY (Lymph nodes swollen) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024m20a and 029I20a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Lung cancer (in remission since November) and Liver disorder (liver problems).   On 19-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 14-May-2021, the patient experienced CARDIAC DISORDER (Heart problems) (seriousness criterion death), DYSPNOEA (Breathing problems) (seriousness criterion death) and LYMPHADENOPATHY (Lymph nodes swollen) (seriousness criterion death). The patient died on 15-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No relevant concomitant medications were provided.  Daughter of the patient reported that the patient passed away after his lymph nodes swollen, had breathing problems, and hart problems. She stated that the patient was in remission of lung cancer since November, and that he was diabetic and had liver problems. They wanted to be part of the trials for the vaccine. She wanted his cases to be research because his lymph nodes  were swollen, and that for her means there's a correlation between the vaccine taking and his demised.  No treatment information was provided.  Very limited information regarding these events has been provided at this time. Further information has been requested. The patient's medical history of diabetes, liver disorder and lung cancer are confounding factors that may play possible contributory roles.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. The patient's medical history of diabetes, liver disorder and lung cancer are confounding factors that may play possible contributory roles.; Reported Cause(s) of Death: passed away
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Myocardial infarction, Thrombosis
Clinical narrative: Heart attack; Stroke; Blood clots; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack), CEREBROVASCULAR ACCIDENT (Stroke) and THROMBOSIS (Blood clots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery for Thrombosis. At the time of the report, MYOCARDIAL INFARCTION (Heart attack), CEREBROVASCULAR ACCIDENT (Stroke) and THROMBOSIS (Blood clots) outcome was unknown.            Concomitant product use was not provided.  It was reported that the patient experienced heart attack, stroke, and uncontrollable blood clotting after 5 days of vaccine. Patient was also admitted at hospital for surgery.  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. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Fatigue, Feeling abnormal, Loss of consciousness
Clinical narrative: sore throat; cold symptoms; felt funny and weird; losing focus like a blackout; blacking out while driving; throwing up; feeling tired; light headedness/dizziness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacking out while driving) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hip replacement. Concurrent medical conditions included Allergy, Hypertension, Clinical depression, Post-traumatic stress disorder, Anxiety, Psoriasis and Lupus erythematosus.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced DIZZINESS (light headedness/dizziness), PAIN IN EXTREMITY (sore arm) and FATIGUE (feeling tired). On 19-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacking out while driving) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (sore throat), NASOPHARYNGITIS (cold symptoms), FEELING ABNORMAL (felt funny and weird), DISTURBANCE IN ATTENTION (losing focus like a blackout) and VOMITING (throwing up). On 23-May-2021, LOSS OF CONSCIOUSNESS (blacking out while driving), DIZZINESS (light headedness/dizziness), OROPHARYNGEAL PAIN (sore throat), NASOPHARYNGITIS (cold symptoms), FEELING ABNORMAL (felt funny and weird), DISTURBANCE IN ATTENTION (losing focus like a blackout), PAIN IN EXTREMITY (sore arm), VOMITING (throwing up) and FATIGUE (feeling tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Additional document received on 28-may-2021. No new information  present in additional document.; 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain in extremity, Vomiting
Clinical narrative: sore throat; cold symptoms; felt funny and weird; losing focus like a blackout; blacking out while driving; throwing up; feeling tired; light headedness/dizziness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacking out while driving) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hip replacement. Concurrent medical conditions included Allergy, Hypertension, Clinical depression, Post-traumatic stress disorder, Anxiety, Psoriasis and Lupus erythematosus.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced DIZZINESS (light headedness/dizziness), PAIN IN EXTREMITY (sore arm) and FATIGUE (feeling tired). On 19-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacking out while driving) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (sore throat), NASOPHARYNGITIS (cold symptoms), FEELING ABNORMAL (felt funny and weird), DISTURBANCE IN ATTENTION (losing focus like a blackout) and VOMITING (throwing up). On 23-May-2021, LOSS OF CONSCIOUSNESS (blacking out while driving), DIZZINESS (light headedness/dizziness), OROPHARYNGEAL PAIN (sore throat), NASOPHARYNGITIS (cold symptoms), FEELING ABNORMAL (felt funny and weird), DISTURBANCE IN ATTENTION (losing focus like a blackout), PAIN IN EXTREMITY (sore arm), VOMITING (throwing up) and FATIGUE (feeling tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Additional document received on 28-may-2021. No new information  present in additional document.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Knocked out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Knocked out) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Knocked out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Knocked out) outcome was unknown.            No relevant concomitant medications were reported.   No treatment information was provided.    Very limited information regarding this event has been provided at this time. Further information has been requested.  Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: B-cells were no longer functioning properly and somehow his immune system is compromised; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (B-cells were no longer functioning properly and somehow his immune system is compromised) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (B-cells were no longer functioning properly and somehow his immune system is compromised) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (B-cells were no longer functioning properly and somehow his immune system is compromised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Malaise
Clinical narrative: reported not feeling well/doesn't feel good; headache; Flu like symptoms; This is a spontaneous report from a contactable consumer. An 81-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9261; Expiration Date: 31May2021) via an unspecified route of administration in right arm on 02Feb2021 08:30 as SINGLE DOSE for covid-19 immunization. Medical history and concurrent conditions include asthma she takes 4-5 pills and inhaler for asthma, diabetes she had this quite a while and consumer says that the paper they gave her gives a bunch of side effects, and she has always got the flu shot, and never had this before. No further details provided about past flu vaccinations. No further details provided about the medications that she takes. Concomitant medications not reported. She received first dose of the COVID-19 vaccine yesterday on 02Jan2021 and she is feeling pretty funky today, she doesn't feel right at all. She would like to know if she can take Tylenol or anything for it. Patient says she doesn't feel good. She says she got her injection, and has a headache and feels unwell, she doesn't feel good, so she would like to know if she can take Tylenol or what she can take. She says she knows there are side effects, she just wants to know what she can take. Also reported Flu like symptoms. Patient treated with drinking a lot of water and about a half a cup of coffee. Outcome of the events unknown.  Follow-up attempts are completed. No further information is expected.