chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site urticaria
Clinical narrative: Chest cold; Flu; Hard welt that burned at the injection site; Sore arm; Diarrhea; Exhausted; welt at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (Chest cold) 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.     Concurrent medical conditions included Rheumatoid arthritis and Sjogren's.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (Chest cold) (seriousness criterion medically significant), INFLUENZA (Flu), VACCINATION SITE PAIN (Hard welt that burned at the injection site), PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), FATIGUE (Exhausted) and INJECTION SITE URTICARIA (welt at the injection site). At the time of the report, LOWER RESPIRATORY TRACT INFECTION (Chest cold) outcome was unknown and INFLUENZA (Flu), VACCINATION SITE PAIN (Hard welt that burned at the injection site), PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), FATIGUE (Exhausted) and INJECTION SITE URTICARIA (welt at the injection site) had not resolved.            Treatment included Gluten free diet. Concomitant medications were not provided.   This case was linked to MOD-2021-099463 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional info-2 On 03-May-2021: Initial additional - NNI; Sender's Comments: Limited information regarding the events has been provided at this time. A causal relationship cannot be excluded. Further information has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Chills, Dizziness, End stage renal disease, Myocardial infarction
Clinical narrative: Multiple mini strokes; Heart attack; End stage kidney disease; Dizziness; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Multiple mini strokes), MYOCARDIAL INFARCTION (Heart attack) and END STAGE RENAL DISEASE (End stage kidney disease) in a 71-year-old male patient who received mRNA-1273 (batch nos. 031m20a and 001bz1a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type II diabetes mellitus.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Multiple mini strokes) (seriousness criteria hospitalization and medically significant), MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant) and END STAGE RENAL DISEASE (End stage kidney disease) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 21-Mar-2021 due to CEREBROVASCULAR ACCIDENT, END STAGE RENAL DISEASE and MYOCARDIAL INFARCTION. At the time of the report, CEREBROVASCULAR ACCIDENT (Multiple mini strokes), MYOCARDIAL INFARCTION (Heart attack), END STAGE RENAL DISEASE (End stage kidney disease), DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.            Concomitant medications taken by the patient were not provided. Treatment activities for event was done with heparin, oxygen and patient was on dialysis.   Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's past medical history of Diabetes may remain as a risk factor for the events(Mini strokes, Myocardial infarction and End stage renal disease).; 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. However, the patient's past medical history of Diabetes may remain as a risk factor for the events(Mini strokes, Myocardial infarction and End stage renal disease).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Multiple mini strokes; Heart attack; End stage kidney disease; Dizziness; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Multiple mini strokes), MYOCARDIAL INFARCTION (Heart attack) and END STAGE RENAL DISEASE (End stage kidney disease) in a 71-year-old male patient who received mRNA-1273 (batch nos. 031m20a and 001bz1a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type II diabetes mellitus.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Multiple mini strokes) (seriousness criteria hospitalization and medically significant), MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant) and END STAGE RENAL DISEASE (End stage kidney disease) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 21-Mar-2021 due to CEREBROVASCULAR ACCIDENT, END STAGE RENAL DISEASE and MYOCARDIAL INFARCTION. At the time of the report, CEREBROVASCULAR ACCIDENT (Multiple mini strokes), MYOCARDIAL INFARCTION (Heart attack), END STAGE RENAL DISEASE (End stage kidney disease), DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.            Concomitant medications taken by the patient were not provided. Treatment activities for event was done with heparin, oxygen and patient was on dialysis.   Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's past medical history of Diabetes may remain as a risk factor for the events(Mini strokes, Myocardial infarction and End stage renal disease).; 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. However, the patient's past medical history of Diabetes may remain as a risk factor for the events(Mini strokes, Myocardial infarction and End stage renal disease).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Confusional state, Cough, Myalgia
Clinical narrative: Covid 19 positive; confusion; weakness; cough; fever; body aches; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Covid 19 positive), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced COVID-19 (Covid 19 positive) (seriousness criterion hospitalization), CONFUSIONAL STATE (confusion) (seriousness criterion hospitalization), ASTHENIA (weakness) (seriousness criterion hospitalization), COUGH (cough) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization) and MYALGIA (body aches) (seriousness criterion hospitalization). The patient was hospitalized on 14-Mar-2021 due to ASTHENIA, CONFUSIONAL STATE, COUGH, COVID-19, MYALGIA and PYREXIA. At the time of the report, COVID-19 (Covid 19 positive), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     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.   Treatment information not reported. No concomitant medications reported.  Company Comment - Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. However, the events of confusional state, asthenia, cough, pyrexia, and myalgia maybe related to COVID infection. Further information has been requested.; Sender's Comments: Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. However, the events of confusional state, asthenia, cough, pyrexia, and myalgia maybe related to COVID infection. Further information has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Covid 19 positive; confusion; weakness; cough; fever; body aches; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Covid 19 positive), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced COVID-19 (Covid 19 positive) (seriousness criterion hospitalization), CONFUSIONAL STATE (confusion) (seriousness criterion hospitalization), ASTHENIA (weakness) (seriousness criterion hospitalization), COUGH (cough) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization) and MYALGIA (body aches) (seriousness criterion hospitalization). The patient was hospitalized on 14-Mar-2021 due to ASTHENIA, CONFUSIONAL STATE, COUGH, COVID-19, MYALGIA and PYREXIA. At the time of the report, COVID-19 (Covid 19 positive), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     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.   Treatment information not reported. No concomitant medications reported.  Company Comment - Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. However, the events of confusional state, asthenia, cough, pyrexia, and myalgia maybe related to COVID infection. Further information has been requested.; Sender's Comments: Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. However, the events of confusional state, asthenia, cough, pyrexia, and myalgia maybe related to COVID infection. Further information has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Crying, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Saw hallucinations; Diarrhea; Dizziness; Shortness of breath; Vertigo; Fever dreams; Very upset / Very emotional; Cried; Paranoia; Fever; Nausea; Extremely cold; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Saw hallucinations) in a 39-year-old male patient who received mRNA-1273 (batch no. Unknown) 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 second dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (Saw hallucinations) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath), VERTIGO (Vertigo), ABNORMAL DREAMS (Fever dreams), EMOTIONAL DISTRESS (Very upset / Very emotional), CRYING (Cried), PARANOIA (Paranoia), PYREXIA (Fever), NAUSEA (Nausea) and FEELING COLD (Extremely cold). At the time of the report, HALLUCINATION (Saw hallucinations), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath), VERTIGO (Vertigo), ABNORMAL DREAMS (Fever dreams), EMOTIONAL DISTRESS (Very upset / Very emotional), CRYING (Cried), PARANOIA (Paranoia), PYREXIA (Fever), NAUSEA (Nausea) and FEELING COLD (Extremely cold) outcome was unknown.            No concomitant medicines were reported. Treatment information included paracetamol for fever.  Company Comment: Based on current available information and the temporal association between product use and the start of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start of the events a causal relationship cannot be excluded.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Emotional distress, Feeling cold, Hallucination, Nausea, Paranoia
Clinical narrative: Saw hallucinations; Diarrhea; Dizziness; Shortness of breath; Vertigo; Fever dreams; Very upset / Very emotional; Cried; Paranoia; Fever; Nausea; Extremely cold; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Saw hallucinations) in a 39-year-old male patient who received mRNA-1273 (batch no. Unknown) 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 second dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (Saw hallucinations) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath), VERTIGO (Vertigo), ABNORMAL DREAMS (Fever dreams), EMOTIONAL DISTRESS (Very upset / Very emotional), CRYING (Cried), PARANOIA (Paranoia), PYREXIA (Fever), NAUSEA (Nausea) and FEELING COLD (Extremely cold). At the time of the report, HALLUCINATION (Saw hallucinations), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath), VERTIGO (Vertigo), ABNORMAL DREAMS (Fever dreams), EMOTIONAL DISTRESS (Very upset / Very emotional), CRYING (Cried), PARANOIA (Paranoia), PYREXIA (Fever), NAUSEA (Nausea) and FEELING COLD (Extremely cold) outcome was unknown.            No concomitant medicines were reported. Treatment information included paracetamol for fever.  Company Comment: Based on current available information and the temporal association between product use and the start of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start of the events a causal relationship cannot be excluded.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: Saw hallucinations; Diarrhea; Dizziness; Shortness of breath; Vertigo; Fever dreams; Very upset / Very emotional; Cried; Paranoia; Fever; Nausea; Extremely cold; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Saw hallucinations) in a 39-year-old male patient who received mRNA-1273 (batch no. Unknown) 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 second dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (Saw hallucinations) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath), VERTIGO (Vertigo), ABNORMAL DREAMS (Fever dreams), EMOTIONAL DISTRESS (Very upset / Very emotional), CRYING (Cried), PARANOIA (Paranoia), PYREXIA (Fever), NAUSEA (Nausea) and FEELING COLD (Extremely cold). At the time of the report, HALLUCINATION (Saw hallucinations), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath), VERTIGO (Vertigo), ABNORMAL DREAMS (Fever dreams), EMOTIONAL DISTRESS (Very upset / Very emotional), CRYING (Cried), PARANOIA (Paranoia), PYREXIA (Fever), NAUSEA (Nausea) and FEELING COLD (Extremely cold) outcome was unknown.            No concomitant medicines were reported. Treatment information included paracetamol for fever.  Company Comment: Based on current available information and the temporal association between product use and the start of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start of the events a causal relationship cannot be excluded.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Lack of spontaneous speech, Mental impairment
Clinical narrative: When patient was having conversations, patient often was drawing a blank; patient was not as sharp mentally; patient was not as sharp mentally, like patient was in a fog; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (patient was not as sharp mentally) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced MENTAL IMPAIRMENT (patient was not as sharp mentally) (seriousness criterion medically significant) and CONFUSIONAL STATE (patient was not as sharp mentally, like patient was in a fog). On an unknown date, the patient experienced LACK OF SPONTANEOUS SPEECH (When patient was having conversations, patient often was drawing a blank). At the time of the report, MENTAL IMPAIRMENT (patient was not as sharp mentally), CONFUSIONAL STATE (patient was not as sharp mentally, like patient was in a fog) and LACK OF SPONTANEOUS SPEECH (When patient was having conversations, patient often was drawing a blank) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. 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.; 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: F
Vaccine: COVID19
Symptoms: Arthralgia, Herpes zoster, Neuropathy peripheral, Pain in extremity
Clinical narrative: Serious neuropathy on both of my upper and lower extremities; Shingles; It's like there is a lightning bolt in my toes; Big flair up but it started to heal, on my spine and between my shoulder blade; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Serious neuropathy on both of my upper and lower extremities) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Triglycerides high and High cholesterol. Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (Serious neuropathy on both of my upper and lower extremities) (seriousness criterion medically significant), HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (It's like there is a lightning bolt in my toes) and ARTHRALGIA (Big flair up but it started to heal, on my spine and between my shoulder blade). At the time of the report, NEUROPATHY PERIPHERAL (Serious neuropathy on both of my upper and lower extremities), HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (It's like there is a lightning bolt in my toes) and ARTHRALGIA (Big flair up but it started to heal, on my spine and between my shoulder blade) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took Acylclovir for 10 days for shingles.  Company comment: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster .  Arthralgia is consistent with the product safety profile.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster .  Arthralgia is consistent with the product safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: Neuropathy on both of my upper and lower extremities; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy on both of my upper and lower extremities) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Triglycerides high and High cholesterol. Concomitant products included METFORMIN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy on both of my upper and lower extremities) (seriousness criterion medically significant) and HERPES ZOSTER (Shingles). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy on both of my upper and lower extremities) outcome was unknown and HERPES ZOSTER (Shingles) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment provided included acyclovir for the shingles.  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 03-May-2021: Follow-up report received on 03MAY2021 included no new information.; 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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypokinesia, Parkinson's disease
Clinical narrative: Parkinson's disease; movements reduced; tiredness; headache; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of PARKINSON'S DISEASE (Parkinson's disease) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PARKINSON'S DISEASE (Parkinson's disease) (seriousness criterion medically significant), HYPOKINESIA (movements reduced), FATIGUE (tiredness) and HEADACHE (headache). At the time of the report, PARKINSON'S DISEASE (Parkinson's disease), HYPOKINESIA (movements reduced), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case is reporter's husband case. The reporter's case number(case#MOD21-068417).  Very limited information regarding this events has been provided at this time.  However, 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: Very limited information regarding this events has been provided at this time.  However, 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: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Blood pressure measurement, Cerebral cyst, Computerised tomogram, Dizziness
Clinical narrative: Blood pressure under 40/60; cyst in the brain; lost his vision,; dizzy; turned white; couldn't speak; felt something on his back (like a pull on his back); eyes went back; arm hurts towards his chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (Blood pressure under 40/60), CEREBRAL CYST (cyst in the brain) and BLINDNESS (lost his vision,) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C221A) 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 MULTIVITAMIN & MINERAL and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced HYPOTENSION (Blood pressure under 40/60) (seriousness criterion hospitalization), CEREBRAL CYST (cyst in the brain) (seriousness criteria hospitalization and medically significant), BLINDNESS (lost his vision,) (seriousness criterion hospitalization), DIZZINESS (dizzy), PALLOR (turned white), SPEECH DISORDER (couldn't speak), FEELING ABNORMAL (felt something on his back (like a pull on his back)), EYE MOVEMENT DISORDER (eyes went back) and PAIN IN EXTREMITY (arm hurts towards his chest). At the time of the report, HYPOTENSION (Blood pressure under 40/60), CEREBRAL CYST (cyst in the brain), BLINDNESS (lost his vision,), DIZZINESS (dizzy), PALLOR (turned white), SPEECH DISORDER (couldn't speak), FEELING ABNORMAL (felt something on his back (like a pull on his back)), EYE MOVEMENT DISORDER (eyes went back) and PAIN IN EXTREMITY (arm hurts towards his chest) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Blood pressure measurement: 40/60 (Low) Low, 90/60 (Low) low and 150/69 (normal) normal. On 28-Apr-2021, Computerised tomogram: abnormal (abnormal) They found a cyst in the brain.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was specified.; Sender's Comments: Very limited information regarding this events has been provided at this time. However,  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. US-MODERNATX, INC.-MOD-2021-101752:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Eye movement disorder, Feeling abnormal, Hypotension, Pain in extremity, Pallor
Clinical narrative: Blood pressure under 40/60; cyst in the brain; lost his vision,; dizzy; turned white; couldn't speak; felt something on his back (like a pull on his back); eyes went back; arm hurts towards his chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (Blood pressure under 40/60), CEREBRAL CYST (cyst in the brain) and BLINDNESS (lost his vision,) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C221A) 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 MULTIVITAMIN & MINERAL and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced HYPOTENSION (Blood pressure under 40/60) (seriousness criterion hospitalization), CEREBRAL CYST (cyst in the brain) (seriousness criteria hospitalization and medically significant), BLINDNESS (lost his vision,) (seriousness criterion hospitalization), DIZZINESS (dizzy), PALLOR (turned white), SPEECH DISORDER (couldn't speak), FEELING ABNORMAL (felt something on his back (like a pull on his back)), EYE MOVEMENT DISORDER (eyes went back) and PAIN IN EXTREMITY (arm hurts towards his chest). At the time of the report, HYPOTENSION (Blood pressure under 40/60), CEREBRAL CYST (cyst in the brain), BLINDNESS (lost his vision,), DIZZINESS (dizzy), PALLOR (turned white), SPEECH DISORDER (couldn't speak), FEELING ABNORMAL (felt something on his back (like a pull on his back)), EYE MOVEMENT DISORDER (eyes went back) and PAIN IN EXTREMITY (arm hurts towards his chest) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Blood pressure measurement: 40/60 (Low) Low, 90/60 (Low) low and 150/69 (normal) normal. On 28-Apr-2021, Computerised tomogram: abnormal (abnormal) They found a cyst in the brain.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was specified.; Sender's Comments: Very limited information regarding this events has been provided at this time. However,  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. US-MODERNATX, INC.-MOD-2021-101752:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Blood pressure under 40/60; cyst in the brain; lost his vision,; dizzy; turned white; couldn't speak; felt something on his back (like a pull on his back); eyes went back; arm hurts towards his chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (Blood pressure under 40/60), CEREBRAL CYST (cyst in the brain) and BLINDNESS (lost his vision,) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C221A) 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 MULTIVITAMIN & MINERAL and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced HYPOTENSION (Blood pressure under 40/60) (seriousness criterion hospitalization), CEREBRAL CYST (cyst in the brain) (seriousness criteria hospitalization and medically significant), BLINDNESS (lost his vision,) (seriousness criterion hospitalization), DIZZINESS (dizzy), PALLOR (turned white), SPEECH DISORDER (couldn't speak), FEELING ABNORMAL (felt something on his back (like a pull on his back)), EYE MOVEMENT DISORDER (eyes went back) and PAIN IN EXTREMITY (arm hurts towards his chest). At the time of the report, HYPOTENSION (Blood pressure under 40/60), CEREBRAL CYST (cyst in the brain), BLINDNESS (lost his vision,), DIZZINESS (dizzy), PALLOR (turned white), SPEECH DISORDER (couldn't speak), FEELING ABNORMAL (felt something on his back (like a pull on his back)), EYE MOVEMENT DISORDER (eyes went back) and PAIN IN EXTREMITY (arm hurts towards his chest) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Blood pressure measurement: 40/60 (Low) Low, 90/60 (Low) low and 150/69 (normal) normal. On 28-Apr-2021, Computerised tomogram: abnormal (abnormal) They found a cyst in the brain.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was specified.; Sender's Comments: Very limited information regarding this events has been provided at this time. However,  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. US-MODERNATX, INC.-MOD-2021-101752:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis perforated, Large intestine perforation, Off label use, Post procedural infection
Clinical narrative: appendix burst; bowel leak where the appendix attaches to the bowel; fighting an infection after getting his Appendix out; about 65 days from first vaccine dose; This spontaneous case was reported by a patient and describes the occurrence of APPENDICITIS PERFORATED (appendix burst) and LARGE INTESTINE PERFORATION (bowel leak where the appendix attaches to the bowel) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced APPENDICITIS PERFORATED (appendix burst) (seriousness criterion hospitalization). On 06-Apr-2021, the patient experienced OFF LABEL USE (about 65 days from first vaccine dose). On an unknown date, the patient experienced LARGE INTESTINE PERFORATION (bowel leak where the appendix attaches to the bowel) (seriousness criterion hospitalization) and POST PROCEDURAL INFECTION (fighting an infection after getting his Appendix out). The patient was hospitalized for 14 days due to APPENDICITIS PERFORATED. The patient was treated with Surgery (appendix removed) for Appendicitis perforated. On 26-Feb-2021, APPENDICITIS PERFORATED (appendix burst) had resolved. On 06-Apr-2021, OFF LABEL USE (about 65 days from first vaccine dose) had resolved. At the time of the report, LARGE INTESTINE PERFORATION (bowel leak where the appendix attaches to the bowel) and POST PROCEDURAL INFECTION (fighting an infection after getting his Appendix out) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       Concomitant product use was not provided by the reporter. Treatment medication included antibiotics for 3 weeks. The patient was on total parenteral nutrition until last Saturday (understood as 01-May-2021).  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship in unlikely.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: additional events reported (fighting an infection after getting his Appendix out, about 65 days from first vaccine dose); Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship in unlikely.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Choking, Dyspnoea, Fatigue, Insomnia, Loss of personal independence in daily activities
Clinical narrative: this has prevented her from doing her exercises; couldnt sleep well due to pain; I cannot bend down; had never experienced a symptom like this one before, do not know how to explain it¨; Tired; choke with my breath; pain in ribs; pain internally in the lungs; I get out of breath when I'm speaking; normal mild pain in arm; swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (choke with my breath) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O1UC21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (normal mild pain in arm) and PERIPHERAL SWELLING (swelling in arm). On 30-Apr-2021, the patient experienced CHOKING (choke with my breath) (seriousness criterion medically significant), MUSCULOSKELETAL CHEST PAIN (pain in ribs), PULMONARY PAIN (pain internally in the lungs), DYSPNOEA (I get out of breath when I'm speaking), MOBILITY DECREASED (I cannot bend down), UNEVALUABLE EVENT (had never experienced a symptom like this one before, do not know how to explain it¨) and FATIGUE (Tired). On 03-May-2021, the patient experienced INSOMNIA (couldnt sleep well due to pain). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (this has prevented her from doing her exercises). On 03-May-2021, PAIN IN EXTREMITY (normal mild pain in arm) and PERIPHERAL SWELLING (swelling in arm) had resolved. At the time of the report, CHOKING (choke with my breath), MUSCULOSKELETAL CHEST PAIN (pain in ribs), PULMONARY PAIN (pain internally in the lungs), DYSPNOEA (I get out of breath when I'm speaking), INSOMNIA (couldnt sleep well due to pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (this has prevented her from doing her exercises), MOBILITY DECREASED (I cannot bend down), UNEVALUABLE EVENT (had never experienced a symptom like this one before, do not know how to explain it¨) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported. Treatment information was not provided.  Company comment:Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue is consistent with the product safety profile.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue is consistent with the product safety profile.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Musculoskeletal chest pain, Pain in extremity, Peripheral swelling, Pulmonary pain
Clinical narrative: this has prevented her from doing her exercises; couldnt sleep well due to pain; I cannot bend down; had never experienced a symptom like this one before, do not know how to explain it¨; Tired; choke with my breath; pain in ribs; pain internally in the lungs; I get out of breath when I'm speaking; normal mild pain in arm; swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (choke with my breath) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O1UC21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (normal mild pain in arm) and PERIPHERAL SWELLING (swelling in arm). On 30-Apr-2021, the patient experienced CHOKING (choke with my breath) (seriousness criterion medically significant), MUSCULOSKELETAL CHEST PAIN (pain in ribs), PULMONARY PAIN (pain internally in the lungs), DYSPNOEA (I get out of breath when I'm speaking), MOBILITY DECREASED (I cannot bend down), UNEVALUABLE EVENT (had never experienced a symptom like this one before, do not know how to explain it¨) and FATIGUE (Tired). On 03-May-2021, the patient experienced INSOMNIA (couldnt sleep well due to pain). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (this has prevented her from doing her exercises). On 03-May-2021, PAIN IN EXTREMITY (normal mild pain in arm) and PERIPHERAL SWELLING (swelling in arm) had resolved. At the time of the report, CHOKING (choke with my breath), MUSCULOSKELETAL CHEST PAIN (pain in ribs), PULMONARY PAIN (pain internally in the lungs), DYSPNOEA (I get out of breath when I'm speaking), INSOMNIA (couldnt sleep well due to pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (this has prevented her from doing her exercises), MOBILITY DECREASED (I cannot bend down), UNEVALUABLE EVENT (had never experienced a symptom like this one before, do not know how to explain it¨) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported. Treatment information was not provided.  Company comment:Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue is consistent with the product safety profile.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue is consistent with the product safety profile.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: this has prevented her from doing her exercises; couldnt sleep well due to pain; I cannot bend down; had never experienced a symptom like this one before, do not know how to explain it¨; Tired; choke with my breath; pain in ribs; pain internally in the lungs; I get out of breath when I'm speaking; normal mild pain in arm; swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (choke with my breath) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O1UC21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (normal mild pain in arm) and PERIPHERAL SWELLING (swelling in arm). On 30-Apr-2021, the patient experienced CHOKING (choke with my breath) (seriousness criterion medically significant), MUSCULOSKELETAL CHEST PAIN (pain in ribs), PULMONARY PAIN (pain internally in the lungs), DYSPNOEA (I get out of breath when I'm speaking), MOBILITY DECREASED (I cannot bend down), UNEVALUABLE EVENT (had never experienced a symptom like this one before, do not know how to explain it¨) and FATIGUE (Tired). On 03-May-2021, the patient experienced INSOMNIA (couldnt sleep well due to pain). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (this has prevented her from doing her exercises). On 03-May-2021, PAIN IN EXTREMITY (normal mild pain in arm) and PERIPHERAL SWELLING (swelling in arm) had resolved. At the time of the report, CHOKING (choke with my breath), MUSCULOSKELETAL CHEST PAIN (pain in ribs), PULMONARY PAIN (pain internally in the lungs), DYSPNOEA (I get out of breath when I'm speaking), INSOMNIA (couldnt sleep well due to pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (this has prevented her from doing her exercises), MOBILITY DECREASED (I cannot bend down), UNEVALUABLE EVENT (had never experienced a symptom like this one before, do not know how to explain it¨) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported. Treatment information was not provided.  Company comment:Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue is consistent with the product safety profile.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue is consistent with the product safety profile.