chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure decreased, Blood pressure measurement, Breast induration, Dizziness
Clinical narrative: hard section on her left breast; whole left side of her chest and breast is red till her arm; had a "mini" anxiety; light headed, passed out and fell cold flat on the floor; Blood pressure dropped; fever; passed out and fell cold flat on the floor; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out and fell cold flat on the floor) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out and fell cold flat on the floor) (seriousness criterion medically significant), ANXIETY (had a "mini" anxiety), DIZZINESS (light headed, passed out and fell cold flat on the floor), BLOOD PRESSURE DECREASED (Blood pressure dropped) and PYREXIA (fever). On 20-Apr-2021, the patient experienced BREAST INDURATION (hard section on her left breast) and ERYTHEMA (whole left side of her chest and breast is red till her arm). On 17-Apr-2021, LOSS OF CONSCIOUSNESS (passed out and fell cold flat on the floor) outcome was unknown. At the time of the report, BREAST INDURATION (hard section on her left breast), ERYTHEMA (whole left side of her chest and breast is red till her arm), ANXIETY (had a "mini" anxiety), DIZZINESS (light headed, passed out and fell cold flat on the floor), BLOOD PRESSURE DECREASED (Blood pressure dropped) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Blood pressure measurement: low blood pressure dropped.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment included acetaminophen.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Loss of consciousness, Pyrexia
Clinical narrative: hard section on her left breast; whole left side of her chest and breast is red till her arm; had a "mini" anxiety; light headed, passed out and fell cold flat on the floor; Blood pressure dropped; fever; passed out and fell cold flat on the floor; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out and fell cold flat on the floor) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out and fell cold flat on the floor) (seriousness criterion medically significant), ANXIETY (had a "mini" anxiety), DIZZINESS (light headed, passed out and fell cold flat on the floor), BLOOD PRESSURE DECREASED (Blood pressure dropped) and PYREXIA (fever). On 20-Apr-2021, the patient experienced BREAST INDURATION (hard section on her left breast) and ERYTHEMA (whole left side of her chest and breast is red till her arm). On 17-Apr-2021, LOSS OF CONSCIOUSNESS (passed out and fell cold flat on the floor) outcome was unknown. At the time of the report, BREAST INDURATION (hard section on her left breast), ERYTHEMA (whole left side of her chest and breast is red till her arm), ANXIETY (had a "mini" anxiety), DIZZINESS (light headed, passed out and fell cold flat on the floor), BLOOD PRESSURE DECREASED (Blood pressure dropped) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Blood pressure measurement: low blood pressure dropped.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment included acetaminophen.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Friend of mine mother is in the hospital for the same thing severe nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NAUSEA (Friend of mine mother is in the hospital for the same thing severe nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified. Concurrent medical conditions included Diabetes and Kidney disorder.   On 24-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 27-Mar-2021, the patient experienced NAUSEA (Friend of mine mother is in the hospital for the same thing severe nausea) (seriousness criterion hospitalization). The patient was hospitalized from 27-Mar-2021 to 06-Apr-2021 due to NAUSEA. At the time of the report, NAUSEA (Friend of mine mother is in the hospital for the same thing severe nausea) outcome was unknown.            Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD21-079111 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-079111:original case
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fall, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19; sore throat; runny nose; Incontinent of diarrhea stool; falling out of bed; Sore injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Heart disease, unspecified.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site). On 12-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) (seriousness criterion hospitalization), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), DIARRHOEA (Incontinent of diarrhea stool) and FALL (falling out of bed). The patient was hospitalized from 15-Apr-2021 to 19-Apr-2021 due to SARS-COV-2 TEST POSITIVE. At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), DIARRHOEA (Incontinent of diarrhea stool), FALL (falling out of bed) and VACCINATION SITE PAIN (Sore injection site) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment included convalescent plasma and Remdesivir. Action taken with mRNA-1273 in response to the event 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.   This case was linked to MOD-2021-082094 (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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: tested positive for Covid-19; sore throat; runny nose; Incontinent of diarrhea stool; falling out of bed; Sore injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Heart disease, unspecified.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site). On 12-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) (seriousness criterion hospitalization), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), DIARRHOEA (Incontinent of diarrhea stool) and FALL (falling out of bed). The patient was hospitalized from 15-Apr-2021 to 19-Apr-2021 due to SARS-COV-2 TEST POSITIVE. At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), DIARRHOEA (Incontinent of diarrhea stool), FALL (falling out of bed) and VACCINATION SITE PAIN (Sore injection site) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment included convalescent plasma and Remdesivir. Action taken with mRNA-1273 in response to the event 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.   This case was linked to MOD-2021-082094 (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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Miscarriage; Patient was unaware that she was pregnant; This spontaneous case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pregnancy test (Negative home pregnancy test.) on 02-Mar-2021.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient was unaware that she was pregnant). On 19-Mar-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and EXPOSURE DURING PREGNANCY (Patient was unaware that she was pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment or concomitant mediation were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Pain in extremity, Sciatic nerve neuropathy
Clinical narrative: sciatic nerve neuropathy; Fatigue; vomiting; leg pain; pain in hip; Back pain; This spontaneous case was reported by a physician and describes the occurrence of SCIATIC NERVE NEUROPATHY (sciatic nerve neuropathy), FATIGUE (Fatigue), VOMITING (vomiting), PAIN IN EXTREMITY (leg pain), ARTHRALGIA (pain in hip) and BACK PAIN (Back pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCIATIC NERVE NEUROPATHY (sciatic nerve neuropathy) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), VOMITING (vomiting) (seriousness criterion medically significant), PAIN IN EXTREMITY (leg pain) (seriousness criterion medically significant), ARTHRALGIA (pain in hip) (seriousness criterion medically significant) and BACK PAIN (Back pain) (seriousness criterion medically significant). At the time of the report, SCIATIC NERVE NEUROPATHY (sciatic nerve neuropathy), PAIN IN EXTREMITY (leg pain), ARTHRALGIA (pain in hip) and BACK PAIN (Back pain) had not resolved and FATIGUE (Fatigue) and VOMITING (vomiting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No corrective treatment was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: sciatic nerve neuropathy; Fatigue; vomiting; leg pain; pain in hip; Back pain; This spontaneous case was reported by a physician and describes the occurrence of SCIATIC NERVE NEUROPATHY (sciatic nerve neuropathy), FATIGUE (Fatigue), VOMITING (vomiting), PAIN IN EXTREMITY (leg pain), ARTHRALGIA (pain in hip) and BACK PAIN (Back pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCIATIC NERVE NEUROPATHY (sciatic nerve neuropathy) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), VOMITING (vomiting) (seriousness criterion medically significant), PAIN IN EXTREMITY (leg pain) (seriousness criterion medically significant), ARTHRALGIA (pain in hip) (seriousness criterion medically significant) and BACK PAIN (Back pain) (seriousness criterion medically significant). At the time of the report, SCIATIC NERVE NEUROPATHY (sciatic nerve neuropathy), PAIN IN EXTREMITY (leg pain), ARTHRALGIA (pain in hip) and BACK PAIN (Back pain) had not resolved and FATIGUE (Fatigue) and VOMITING (vomiting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No corrective treatment was reported.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Faintness; Eyes are yellow; Stomach cramps; Diarrhea; Can't sleep; Feeling unwell; Dizzy; Chills; Light headache; Nausea; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faintness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    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 SYNCOPE (Faintness) (seriousness criterion medically significant), OCULAR ICTERUS (Eyes are yellow), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), SLEEP DISORDER (Can't sleep), MALAISE (Feeling unwell), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Light headache), NAUSEA (Nausea) and FATIGUE (Tiredness). At the time of the report, SYNCOPE (Faintness), OCULAR ICTERUS (Eyes are yellow), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), SLEEP DISORDER (Can't sleep), MALAISE (Feeling unwell), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Light headache), NAUSEA (Nausea) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Ocular icterus, Sleep disorder
Clinical narrative: Faintness; Eyes are yellow; Stomach cramps; Diarrhea; Can't sleep; Feeling unwell; Dizzy; Chills; Light headache; Nausea; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faintness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    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 SYNCOPE (Faintness) (seriousness criterion medically significant), OCULAR ICTERUS (Eyes are yellow), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), SLEEP DISORDER (Can't sleep), MALAISE (Feeling unwell), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Light headache), NAUSEA (Nausea) and FATIGUE (Tiredness). At the time of the report, SYNCOPE (Faintness), OCULAR ICTERUS (Eyes are yellow), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), SLEEP DISORDER (Can't sleep), MALAISE (Feeling unwell), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Light headache), NAUSEA (Nausea) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Faintness; Eyes are yellow; Stomach cramps; Diarrhea; Can't sleep; Feeling unwell; Dizzy; Chills; Light headache; Nausea; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faintness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    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 SYNCOPE (Faintness) (seriousness criterion medically significant), OCULAR ICTERUS (Eyes are yellow), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), SLEEP DISORDER (Can't sleep), MALAISE (Feeling unwell), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Light headache), NAUSEA (Nausea) and FATIGUE (Tiredness). At the time of the report, SYNCOPE (Faintness), OCULAR ICTERUS (Eyes are yellow), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), SLEEP DISORDER (Can't sleep), MALAISE (Feeling unwell), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Light headache), NAUSEA (Nausea) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Illness, Pyrexia
Clinical narrative: Aggrevated ankylosing spondylitis; Sickness; Fatigue; Joint Pain; Headache; Fever; This spontaneous case was reported by a physician and describes the occurrence of ANKYLOSING SPONDYLITIS (Aggrevated ankylosing spondylitis) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MELOXICAM and ADALIMUMAB (HUMIRA) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced ILLNESS (Sickness), FATIGUE (Fatigue), ARTHRALGIA (Joint Pain), HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Aggrevated ankylosing spondylitis) (seriousness criterion medically significant). At the time of the report, ANKYLOSING SPONDYLITIS (Aggrevated ankylosing spondylitis), ILLNESS (Sickness), FATIGUE (Fatigue), ARTHRALGIA (Joint Pain), HEADACHE (Headache) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ILLNESS (Sickness), FATIGUE (Fatigue), ARTHRALGIA (Joint Pain), HEADACHE (Headache) and PYREXIA (Fever) to be probably related and ANKYLOSING SPONDYLITIS (Aggrevated ankylosing spondylitis) to be not related.    Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events was not applicable.  Company comment: This case concerns a 39-year-old female with a serious unexpected event of ankylosing spondylitis exacerbation, and no serious unexpected illness, and expected pyrexia, fatigue, headache, arthralgia. Event onset the same day as after second dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-082546 (Patient Link).; Sender's Comments: This case concerns a 39-year-old female with a serious unexpected event of ankylosing spondylitis exacerbation, and nonserious unexpected illness, and expected pyrexia, fatigue, headache, arthralgia. Event onset the same day as after second dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Suicidal ideation
Clinical narrative: suicidal thoughts; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SUICIDAL IDEATION (suicidal thoughts) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUICIDAL IDEATION (suicidal thoughts) (seriousness criterion medically significant). At the time of the report, SUICIDAL IDEATION (suicidal thoughts) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.   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.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced HERPES ZOSTER (shingles) (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER (shingles) 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  No concomitant medication reported.  The patient was taking valacyclovir, gabapentin and hydrocodone for the treatment of shingles.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram, Dyspnoea, Intentional product use issue
Clinical narrative: Was scheduled for 2nd dose 10Apr2021, caller felt body was not in best shape to receive dose, so declined vaccine; Seizure like activity; Jaw pain; Chest pain; Shortness of breath; Soreness to arm at site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE LIKE PHENOMENA (Seizure like activity) in a 53-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 Seizure like phenomena since an unknown date. Concurrent medical conditions included Brain neoplasm malignant. Concomitant products included LACOSAMIDE (VIMPAT) and PREDNISONE for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath) and VACCINATION SITE PAIN (Soreness to arm at site of injection). On 18-Mar-2021, the patient experienced PAIN IN JAW (Jaw pain) and CHEST PAIN (Chest pain). On 02-Apr-2021, the patient experienced SEIZURE LIKE PHENOMENA (Seizure like activity) (seriousness criterion medically significant). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Was scheduled for 2nd dose 10Apr2021, caller felt body was not in best shape to receive dose, so declined vaccine). At the time of the report, SEIZURE LIKE PHENOMENA (Seizure like activity), PAIN IN JAW (Jaw pain), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), VACCINATION SITE PAIN (Soreness to arm at site of injection) and INTENTIONAL PRODUCT USE ISSUE (Was scheduled for 2nd dose 10Apr2021, caller felt body was not in best shape to receive dose, so declined vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: elevated dimer (High) elevated dimer. On an unknown date, Computerised tomogram: unknown (Inconclusive) unknown. On an unknown date, Magnetic resonance imaging: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes Vimpat, Prednisone.  Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain in jaw, Seizure like phenomena, Vaccination site pain
Clinical narrative: Was scheduled for 2nd dose 10Apr2021, caller felt body was not in best shape to receive dose, so declined vaccine; Seizure like activity; Jaw pain; Chest pain; Shortness of breath; Soreness to arm at site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE LIKE PHENOMENA (Seizure like activity) in a 53-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 Seizure like phenomena since an unknown date. Concurrent medical conditions included Brain neoplasm malignant. Concomitant products included LACOSAMIDE (VIMPAT) and PREDNISONE for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath) and VACCINATION SITE PAIN (Soreness to arm at site of injection). On 18-Mar-2021, the patient experienced PAIN IN JAW (Jaw pain) and CHEST PAIN (Chest pain). On 02-Apr-2021, the patient experienced SEIZURE LIKE PHENOMENA (Seizure like activity) (seriousness criterion medically significant). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Was scheduled for 2nd dose 10Apr2021, caller felt body was not in best shape to receive dose, so declined vaccine). At the time of the report, SEIZURE LIKE PHENOMENA (Seizure like activity), PAIN IN JAW (Jaw pain), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), VACCINATION SITE PAIN (Soreness to arm at site of injection) and INTENTIONAL PRODUCT USE ISSUE (Was scheduled for 2nd dose 10Apr2021, caller felt body was not in best shape to receive dose, so declined vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: elevated dimer (High) elevated dimer. On an unknown date, Computerised tomogram: unknown (Inconclusive) unknown. On an unknown date, Magnetic resonance imaging: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes Vimpat, Prednisone.  Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Concussion, Dizziness, Pain in extremity
Clinical narrative: Fainted; Concussion; Dizziness / Light-headed; Vertigo; Loss of  taste; Lost sense of smell; Soreness in the arm; This spontaneous case was reported by a physician assistant and describes the occurrence of SYNCOPE (Fainted) and CONCUSSION (Concussion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid activity decreased and Allergy (Undefined allergies). Concomitant products included CLARITHROMYCIN (CLARITRON) for Allergy, THYROID for Thyroid activity decreased.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). On 17-Apr-2021, the patient experienced VERTIGO CNS ORIGIN (Vertigo), AGEUSIA (Loss of  taste) and ANOSMIA (Lost sense of smell). On 18-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), CONCUSSION (Concussion) (seriousness criterion medically significant) and DIZZINESS (Dizziness / Light-headed). On 18-Apr-2021, SYNCOPE (Fainted) had resolved. At the time of the report, CONCUSSION (Concussion), AGEUSIA (Loss of  taste) and ANOSMIA (Lost sense of smell) outcome was unknown and DIZZINESS (Dizziness / Light-headed), PAIN IN EXTREMITY (Soreness in the arm) and VERTIGO CNS ORIGIN (Vertigo) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received her first dose of the Moderna COVID-19 vaccine on Friday (16-Apr-2021) morning in the left arm and had very minimal symptoms, just soreness in the arm.   On Saturday evening, she experienced dizziness, was light-headed and fainted  She had a concussion because she fell on the floor in her home.   She is currently experiencing vertigo and still feels dizzy and light-headed, probably as a result of the concussion.   She lost her sense of taste and smell more than likely as a consequence of the concussion. Her arm is still a little bit sore.  Treatment for the events: Tylenol (acetaminophen) and Benadryl (diphenhydramine) to sleep at night.  company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vertigo CNS origin
Clinical narrative: Fainted; Concussion; Dizziness / Light-headed; Vertigo; Loss of  taste; Lost sense of smell; Soreness in the arm; This spontaneous case was reported by a physician assistant and describes the occurrence of SYNCOPE (Fainted) and CONCUSSION (Concussion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid activity decreased and Allergy (Undefined allergies). Concomitant products included CLARITHROMYCIN (CLARITRON) for Allergy, THYROID for Thyroid activity decreased.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). On 17-Apr-2021, the patient experienced VERTIGO CNS ORIGIN (Vertigo), AGEUSIA (Loss of  taste) and ANOSMIA (Lost sense of smell). On 18-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), CONCUSSION (Concussion) (seriousness criterion medically significant) and DIZZINESS (Dizziness / Light-headed). On 18-Apr-2021, SYNCOPE (Fainted) had resolved. At the time of the report, CONCUSSION (Concussion), AGEUSIA (Loss of  taste) and ANOSMIA (Lost sense of smell) outcome was unknown and DIZZINESS (Dizziness / Light-headed), PAIN IN EXTREMITY (Soreness in the arm) and VERTIGO CNS ORIGIN (Vertigo) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received her first dose of the Moderna COVID-19 vaccine on Friday (16-Apr-2021) morning in the left arm and had very minimal symptoms, just soreness in the arm.   On Saturday evening, she experienced dizziness, was light-headed and fainted  She had a concussion because she fell on the floor in her home.   She is currently experiencing vertigo and still feels dizzy and light-headed, probably as a result of the concussion.   She lost her sense of taste and smell more than likely as a consequence of the concussion. Her arm is still a little bit sore.  Treatment for the events: Tylenol (acetaminophen) and Benadryl (diphenhydramine) to sleep at night.  company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Hypotension, Loss of consciousness
Clinical narrative: Blood pressure low; Rash on the stomach, chest, arms, thighs, toes, legs and face; Chills; Tremendous headache; Fever of 100.5; Weakness; Collasped; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Collasped) and HYPOTENSION (Blood pressure low) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Collasped) (seriousness criterion medically significant) and ASTHENIA (Weakness). On 30-Mar-2021, the patient experienced CHILLS (Chills), HEADACHE (Tremendous headache) and PYREXIA (Fever of 100.5). On 01-Apr-2021, the patient experienced HYPOTENSION (Blood pressure low) (seriousness criterion hospitalization) and RASH (Rash on the stomach, chest, arms, thighs, toes, legs and face). On 29-Mar-2021, LOSS OF CONSCIOUSNESS (Collasped) had resolved. At the time of the report, HYPOTENSION (Blood pressure low), ASTHENIA (Weakness), CHILLS (Chills), HEADACHE (Tremendous headache) and PYREXIA (Fever of 100.5) outcome was unknown and RASH (Rash on the stomach, chest, arms, thighs, toes, legs and face) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Pyrexia: 100.5 Patient experienced fever of 100.5..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included diphenhydramine and acetaminophen.   On 01 Apr 2021, the patient experienced a fever of 100.5 degree Fahrenheit and noted a rash to the stomach. The patient then called 911. The paramedics checked the patient out and noted patient's blood pressure to be low and was taken to the hospital.   On unknown date, the patient was discharged home after receiving some unspecified medications.  On 02 Apr 2021, the patient reported the rash was full blown, was on the stomach, chest, arms, thighs, toes, legs and face. The rash subsided on unknown date.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Blood pressure low; Rash on the stomach, chest, arms, thighs, toes, legs and face; Chills; Tremendous headache; Fever of 100.5; Weakness; Collasped; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Collasped) and HYPOTENSION (Blood pressure low) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Collasped) (seriousness criterion medically significant) and ASTHENIA (Weakness). On 30-Mar-2021, the patient experienced CHILLS (Chills), HEADACHE (Tremendous headache) and PYREXIA (Fever of 100.5). On 01-Apr-2021, the patient experienced HYPOTENSION (Blood pressure low) (seriousness criterion hospitalization) and RASH (Rash on the stomach, chest, arms, thighs, toes, legs and face). On 29-Mar-2021, LOSS OF CONSCIOUSNESS (Collasped) had resolved. At the time of the report, HYPOTENSION (Blood pressure low), ASTHENIA (Weakness), CHILLS (Chills), HEADACHE (Tremendous headache) and PYREXIA (Fever of 100.5) outcome was unknown and RASH (Rash on the stomach, chest, arms, thighs, toes, legs and face) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Pyrexia: 100.5 Patient experienced fever of 100.5..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included diphenhydramine and acetaminophen.   On 01 Apr 2021, the patient experienced a fever of 100.5 degree Fahrenheit and noted a rash to the stomach. The patient then called 911. The paramedics checked the patient out and noted patient's blood pressure to be low and was taken to the hospital.   On unknown date, the patient was discharged home after receiving some unspecified medications.  On 02 Apr 2021, the patient reported the rash was full blown, was on the stomach, chest, arms, thighs, toes, legs and face. The rash subsided on unknown date.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage, Hypoaesthesia, Tinnitus
Clinical narrative: Broken blood vessels in left eye; Slight face numbness; Ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (Broken blood vessels in left eye) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 20-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) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced TINNITUS (Ringing in ears). On 20-Apr-2021, the patient experienced HYPOAESTHESIA (Slight face numbness). On 21-Apr-2021, the patient experienced CONJUNCTIVAL HAEMORRHAGE (Broken blood vessels in left eye) (seriousness criterion medically significant). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (Broken blood vessels in left eye) and HYPOAESTHESIA (Slight face numbness) outcome was unknown and TINNITUS (Ringing in ears) had not resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided.  Company comment:This case concerns a 41-year-old female with a serious unexpected event of conjunctival hemorrhage, and nonserious unexpected hypoaesthesia and ongoing tinnitus. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Tinnitus ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-083153 (E2B Linked Report).; Sender's Comments: This case concerns a 41-year-old female with a serious unexpected event of conjunctival hemorrhage, and nonserious unexpected hypoaesthesia and ongoing tinnitus. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Tinnitus ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD-2021-083153:CROSS LINKED WITH DOSE 1
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Coma, Dyspnoea
Clinical narrative: could not breath; in induced coma; went into cardiac arrest; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COMA (in induced coma), CARDIAC ARREST (went into cardiac arrest) and DYSPNOEA (could not breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043021A and 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 18-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 19-Apr-2021, the patient experienced COMA (in induced coma) (seriousness criterion hospitalization) and CARDIAC ARREST (went into cardiac arrest) (seriousness criterion hospitalization). On 19-Apr-2021 at 1:00 AM, the patient experienced DYSPNOEA (could not breath) (seriousness criterion hospitalization). The patient was hospitalized on 19-Apr-2020 due to COMA, then on 19-Apr-2021 due to CARDIAC ARREST and DYSPNOEA. The patient was treated with Manual therapy (CPR) for Cardiac arrest and Manual therapy (CPR) for Dyspnoea. At the time of the report, COMA (in induced coma), CARDIAC ARREST (went into cardiac arrest) and DYSPNOEA (could not breath) outcome was unknown.            No concomitant medications were reported.  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.