chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Diabetes mellitus, Gait disturbance, Muscle spasms, Restless legs syndrome
Clinical narrative: Diabetes; Severe leg cramps made walking difficult; Dehydrated; Restless leg syndrome; Severe leg cramps; Rash on arm following second dose of COVID vaccine; This spontaneous case was reported by a physician and describes the occurrence of DIABETES MELLITUS (Diabetes) in a 58-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.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included UPADACITINIB (RINVOQ) 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 DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant), GAIT DISTURBANCE (Severe leg cramps made walking difficult), DEHYDRATION (Dehydrated), RESTLESS LEGS SYNDROME (Restless leg syndrome), MUSCLE SPASMS (Severe leg cramps) and VACCINATION SITE RASH (Rash on arm following second dose of COVID vaccine). At the time of the report, DIABETES MELLITUS (Diabetes) and RESTLESS LEGS SYNDROME (Restless leg syndrome) outcome was unknown and GAIT DISTURBANCE (Severe leg cramps made walking difficult), DEHYDRATION (Dehydrated), MUSCLE SPASMS (Severe leg cramps) and VACCINATION SITE RASH (Rash on arm following second dose of COVID vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE RASH (Rash on arm following second dose of COVID vaccine) to be probably related. No further causality assessments were provided for DIABETES MELLITUS (Diabetes), GAIT DISTURBANCE (Severe leg cramps made walking difficult), DEHYDRATION (Dehydrated), RESTLESS LEGS SYNDROME (Restless leg syndrome) and MUSCLE SPASMS (Severe leg cramps).    No concomitant medications provided. No treatment information provided.  Based on the current available information and temporal association between the use of the product and the start of diabetes mellitus, gait disturbance, dehydration and restless leg syndrome, muscle spasm,  vaccination site rash, 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 of diabetes mellitus, gait disturbance, dehydration and restless leg syndrome, muscle spasm,  vaccination site rash, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Diabetes; Severe leg cramps made walking difficult; Dehydrated; Restless leg syndrome; Severe leg cramps; Rash on arm following second dose of COVID vaccine; This spontaneous case was reported by a physician and describes the occurrence of DIABETES MELLITUS (Diabetes) in a 58-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.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included UPADACITINIB (RINVOQ) 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 DIABETES MELLITUS (Diabetes) (seriousness criterion medically significant), GAIT DISTURBANCE (Severe leg cramps made walking difficult), DEHYDRATION (Dehydrated), RESTLESS LEGS SYNDROME (Restless leg syndrome), MUSCLE SPASMS (Severe leg cramps) and VACCINATION SITE RASH (Rash on arm following second dose of COVID vaccine). At the time of the report, DIABETES MELLITUS (Diabetes) and RESTLESS LEGS SYNDROME (Restless leg syndrome) outcome was unknown and GAIT DISTURBANCE (Severe leg cramps made walking difficult), DEHYDRATION (Dehydrated), MUSCLE SPASMS (Severe leg cramps) and VACCINATION SITE RASH (Rash on arm following second dose of COVID vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE RASH (Rash on arm following second dose of COVID vaccine) to be probably related. No further causality assessments were provided for DIABETES MELLITUS (Diabetes), GAIT DISTURBANCE (Severe leg cramps made walking difficult), DEHYDRATION (Dehydrated), RESTLESS LEGS SYNDROME (Restless leg syndrome) and MUSCLE SPASMS (Severe leg cramps).    No concomitant medications provided. No treatment information provided.  Based on the current available information and temporal association between the use of the product and the start of diabetes mellitus, gait disturbance, dehydration and restless leg syndrome, muscle spasm,  vaccination site rash, 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 of diabetes mellitus, gait disturbance, dehydration and restless leg syndrome, muscle spasm,  vaccination site rash, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Product dose omission issue
Clinical narrative: stroke; Caller would like to know if can get the second shot now; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-May-2021 and was forwarded to Moderna on 07-May-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Caller would like to know if can get the second shot now). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Caller would like to know if can get the second shot now) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information provided. No treatment information provided.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cerebrovascular accident, Diarrhoea, Dizziness, Eye disorder
Clinical narrative: stroke; feeling exhausted; problems with her eye after the stroke; threw up everything/ vomiting; fever; diarrhea; no energy; dizzy; nauseous; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 39-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.     Concurrent medical conditions included Osteoporosis and Common variable immunodeficiency. Concomitant products included ZOLEDRONIC ACID (RECLAST) for Osteoporosis, LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication.   On 02-May-2021 at 10:20 AM, 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 02-May-2021, the patient experienced DIZZINESS (dizzy) and NAUSEA (nauseous). On 03-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant), DIARRHOEA (diarrhea), ASTHENIA (no energy), VOMITING (threw up everything/ vomiting) and PYREXIA (fever). On 04-May-2021, the patient experienced EYE DISORDER (problems with her eye after the stroke). On 07-May-2021, the patient experienced FATIGUE (feeling exhausted). The patient was hospitalized from 03-May-2021 to 04-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), DIARRHOEA (diarrhea), ASTHENIA (no energy) and VOMITING (threw up everything/ vomiting) outcome was unknown and DIZZINESS (dizzy), EYE DISORDER (problems with her eye after the stroke), NAUSEA (nauseous), PYREXIA (fever) and FATIGUE (feeling exhausted) had not resolved.            Patient gets Immunoglobin infusion for autoimmune disease Common variable immunodeficiency (CVID). At the hospital patient was treated with intravenous medication, blood thinners and she took Ibuprofen.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the 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.   This case was linked to MOD-2021-106750 (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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: stroke; feeling exhausted; problems with her eye after the stroke; threw up everything/ vomiting; fever; diarrhea; no energy; dizzy; nauseous; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 39-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.     Concurrent medical conditions included Osteoporosis and Common variable immunodeficiency. Concomitant products included ZOLEDRONIC ACID (RECLAST) for Osteoporosis, LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication.   On 02-May-2021 at 10:20 AM, 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 02-May-2021, the patient experienced DIZZINESS (dizzy) and NAUSEA (nauseous). On 03-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant), DIARRHOEA (diarrhea), ASTHENIA (no energy), VOMITING (threw up everything/ vomiting) and PYREXIA (fever). On 04-May-2021, the patient experienced EYE DISORDER (problems with her eye after the stroke). On 07-May-2021, the patient experienced FATIGUE (feeling exhausted). The patient was hospitalized from 03-May-2021 to 04-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), DIARRHOEA (diarrhea), ASTHENIA (no energy) and VOMITING (threw up everything/ vomiting) outcome was unknown and DIZZINESS (dizzy), EYE DISORDER (problems with her eye after the stroke), NAUSEA (nauseous), PYREXIA (fever) and FATIGUE (feeling exhausted) had not resolved.            Patient gets Immunoglobin infusion for autoimmune disease Common variable immunodeficiency (CVID). At the hospital patient was treated with intravenous medication, blood thinners and she took Ibuprofen.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the 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.   This case was linked to MOD-2021-106750 (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: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Oxygen saturation abnormal, Product dose omission issue, Pulmonary embolism
Clinical narrative: Blood Clot Left Lung; Has not received 2nd dose; ow 90's and high 50s oxygen levels; Feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood Clot Left Lung) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Chronic kidney disease, Thrombus and Cancer. Concomitant products included SODIUM BICARBONATE (SODIUM BICARB.PED), HYDRALAZINE, Folic Acid, SEVELAMER CARBONATE (RENVELA), AMLODIPINE BESILATE (AMLODIPINE (ALS BESILAAT) SANDOZ), FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K), PRAVASTATIN and MONTELUKAST for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PULMONARY EMBOLISM (Blood Clot Left Lung) (seriousness criteria hospitalization and medically significant), OXYGEN SATURATION ABNORMAL (ow 90's and high 50s oxygen levels) and FEELING ABNORMAL (Feeling bad). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose). At the time of the report, PULMONARY EMBOLISM (Blood Clot Left Lung), OXYGEN SATURATION ABNORMAL (ow 90's and high 50s oxygen levels), FEELING ABNORMAL (Feeling bad) and PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment with warfarin to treat the blood clot as provided by the patient.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD21-087825, US-MODERNATX, INC.-MOD-2021-114702 (E2B Linked Report).; 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 cannot be excluded. US-MODERNATX, INC.-MOD-2021-114702:Case for husband
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pyrexia, Syncope, Vaccination site pruritus
Clinical narrative: swollen right arm; rash in the right arm; she fainted; flu like symptoms; fever; tiredness; itchiness in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (she fainted) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever) and FATIGUE (tiredness). On 03-May-2021, the patient experienced SYNCOPE (she fainted) (seriousness criterion medically significant). On 07-May-2021, the patient experienced VACCINATION SITE SWELLING (swollen right arm) and VACCINATION SITE RASH (rash in the right arm). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchiness in the right arm). At the time of the report, SYNCOPE (she fainted), INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PRURITUS (itchiness in the right arm), VACCINATION SITE SWELLING (swollen right arm), VACCINATION SITE RASH (rash in the right arm), PYREXIA (fever) and FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: swollen right arm; rash in the right arm; she fainted; flu like symptoms; fever; tiredness; itchiness in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (she fainted) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever) and FATIGUE (tiredness). On 03-May-2021, the patient experienced SYNCOPE (she fainted) (seriousness criterion medically significant). On 07-May-2021, the patient experienced VACCINATION SITE SWELLING (swollen right arm) and VACCINATION SITE RASH (rash in the right arm). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchiness in the right arm). At the time of the report, SYNCOPE (she fainted), INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PRURITUS (itchiness in the right arm), VACCINATION SITE SWELLING (swollen right arm), VACCINATION SITE RASH (rash in the right arm), PYREXIA (fever) and FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Herpes zoster, Product dose omission issue, Pruritus, Vaccination site discolouration
Clinical narrative: beyond 36 days since first dose; diagnosed with shingles; now plum; bumps; itchy; itchy; bright red; left arm rash; hemorrhage in her right eye after dental work; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE HAEMORRHAGE (hemorrhage in her right eye after dental work) and HERPES ZOSTER (diagnosed with shingles) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high, Shingles (at age 30) and H1N1 influenza in 2009. Previously administered products included for Product used for unknown indication: varicella zoster in November 2020 and varicella zoster on 06-Mar-2021. Past adverse reactions to the above products included No adverse event with varicella zoster and varicella zoster.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced EYE HAEMORRHAGE (hemorrhage in her right eye after dental work) (seriousness criterion medically significant). On 04-May-2021, the patient experienced VACCINATION SITE DISCOLOURATION (now plum), VACCINATION SITE MASS (bumps), PRURITUS (itchy), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (bright red) and VACCINATION SITE RASH (left arm rash). On 06-May-2021, the patient experienced HERPES ZOSTER (diagnosed with shingles) (seriousness criterion medically significant). On 07-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (beyond 36 days since first dose). At the time of the report, EYE HAEMORRHAGE (hemorrhage in her right eye after dental work), HERPES ZOSTER (diagnosed with shingles), VACCINATION SITE DISCOLOURATION (now plum), VACCINATION SITE MASS (bumps), PRODUCT DOSE OMISSION ISSUE (beyond 36 days since first dose), PRURITUS (itchy), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (bright red) and VACCINATION SITE RASH (left arm rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was given a "pain medication" from the ER on 04MAY2021 and valacyclovir on 06MAY2021 when she was diagnosed with shingles. Valacyclovir was prescribed as treatment for shingles.    The patient does not want her second dose, which has been postponed from 23APR2021 to 17MAY2021, and instead wants to wait for a "booster shot".  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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site rash
Clinical narrative: beyond 36 days since first dose; diagnosed with shingles; now plum; bumps; itchy; itchy; bright red; left arm rash; hemorrhage in her right eye after dental work; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE HAEMORRHAGE (hemorrhage in her right eye after dental work) and HERPES ZOSTER (diagnosed with shingles) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high, Shingles (at age 30) and H1N1 influenza in 2009. Previously administered products included for Product used for unknown indication: varicella zoster in November 2020 and varicella zoster on 06-Mar-2021. Past adverse reactions to the above products included No adverse event with varicella zoster and varicella zoster.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced EYE HAEMORRHAGE (hemorrhage in her right eye after dental work) (seriousness criterion medically significant). On 04-May-2021, the patient experienced VACCINATION SITE DISCOLOURATION (now plum), VACCINATION SITE MASS (bumps), PRURITUS (itchy), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (bright red) and VACCINATION SITE RASH (left arm rash). On 06-May-2021, the patient experienced HERPES ZOSTER (diagnosed with shingles) (seriousness criterion medically significant). On 07-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (beyond 36 days since first dose). At the time of the report, EYE HAEMORRHAGE (hemorrhage in her right eye after dental work), HERPES ZOSTER (diagnosed with shingles), VACCINATION SITE DISCOLOURATION (now plum), VACCINATION SITE MASS (bumps), PRODUCT DOSE OMISSION ISSUE (beyond 36 days since first dose), PRURITUS (itchy), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (bright red) and VACCINATION SITE RASH (left arm rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was given a "pain medication" from the ER on 04MAY2021 and valacyclovir on 06MAY2021 when she was diagnosed with shingles. Valacyclovir was prescribed as treatment for shingles.    The patient does not want her second dose, which has been postponed from 23APR2021 to 17MAY2021, and instead wants to wait for a "booster shot".  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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Dizziness, Dysphagia, Food intolerance
Clinical narrative: fainted; Can't do a lot,has been staying in bed; Dizzy; Aches and pains; Fever of 102.5 degrees; right arm soreness; Vomiting a little; very nauseous/nausea; Headache; Dry heaving; She can't drink a lot of liquids; Can't keep food down; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 25-year-old patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023b21 and 016b21a) 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 ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) and ISOTRETINOIN for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced FOOD INTOLERANCE (Can't keep food down), RETCHING (Dry heaving), DYSPHAGIA (She can't drink a lot of liquids), PAIN IN EXTREMITY (right arm soreness), VOMITING (Vomiting a little), NAUSEA (very nauseous/nausea) and HEADACHE (Headache). On 06-May-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), BEDRIDDEN (Can't do a lot,has been staying in bed), PAIN (Aches and pains), DIZZINESS (Dizzy) and PYREXIA (Fever of 102.5 degrees). On 05-May-2021, PAIN IN EXTREMITY (right arm soreness) had resolved. On 06-May-2021, SYNCOPE (fainted) and DIZZINESS (Dizzy) had resolved. On 07-May-2021, PYREXIA (Fever of 102.5 degrees) had resolved. At the time of the report, FOOD INTOLERANCE (Can't keep food down), BEDRIDDEN (Can't do a lot,has been staying in bed), RETCHING (Dry heaving), DYSPHAGIA (She can't drink a lot of liquids), PAIN (Aches and pains), VOMITING (Vomiting a little), NAUSEA (very nauseous/nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Body temperature: 102.5 (High) 102.5 degree F.         No treatment medication were received.  Company Comment : Based on current available information and the temporal association between product use and the start date 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 date of the events a causal relationship cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: fainted; Can't do a lot,has been staying in bed; Dizzy; Aches and pains; Fever of 102.5 degrees; right arm soreness; Vomiting a little; very nauseous/nausea; Headache; Dry heaving; She can't drink a lot of liquids; Can't keep food down; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 25-year-old patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023b21 and 016b21a) 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 ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) and ISOTRETINOIN for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced FOOD INTOLERANCE (Can't keep food down), RETCHING (Dry heaving), DYSPHAGIA (She can't drink a lot of liquids), PAIN IN EXTREMITY (right arm soreness), VOMITING (Vomiting a little), NAUSEA (very nauseous/nausea) and HEADACHE (Headache). On 06-May-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), BEDRIDDEN (Can't do a lot,has been staying in bed), PAIN (Aches and pains), DIZZINESS (Dizzy) and PYREXIA (Fever of 102.5 degrees). On 05-May-2021, PAIN IN EXTREMITY (right arm soreness) had resolved. On 06-May-2021, SYNCOPE (fainted) and DIZZINESS (Dizzy) had resolved. On 07-May-2021, PYREXIA (Fever of 102.5 degrees) had resolved. At the time of the report, FOOD INTOLERANCE (Can't keep food down), BEDRIDDEN (Can't do a lot,has been staying in bed), RETCHING (Dry heaving), DYSPHAGIA (She can't drink a lot of liquids), PAIN (Aches and pains), VOMITING (Vomiting a little), NAUSEA (very nauseous/nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Body temperature: 102.5 (High) 102.5 degree F.         No treatment medication were received.  Company Comment : Based on current available information and the temporal association between product use and the start date 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 date of the events a causal relationship cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Retching, Syncope, Vomiting
Clinical narrative: fainted; Can't do a lot,has been staying in bed; Dizzy; Aches and pains; Fever of 102.5 degrees; right arm soreness; Vomiting a little; very nauseous/nausea; Headache; Dry heaving; She can't drink a lot of liquids; Can't keep food down; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 25-year-old patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023b21 and 016b21a) 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 ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) and ISOTRETINOIN for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced FOOD INTOLERANCE (Can't keep food down), RETCHING (Dry heaving), DYSPHAGIA (She can't drink a lot of liquids), PAIN IN EXTREMITY (right arm soreness), VOMITING (Vomiting a little), NAUSEA (very nauseous/nausea) and HEADACHE (Headache). On 06-May-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), BEDRIDDEN (Can't do a lot,has been staying in bed), PAIN (Aches and pains), DIZZINESS (Dizzy) and PYREXIA (Fever of 102.5 degrees). On 05-May-2021, PAIN IN EXTREMITY (right arm soreness) had resolved. On 06-May-2021, SYNCOPE (fainted) and DIZZINESS (Dizzy) had resolved. On 07-May-2021, PYREXIA (Fever of 102.5 degrees) had resolved. At the time of the report, FOOD INTOLERANCE (Can't keep food down), BEDRIDDEN (Can't do a lot,has been staying in bed), RETCHING (Dry heaving), DYSPHAGIA (She can't drink a lot of liquids), PAIN (Aches and pains), VOMITING (Vomiting a little), NAUSEA (very nauseous/nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Body temperature: 102.5 (High) 102.5 degree F.         No treatment medication were received.  Company Comment : Based on current available information and the temporal association between product use and the start date 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 date of the events a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Transient ischaemic attack
Clinical narrative: TIA; Slurred speech; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 05-Apr-2021 to 07-Apr-2021 due to TRANSIENT ISCHAEMIC ATTACK. On 07-Apr-2021, TRANSIENT ISCHAEMIC ATTACK (TIA) 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.   Concomitant medications and treatment information was not provided by the reporter.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD21-087942 (E2B Linked Report). This case was linked to MOD-2021-114502 (Patient Link).; 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 cannot be excluded. US-MODERNATX, INC.-MOD21-087942:2nd dose
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Dizziness, Fatigue
Clinical narrative: fainted; Patient was dizzy; migraine; Patient had a panic attack before heading to the emergency room; fatigue; uncontrollable vomiting; temperature was 103; injection site pain; joint pain; Headache; neck pain; back pain; general body pain; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (fainted) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21AE and 031L20AE) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included THYROID (ARMOUR THYROID) and ESCITALOPRAM OXALATE (LEXAPRO) 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 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced NECK PAIN (neck pain), BACK PAIN (back pain), PAIN (general body pain), VACCINATION SITE PAIN (injection site pain), ARTHRALGIA (joint pain) and HEADACHE (Headache). On 17-Apr-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), DIZZINESS (Patient was dizzy), MIGRAINE (migraine), PANIC ATTACK (Patient had a panic attack before heading to the emergency room), FATIGUE (fatigue), VOMITING (uncontrollable vomiting) and PYREXIA (temperature was 103, high temperature). On 17-Apr-2021, SYNCOPE (fainted) had resolved. At the time of the report, DIZZINESS (Patient was dizzy), MIGRAINE (migraine), PANIC ATTACK (Patient had a panic attack before heading to the emergency room), NECK PAIN (neck pain), BACK PAIN (back pain), PAIN (general body pain), FATIGUE (fatigue), VOMITING (uncontrollable vomiting), PYREXIA (temperature was 103, high temperature), VACCINATION SITE PAIN (injection site pain), ARTHRALGIA (joint pain) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 103 (High) 103.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Imitrex, Tylenol, Steroids, Benadryl, Zofran, and Morphine.  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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Neck pain, Pain, Panic attack
Clinical narrative: fainted; Patient was dizzy; migraine; Patient had a panic attack before heading to the emergency room; fatigue; uncontrollable vomiting; temperature was 103; injection site pain; joint pain; Headache; neck pain; back pain; general body pain; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (fainted) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21AE and 031L20AE) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included THYROID (ARMOUR THYROID) and ESCITALOPRAM OXALATE (LEXAPRO) 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 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced NECK PAIN (neck pain), BACK PAIN (back pain), PAIN (general body pain), VACCINATION SITE PAIN (injection site pain), ARTHRALGIA (joint pain) and HEADACHE (Headache). On 17-Apr-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), DIZZINESS (Patient was dizzy), MIGRAINE (migraine), PANIC ATTACK (Patient had a panic attack before heading to the emergency room), FATIGUE (fatigue), VOMITING (uncontrollable vomiting) and PYREXIA (temperature was 103, high temperature). On 17-Apr-2021, SYNCOPE (fainted) had resolved. At the time of the report, DIZZINESS (Patient was dizzy), MIGRAINE (migraine), PANIC ATTACK (Patient had a panic attack before heading to the emergency room), NECK PAIN (neck pain), BACK PAIN (back pain), PAIN (general body pain), FATIGUE (fatigue), VOMITING (uncontrollable vomiting), PYREXIA (temperature was 103, high temperature), VACCINATION SITE PAIN (injection site pain), ARTHRALGIA (joint pain) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 103 (High) 103.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Imitrex, Tylenol, Steroids, Benadryl, Zofran, and Morphine.  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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope, Vaccination site pain, Vomiting
Clinical narrative: fainted; Patient was dizzy; migraine; Patient had a panic attack before heading to the emergency room; fatigue; uncontrollable vomiting; temperature was 103; injection site pain; joint pain; Headache; neck pain; back pain; general body pain; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (fainted) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21AE and 031L20AE) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included THYROID (ARMOUR THYROID) and ESCITALOPRAM OXALATE (LEXAPRO) 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 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced NECK PAIN (neck pain), BACK PAIN (back pain), PAIN (general body pain), VACCINATION SITE PAIN (injection site pain), ARTHRALGIA (joint pain) and HEADACHE (Headache). On 17-Apr-2021, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), DIZZINESS (Patient was dizzy), MIGRAINE (migraine), PANIC ATTACK (Patient had a panic attack before heading to the emergency room), FATIGUE (fatigue), VOMITING (uncontrollable vomiting) and PYREXIA (temperature was 103, high temperature). On 17-Apr-2021, SYNCOPE (fainted) had resolved. At the time of the report, DIZZINESS (Patient was dizzy), MIGRAINE (migraine), PANIC ATTACK (Patient had a panic attack before heading to the emergency room), NECK PAIN (neck pain), BACK PAIN (back pain), PAIN (general body pain), FATIGUE (fatigue), VOMITING (uncontrollable vomiting), PYREXIA (temperature was 103, high temperature), VACCINATION SITE PAIN (injection site pain), ARTHRALGIA (joint pain) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 103 (High) 103.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Imitrex, Tylenol, Steroids, Benadryl, Zofran, and Morphine.  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: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Moderna vaccine was expiring at 4:22AM on 5/19/21 (but it was till in the refrigerator), on the same day at about 10:45AM the pharmacist inject patient with the expired vaccine. Attention was brought to patient the following day, no adverse side effect per patient. A pharmacist spoke with a representative at Moderna (case #MOD21-091951), we were advised against revaccination. We will follow up with patient in the next week.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID 19 almost 2 months after receiving 2nd shot.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Patient appears uncontrolled shaking of both legs and arms 15 minutes after reaction. We had patient sits down and gave her 50 mg of Benadryl, temperature 97.3F. After 15 minutes, the shaking was still occurring and we offered to call 911. The paramedics arrived after 5 minutes, patient's blood pressure is 142/100, pulse is 103, 100% oxygen saturation. Patient appeared to stop shaking. Out of precaution, the paramedics offer to take her to the emergency room, and patient accepted.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Feeling abnormal, Pyrexia, Vaccination complication
Clinical narrative: "severe reactions"; very weak; Felt Bad; shortness of breath; Fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION ("severe reactions") and ASTHENIA (very weak) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Reporter stated that the patient had a history of "health problems."  No specifics were provided.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and MELATONIN for an unknown indication.   In April 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. In April 2021, the patient experienced VACCINATION COMPLICATION ("severe reactions") (seriousness criterion death), ASTHENIA (very weak) (seriousness criterion death), FEELING ABNORMAL (Felt Bad), DYSPNOEA (shortness of breath) and PYREXIA (Fever). On 06-May-2021, FEELING ABNORMAL (Felt Bad), DYSPNOEA (shortness of breath) and PYREXIA (Fever) outcome was unknown. The patient died on 06-May-2021. The cause of death was not reported. An autopsy was not performed.            Patient had no symptoms or side effects after the 1st dose. Patient was never hospitalized for the reported events.  A 71-year-old male patient who received mRNA-1273 experienced Pyrexia, Feeling Abnormal, Dyspnea, Asthenia and Vaccination Complication and died on an unknown days after the second dose of vaccine.  Patient had a history of unspecified health problems which may confound the event. Unlikely that the events are related to the vaccine. Very limited information has been reported at this time. Further information is not expected.; Sender's Comments: A 71-year-old male patient who received mRNA-1273 experienced Pyrexia, Feeling Abnormal, Dyspnea, Asthenia and Vaccination Complication and died on an unknown days after the second dose of vaccine.  Patient had a history of unspecified health problems which may confound the event. Unlikely that the events are related to the vaccine. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death