chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Limb injury, Vertigo
Clinical narrative: bled 2 colors of blood; Cut himself  in his finger (like a paper cut); vertigo; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bled 2 colors of blood) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (bled 2 colors of blood) (seriousness criterion medically significant), LIMB INJURY (Cut himself  in his finger (like a paper cut)) and VERTIGO (vertigo). At the time of the report, HAEMORRHAGE (bled 2 colors of blood), LIMB INJURY (Cut himself  in his finger (like a paper cut)) and VERTIGO (vertigo) outcome was unknown.            No concomitants were reported. No treatment was reported.   This case was linked to MOD-2021-089420 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Head discomfort, Headache, Lymph node pain
Clinical narrative: "swollen and painful right cervical lymph node "; hardness of right cervical lymph node; cannot raise head; mild swollen of left cervical lymph node; pass out; lot of fatigue; lost of appetite; nausea; minor fever; shivering throbbing headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (pass out) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (pass out) (seriousness criterion medically significant), FATIGUE (lot of fatigue), DECREASED APPETITE (lost of appetite), NAUSEA (nausea ), PYREXIA (minor fever), HEADACHE (shivering throbbing headache) and PAIN IN EXTREMITY (sore arm ). On 29-Apr-2021, the patient experienced LYMPH NODE PAIN ("swollen and painful right cervical lymph node "), LYMPH NODE PAIN (hardness of right cervical lymph node), HEAD DISCOMFORT (cannot raise head) and LYMPHADENOPATHY (mild swollen of left cervical lymph node). On 24-Apr-2021, PAIN IN EXTREMITY (sore arm ) had resolved. On 25-Apr-2021, LOSS OF CONSCIOUSNESS (pass out), FATIGUE (lot of fatigue), DECREASED APPETITE (lost of appetite), NAUSEA (nausea ) and PYREXIA (minor fever) had resolved. On 01-May-2021, LYMPHADENOPATHY (mild swollen of left cervical lymph node) had resolved. At the time of the report, LYMPH NODE PAIN ("swollen and painful right cervical lymph node "), LYMPH NODE PAIN (hardness of right cervical lymph node) and HEAD DISCOMFORT (cannot raise head) outcome was unknown.            the swelling and  hardness of right cervical lymph node was the cause of clinic visit, the Physician said it was "benign", no treatment for it. This symptoms still bothering the patient. Patient assumed that was previously exposed COVID-19 in March2020 but had no confirmed results, his test was suspended and was not repeated.   Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided. The concomitant taken by the patient was, vitamin C , vitamin D , man's 50 plus gummy, risperidone.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain in extremity, Pyrexia, Syncope
Clinical narrative: "swollen and painful right cervical lymph node "; hardness of right cervical lymph node; cannot raise head; mild swollen of left cervical lymph node; pass out; lot of fatigue; lost of appetite; nausea; minor fever; shivering throbbing headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (pass out) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (pass out) (seriousness criterion medically significant), FATIGUE (lot of fatigue), DECREASED APPETITE (lost of appetite), NAUSEA (nausea ), PYREXIA (minor fever), HEADACHE (shivering throbbing headache) and PAIN IN EXTREMITY (sore arm ). On 29-Apr-2021, the patient experienced LYMPH NODE PAIN ("swollen and painful right cervical lymph node "), LYMPH NODE PAIN (hardness of right cervical lymph node), HEAD DISCOMFORT (cannot raise head) and LYMPHADENOPATHY (mild swollen of left cervical lymph node). On 24-Apr-2021, PAIN IN EXTREMITY (sore arm ) had resolved. On 25-Apr-2021, LOSS OF CONSCIOUSNESS (pass out), FATIGUE (lot of fatigue), DECREASED APPETITE (lost of appetite), NAUSEA (nausea ) and PYREXIA (minor fever) had resolved. On 01-May-2021, LYMPHADENOPATHY (mild swollen of left cervical lymph node) had resolved. At the time of the report, LYMPH NODE PAIN ("swollen and painful right cervical lymph node "), LYMPH NODE PAIN (hardness of right cervical lymph node) and HEAD DISCOMFORT (cannot raise head) outcome was unknown.            the swelling and  hardness of right cervical lymph node was the cause of clinic visit, the Physician said it was "benign", no treatment for it. This symptoms still bothering the patient. Patient assumed that was previously exposed COVID-19 in March2020 but had no confirmed results, his test was suspended and was not repeated.   Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided. The concomitant taken by the patient was, vitamin C , vitamin D , man's 50 plus gummy, risperidone.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Loss of consciousness
Clinical narrative: patient passed out; shot may him whoosy however he stayed in bed; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (patient passed out) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (patient passed out) (seriousness criterion medically significant) and CONFUSIONAL STATE (shot may him whoosy however he stayed in bed). At the time of the report, LOSS OF CONSCIOUSNESS (patient passed out) outcome was unknown and CONFUSIONAL STATE (shot may him whoosy however he stayed in bed) had resolved.            Concomitant and treatment information not provided.   This case was linked to MOD-2021-033479 (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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme increased, Idiosyncratic drug reaction, Lymphadenopathy, Pruritus, Rash
Clinical narrative: severe idiosyncratic multi-symptom; rash soon after second vaccination that went up her arm to her Lymph Nodes/rash did not get better/rash is covering 90% of her body/Entire body had rash except for feet, face/rash on chest/rash on arms/rash on head through hair; Elevated liver enzymes; Scalp is itchy; long term delayed reaction; Lymph Nodes are swollen; This spontaneous case was reported by a consumer and describes the occurrence of IDIOSYNCRATIC DRUG REACTION (severe idiosyncratic multi-symptom), RASH (rash soon after second vaccination that went up her arm to her Lymph Nodes/rash did not get better/rash is covering 90% of her body/Entire body had rash except for feet, face/rash on chest/rash on arms/rash on head through hair) and HEPATIC ENZYME INCREASED (Elevated liver enzymes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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 PREDNISONE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and BETAMETHASONE for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IDIOSYNCRATIC DRUG REACTION (severe idiosyncratic multi-symptom) (seriousness criterion medically significant), RASH (rash soon after second vaccination that went up her arm to her Lymph Nodes/rash did not get better/rash is covering 90% of her body/Entire body had rash except for feet, face/rash on chest/rash on arms/rash on head through hair) (seriousness criterion medically significant), HEPATIC ENZYME INCREASED (Elevated liver enzymes) (seriousness criterion medically significant), PRURITUS (Scalp is itchy), SKIN REACTION (long term delayed reaction) and LYMPHADENOPATHY (Lymph Nodes are swollen). At the time of the report, IDIOSYNCRATIC DRUG REACTION (severe idiosyncratic multi-symptom), RASH (rash soon after second vaccination that went up her arm to her Lymph Nodes/rash did not get better/rash is covering 90% of her body/Entire body had rash except for feet, face/rash on chest/rash on arms/rash on head through hair), HEPATIC ENZYME INCREASED (Elevated liver enzymes), PRURITUS (Scalp is itchy), SKIN REACTION (long term delayed reaction) and LYMPHADENOPATHY (Lymph Nodes are swollen) 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.   .Very limited information regarding these events have  been provided at this time.  Further information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: severe idiosyncratic multi-symptom; rash soon after second vaccination that went up her arm to her Lymph Nodes/rash did not get better/rash is covering 90% of her body/Entire body had rash except for feet, face/rash on chest/rash on arms/rash on head through hair; Elevated liver enzymes; Scalp is itchy; long term delayed reaction; Lymph Nodes are swollen; This spontaneous case was reported by a consumer and describes the occurrence of IDIOSYNCRATIC DRUG REACTION (severe idiosyncratic multi-symptom), RASH (rash soon after second vaccination that went up her arm to her Lymph Nodes/rash did not get better/rash is covering 90% of her body/Entire body had rash except for feet, face/rash on chest/rash on arms/rash on head through hair) and HEPATIC ENZYME INCREASED (Elevated liver enzymes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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 PREDNISONE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and BETAMETHASONE for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IDIOSYNCRATIC DRUG REACTION (severe idiosyncratic multi-symptom) (seriousness criterion medically significant), RASH (rash soon after second vaccination that went up her arm to her Lymph Nodes/rash did not get better/rash is covering 90% of her body/Entire body had rash except for feet, face/rash on chest/rash on arms/rash on head through hair) (seriousness criterion medically significant), HEPATIC ENZYME INCREASED (Elevated liver enzymes) (seriousness criterion medically significant), PRURITUS (Scalp is itchy), SKIN REACTION (long term delayed reaction) and LYMPHADENOPATHY (Lymph Nodes are swollen). At the time of the report, IDIOSYNCRATIC DRUG REACTION (severe idiosyncratic multi-symptom), RASH (rash soon after second vaccination that went up her arm to her Lymph Nodes/rash did not get better/rash is covering 90% of her body/Entire body had rash except for feet, face/rash on chest/rash on arms/rash on head through hair), HEPATIC ENZYME INCREASED (Elevated liver enzymes), PRURITUS (Scalp is itchy), SKIN REACTION (long term delayed reaction) and LYMPHADENOPATHY (Lymph Nodes are swollen) 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.   .Very limited information regarding these events have  been provided at this time.  Further information has been requested.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Sore muscles; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L02A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) for Drug therapy, METOPROLOL SUCCINATE and DOXYCYCLINE for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced MYALGIA (Sore muscles) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). At the time of the report, MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications reported.  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 MOD-2021-256561 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Heart rate, Influenza like illness, Myalgia
Clinical narrative: Rash on chest that went to his stomach; Went to hospital for fast heart rate; Trouble breathing; Felt like he had the flu; Sore muscles; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Went to hospital for fast heart rate), DYSPNOEA (Trouble breathing) and RASH (Rash on chest that went to his stomach) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, METOPROLOL SUCCINATE and DOXYCYCLINE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain). In May 2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like he had the flu). On 30-May-2021, the patient experienced TACHYCARDIA (Went to hospital for fast heart rate) (seriousness criterion medically significant) and DYSPNOEA (Trouble breathing) (seriousness criterion medically significant). On 01-Jul-2021, the patient experienced RASH (Rash on chest that went to his stomach) (seriousness criterion medically significant). At the time of the report, TACHYCARDIA (Went to hospital for fast heart rate), DYSPNOEA (Trouble breathing), RASH (Rash on chest that went to his stomach), INFLUENZA LIKE ILLNESS (Felt like he had the flu), MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Heart rate: fast (High) Fast.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-256548 (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: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Tachycardia
Clinical narrative: Rash on chest that went to his stomach; Went to hospital for fast heart rate; Trouble breathing; Felt like he had the flu; Sore muscles; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Went to hospital for fast heart rate), DYSPNOEA (Trouble breathing) and RASH (Rash on chest that went to his stomach) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, METOPROLOL SUCCINATE and DOXYCYCLINE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain). In May 2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like he had the flu). On 30-May-2021, the patient experienced TACHYCARDIA (Went to hospital for fast heart rate) (seriousness criterion medically significant) and DYSPNOEA (Trouble breathing) (seriousness criterion medically significant). On 01-Jul-2021, the patient experienced RASH (Rash on chest that went to his stomach) (seriousness criterion medically significant). At the time of the report, TACHYCARDIA (Went to hospital for fast heart rate), DYSPNOEA (Trouble breathing), RASH (Rash on chest that went to his stomach), INFLUENZA LIKE ILLNESS (Felt like he had the flu), MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Heart rate: fast (High) Fast.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-256548 (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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Gait disturbance, Lethargy, Neuropathy peripheral, Renal failure
Clinical narrative: had a kidney failure; severe neuropathy in both her legs, about a month and a half later, it's on her legs and into her feet and keeps traveling down; letargic; could not stand up/could not use her legs; could not walk; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (had a kidney failure) and NEUROPATHY PERIPHERAL (severe neuropathy in both her legs, about a month and a half later, it's on her legs and into her feet and keeps traveling down) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dialysis. Concurrent medical conditions included Kidney failure. Concomitant products included PREGABALIN (LYRICA), GABAPENTIN and TIZANIDINE HYDROCHLORIDE (ZANAFLEX) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL FAILURE (had a kidney failure) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (severe neuropathy in both her legs, about a month and a half later, it's on her legs and into her feet and keeps traveling down) (seriousness criterion medically significant), LETHARGY (letargic), DYSSTASIA (could not stand up/could not use her legs) and GAIT DISTURBANCE (could not walk). At the time of the report, RENAL FAILURE (had a kidney failure), NEUROPATHY PERIPHERAL (severe neuropathy in both her legs, about a month and a half later, it's on her legs and into her feet and keeps traveling down), LETHARGY (letargic), DYSSTASIA (could not stand up/could not use her legs) and GAIT DISTURBANCE (could not walk) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was in prison when she took the second dose and they sent her home early as she had a kidney dialysis on 19-4-2021. The patient was in ICU after 9 days of second dose. Concomitant medications- Pracoceic Treatment- Physical therapy twice a week, medication for neuropathy.  Very limited information regarding this event has been provided at this time. However, discharge summary/hospital notes are required for further assessment.; Sender's Comments: Very limited information regarding this event has been provided at this time. However, discharge summary/hospital notes are required for further assessment.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Apnoea, Energy increased, Pain in extremity
Clinical narrative: Delayed due to due to sleep apnea; Minor sore arm; increase in energy for about 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of APNOEA (Delayed due to due to sleep apnea) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mast cell activation syndrome (Mast cell reaction), Tachycardia (POTS) and Excessive daytime sleepiness. Concurrent medical conditions included Drug allergy (Novocain), Drug allergy (slurines), Drug allergy (singular), Drug allergy (Cromolyn sodium) and Drug allergy (Most add meds). Concomitant products included IVABRADINE HYDROCHLORIDE (CORLANOR), RIVASTIGMINE (EXELON), BUPROPION HYDROCHLORIDE (WELLBUTRIN), KETOTIFEN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FAMOTIDINE (PEPCID [FAMOTIDINE]), NALTREXONE, IMMUNOGLOBULINS NOS and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced APNOEA (Delayed due to due to sleep apnea) (seriousness criterion medically significant), PAIN IN EXTREMITY (Minor sore arm) and ENERGY INCREASED (increase in energy for about 3 weeks). At the time of the report, APNOEA (Delayed due to due to sleep apnea), PAIN IN EXTREMITY (Minor sore arm) and ENERGY INCREASED (increase in energy for about 3 weeks) 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.   Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's comorbidities are risk factors and confounds causality assessment. Further information has been requested.   This case was linked to MOD-2021-256730 (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. However, the patient's comorbidities are risk factors and confounds causality assessment.Further information has been requested.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dehydration, Disorientation, Lethargy, Pulmonary oedema
Clinical narrative: Fluid in lungs; Lethargic after second vaccine; disoriented/confusion; Dehydration; Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), DEHYDRATION (Dehydration), PULMONARY OEDEMA (Fluid in lungs), LETHARGY (Lethargic after second vaccine) and DISORIENTATION (disoriented/confusion) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD since 06-Jan-2021. Concomitant products included PREDNISONE from 10-May-2020 to an unknown date for Bullous pemphigoid, ROSUVASTATIN CALCIUM (CRESTOR) and ACETYLSALICYLIC ACID, DIPYRIDAMOLE (AGGRENOX) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced DEHYDRATION (Dehydration) (seriousness criterion hospitalization), LETHARGY (Lethargic after second vaccine) (seriousness criterion hospitalization) and DISORIENTATION (disoriented/confusion) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY OEDEMA (Fluid in lungs) (seriousness criteria hospitalization and medically significant). The patient died on 26-Jun-2021. The cause of death was not reported. An autopsy was not performed. At the time of death, DEHYDRATION (Dehydration), LETHARGY (Lethargic after second vaccine) and DISORIENTATION (disoriented/confusion) had resolved and PULMONARY OEDEMA (Fluid in lungs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   After 2nd vaccine 09-apr-2021, 36 hrs later (name) Lethargic, Disorientated ems to hospital. Some dehydration, fluids, than he has fluid in lungs. 8 days hospital. Never the some after discharged 4/19/21. (name) declined until his DEATH on 26-Jun-2021.  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-2021-042828 (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.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          Concomitant product was not reported. Treatment was not reported. Company Comment : Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Fall, Intentional product use issue, Limb injury
Clinical narrative: hurt their humerus and shoulder on the left side; patient had a feel; Got the first dose on 03May2021 and has not gotten the second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Fell and hurt their humerus and shoulder on the left side) in a female patient of an unknown age 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.     No medical history was provided by the reporter.  Concomitant products included ALLOPURINOL for Gout, LEVOTHYROXINE SODIUM (ELTROXIN) for Thyroid disorder, CLONIDINE, COLECALCIFEROL (VITAMIN D3), OLMESARTAN MEDOXOMIL (BENICAR), AMLODIPINE BESILATE (AMLODIPINE BESYLATE) and MECOBALAMIN (NEUROMET [MECOBALAMIN]) for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced LIMB INJURY (Fell and hurt their humerus and shoulder on the left side) (seriousness criterion hospitalization) due to FALL (had a feel) (serious criterion hospitalization). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Got the first dose on 03May2021 and has not gotten the second dose yet). The patient was hospitalized on 25-May-2021 due to LIMB INJURY. The patient was treated with Rehabilitation therapy for limb injury. At the time of the report, LIMB INJURY (Fell and hurt their humerus and shoulder on the left side), FALL (had a feel) and INTENTIONAL PRODUCT USE ISSUE (Got the first dose on 03May2021 and has not gotten the second dose yet) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included Chymostatin. Second dose was scheduled on 01 June 2021 but was not able to get it because patient was in hospital. She remained in hospital till 2 weeks ago approximately.; 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 of fall and limb injury, a causal relationship cannot be excluded.   This report ralso efers to a case of Intentional product use issue for mRNA-1273, lot # 007B21A
Sex: U
Vaccine: COVID19
Symptoms: Coma
Clinical narrative: Induced coma; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COMA (Induced coma) in a child patient of an unknown 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COMA (Induced coma) (seriousness criterion medically significant). At the time of the report, COMA (Induced coma) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported .Treatment information was not provided.  The reporter stated that the child of his neighbor was in an induced coma after getting the mRNA Covid-19 vaccine (he was not sure if it was Moderna or Pfizer that was administered).  Very limited information regarding this event have been provided. Further information has been requested.; Sender's Comments: Very limited information regarding this event have been provided. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: loss of hearing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEAFNESS (loss of hearing) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (loss of hearing) (seriousness criterion medically significant). At the time of the report, DEAFNESS (loss of hearing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Rheumatoid arthritis
Clinical narrative: I have rheumatoid arthritis and aboat 6 weeks i have terible pain in my legs; terrible pain in my legs; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (I have rheumatoid arthritis and aboat 6 weeks i have terible pain in my legs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (I have rheumatoid arthritis and aboat 6 weeks i have terible pain in my legs) (seriousness criterion medically significant) and PAIN IN EXTREMITY (terrible pain in my legs). At the time of the report, RHEUMATOID ARTHRITIS (I have rheumatoid arthritis and aboat 6 weeks i have terible pain in my legs) and PAIN IN EXTREMITY (terrible pain in my legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       The patient had rheumatoid arthritis and about 6 weeks and had terrible pain in legs. Concomitant medication list was not reported. No treatment information was provided.  Very limited information regarding this events has been provided at this time. Start Date of vaccination was not provided. Further information is not expected (denied follow up).   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Start Date of vaccination was not provided. Further information is not expected (denied follow up).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Confusional state, Lethargy, Pruritus, Somnolence
Clinical narrative: Not having control of their bowels; Completely confused; Constant itching; Very lethargic; Never slept past 9am but after receiving the second dose they could not get up before 11am; This spontaneous case was reported by a consumer and describes the occurrence of BOWEL INCONTINENCE (Not having control of their bowels) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VALSARTAN, METFORMIN, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and METOPROLOL for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced BOWEL INCONTINENCE (Not having control of their bowels) (seriousness criterion hospitalization) and CONFUSIONAL STATE (Completely confused) (seriousness criterion hospitalization) . On an unknown date, the patient experienced PRURITUS (Constant itching), LETHARGY (Very lethargic) and SOMNOLENCE (Never slept past 9am but after receiving the second dose they could not get up before 11am). At the time of the report, BOWEL INCONTINENCE (Not having control of their bowels), CONFUSIONAL STATE (Completely confused),  and SOMNOLENCE (Never slept past 9am but after receiving the second dose they could not get up before 11am) outcome was unknown, and the events of PRURITUS (Constant itching), LETHARGY (Very lethargic) was not resolved.   On 06July2021, the caller could not get a hold of the patient. The caller called 911 to check on the patient. The caller found the patient at home completely confused (not knowing themselves or recognizing any family members), the patient was in their underwear. The patient was admitted to the hospital and stayed for about 10 days. The health care providers have done every test possible according to the caller and tests have come back negative and the HCPs stating "the patient is 100% healthy. No treatment drug details was reported.; 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: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Inappropriate schedule of product administration
Clinical narrative: heart arrhythmia; It has been more than 36 days and the patient has not received the second dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (heart arrhythmia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced ARRHYTHMIA (heart arrhythmia) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 days and the patient has not received the second dose). The patient was hospitalized on 12-Mar-2021 due to ARRHYTHMIA. At the time of the report, ARRHYTHMIA (heart arrhythmia) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 days and the patient has not received the second dose) had resolved.        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.   Concomitant product was not provided. Treatment medication was not reported.  This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 031M120A) with associated SAE reported as arrhythmia after the first dose of the vaccine.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 031M120A) with associated SAE reported as arrhythmia after the first dose of the vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Facial paresis, Facial spasm
Clinical narrative: Early April wife noticed major changes (face dropping) doctor said reoccurrence after surgery is rare; Facial weakness and spasms; Facial weakness and spasms; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Early April wife noticed major changes (face dropping) doctor said reoccurrence after surgery is rare) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Facial weakness, Facial spasm and Surgery (To eliminate left side facial weakness and spasms.) in 2015. Concomitant products included TIABENDAZOLE (STATIN [TIABENDAZOLE]), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), VITAMIN B12 [VITAMIN B12 NOS] and BOTULINUM TOXIN TYPE A (BOTOX) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (Early April wife noticed major changes (face dropping) doctor said reoccurrence after surgery is rare) (seriousness criterion medically significant), FACIAL PARESIS (Facial weakness and spasms) and FACIAL SPASM (Facial weakness and spasms). At the time of the report, FACIAL PARALYSIS (Early April wife noticed major changes (face dropping) doctor said reoccurrence after surgery is rare), FACIAL PARESIS (Facial weakness and spasms) and FACIAL SPASM (Facial weakness and spasms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information included blood pressure medication (not specified).  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Seizure
Clinical narrative: passed out; seizure; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and SEIZURE (seizure) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criteria hospitalization and medically significant) and SEIZURE (seizure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 5 days due to LOSS OF CONSCIOUSNESS and SEIZURE. At the time of the report, LOSS OF CONSCIOUSNESS (passed out) and SEIZURE (seizure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant product information was provided.  No treatment information was provided.  Company Comment: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Bell's palsy, Dysgeusia, Facial discomfort, Taste disorder
Clinical narrative: bell's palsy; face was tilted; she felt a little off balance; metal taste; Taste bud changed; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (bell's palsy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009021A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy bilateral. Concurrent medical conditions included Lupus erythematosus and Blood pressure high. Concomitant products included ANASTROZOLE and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jul-2021, the patient experienced BALANCE DISORDER (she felt a little off balance), DYSGEUSIA (metal taste) and TASTE DISORDER (Taste bud changed). On 04-Jul-2021, the patient experienced FACIAL DISCOMFORT (face was tilted). On 06-Jul-2021, the patient experienced BELL'S PALSY (bell's palsy) (seriousness criterion medically significant). The patient was treated with ANTIVIRALS at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (bell's palsy), BALANCE DISORDER (she felt a little off balance), DYSGEUSIA (metal taste), TASTE DISORDER (Taste bud changed) and FACIAL DISCOMFORT (face was tilted) 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 events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-258142 (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.