chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Headache, Hypoaesthesia
Clinical narrative: similar to Bells Palsy; Very dull numbness in the left side of her face; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (similar to Bells Palsy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced FACIAL PARALYSIS (similar to Bells Palsy) (seriousness criterion medically significant), HYPOAESTHESIA (Very dull numbness in the left side of her face) and HEADACHE (slight headache). At the time of the report, FACIAL PARALYSIS (similar to Bells Palsy), HYPOAESTHESIA (Very dull numbness in the left side of her face) and HEADACHE (slight headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Depressed mood, Erythema, Headache, Hypokinesia
Clinical narrative: chills to the bone; couldn't crawl herself to bed; slept for 18 hours; headache was worst than a migraine; vomiting; passed out; arm sun brunt; swollen; arm red; she wish she was dead,brutal; four good days of life, not a happy camper, lost three days of existing; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and SUICIDAL IDEATION (she wish she was dead,brutal) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 CHILLS (chills to the bone), HYPOKINESIA (couldn't crawl herself to bed), SOMNOLENCE (slept for 18 hours), HEADACHE (headache was worst than a migraine), VOMITING (vomiting), LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), SUNBURN (arm sun brunt), PERIPHERAL SWELLING (swollen), ERYTHEMA (arm red), SUICIDAL IDEATION (she wish she was dead,brutal) (seriousness criterion medically significant) and DEPRESSED MOOD (four good days of life, not a happy camper, lost three days of existing). At the time of the report, CHILLS (chills to the bone), HYPOKINESIA (couldn't crawl herself to bed), SOMNOLENCE (slept for 18 hours), HEADACHE (headache was worst than a migraine), VOMITING (vomiting), LOSS OF CONSCIOUSNESS (passed out), SUNBURN (arm sun brunt), PERIPHERAL SWELLING (swollen), ERYTHEMA (arm red), SUICIDAL IDEATION (she wish she was dead,brutal) and DEPRESSED MOOD (four good days of life, not a happy camper, lost three days of existing) outcome was unknown.            No concomitant medication were not provided patient underwent treatment medication of Tylenol  Very limited information regarding these events has been provided at this time. No follow up is possible.; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Peripheral swelling, Somnolence, Suicidal ideation, Sunburn
Clinical narrative: chills to the bone; couldn't crawl herself to bed; slept for 18 hours; headache was worst than a migraine; vomiting; passed out; arm sun brunt; swollen; arm red; she wish she was dead,brutal; four good days of life, not a happy camper, lost three days of existing; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and SUICIDAL IDEATION (she wish she was dead,brutal) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 CHILLS (chills to the bone), HYPOKINESIA (couldn't crawl herself to bed), SOMNOLENCE (slept for 18 hours), HEADACHE (headache was worst than a migraine), VOMITING (vomiting), LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), SUNBURN (arm sun brunt), PERIPHERAL SWELLING (swollen), ERYTHEMA (arm red), SUICIDAL IDEATION (she wish she was dead,brutal) (seriousness criterion medically significant) and DEPRESSED MOOD (four good days of life, not a happy camper, lost three days of existing). At the time of the report, CHILLS (chills to the bone), HYPOKINESIA (couldn't crawl herself to bed), SOMNOLENCE (slept for 18 hours), HEADACHE (headache was worst than a migraine), VOMITING (vomiting), LOSS OF CONSCIOUSNESS (passed out), SUNBURN (arm sun brunt), PERIPHERAL SWELLING (swollen), ERYTHEMA (arm red), SUICIDAL IDEATION (she wish she was dead,brutal) and DEPRESSED MOOD (four good days of life, not a happy camper, lost three days of existing) outcome was unknown.            No concomitant medication were not provided patient underwent treatment medication of Tylenol  Very limited information regarding these events has been provided at this time. No follow up is possible.; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: chills to the bone; couldn't crawl herself to bed; slept for 18 hours; headache was worst than a migraine; vomiting; passed out; arm sun brunt; swollen; arm red; she wish she was dead,brutal; four good days of life, not a happy camper, lost three days of existing; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and SUICIDAL IDEATION (she wish she was dead,brutal) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 CHILLS (chills to the bone), HYPOKINESIA (couldn't crawl herself to bed), SOMNOLENCE (slept for 18 hours), HEADACHE (headache was worst than a migraine), VOMITING (vomiting), LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), SUNBURN (arm sun brunt), PERIPHERAL SWELLING (swollen), ERYTHEMA (arm red), SUICIDAL IDEATION (she wish she was dead,brutal) (seriousness criterion medically significant) and DEPRESSED MOOD (four good days of life, not a happy camper, lost three days of existing). At the time of the report, CHILLS (chills to the bone), HYPOKINESIA (couldn't crawl herself to bed), SOMNOLENCE (slept for 18 hours), HEADACHE (headache was worst than a migraine), VOMITING (vomiting), LOSS OF CONSCIOUSNESS (passed out), SUNBURN (arm sun brunt), PERIPHERAL SWELLING (swollen), ERYTHEMA (arm red), SUICIDAL IDEATION (she wish she was dead,brutal) and DEPRESSED MOOD (four good days of life, not a happy camper, lost three days of existing) outcome was unknown.            No concomitant medication were not provided patient underwent treatment medication of Tylenol  Very limited information regarding these events has been provided at this time. No follow up is possible.; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Paraesthesia
Clinical narrative: Left side of head fells like needles; Arm pain; Sleepiness and fatigue; Splitting headache on the left side of head/throbbing; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Left side of head fells like needles) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 001321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tuberculosis.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PARAESTHESIA (Left side of head fells like needles) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm pain), FATIGUE (Sleepiness and fatigue) and HEADACHE (Splitting headache on the left side of head/throbbing). At the time of the report, PARAESTHESIA (Left side of head fells like needles), PAIN IN EXTREMITY (Arm pain), FATIGUE (Sleepiness and fatigue) and HEADACHE (Splitting headache on the left side of head/throbbing) had not resolved.     Concomitant medication was not reported. Treatment medication included paracetamol and oxycodone 5 mg.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. Company comment:This case concerns a 63-year-old male with a serious unexpected event of paranesthesia, and non serious unexpected pain in extremity, and expected fatigue and headache. Event onset the same day as second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 63-year-old male with a serious unexpected event of paranesthesia, and nonserious unexpected pain in extremity, and expected fatigue and headache. Event onset the same day as second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Dyspnoea, Eye swelling
Clinical narrative: Dizzy; Weak; All of the sudden he had difficulty breathing¨; Fast heart beat; Is still very tired; Swelling of his face and throat; Fall; Rib fracture; Pharyngeal swelling; His eyes were swelled like mush mellows; Vomiting; Muscle pain; Joint pain; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weak), DYSPNOEA (All of the sudden he had difficulty breathing¨) and HEART RATE INCREASED (Fast heart beat) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Emphysema, Kidney function abnormal, Heart disorder, Rheumatoid arthritis aggravated and Hypoxia. Concomitant products included OXYGEN for COPD and Emphysema, METHADONE and OXYCODONE for Rheumatoid arthritis, PREDNISONE for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (Dizzy) (seriousness criterion hospitalization), ASTHENIA (Weak) (seriousness criterion hospitalization), DYSPNOEA (All of the sudden he had difficulty breathing¨) (seriousness criteria hospitalization and medically significant), HEART RATE INCREASED (Fast heart beat) (seriousness criterion hospitalization), SWELLING FACE (Swelling of his face and throat), FALL (Fall), RIB FRACTURE (Rib fracture), PHARYNGEAL SWELLING (Pharyngeal swelling), EYE SWELLING (His eyes were swelled like mush mellows), VOMITING (Vomiting), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever). On 19-Apr-2021, the patient experienced FATIGUE (Is still very tired). The patient was hospitalized from 14-Apr-2021 to 17-Apr-2021 due to ASTHENIA, DIZZINESS, DYSPNOEA and HEART RATE INCREASED. On 17-Apr-2021, DIZZINESS (Dizzy), ASTHENIA (Weak), DYSPNOEA (All of the sudden he had difficulty breathing¨), HEART RATE INCREASED (Fast heart beat), SWELLING FACE (Swelling of his face and throat), EYE SWELLING (His eyes were swelled like mush mellows), VOMITING (Vomiting), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown. At the time of the report, FALL (Fall), RIB FRACTURE (Rib fracture), PHARYNGEAL SWELLING (Pharyngeal swelling) and FATIGUE (Is still very tired) outcome was unknown.        This case was linked to MOD-2021-080525 (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. MOD-2021-080525:caller's case
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Fatigue, Heart rate increased, Myalgia, Pharyngeal swelling
Clinical narrative: Dizzy; Weak; All of the sudden he had difficulty breathing¨; Fast heart beat; Is still very tired; Swelling of his face and throat; Fall; Rib fracture; Pharyngeal swelling; His eyes were swelled like mush mellows; Vomiting; Muscle pain; Joint pain; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weak), DYSPNOEA (All of the sudden he had difficulty breathing¨) and HEART RATE INCREASED (Fast heart beat) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Emphysema, Kidney function abnormal, Heart disorder, Rheumatoid arthritis aggravated and Hypoxia. Concomitant products included OXYGEN for COPD and Emphysema, METHADONE and OXYCODONE for Rheumatoid arthritis, PREDNISONE for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (Dizzy) (seriousness criterion hospitalization), ASTHENIA (Weak) (seriousness criterion hospitalization), DYSPNOEA (All of the sudden he had difficulty breathing¨) (seriousness criteria hospitalization and medically significant), HEART RATE INCREASED (Fast heart beat) (seriousness criterion hospitalization), SWELLING FACE (Swelling of his face and throat), FALL (Fall), RIB FRACTURE (Rib fracture), PHARYNGEAL SWELLING (Pharyngeal swelling), EYE SWELLING (His eyes were swelled like mush mellows), VOMITING (Vomiting), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever). On 19-Apr-2021, the patient experienced FATIGUE (Is still very tired). The patient was hospitalized from 14-Apr-2021 to 17-Apr-2021 due to ASTHENIA, DIZZINESS, DYSPNOEA and HEART RATE INCREASED. On 17-Apr-2021, DIZZINESS (Dizzy), ASTHENIA (Weak), DYSPNOEA (All of the sudden he had difficulty breathing¨), HEART RATE INCREASED (Fast heart beat), SWELLING FACE (Swelling of his face and throat), EYE SWELLING (His eyes were swelled like mush mellows), VOMITING (Vomiting), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown. At the time of the report, FALL (Fall), RIB FRACTURE (Rib fracture), PHARYNGEAL SWELLING (Pharyngeal swelling) and FATIGUE (Is still very tired) outcome was unknown.        This case was linked to MOD-2021-080525 (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. MOD-2021-080525:caller's case
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rib fracture, Swelling face, Vomiting
Clinical narrative: Dizzy; Weak; All of the sudden he had difficulty breathing¨; Fast heart beat; Is still very tired; Swelling of his face and throat; Fall; Rib fracture; Pharyngeal swelling; His eyes were swelled like mush mellows; Vomiting; Muscle pain; Joint pain; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weak), DYSPNOEA (All of the sudden he had difficulty breathing¨) and HEART RATE INCREASED (Fast heart beat) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Emphysema, Kidney function abnormal, Heart disorder, Rheumatoid arthritis aggravated and Hypoxia. Concomitant products included OXYGEN for COPD and Emphysema, METHADONE and OXYCODONE for Rheumatoid arthritis, PREDNISONE for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (Dizzy) (seriousness criterion hospitalization), ASTHENIA (Weak) (seriousness criterion hospitalization), DYSPNOEA (All of the sudden he had difficulty breathing¨) (seriousness criteria hospitalization and medically significant), HEART RATE INCREASED (Fast heart beat) (seriousness criterion hospitalization), SWELLING FACE (Swelling of his face and throat), FALL (Fall), RIB FRACTURE (Rib fracture), PHARYNGEAL SWELLING (Pharyngeal swelling), EYE SWELLING (His eyes were swelled like mush mellows), VOMITING (Vomiting), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever). On 19-Apr-2021, the patient experienced FATIGUE (Is still very tired). The patient was hospitalized from 14-Apr-2021 to 17-Apr-2021 due to ASTHENIA, DIZZINESS, DYSPNOEA and HEART RATE INCREASED. On 17-Apr-2021, DIZZINESS (Dizzy), ASTHENIA (Weak), DYSPNOEA (All of the sudden he had difficulty breathing¨), HEART RATE INCREASED (Fast heart beat), SWELLING FACE (Swelling of his face and throat), EYE SWELLING (His eyes were swelled like mush mellows), VOMITING (Vomiting), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown. At the time of the report, FALL (Fall), RIB FRACTURE (Rib fracture), PHARYNGEAL SWELLING (Pharyngeal swelling) and FATIGUE (Is still very tired) outcome was unknown.        This case was linked to MOD-2021-080525 (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. MOD-2021-080525:caller's case
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Gastrointestinal disorder, Headache
Clinical narrative: shortness of breath; chest pain; low humming in the left ear; abdominal fulness; headache; horizontal pain across back below the shoulder blades; pain in the left arm; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), TINNITUS (low humming in the left ear), GASTROINTESTINAL DISORDER (abdominal fulness) and HEADACHE (headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced BACK PAIN (horizontal pain across back below the shoulder blades) and PAIN IN EXTREMITY (pain in the left arm). On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion medically significant), CHEST PAIN (chest pain) (seriousness criterion medically significant), TINNITUS (low humming in the left ear) (seriousness criterion medically significant), GASTROINTESTINAL DISORDER (abdominal fulness) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). On 24-Feb-2021, BACK PAIN (horizontal pain across back below the shoulder blades) had resolved. At the time of the report, DYSPNOEA (shortness of breath) and PAIN IN EXTREMITY (pain in the left arm) had resolved and CHEST PAIN (chest pain), TINNITUS (low humming in the left ear), GASTROINTESTINAL DISORDER (abdominal fulness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment is provided. No Concomitant list is provided.   This case was linked to MOD-2021-080428, MOD-2021-080027 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-080428:case for second dose MOD-2021-080027:case for wife
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: shortness of breath; chest pain; low humming in the left ear; abdominal fulness; headache; horizontal pain across back below the shoulder blades; pain in the left arm; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), TINNITUS (low humming in the left ear), GASTROINTESTINAL DISORDER (abdominal fulness) and HEADACHE (headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced BACK PAIN (horizontal pain across back below the shoulder blades) and PAIN IN EXTREMITY (pain in the left arm). On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion medically significant), CHEST PAIN (chest pain) (seriousness criterion medically significant), TINNITUS (low humming in the left ear) (seriousness criterion medically significant), GASTROINTESTINAL DISORDER (abdominal fulness) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). On 24-Feb-2021, BACK PAIN (horizontal pain across back below the shoulder blades) had resolved. At the time of the report, DYSPNOEA (shortness of breath) and PAIN IN EXTREMITY (pain in the left arm) had resolved and CHEST PAIN (chest pain), TINNITUS (low humming in the left ear), GASTROINTESTINAL DISORDER (abdominal fulness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment is provided. No Concomitant list is provided.   This case was linked to MOD-2021-080428, MOD-2021-080027 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-080428:case for second dose MOD-2021-080027:case for wife
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, Palpitations, Troponin increased
Clinical narrative: Tightness in breath; Heart palpitation; Pain; Troponin increased; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Tightness in breath) and PALPITATIONS (Heart palpitation) in a 21-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.     The patient's past medical history included Asthma.   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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Tightness in breath) (seriousness criterion hospitalization), PALPITATIONS (Heart palpitation) (seriousness criterion hospitalization), PAIN (Pain) and TROPONIN INCREASED (Troponin increased). At the time of the report, DYSPNOEA (Tightness in breath), PALPITATIONS (Heart palpitation), PAIN (Pain) and TROPONIN INCREASED (Troponin increased) 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 (days after second administration), a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (days after second administration), a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Ear haemorrhage, Haematochezia, Headache
Clinical narrative: Blood in diaper; Dizziness; Bleeding in her left ear; Severe bruising on left side; Red dots all over her skin; Nausea; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in diaper) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disease, unspecified (Under hospice care for heart condition). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Heart disease, unspecified.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-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 HAEMATOCHEZIA (Blood in diaper) (seriousness criterion medically significant), DIZZINESS (Dizziness), EAR HAEMORRHAGE (Bleeding in her left ear), CONTUSION (Severe bruising on left side), PETECHIAE (Red dots all over her skin), NAUSEA (Nausea) and HEADACHE (Headaches). At the time of the report, HAEMATOCHEZIA (Blood in diaper), DIZZINESS (Dizziness), EAR HAEMORRHAGE (Bleeding in her left ear), CONTUSION (Severe bruising on left side), PETECHIAE (Red dots all over her skin), NAUSEA (Nausea) and HEADACHE (Headaches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported. It was reported that the patient hasn't seen the doctor about her side effects yet.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Petechiae
Clinical narrative: Blood in diaper; Dizziness; Bleeding in her left ear; Severe bruising on left side; Red dots all over her skin; Nausea; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in diaper) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disease, unspecified (Under hospice care for heart condition). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Heart disease, unspecified.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-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 HAEMATOCHEZIA (Blood in diaper) (seriousness criterion medically significant), DIZZINESS (Dizziness), EAR HAEMORRHAGE (Bleeding in her left ear), CONTUSION (Severe bruising on left side), PETECHIAE (Red dots all over her skin), NAUSEA (Nausea) and HEADACHE (Headaches). At the time of the report, HAEMATOCHEZIA (Blood in diaper), DIZZINESS (Dizziness), EAR HAEMORRHAGE (Bleeding in her left ear), CONTUSION (Severe bruising on left side), PETECHIAE (Red dots all over her skin), NAUSEA (Nausea) and HEADACHE (Headaches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported. It was reported that the patient hasn't seen the doctor about her side effects yet.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Gait disturbance, Neurological symptom, Product dose omission issue, Speech disorder
Clinical narrative: possibility of having a stroke; severe neurological symptoms; difficulty with her speech (can think of the word, but could not get it out); she had gait problems; Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (possibility of having a stroke), NEUROLOGICAL SYMPTOM (severe neurological symptoms), SPEECH DISORDER (difficulty with her speech (can think of the word, but could not get it out)) and GAIT DISTURBANCE (she had gait problems) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, MORPHINE SULFATE, AMITRIPTYLINE, METFORMIN, GABAPENTIN, LOSARTAN, CLOPIDOGREL, PANTOPRAZOLE, RISPERIDONE, DAILYVIT WOMEN 50+, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN N) and INSULIN ASPART for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (possibility of having a stroke) (seriousness criterion hospitalization), NEUROLOGICAL SYMPTOM (severe neurological symptoms) (seriousness criterion hospitalization), SPEECH DISORDER (difficulty with her speech (can think of the word, but could not get it out)) (seriousness criterion hospitalization) and GAIT DISTURBANCE (she had gait problems) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose ). The patient was hospitalized on 21-Feb-2021 due to CEREBROVASCULAR ACCIDENT, GAIT DISTURBANCE, NEUROLOGICAL SYMPTOM and SPEECH DISORDER. On 10-Mar-2021, CEREBROVASCULAR ACCIDENT (possibility of having a stroke), NEUROLOGICAL SYMPTOM (severe neurological symptoms), SPEECH DISORDER (difficulty with her speech (can think of the word, but could not get it out)) and GAIT DISTURBANCE (she had gait problems) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose ) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Company comment:Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Chills, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: cellulitis; Sepsis; Elevated heart rate; Rash from the waist down on left side of body; chills; Fever; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis) and SEPSIS (Sepsis) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart rate increased (elevated heartrate).   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (Fever). On 15-Apr-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion hospitalization), SEPSIS (Sepsis) (seriousness criterion hospitalization) and RASH (Rash from the waist down on left side of body). On an unknown date, the patient experienced HEART RATE INCREASED (Elevated heart rate). The patient was hospitalized from sometime in April 2021 to sometime in April 2021 due to CELLULITIS and SEPSIS. At the time of the report, CELLULITIS (cellulitis), SEPSIS (Sepsis), HEART RATE INCREASED (Elevated heart rate), RASH (Rash from the waist down on left side of body), CHILLS (chills) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Heart rate: 132 (High) 132 beats per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. She was admitted to the hospital and hospitalized for four days. She was diagnosed with cellulitis and sepsis. She was discharged  home from the hospital with Augmentin (Amoxicillin / Clavulanic acid) for 10 days.  Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded. However, Further information has been requested   This case was linked to MODERNATX, INC.-MOD-2021-081503~, MODERNATX, INC.-MOD-2021-081439, MODERNATX, INC.-MOD-2021-081647 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded. However, Further information has been requested MODERNATX, INC.-MOD-2021-081503 :Fourth patient-Same reporter MODERNATX, INC.-MOD-2021-081439:First patient-Same reporter US-MODERNATX, INC.-MOD-2021-081647:Third patient-Same reporter
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Sepsis
Clinical narrative: cellulitis; Sepsis; Elevated heart rate; Rash from the waist down on left side of body; chills; Fever; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis) and SEPSIS (Sepsis) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart rate increased (elevated heartrate).   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (Fever). On 15-Apr-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion hospitalization), SEPSIS (Sepsis) (seriousness criterion hospitalization) and RASH (Rash from the waist down on left side of body). On an unknown date, the patient experienced HEART RATE INCREASED (Elevated heart rate). The patient was hospitalized from sometime in April 2021 to sometime in April 2021 due to CELLULITIS and SEPSIS. At the time of the report, CELLULITIS (cellulitis), SEPSIS (Sepsis), HEART RATE INCREASED (Elevated heart rate), RASH (Rash from the waist down on left side of body), CHILLS (chills) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Heart rate: 132 (High) 132 beats per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. She was admitted to the hospital and hospitalized for four days. She was diagnosed with cellulitis and sepsis. She was discharged  home from the hospital with Augmentin (Amoxicillin / Clavulanic acid) for 10 days.  Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded. However, Further information has been requested   This case was linked to MODERNATX, INC.-MOD-2021-081503~, MODERNATX, INC.-MOD-2021-081439, MODERNATX, INC.-MOD-2021-081647 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded. However, Further information has been requested MODERNATX, INC.-MOD-2021-081503 :Fourth patient-Same reporter MODERNATX, INC.-MOD-2021-081439:First patient-Same reporter US-MODERNATX, INC.-MOD-2021-081647:Third patient-Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypertension, Myalgia, Tubulointerstitial nephritis
Clinical narrative: interstitial nephritis; severe headache; Dizziness; whole body ache; high blood pressure; Vitamin-D was 13; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TUBULOINTERSTITIAL NEPHRITIS (interstitial nephritis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TUBULOINTERSTITIAL NEPHRITIS (interstitial nephritis) (seriousness criterion medically significant), HEADACHE (severe headache), DIZZINESS (Dizziness), MYALGIA (whole body ache), HYPERTENSION (high blood pressure) and VITAMIN D DEFICIENCY (Vitamin-D was 13). At the time of the report, TUBULOINTERSTITIAL NEPHRITIS (interstitial nephritis), HEADACHE (severe headache), DIZZINESS (Dizziness), MYALGIA (whole body ache), HYPERTENSION (high blood pressure) and VITAMIN D DEFICIENCY (Vitamin-D was 13) outcome was unknown.      No concomitant medications reported.  Treatment of these events included Tylenol and dexamethasone.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vitamin D deficiency
Clinical narrative: interstitial nephritis; severe headache; Dizziness; whole body ache; high blood pressure; Vitamin-D was 13; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TUBULOINTERSTITIAL NEPHRITIS (interstitial nephritis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TUBULOINTERSTITIAL NEPHRITIS (interstitial nephritis) (seriousness criterion medically significant), HEADACHE (severe headache), DIZZINESS (Dizziness), MYALGIA (whole body ache), HYPERTENSION (high blood pressure) and VITAMIN D DEFICIENCY (Vitamin-D was 13). At the time of the report, TUBULOINTERSTITIAL NEPHRITIS (interstitial nephritis), HEADACHE (severe headache), DIZZINESS (Dizziness), MYALGIA (whole body ache), HYPERTENSION (high blood pressure) and VITAMIN D DEFICIENCY (Vitamin-D was 13) outcome was unknown.      No concomitant medications reported.  Treatment of these events included Tylenol and dexamethasone.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Pulmonary embolism
Clinical narrative: multiple pulmonary emboli; could barely breath; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (multiple pulmonary emboli) and DYSPNOEA (could barely breath) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062G20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gallbladder removal on 25-Mar-2021.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (fatigue). On 27-Mar-2021, the patient experienced PULMONARY EMBOLISM (multiple pulmonary emboli) (seriousness criteria hospitalization prolonged, medically significant and life threatening) and DYSPNOEA (could barely breath) (seriousness criteria hospitalization prolonged, medically significant and life threatening). The patient was hospitalized for 3 days due to DYSPNOEA and PULMONARY EMBOLISM. On 13-Feb-2021, FATIGUE (fatigue) had resolved. At the time of the report, PULMONARY EMBOLISM (multiple pulmonary emboli) and DYSPNOEA (could barely breath) outcome was unknown.            The doctors believed that her diagnosis was not a common side effect from the surgery and believed that the vaccine contributed to the diagnosis. She was treated with apixaban, omeprazole and aspirin 81mg (once daily).  The patient is scheduled to visit a hematologist after 6 months.  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   This case was linked to MOD-2021-081407 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested MOD-2021-081407:Crosslinked case; Dose 1
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Joint stiffness, Muscle spasticity, Myalgia
Clinical narrative: Has to make a conscious effort to open hands; joint pain- stiffness; joint pain especially in hands and knees but all joints / joints very painful; pain at shoulder; Fatigue; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASTICITY (Has to make a conscious effort to open hands) and JOINT STIFFNESS (joint pain- stiffness) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced MUSCLE SPASTICITY (Has to make a conscious effort to open hands) (seriousness criterion medically significant), JOINT STIFFNESS (joint pain- stiffness) (seriousness criterion medically significant), ARTHRALGIA (joint pain especially in hands and knees but all joints / joints very painful), ARTHRALGIA (pain at shoulder), FATIGUE (Fatigue) and MYALGIA (muscle aches). On 22-Mar-2021, ARTHRALGIA (pain at shoulder) had resolved. At the time of the report, MUSCLE SPASTICITY (Has to make a conscious effort to open hands), JOINT STIFFNESS (joint pain- stiffness), ARTHRALGIA (joint pain especially in hands and knees but all joints / joints very painful), FATIGUE (Fatigue) and MYALGIA (muscle aches) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Concomitant medications were not reported.  Treatment was reported as ibuprofen 2-3 tablets per day.