chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: her Atrial fibrillation (AF or afib) started again; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (her Atrial fibrillation (AF or afib) started again) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. V029A21A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation (Atrial fibrillation (AF or afib) started again, it was dormant for 5 or 6 years). Concomitant products included DRONEDARONE HYDROCHLORIDE (MULTAQ) for AFib, APIXABAN (ELIQUIS) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 07-Mar-2021, the patient experienced ATRIAL FIBRILLATION (her Atrial fibrillation (AF or afib) started again) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (her Atrial fibrillation (AF or afib) started again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Feeling hot, Malaise, Nausea
Clinical narrative: started feeling really sick; lightheaded; didn't feel well; felt hot; felt like she was going to pass out; vomiting; nauseated; right shoulder became very sore; right shoulder became tender; sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like she was going to pass out) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stevens-Johnson syndrome. Concurrent medical conditions included Allergy to antibiotic (Name unknown. Antibiotic caused Stevens-Johnson Syndrome.).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore right arm). On 03-Mar-2021, the patient experienced TENDERNESS (right shoulder became tender) and ARTHRALGIA (right shoulder became very sore). On 17-Mar-2021, the patient experienced PRESYNCOPE (felt like she was going to pass out) (seriousness criterion medically significant), MALAISE (started feeling really sick), DIZZINESS (lightheaded), MALAISE (didn't feel well), FEELING HOT (felt hot), VOMITING (vomiting) and NAUSEA (nauseated). On 03-Mar-2021, TENDERNESS (right shoulder became tender) and ARTHRALGIA (right shoulder became very sore) had resolved. On 17-Mar-2021, PRESYNCOPE (felt like she was going to pass out), MALAISE (started feeling really sick), DIZZINESS (lightheaded), MALAISE (didn't feel well), FEELING HOT (felt hot), VOMITING (vomiting) and NAUSEA (nauseated) had resolved. At the time of the report, PAIN IN EXTREMITY (sore right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Presyncope, Tenderness, Vomiting
Clinical narrative: started feeling really sick; lightheaded; didn't feel well; felt hot; felt like she was going to pass out; vomiting; nauseated; right shoulder became very sore; right shoulder became tender; sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like she was going to pass out) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stevens-Johnson syndrome. Concurrent medical conditions included Allergy to antibiotic (Name unknown. Antibiotic caused Stevens-Johnson Syndrome.).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore right arm). On 03-Mar-2021, the patient experienced TENDERNESS (right shoulder became tender) and ARTHRALGIA (right shoulder became very sore). On 17-Mar-2021, the patient experienced PRESYNCOPE (felt like she was going to pass out) (seriousness criterion medically significant), MALAISE (started feeling really sick), DIZZINESS (lightheaded), MALAISE (didn't feel well), FEELING HOT (felt hot), VOMITING (vomiting) and NAUSEA (nauseated). On 03-Mar-2021, TENDERNESS (right shoulder became tender) and ARTHRALGIA (right shoulder became very sore) had resolved. On 17-Mar-2021, PRESYNCOPE (felt like she was going to pass out), MALAISE (started feeling really sick), DIZZINESS (lightheaded), MALAISE (didn't feel well), FEELING HOT (felt hot), VOMITING (vomiting) and NAUSEA (nauseated) had resolved. At the time of the report, PAIN IN EXTREMITY (sore right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Off label use
Clinical narrative: hospitalized with COVID pneumonia after first dose; More than 36 days have passed since first dose/doctor told her to wait for 90 days for second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 PNEUMONIA (hospitalized with COVID pneumonia after first dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 medical history reported.).  On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced COVID-19 PNEUMONIA (hospitalized with COVID pneumonia after first dose) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced OFF LABEL USE (More than 36 days have passed since first dose/doctor told her to wait for 90 days for second dose). The patient was hospitalized from 29-Jan-2021 to 18-Feb-2021 due to COVID-19 PNEUMONIA. At the time of the report, COVID-19 PNEUMONIA (hospitalized with COVID pneumonia after first dose) and OFF LABEL USE (More than 36 days have passed since first dose/doctor told her to wait for 90 days for second dose) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No treatment information was provide. Patient was told to wait 90 days to receive the second dose by her doctor. This report refers to a case of Off label use for mRNA-1273, lot # 013L20A with an associated AE. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 Pneumonia after vaccination, this event is assessed as unlikely related to mRNA-1273.; Sender's Comments: This report refers to a case of Off label use for mRNA-1273, lot # 013L20A with an associated AE. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 Pneumonia after vaccination, this event is assessed as unlikely related to mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Pain, Seizure, Transient ischaemic attack
Clinical narrative: seizure or mini stroke; hallucinations; seizure or mini stroke; pain; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (seizure or mini stroke), HALLUCINATION (hallucinations) and SEIZURE (seizure or mini stroke) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 030b21A) 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 Relevant medical information provided). Concomitant products included GALANTAMINE and LEVETIRACETAM (KEPPRA) for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (seizure or mini stroke) (seriousness criterion medically significant), HALLUCINATION (hallucinations) (seriousness criterion medically significant) and PAIN (pain). On an unknown date, the patient experienced SEIZURE (seizure or mini stroke) (seriousness criterion medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (seizure or mini stroke), HALLUCINATION (hallucinations), PAIN (pain) and SEIZURE (seizure or mini stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Aspirin. The drug history included "blood pressure medication"; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Haemangioma of skin, Immune thrombocytopenia, Pruritus, Rash
Clinical narrative: Idiopathic thrombocytopenic purpura; Itching; Rash on her chest; Cherry angioma; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 05-Apr-2021, the patient experienced HAEMANGIOMA OF SKIN (Cherry angioma). On 06-Apr-2021, the patient experienced PRURITUS (Itching) and RASH (Rash on her chest). On 07-Apr-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura), HAEMANGIOMA OF SKIN (Cherry angioma), PRURITUS (Itching) and RASH (Rash on her chest) 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.   Her doctor thinks it an allergic reaction and an early stage ITP (idiopathic thrombocytopenic purpura).  No concomitant medication reported by the reporter.  No treatment medication reported by the reporter  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.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Contusion, Sinusitis
Clinical narrative: bruised the right side of his face/walking into door leading to bruise on face; Bell's Palsy; sinus infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) 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.     The patient's past medical history included Sclerosis of liver and Stent placement.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SINUSITIS (sinus infection). On 05-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). On 07-Apr-2021, the patient experienced CONTUSION (bruised the right side of his face). On 07-Apr-2021, PAIN (pain is almost 100% gone) had resolved. At the time of the report, FACIAL PARALYSIS (Bell's Palsy), SINUSITIS (sinus infection) and CONTUSION (bruised the right side of his face) had resolved.; Sender's Comments: This case is regarding a Male patient of unknown age who experienced the events Facial paralysis, pain, sinusitis, and contusion.  The events of sinusitis and contusion were assessed as unlikely related to study drug as the contusion occurred due to patient walking into a door.   The sinusitis can be due to an infection causing inflammation of sinus.  Based on the current available information and temporal association between the use of the product and the start date of the event, Facial paralysis, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). On 23-Mar-2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was provided.; Sender's Comments: This case concerns a 58-year-old male with a serious unexpected event of loss of consciousness. Event onset the same day as first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Haematochezia
Clinical narrative: passing blood in his stool; stomach pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HAEMATOCHEZIA (passing blood in his stool) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) 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 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced HAEMATOCHEZIA (passing blood in his stool) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (stomach pain). On 07-Apr-2021, HAEMATOCHEZIA (passing blood in his stool) and ABDOMINAL PAIN UPPER (stomach pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified blood thinners.  Treatment information was not provided.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Unspecified Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Unspecified Adverse event) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Unspecified Adverse event) (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (Unspecified Adverse event) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Feeling drunk, Heart rate increased, Hypoaesthesia oral
Clinical narrative: Numbness; numbness; anxiety; Heart rate; she was out of it; feeling drunk; Fainted; Tightness in her Face; Weakness in the legs; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted), MUSCLE TIGHTNESS (Tightness in her Face), MUSCULAR WEAKNESS (Weakness in the legs), HYPOAESTHESIA ORAL (Numbness) and HYPOAESTHESIA ORAL (numbness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 008B21-2A) 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 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), MUSCLE TIGHTNESS (Tightness in her Face) (seriousness criterion medically significant) and MUSCULAR WEAKNESS (Weakness in the legs) (seriousness criterion medically significant). On 08-Apr-2021, the patient experienced HYPOAESTHESIA ORAL (Numbness) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (numbness) (seriousness criterion medically significant), ANXIETY (anxiety), HEART RATE INCREASED (Heart rate), MALAISE (she was out of it) and FEELING DRUNK (feeling drunk). On 23-Mar-2021, SYNCOPE (Fainted), MUSCLE TIGHTNESS (Tightness in her Face) and MUSCULAR WEAKNESS (Weakness in the legs) had resolved. At the time of the report, HYPOAESTHESIA ORAL (Numbness), HYPOAESTHESIA ORAL (numbness), ANXIETY (anxiety), HEART RATE INCREASED (Heart rate), MALAISE (she was out of it) and FEELING DRUNK (feeling drunk) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Body temperature: 99.5 (Inconclusive) Degrees Fahrenheit.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No medication as administrated ( No Epi Pen). Hospital doctor stated that the patient had anxiety attack. Patient stated she does not have history of anxiety. Patient was released from ER in the same day.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscle tightness, Muscular weakness, Syncope
Clinical narrative: Numbness; numbness; anxiety; Heart rate; she was out of it; feeling drunk; Fainted; Tightness in her Face; Weakness in the legs; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted), MUSCLE TIGHTNESS (Tightness in her Face), MUSCULAR WEAKNESS (Weakness in the legs), HYPOAESTHESIA ORAL (Numbness) and HYPOAESTHESIA ORAL (numbness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 008B21-2A) 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 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), MUSCLE TIGHTNESS (Tightness in her Face) (seriousness criterion medically significant) and MUSCULAR WEAKNESS (Weakness in the legs) (seriousness criterion medically significant). On 08-Apr-2021, the patient experienced HYPOAESTHESIA ORAL (Numbness) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (numbness) (seriousness criterion medically significant), ANXIETY (anxiety), HEART RATE INCREASED (Heart rate), MALAISE (she was out of it) and FEELING DRUNK (feeling drunk). On 23-Mar-2021, SYNCOPE (Fainted), MUSCLE TIGHTNESS (Tightness in her Face) and MUSCULAR WEAKNESS (Weakness in the legs) had resolved. At the time of the report, HYPOAESTHESIA ORAL (Numbness), HYPOAESTHESIA ORAL (numbness), ANXIETY (anxiety), HEART RATE INCREASED (Heart rate), MALAISE (she was out of it) and FEELING DRUNK (feeling drunk) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Body temperature: 99.5 (Inconclusive) Degrees Fahrenheit.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No medication as administrated ( No Epi Pen). Hospital doctor stated that the patient had anxiety attack. Patient stated she does not have history of anxiety. Patient was released from ER in the same day.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: 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: F
Vaccine: COVID19
Symptoms: Syncope, Vertigo
Clinical narrative: near fainting spell/like intermittent fainting spells; feels like vertigo; This spontaneous case was reported by a non-health professional and describes the occurrence of SYNCOPE (near fainting spell/like intermittent fainting spells) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 03-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 03-Apr-2021, the patient experienced SYNCOPE (near fainting spell/like intermittent fainting spells) (seriousness criterion medically significant) and VERTIGO (feels like vertigo). At the time of the report, SYNCOPE (near fainting spell/like intermittent fainting spells) and VERTIGO (feels like vertigo) outcome was unknown.            Onset date of events was 4 hours after second shot, which is again 03-apr-2021 and outcome as unknown.  Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. 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 event, a causal relationship cannot be excluded.  No further information is expected at this time.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Myalgia, Urticaria
Clinical narrative: Cellulitis; huge hives; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history) since an unknown date.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced MYALGIA (Sore arm). On 04-Apr-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant) and URTICARIA (huge hives). In March 2021, MYALGIA (Sore arm) had resolved. At the time of the report, CELLULITIS (Cellulitis) and URTICARIA (huge hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had a sore arm after vaccination.  A week later she developed huge hives and was diagnosed with cellulitis in her left arm at the doctor's office.   No concomitant medications were reported.  Treatment included doxycycline 100 mg.  Based on the information provided to include the location (Left arm-same as injected arm) and the onsets of the reported events, a causal association between the administration of mRNA-1273 and the events cannot be excluded.; Sender's Comments: Based on the information provided to include the location (Left arm-same as injected arm) and the onsets of the reported events, a causal association between the administration of mRNA-1273 and the events cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cor pulmonale acute, Dizziness, Dyspnoea, Palpitations, Pulmonary embolism
Clinical narrative: Acute cor pulmonale; problems breathing; experienced heart strongest beat; dizziness; Saddle embolism pulmonary art; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Saddle embolism pulmonary art), COR PULMONALE ACUTE (Acute cor pulmonale), DYSPNOEA (problems breathing), PALPITATIONS (experienced heart strongest beat) and DIZZINESS (dizziness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ERENUMAB (AIMOVIG [ERENUMAB]) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PULMONARY EMBOLISM (Saddle embolism pulmonary art) (seriousness criteria hospitalization and life threatening), DYSPNOEA (problems breathing) (seriousness criterion hospitalization), PALPITATIONS (experienced heart strongest beat) (seriousness criterion hospitalization) and DIZZINESS (dizziness) (seriousness criterion hospitalization). On an unknown date, the patient experienced COR PULMONALE ACUTE (Acute cor pulmonale) (seriousness criteria hospitalization and life threatening). The patient was hospitalized from 28-Mar-2021 to 31-Mar-2021 due to COR PULMONALE ACUTE, DIZZINESS, DYSPNOEA, PALPITATIONS and PULMONARY EMBOLISM. On 31-Mar-2021, PULMONARY EMBOLISM (Saddle embolism pulmonary art) outcome was unknown. At the time of the report, COR PULMONALE ACUTE (Acute cor pulmonale), DYSPNOEA (problems breathing), PALPITATIONS (experienced heart strongest beat) and DIZZINESS (dizziness) 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.   After 2 weeks of vaccination, the patient started to experienced heart strongest beat, problems to breathing and dizziness. On 28 MAR 2021 she felt this symptom and she thought "something is going bad" and has to be hospitalized on intensive care unit (ICU)  from 28MAR2021 to 31MAR2021 (4 days). They diagnosticated "saddle embolism pulmonary art with acute cor pulmonale". They found several clots in both lungs and one big clot/ one large clot in the pulmonary artery. Pulmonary embolism between lungs.  Treatment information was not provided. Vaccination second dose was recommended.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Epilepsy.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  Three hours after the first dose, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant).   At the time of the report, SEIZURE (Seizure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Description: The consumer got the first dose and developed seizure (medically significant) for three hours.  No treatment information was provided.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Herpes zoster, Illness, Malaise, Pain
Clinical narrative: Very sick; had some of the typical symptoms like achy; weak; just threw up; it developed into a horrible, very severe case of shingles/still has shingles; did not feel very well/was not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (it developed into a horrible, very severe case of shingles/still has shingles) in an 85-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 Shingles (Had received the shingles vaccine). Concurrent medical conditions included AFib (She takes a blood thinner).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced HERPES ZOSTER (it developed into a horrible, very severe case of shingles/still has shingles) (seriousness criterion medically significant) and MALAISE (did not feel very well/was not feeling well). On an unknown date, the patient experienced ILLNESS (Very sick), PAIN (had some of the typical symptoms like achy), ASTHENIA (weak) and VOMITING (just threw up). At the time of the report, HERPES ZOSTER (it developed into a horrible, very severe case of shingles/still has shingles), MALAISE (did not feel very well/was not feeling well), ILLNESS (Very sick), PAIN (had some of the typical symptoms like achy), ASTHENIA (weak) and VOMITING (just threw up) had not resolved.            The patient was taken twice to the emergency room because she developed very severe shingles. The reporter got a message that the patient threw up and patient was taken to the hospital. treatment for the events included antibiotic and pain medication.; 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: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Very sick; had some of the typical symptoms like achy; weak; just threw up; it developed into a horrible, very severe case of shingles/still has shingles; did not feel very well/was not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (it developed into a horrible, very severe case of shingles/still has shingles) in an 85-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 Shingles (Had received the shingles vaccine). Concurrent medical conditions included AFib (She takes a blood thinner).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced HERPES ZOSTER (it developed into a horrible, very severe case of shingles/still has shingles) (seriousness criterion medically significant) and MALAISE (did not feel very well/was not feeling well). On an unknown date, the patient experienced ILLNESS (Very sick), PAIN (had some of the typical symptoms like achy), ASTHENIA (weak) and VOMITING (just threw up). At the time of the report, HERPES ZOSTER (it developed into a horrible, very severe case of shingles/still has shingles), MALAISE (did not feel very well/was not feeling well), ILLNESS (Very sick), PAIN (had some of the typical symptoms like achy), ASTHENIA (weak) and VOMITING (just threw up) had not resolved.            The patient was taken twice to the emergency room because she developed very severe shingles. The reporter got a message that the patient threw up and patient was taken to the hospital. treatment for the events included antibiotic and pain medication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: lmost passed out, almost blackout; woke up and broke out in sweats all over her body; restless was tossing and turning; symptoms hit her like a ton of bricks; threw up could not keep any food or water down; headache (throbbed with every heartbeat); Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (lmost passed out, almost blackout) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) 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 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (lmost passed out, almost blackout) (seriousness criterion medically significant), HYPERHIDROSIS (woke up and broke out in sweats all over her body), RESTLESSNESS (restless was tossing and turning), FEELING ABNORMAL (symptoms hit her like a ton of bricks), VOMITING (threw up could not keep any food or water down), HEADACHE (headache (throbbed with every heartbeat)) and NAUSEA (Nausea). On 26-Mar-2021, LOSS OF CONSCIOUSNESS (lmost passed out, almost blackout), HYPERHIDROSIS (woke up and broke out in sweats all over her body), RESTLESSNESS (restless was tossing and turning), FEELING ABNORMAL (symptoms hit her like a ton of bricks), VOMITING (threw up could not keep any food or water down), HEADACHE (headache (throbbed with every heartbeat)) and NAUSEA (Nausea) had resolved.            No concomitant medications were provided No treatment medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-071431 (E2B Linked Report).; Sender's Comments: This case concerns a female adult with a serious unexpected event of loss of consciousness, and nonserious unexpected feeling abnormal, hyperhidrosis, restlessness, and expected nausea, vomiting, headache. 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. MODERNATX, INC.-MOD-2021-071431:Crosslinked case
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, Vomiting
Clinical narrative: lmost passed out, almost blackout; woke up and broke out in sweats all over her body; restless was tossing and turning; symptoms hit her like a ton of bricks; threw up could not keep any food or water down; headache (throbbed with every heartbeat); Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (lmost passed out, almost blackout) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) 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 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (lmost passed out, almost blackout) (seriousness criterion medically significant), HYPERHIDROSIS (woke up and broke out in sweats all over her body), RESTLESSNESS (restless was tossing and turning), FEELING ABNORMAL (symptoms hit her like a ton of bricks), VOMITING (threw up could not keep any food or water down), HEADACHE (headache (throbbed with every heartbeat)) and NAUSEA (Nausea). On 26-Mar-2021, LOSS OF CONSCIOUSNESS (lmost passed out, almost blackout), HYPERHIDROSIS (woke up and broke out in sweats all over her body), RESTLESSNESS (restless was tossing and turning), FEELING ABNORMAL (symptoms hit her like a ton of bricks), VOMITING (threw up could not keep any food or water down), HEADACHE (headache (throbbed with every heartbeat)) and NAUSEA (Nausea) had resolved.            No concomitant medications were provided No treatment medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-071431 (E2B Linked Report).; Sender's Comments: This case concerns a female adult with a serious unexpected event of loss of consciousness, and nonserious unexpected feeling abnormal, hyperhidrosis, restlessness, and expected nausea, vomiting, headache. 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. MODERNATX, INC.-MOD-2021-071431:Crosslinked case
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Product dose omission issue
Clinical narrative: I missed my 2nd dose because I had pneumonia and was in the hospital; I am overdue for my 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (I missed my 2nd dose because I had pneumonia and was in the hospital) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included TRAZODONE and VITAMINS NOS for an unknown indication.    On 05-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 PNEUMONIA (I missed my 2nd dose because I had pneumonia and was in the hospital) (seriousness criteria hospitalization and medically significant) and PRODUCT DOSE OMISSION ISSUE (I am overdue for my 2nd dose). The patient was hospitalized from 30-Mar-2021 to 05-Apr-2021 due to PNEUMONIA. At the time of the report, PNEUMONIA (I missed my 2nd dose because I had pneumonia and was in the hospital) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (I am overdue for my 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment mediaction provided included Cefuroxime for Pneumonia.  Very limited information regarding these events have been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time.  Further information has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills,shivering; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (chills,shivering) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METHOTREXATE, LISINOPRIL, FOLIC ACID and CHROMIC CHLORIDE, CINNAMOMUM SPP., GYMNEMA SYLVESTRE, THIOCTIC ACID (DIABETES) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 11-Mar-2021, the patient experienced CHILLS (chills,shivering) (seriousness criterion hospitalization). At the time of the report, CHILLS (chills,shivering) outcome was unknown.        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.; Reporter'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. Further information has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: Polymyalgia rheumatica; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 02-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) (seriousness criterion medically significant). At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) outcome was unknown. Not Provided          The patient was taking prednisone he is following up with the doctor on 16 Apr 2021.  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.   This case was linked to MOD21-072303 (E2B Linked Report). This case was linked to MOD-2021-071546 (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 this event, a causal relationship cannot be excluded. MOD21-072303:
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Scleral haemorrhage
Clinical narrative: Scleral hemorrhaging of the right eye; This spontaneous case was reported by a consumer and describes the occurrence of SCLERAL HAEMORRHAGE (Scleral hemorrhaging of the right eye) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 SCLERAL HAEMORRHAGE (Scleral hemorrhaging of the right eye) (seriousness criterion medically significant). At the time of the report, SCLERAL HAEMORRHAGE (Scleral hemorrhaging of the right eye) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.      This case was linked to MOD-2021-072179 (Patient Link).