chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypotension, Loss of consciousness, Nasal congestion, Nasopharyngitis
Clinical narrative: cold like symptoms; stuffy nose; sore arm; headache; unconscious; fainted; blood pressure was low; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (unconscious) and SYNCOPE (fainted) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (unconscious) (seriousness criterion medically significant), SYNCOPE (fainted) (seriousness criterion medically significant) and HYPOTENSION (blood pressure was low). On 19-Apr-2021, the patient experienced NASOPHARYNGITIS (cold like symptoms), NASAL CONGESTION (stuffy nose), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). On 23-Apr-2021, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (unconscious), SYNCOPE (fainted) and HYPOTENSION (blood pressure was low) had resolved and NASOPHARYNGITIS (cold like symptoms) and NASAL CONGESTION (stuffy nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. As treatment, the patient took acetaminophen, ibuprofen and antihistamine.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Syncope
Clinical narrative: cold like symptoms; stuffy nose; sore arm; headache; unconscious; fainted; blood pressure was low; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (unconscious) and SYNCOPE (fainted) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (unconscious) (seriousness criterion medically significant), SYNCOPE (fainted) (seriousness criterion medically significant) and HYPOTENSION (blood pressure was low). On 19-Apr-2021, the patient experienced NASOPHARYNGITIS (cold like symptoms), NASAL CONGESTION (stuffy nose), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). On 23-Apr-2021, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (unconscious), SYNCOPE (fainted) and HYPOTENSION (blood pressure was low) had resolved and NASOPHARYNGITIS (cold like symptoms) and NASAL CONGESTION (stuffy nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. As treatment, the patient took acetaminophen, ibuprofen and antihistamine.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Pollakiuria, Pruritus, Pyrexia, Syncope
Clinical narrative: Fainting; frequent urination; MODERNA toes/dots on her foot which still persist; itchiness; Dehydration; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) in a 76-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 reported by the reporter.  Concomitant products included DORZOLAMIDE HYDROCHLORIDE (DORZOLOMIDE HYDROCHLORIDE), TIMOLOL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), POLLAKIURIA (frequent urination), VACCINATION COMPLICATION (MODERNA toes/dots on her foot which still persist), PRURITUS (itchiness), DEHYDRATION (Dehydration) and PYREXIA (Fever). At the time of the report, SYNCOPE (Fainting), POLLAKIURIA (frequent urination), DEHYDRATION (Dehydration) and PYREXIA (Fever) outcome was unknown, VACCINATION COMPLICATION (MODERNA toes/dots on her foot which still persist) had not resolved and PRURITUS (itchiness) had resolved.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments  Treatment medications were not reported.  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.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-089293 (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. MODERNATX, INC.-MOD-2021-089293:Husband case
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Fainting; frequent urination; MODERNA toes/dots on her foot which still persist; itchiness; Dehydration; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) in a 76-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 reported by the reporter.  Concomitant products included DORZOLAMIDE HYDROCHLORIDE (DORZOLOMIDE HYDROCHLORIDE), TIMOLOL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), POLLAKIURIA (frequent urination), VACCINATION COMPLICATION (MODERNA toes/dots on her foot which still persist), PRURITUS (itchiness), DEHYDRATION (Dehydration) and PYREXIA (Fever). At the time of the report, SYNCOPE (Fainting), POLLAKIURIA (frequent urination), DEHYDRATION (Dehydration) and PYREXIA (Fever) outcome was unknown, VACCINATION COMPLICATION (MODERNA toes/dots on her foot which still persist) had not resolved and PRURITUS (itchiness) had resolved.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments  Treatment medications were not reported.  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.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-089293 (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. MODERNATX, INC.-MOD-2021-089293:Husband case
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, X-ray
Clinical narrative: Passed out, blacked out, landed flat on her face, hospitalized due to the events; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out, blacked out, landed flat on her face, hospitalized due to the events) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included Nerve pain in July 2020, Carpal tunnel syndrome, Broken foot (40 years prior to reporting time.), Lung operation NOS in July 2020, Hip replacement in 2017, Hip replacement in December 2020, Bladder operation NOS in November 2020, Foot surgery, Knee surgery NOS, Shoulder operation NOS and Tubal ligation. Concurrent medical conditions included Allergy to antibiotic and Allergy. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], SERTRALINE, GABAPENTIN and ASCORBIC ACID, RETINOL, TOCOPHEROL (OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out, blacked out, landed flat on her face, hospitalized due to the events) (seriousness criterion hospitalization). The patient was hospitalized from 17-Apr-2021 to 19-Apr-2021 due to LOSS OF CONSCIOUSNESS. On 19-Apr-2021, LOSS OF CONSCIOUSNESS (Passed out, blacked out, landed flat on her face, hospitalized due to the events) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Cardiac function test: normal (normal) normal. On an unknown date, Chest X-ray: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal, normal (normal) normal and normal (normal) CT Scan Head/Brain with Contrast. On an unknown date, Echocardiogram: normal (normal) normal. On an unknown date, X-ray: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's Primary Care Physician scheduled an MRI and Carotid Artery Ultrasound after a week from the reporting time. She was also placed on a heart monitor for 30 days. This case concerns a 68-year-old female hospitalized with a serious unexpected event of Loss of consciousness.  Event latency 5 days after 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.; Sender's Comments: This case concerns a 68-year-old female hospitalized with a serious unexpected event of Loss of consciousness.  Event latency 5 days after 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness neurosensory, Ear discomfort, Headache, Suicidal ideation, Tinnitus
Clinical narrative: contemplated suicide; She lost 55 decibel in left ear/ was diagnosed with sensorineural hearing loss; left ear felt like I am in the plane and need to pop my ear; She had tinnitus/ringing in her ear; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS NEUROSENSORY (She lost 55 decibel in left ear/ was diagnosed with sensorineural hearing loss) and SUICIDAL IDEATION (contemplated suicide) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported by the reporter.  The patient's past medical history included No adverse event (No Historical Condition reported). Concomitant products included CALCIUM and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Bone disorder NOS.   On 13-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 EAR DISCOMFORT (left ear felt like I am in the plane and need to pop my ear), TINNITUS (She had tinnitus/ringing in her ear) and HEADACHE (Headache). On 15-Apr-2021, the patient experienced DEAFNESS NEUROSENSORY (She lost 55 decibel in left ear/ was diagnosed with sensorineural hearing loss) (seriousness criterion medically significant). On an unknown date, the patient experienced SUICIDAL IDEATION (contemplated suicide) (seriousness criterion medically significant). At the time of the report, DEAFNESS NEUROSENSORY (She lost 55 decibel in left ear/ was diagnosed with sensorineural hearing loss) was resolving, SUICIDAL IDEATION (contemplated suicide), EAR DISCOMFORT (left ear felt like I am in the plane and need to pop my ear) and HEADACHE (Headache) outcome was unknown and TINNITUS (She had tinnitus/ringing in her ear) had not resolved. Not Provided          Treatment medications included prednisone 60 mg for 10 days.  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: M
Vaccine: COVID19
Symptoms: Dehydration, Fall, Pollakiuria, Pruritus, Pyrexia
Clinical narrative: fainting; fall; Dehydration; itchiness; frequent urination; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainting) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history reported.  Concomitant products included DORZOLAMIDE HYDROCHLORIDE (DORZOLOMIDE HYDROCHLORIDE), TIMOLOL and LATANOPROST for an unknown indication.    On 06-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (fainting) (seriousness criterion medically significant), FALL (fall), DEHYDRATION (Dehydration), PRURITUS (itchiness), POLLAKIURIA (frequent urination) and PYREXIA (Fever). At the time of the report, SYNCOPE (fainting), FALL (fall), DEHYDRATION (Dehydration), PRURITUS (itchiness), POLLAKIURIA (frequent urination) and PYREXIA (Fever) outcome was unknown.            Treatment of the events were not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-089270 (E2B Linked Report).   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, a causal relationship cannot be excluded MODERNATX, INC.-MOD-2021-089270:Wife case
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainting; fall; Dehydration; itchiness; frequent urination; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainting) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history reported.  Concomitant products included DORZOLAMIDE HYDROCHLORIDE (DORZOLOMIDE HYDROCHLORIDE), TIMOLOL and LATANOPROST for an unknown indication.    On 06-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (fainting) (seriousness criterion medically significant), FALL (fall), DEHYDRATION (Dehydration), PRURITUS (itchiness), POLLAKIURIA (frequent urination) and PYREXIA (Fever). At the time of the report, SYNCOPE (fainting), FALL (fall), DEHYDRATION (Dehydration), PRURITUS (itchiness), POLLAKIURIA (frequent urination) and PYREXIA (Fever) outcome was unknown.            Treatment of the events were not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-089270 (E2B Linked Report).   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, a causal relationship cannot be excluded MODERNATX, INC.-MOD-2021-089270:Wife case
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Tremor, Visual impairment
Clinical narrative: Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot; Woke up shaking; Eyesight effected; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot), TREMOR (Woke up shaking) and VISUAL IMPAIRMENT (Eyesight effected) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seizure.   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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot) (seriousness criteria hospitalization prolonged, disability and life threatening), TREMOR (Woke up shaking) (seriousness criterion hospitalization prolonged) and VISUAL IMPAIRMENT (Eyesight effected) (seriousness criterion hospitalization prolonged). The patient was hospitalized on sometime in March 2021 due to CEREBROVASCULAR ACCIDENT. The patient was treated with Rehabilitation therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot), TREMOR (Woke up shaking) and VISUAL IMPAIRMENT (Eyesight effected) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Products known to have been used by the patient, within two weeks prior to the event, included seizure medication. Treatment for the event included intensive care and stroke unit.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information regarding this event has been provided at this time. 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. However, Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included hospitalization. Very limited information regarding this event/s has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: DOB and patient initials corrected by the reporter; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral
Clinical narrative: Loss of vision in left eye; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS UNILATERAL (Loss of vision in left eye) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced BLINDNESS UNILATERAL (Loss of vision in left eye) (seriousness criterion medically significant). At the time of the report, BLINDNESS UNILATERAL (Loss of vision in left eye) had not resolved. Not Provided          On 23-Apr-2021 (2 weeks after receiving the second dose), patient had loss of vision in the left eye.   Concomitant product use was not provided by the reporter. No treatment was received by the patient.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Muscle spasms, Ocular hyperaemia, Sleep disorder
Clinical narrative: She did not get much sleep one night; Bleeding profusely; Horrible cramping; Blood red, vampire red eye; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding profusely) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced HAEMORRHAGE (Bleeding profusely) (seriousness criterion medically significant), MUSCLE SPASMS (Horrible cramping) and OCULAR HYPERAEMIA (Blood red, vampire red eye). On an unknown date, the patient experienced SLEEP DISORDER (She did not get much sleep one night). At the time of the report, HAEMORRHAGE (Bleeding profusely), MUSCLE SPASMS (Horrible cramping) and SLEEP DISORDER (She did not get much sleep one night) outcome was unknown and OCULAR HYPERAEMIA (Blood red, vampire red eye) had not resolved.            She is on HRT implant called BioTe and is scheduled for a Pap Smear  After the first dose apart from fever she got all the flu like symptoms which lasted 6 days. 2 weeks after the second dose, she got horrible cramping and bled profusely for 7 days. She adds that her husband snores and she did not get much sleep one night and woke up the next day with some redness in her left eye which turned blood red, vampire red in the next few days. The eye is still red so she went to her retinologist to get her eye checked and he said there is no issue with the eye. She is concerned about her upcoming cataract surgery on Monday.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Chest pain, Electrocardiogram ambulatory, Heart rate increased, Limb discomfort
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (arrhythmia), TACHYCARDIA (tachycardia) and HEART RATE INCREASED (190bpm heart rate) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arrhythmia (No symptoms over the past six years.). Concomitant products included OLOPATADINE HYDROCHLORIDE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ARRHYTHMIA (arrhythmia) (seriousness criterion hospitalization prolonged), TACHYCARDIA (tachycardia) (seriousness criterion hospitalization prolonged) and HEART RATE INCREASED (190bpm heart rate) (seriousness criterion hospitalization prolonged). On 23-Mar-2021, the patient experienced SUPRAVENTRICULAR EXTRASYSTOLES (premature arterio contraction) and SUPRAVENTRICULAR TACHYCARDIA (supraventricular tachycardia). On an unknown date, the patient experienced PRESYNCOPE (almost passed out), LIMB DISCOMFORT (legs feel heavy) and CHEST PAIN (chest feel sore). The patient was hospitalized on 08-Apr-2021 due to ARRHYTHMIA, HEART RATE INCREASED and TACHYCARDIA. At the time of the report, ARRHYTHMIA (arrhythmia), TACHYCARDIA (tachycardia), HEART RATE INCREASED (190bpm heart rate), SUPRAVENTRICULAR EXTRASYSTOLES (premature arterio contraction), SUPRAVENTRICULAR TACHYCARDIA (supraventricular tachycardia), PRESYNCOPE (almost passed out), LIMB DISCOMFORT (legs feel heavy) and CHEST PAIN (chest feel sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Tachycardia: 190 (High) increased. On 23-Mar-2021, Electrocardiogram ambulatory: abnormal (abnormal) abnormal. On 08-Apr-2021, Tachycardia: 190 (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 23-Mar-2021, the patient saw the cardiologist and reported that testing, including Holter monitoring was performed.  On 14-Apr-2021, ablation surgery was performed.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Supraventricular extrasystoles, Supraventricular tachycardia, Tachycardia
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (arrhythmia), TACHYCARDIA (tachycardia) and HEART RATE INCREASED (190bpm heart rate) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arrhythmia (No symptoms over the past six years.). Concomitant products included OLOPATADINE HYDROCHLORIDE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ARRHYTHMIA (arrhythmia) (seriousness criterion hospitalization prolonged), TACHYCARDIA (tachycardia) (seriousness criterion hospitalization prolonged) and HEART RATE INCREASED (190bpm heart rate) (seriousness criterion hospitalization prolonged). On 23-Mar-2021, the patient experienced SUPRAVENTRICULAR EXTRASYSTOLES (premature arterio contraction) and SUPRAVENTRICULAR TACHYCARDIA (supraventricular tachycardia). On an unknown date, the patient experienced PRESYNCOPE (almost passed out), LIMB DISCOMFORT (legs feel heavy) and CHEST PAIN (chest feel sore). The patient was hospitalized on 08-Apr-2021 due to ARRHYTHMIA, HEART RATE INCREASED and TACHYCARDIA. At the time of the report, ARRHYTHMIA (arrhythmia), TACHYCARDIA (tachycardia), HEART RATE INCREASED (190bpm heart rate), SUPRAVENTRICULAR EXTRASYSTOLES (premature arterio contraction), SUPRAVENTRICULAR TACHYCARDIA (supraventricular tachycardia), PRESYNCOPE (almost passed out), LIMB DISCOMFORT (legs feel heavy) and CHEST PAIN (chest feel sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Tachycardia: 190 (High) increased. On 23-Mar-2021, Electrocardiogram ambulatory: abnormal (abnormal) abnormal. On 08-Apr-2021, Tachycardia: 190 (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 23-Mar-2021, the patient saw the cardiologist and reported that testing, including Holter monitoring was performed.  On 14-Apr-2021, ablation surgery was performed.; 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product availability issue, Syncope
Clinical narrative: Fainted after 2nd dose; there was a delay (late) in her receiving her 2nd dose due to a hailstorm; there was a delay (late) in her receiving her 2nd dose due to a hailstorm; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted after 2nd dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (there was a delay (late) in her receiving her 2nd dose due to a hailstorm) and PRODUCT AVAILABILITY ISSUE (there was a delay (late) in her receiving her 2nd dose due to a hailstorm). On 20-Apr-2021, the patient experienced SYNCOPE (Fainted after 2nd dose) (seriousness criterion medically significant). On 19-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (there was a delay (late) in her receiving her 2nd dose due to a hailstorm) and PRODUCT AVAILABILITY ISSUE (there was a delay (late) in her receiving her 2nd dose due to a hailstorm) had resolved. On 20-Apr-2021, SYNCOPE (Fainted after 2nd dose) had resolved.            No treatment information for the event was reported.  Company comment:This case of 31- year-old female patient who experienced unexpected event of syncope and there was a delay in her receiving her 2nd dose due to a hailstorm (product availability issue, inappropriate schedule of vaccine administered). There were no reported AEs associated with the events of product availability issue/inappropriate schedule of vaccine administered.  Based on temporal association with the use of mRNA-1273 vaccine and onset of syncope, a causal relationship cannot be excluded.; Sender's Comments: This case of 31- year-old female patient who experienced unexpected event of syncope and there was a delay in her receiving her 2nd dose due to a hailstorm (product availability issue, inappropriate schedule of vaccine administered). There were no reported AEs associated with the events of product availability issue/inappropriate schedule of vaccine administered.  Based on temporal association with the use of mRNA-1273 vaccine and onset of syncope, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: 2 additional people passed out at vaccination facility; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of LOSS OF CONSCIOUSNESS (2 additional people passed out at vaccination facility) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (2 additional people passed out at vaccination facility) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (2 additional people passed out at vaccination facility) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant product use was not provided by the reporter. Treatment information was not provided. NO relevant medical history provided.  Company comment: Very limited information regarding this case has been provided at this time.  Further information has been requested.   This case was linked to MODERNATX, INC.-MOD-2021-089124 (E2B Linked Report).; Sender's Comments: Very limited information regarding this case has been provided at this time.  Further information has been requested. MODERNATX, INC.-MOD-2021-089124:Case for patient
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Genital discomfort, Genital haemorrhage, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of GENITAL HAEMORRHAGE (Bleeding from scrotum) in an 87-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 Pelvic fracture in 1952 and Aneurysm aortic. Concurrent medical conditions included Pneumoperitoneum. Concomitant products included ATORVASTATIN CALCIUM for Cholesterol, HYDROCHLOROTHIAZIDE, METOPROLOL and HYDRALAZINE for Hypertension.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GENITAL HAEMORRHAGE (Bleeding from scrotum) (seriousness criterion medically significant), GENITAL DISCOMFORT (irritation) and HEADACHE (headache). At the time of the report, GENITAL HAEMORRHAGE (Bleeding from scrotum) had resolved and GENITAL DISCOMFORT (irritation) and HEADACHE (headache) outcome was unknown.            Patient reported using cold compress to treat the event. 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
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Ageusia, Anosmia, Asthenia, COVID-19
Clinical narrative: hospitalized due to dehydration from COVID; she felt sick; diarrhea; loss of smell; loss of taste; felt weak; could not eat as her stomach was bothering her; soreness of her arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEHYDRATION (hospitalized due to dehydration from COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) 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).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced DEHYDRATION (hospitalized due to dehydration from COVID) (seriousness criterion hospitalization). On an unknown date, the patient experienced ILLNESS (she felt sick), DIARRHOEA (diarrhea), ANOSMIA (loss of smell), AGEUSIA (loss of taste), ASTHENIA (felt weak), ABDOMINAL DISCOMFORT (could not eat as her stomach was bothering her) and PAIN IN EXTREMITY (soreness of her arm). The patient was hospitalized until 07-Apr-2021 due to DEHYDRATION. On 07-Apr-2021, DEHYDRATION (hospitalized due to dehydration from COVID) had resolved. At the time of the report, ILLNESS (she felt sick), DIARRHOEA (diarrhea), ANOSMIA (loss of smell), AGEUSIA (loss of taste), ASTHENIA (felt weak), ABDOMINAL DISCOMFORT (could not eat as her stomach was bothering her) and PAIN IN EXTREMITY (soreness of her arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. Patient was hospitalized for a day and received fluids.  Company Comment: This case concerns an adult female hospitalized with serious unexpected events of covid-19 and dehydration, and nonserious unexpected illness, diarrhea, anosmia, ageusia, asthenia, abdominal discomfort, and pain in extremity.  Event latency 16 days from first dose mRNA-1273. 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 an adult female hospitalized with serious unexpected events of covid-19 and dehydration, and nonserious unexpected illness, diarrhea, anosmia, ageusia, asthenia, abdominal discomfort, and pain in extremity.  Event latency 16 days from first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Illness, Pain in extremity
Clinical narrative: hospitalized due to dehydration from COVID; she felt sick; diarrhea; loss of smell; loss of taste; felt weak; could not eat as her stomach was bothering her; soreness of her arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEHYDRATION (hospitalized due to dehydration from COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) 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).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced DEHYDRATION (hospitalized due to dehydration from COVID) (seriousness criterion hospitalization). On an unknown date, the patient experienced ILLNESS (she felt sick), DIARRHOEA (diarrhea), ANOSMIA (loss of smell), AGEUSIA (loss of taste), ASTHENIA (felt weak), ABDOMINAL DISCOMFORT (could not eat as her stomach was bothering her) and PAIN IN EXTREMITY (soreness of her arm). The patient was hospitalized until 07-Apr-2021 due to DEHYDRATION. On 07-Apr-2021, DEHYDRATION (hospitalized due to dehydration from COVID) had resolved. At the time of the report, ILLNESS (she felt sick), DIARRHOEA (diarrhea), ANOSMIA (loss of smell), AGEUSIA (loss of taste), ASTHENIA (felt weak), ABDOMINAL DISCOMFORT (could not eat as her stomach was bothering her) and PAIN IN EXTREMITY (soreness of her arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. Patient was hospitalized for a day and received fluids.  Company Comment: This case concerns an adult female hospitalized with serious unexpected events of covid-19 and dehydration, and nonserious unexpected illness, diarrhea, anosmia, ageusia, asthenia, abdominal discomfort, and pain in extremity.  Event latency 16 days from first dose mRNA-1273. 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 an adult female hospitalized with serious unexpected events of covid-19 and dehydration, and nonserious unexpected illness, diarrhea, anosmia, ageusia, asthenia, abdominal discomfort, and pain in extremity.  Event latency 16 days from first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hip fracture
Clinical narrative: Took a fall and broke her hip; Took a fall and broke her hip; This spontaneous case was reported by a consumer and describes the occurrence of HIP FRACTURE (Took a fall and broke her hip) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HIP FRACTURE (Took a fall and broke her hip) (seriousness criteria hospitalization and medically significant) and FALL (Took a fall and broke her hip). At the time of the report, HIP FRACTURE (Took a fall and broke her hip) and FALL (Took a fall and broke her hip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded but is unlikely according to the reporter.; 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 but is unlikely according to the reporter.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diplopia, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Double vision; blurry vision (unable to see clearly with prescribed glasses); swollen lymph nodes under left arm; fever 101; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PYREXIA (fever 101) and HEADACHE (headache). On 22-Apr-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes under left arm). On 23-Apr-2021, the patient experienced DIPLOPIA (Double vision) (seriousness criterion medically significant) and VISION BLURRED (blurry vision (unable to see clearly with prescribed glasses)). On 23-Apr-2021, PYREXIA (fever 101) had resolved. At the time of the report, DIPLOPIA (Double vision) outcome was unknown, VISION BLURRED (blurry vision (unable to see clearly with prescribed glasses)) was resolving and HEADACHE (headache) and LYMPHADENOPATHY (swollen lymph nodes under left arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 101 (High) High.         Patient received treatment with ibuprofen (Motrin) and acetaminophen (Tylenol).  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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Double vision; blurry vision (unable to see clearly with prescribed glasses); swollen lymph nodes under left arm; fever 101; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PYREXIA (fever 101) and HEADACHE (headache). On 22-Apr-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes under left arm). On 23-Apr-2021, the patient experienced DIPLOPIA (Double vision) (seriousness criterion medically significant) and VISION BLURRED (blurry vision (unable to see clearly with prescribed glasses)). On 23-Apr-2021, PYREXIA (fever 101) had resolved. At the time of the report, DIPLOPIA (Double vision) outcome was unknown, VISION BLURRED (blurry vision (unable to see clearly with prescribed glasses)) was resolving and HEADACHE (headache) and LYMPHADENOPATHY (swollen lymph nodes under left arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 101 (High) High.         Patient received treatment with ibuprofen (Motrin) and acetaminophen (Tylenol).  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