chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: STIFFNESS IN THE NECK; HEADACHE; TIREDNESS; SORENESS IN THE INJECTION SITE (LEFT ARM); MUSCLE ACHE; This spontaneous report received from a consumer concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 30-JUN-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 01-JUL-2021, the subject experienced stiffness in the neck. On 01-JUL-2021, the subject experienced headache. On 01-JUL-2021, the subject experienced tiredness. On 01-JUL-2021, the subject experienced soreness in the injection site (left arm). On 01-JUL-2021, the subject experienced muscle ache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiffness in the neck, headache, tiredness, soreness in the injection site (left arm), and muscle ache. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: STIFFNESS IN THE NECK; HEADACHE; TIREDNESS; SORENESS IN THE INJECTION SITE (LEFT ARM); MUSCLE ACHE; This spontaneous report received from a consumer concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 30-JUN-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 01-JUL-2021, the subject experienced stiffness in the neck. On 01-JUL-2021, the subject experienced headache. On 01-JUL-2021, the subject experienced tiredness. On 01-JUL-2021, the subject experienced soreness in the injection site (left arm). On 01-JUL-2021, the subject experienced muscle ache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiffness in the neck, headache, tiredness, soreness in the injection site (left arm), and muscle ache. This report was non-serious.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema multiforme, Injection site reaction, Rash pruritic
Clinical narrative: Delayed hypersensitivity eruption; Erythema multiforms; Rash on back and neck that itches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA MULTIFORME (Erythema multiforms) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Coronary artery disease, GERD and Prostate cancer (Historyan of Prostate cancer). Concomitant products included GATIFLOXACIN, LOTEPREDNOL ETABONATE (LOTREL G) and POTASSIUM for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Rash on back and neck that itches). On 18-Mar-2021, the patient experienced ERYTHEMA MULTIFORME (Erythema multiforms) (seriousness criterion medically significant). On an unknown date, the patient experienced INJECTION SITE REACTION (Delayed hypersensitivity eruption). The patient was treated with TRIAMCINOLONE (topical) for Hypersensitivity reaction (NOS), at a dose of UNK dosage form and GRAMICIDIN, NEOMYCIN SULFATE, TRIAMCINOLONE ACETONIDE (KENALOG-S OPH.) (intramuscular) for Rash, at a dose of 60 milligram. At the time of the report, ERYTHEMA MULTIFORME (Erythema multiforms) and INJECTION SITE REACTION (Delayed hypersensitivity eruption) outcome was unknown and RASH PRURITIC (Rash on back and neck that itches) had resolved.            The action taken with mRNA-1273 in response to the event was not applicable.  It was reported that, the patient developed a maculopapular itchy rash on 10-Mar-2021 after 8 days after receiving second dose. He had no fever and chills. He was diagnosed with a delayed hypersensitivity eruption due to vaccine. Topical Triamcinolone was given for symptomatic relief, Later, he developed dusky erythema but itching improved. He was then treated with IM Kenalog 60 mg and improvement in rash was noted in 3-4 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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: The case was upgrade to serious as new event erythema multiforms added along with delayed hypersensitivity eruption, patient demographics updated along with HCP details.; 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Carditis, Fluid retention, Vaccination site rash
Clinical narrative: Sever inflammation of heart/ heart congestion; Abdominal area down to legs fluid retention/ weight gain 30 pounds; Horizontal and vertical rash at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of CARDITIS (Sever inflammation of heart/ heart congestion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FLUID RETENTION (Abdominal area down to legs fluid retention/ weight gain 30 pounds) and VACCINATION SITE RASH (Horizontal and vertical rash at the injection site.). On an unknown date, the patient experienced CARDITIS (Sever inflammation of heart/ heart congestion) (seriousness criterion medically significant). At the time of the report, CARDITIS (Sever inflammation of heart/ heart congestion), FLUID RETENTION (Abdominal area down to legs fluid retention/ weight gain 30 pounds) and VACCINATION SITE RASH (Horizontal and vertical rash at the injection site.) outcome was unknown.            Concomitant medications were not provided. Treatment included fluid pills (details not provided).  On an unknown date, the following tests were performed but results were not provided: Cardio scan, computerized tomogram, and ultrasound.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-032565 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Updated event Carditis.  Case upgraded to serious.; 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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Autism spectrum disorder, Gait disturbance, Loss of personal independence in daily activities, Tremor
Clinical narrative: Cannot walk again; Autism has increased; Shaking; Having trouble with daily activities; This spontaneous case was reported by a consumer and describes the occurrence of AUTISM SPECTRUM DISORDER (Autism has increased) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chromosomal anomalies (Potocki-Lupski syndrome since 14 years old.), Autism and Physical impairment.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AUTISM SPECTRUM DISORDER (Autism has increased) (seriousness criterion medically significant), TREMOR (Shaking) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Having trouble with daily activities). On an unknown date, the patient experienced GAIT DISTURBANCE (Cannot walk again). At the time of the report, AUTISM SPECTRUM DISORDER (Autism has increased), TREMOR (Shaking), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Having trouble with daily activities) and GAIT DISTURBANCE (Cannot walk again) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No concomitant medications were provided by the reporter.  No treatment information was provided.  Reporter states that her daughter had shaking, trouble with daily activities and autism has increased. Patient saw her Psychiatrist that said this is not related to autism and referred the patient to a neurologist.  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, multiple underlying co-morbidities may remain as confounding factors. Further information is required.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received, events added; 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, multiple underlying co-morbidities may remain as confounding factors.Further information is required.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Multiple sclerosis, Pain in extremity
Clinical narrative: multiple sclerosis; dizzy on and off; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (multiple sclerosis) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, METOPROLOL and AMLODIPINE for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (multiple sclerosis) (seriousness criterion medically significant), DIZZINESS (dizzy on and off) and PAIN IN EXTREMITY (sore arm). The patient was treated with PSEUDOEPHEDRINE at a dose of 2 pills of 3 mg. At the time of the report, MULTIPLE SCLEROSIS (multiple sclerosis), DIZZINESS (dizzy on and off) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID 19 virus; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID 19 virus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 COVID-19 (COVID 19 virus) (seriousness criterion hospitalization). The patient was hospitalized from 28-Mar-2021 to 01-Apr-2021 due to COVID-19. At the time of the report, COVID-19 (COVID 19 virus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Gait inability, Hypoaesthesia, Magnetic resonance imaging, Myelitis transverse
Clinical narrative: Diagnosed with Transverse myelitis; Numbness; Paresthesia; Progressed to a point that the patient can no longer walk and no is on wheel chair; Progressive weakness in lower extremities and worked its way up to mid torso/ Weakness; This spontaneous case was reported by a health care professional and describes the occurrence of MYELITIS TRANSVERSE (Diagnosed with Transverse myelitis) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concomitant products included ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], UBIDECARENONE (COQ10 [UBIDECARENONE]) and PANTOPRAZOLE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MYELITIS TRANSVERSE (Diagnosed with Transverse myelitis) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness), PARAESTHESIA (Paresthesia), GAIT INABILITY (Progressed to a point that the patient can no longer walk and no is on wheel chair) and ASTHENIA (Progressive weakness in lower extremities and worked its way up to mid torso/ Weakness). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, MYELITIS TRANSVERSE (Diagnosed with Transverse myelitis), HYPOAESTHESIA (Numbness), PARAESTHESIA (Paresthesia), GAIT INABILITY (Progressed to a point that the patient can no longer walk and no is on wheel chair) and ASTHENIA (Progressive weakness in lower extremities and worked its way up to mid torso/ Weakness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Magnetic resonance imaging: abnormal (abnormal) Diagnosed with Transverse Myelitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Company comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Further details regarding medical history and treatment for assessment.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021 contains Non-Significant information.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Further details regarding medical history and treatment for assessment.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Diagnosed with Transverse myelitis; Numbness; Paresthesia; Progressed to a point that the patient can no longer walk and no is on wheel chair; Progressive weakness in lower extremities and worked its way up to mid torso/ Weakness; This spontaneous case was reported by a health care professional and describes the occurrence of MYELITIS TRANSVERSE (Diagnosed with Transverse myelitis) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concomitant products included ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], UBIDECARENONE (COQ10 [UBIDECARENONE]) and PANTOPRAZOLE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MYELITIS TRANSVERSE (Diagnosed with Transverse myelitis) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness), PARAESTHESIA (Paresthesia), GAIT INABILITY (Progressed to a point that the patient can no longer walk and no is on wheel chair) and ASTHENIA (Progressive weakness in lower extremities and worked its way up to mid torso/ Weakness). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, MYELITIS TRANSVERSE (Diagnosed with Transverse myelitis), HYPOAESTHESIA (Numbness), PARAESTHESIA (Paresthesia), GAIT INABILITY (Progressed to a point that the patient can no longer walk and no is on wheel chair) and ASTHENIA (Progressive weakness in lower extremities and worked its way up to mid torso/ Weakness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Magnetic resonance imaging: abnormal (abnormal) Diagnosed with Transverse Myelitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Company comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Further details regarding medical history and treatment for assessment.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021 contains Non-Significant information.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Further details regarding medical history and treatment for assessment.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: My husband devloped Bells Palsy after he got the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (My husband devloped Bells Palsy after he got the vaccine.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced BELL'S PALSY (My husband devloped Bells Palsy after he got the vaccine.) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (My husband devloped Bells Palsy after he got the vaccine.) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment drug information provided. No concomitant drug information provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Gait disturbance, Neuralgia, Neuropathy peripheral, Peripheral swelling
Clinical narrative: nerve on top of her left foot was disturbed; swollen feet and veins on legs (between knees and ankles; painful veins on her legs (between knees and ankles); nerve on top of left foot was disturbed which gives constant pain; Cannot walk as much as she needs to; Swollen veins; stomach issues and discomfort; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed) (seriousness criterion medically significant), PERIPHERAL SWELLING (swollen feet and veins on legs (between knees and ankles), VASCULAR PAIN (painful veins on her legs (between knees and ankles)), NEURALGIA (nerve on top of left foot was disturbed which gives constant pain), GAIT DISTURBANCE (Cannot walk as much as she needs to), PERIPHERAL VENOUS DISEASE (Swollen veins) and ABDOMINAL DISCOMFORT (stomach issues and discomfort). At the time of the report, NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed), PERIPHERAL SWELLING (swollen feet and veins on legs (between knees and ankles), VASCULAR PAIN (painful veins on her legs (between knees and ankles)), NEURALGIA (nerve on top of left foot was disturbed which gives constant pain), GAIT DISTURBANCE (Cannot walk as much as she needs to), PERIPHERAL VENOUS DISEASE (Swollen veins) and ABDOMINAL DISCOMFORT (stomach issues and discomfort) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral venous disease, Vascular pain
Clinical narrative: nerve on top of her left foot was disturbed; swollen feet and veins on legs (between knees and ankles; painful veins on her legs (between knees and ankles); nerve on top of left foot was disturbed which gives constant pain; Cannot walk as much as she needs to; Swollen veins; stomach issues and discomfort; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed) (seriousness criterion medically significant), PERIPHERAL SWELLING (swollen feet and veins on legs (between knees and ankles), VASCULAR PAIN (painful veins on her legs (between knees and ankles)), NEURALGIA (nerve on top of left foot was disturbed which gives constant pain), GAIT DISTURBANCE (Cannot walk as much as she needs to), PERIPHERAL VENOUS DISEASE (Swollen veins) and ABDOMINAL DISCOMFORT (stomach issues and discomfort). At the time of the report, NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed), PERIPHERAL SWELLING (swollen feet and veins on legs (between knees and ankles), VASCULAR PAIN (painful veins on her legs (between knees and ankles)), NEURALGIA (nerve on top of left foot was disturbed which gives constant pain), GAIT DISTURBANCE (Cannot walk as much as she needs to), PERIPHERAL VENOUS DISEASE (Swollen veins) and ABDOMINAL DISCOMFORT (stomach issues and discomfort) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: Very limited information regarding this events has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Heart rate, Hypertension, Pyrexia
Clinical narrative: blood pressure was sky-high, high 290 or whatever/ ended up in the hospital; dizzy; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure was sky-high, high 290 or whatever/ ended up in the hospital) 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 14-Jun-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 an unknown date, the patient experienced HYPERTENSION (blood pressure was sky-high, high 290 or whatever/ ended up in the hospital) (seriousness criterion hospitalization), DIZZINESS (dizzy) and PYREXIA (fever). The patient was hospitalized for 1 day due to HYPERTENSION. The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERINE) ongoing since an unknown date at a dose of 1 dosage form and MORPHINE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, HYPERTENSION (blood pressure was sky-high, high 290 or whatever/ ended up in the hospital), DIZZINESS (dizzy) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 290. On an unknown date, Heart rate: increased.         No concomitant drug information provided. Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the events 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. Very limited information regarding the events has been provided at this time. Further information has been requested.
Age: 0.25
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk, Seizure, Specialist consultation
Clinical narrative: Seizure; Breastfeeding after Vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 3-month-old infant of an unknown gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding since 18-Jun-2021.    MEDICAL HISTORY (Patient): Concurrent medical conditions included Seizure since 18-Jun-2021.    On 18-Jun-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Jun-2021,  after exposure to mRNA-1273 (Moderna COVID-19 Vaccine), the infant was diagnosed with SEIZURE (Seizure) (seriousness criteria hospitalization and medically significant) and EXPOSURE VIA BREAST MILK (Breastfeeding after Vaccination). The infant was treated with LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) ongoing since an unknown date for Seizure, at an unspecified dose and frequency. At the time of the report, SEIZURE (Seizure) and EXPOSURE VIA BREAST MILK (Breastfeeding after Vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jun-2021, Specialist consultation: seizure (abnormal) baby was Diagnosed with Seizure by MD.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.  Reporter reported that the baby started having a seizure 7 hours later the breastfeed. The baby did not have a fever. The baby had a seizure at home and another one at the hospital. The baby was Diagnosed with Seizure by MD.  Company Comment: This is a case of product exposure during breastfeeding with an associated adverse event of seizure in the baby. Based on temporal association a causal relationship cannot be excluded   This case was linked to MOD-2021-231410 (Parent-Child Link).   See case MOD-2021-231410 for details regarding the Parent case.; Sender's Comments: This is a case of product exposure during breastfeeding with an associated adverse event of seizure in the baby. Based on temporal association a causal relationship cannot be excluded
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Gait disturbance, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Blood clot; feels like his skin is going to rip open; arm was a little sore; Left leg was swollen, Twice the size of his right leg; Really tight; Very uncomfortable; Can't walk dog; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced PERIPHERAL SWELLING (Left leg was swollen, Twice the size of his right leg), MUSCULOSKELETAL STIFFNESS (Really tight), DISCOMFORT (Very uncomfortable) and GAIT DISTURBANCE (Can't walk dog). On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant), SKIN DISORDER (feels like his skin is going to rip open) and PAIN IN EXTREMITY (arm was a little sore). At the time of the report, THROMBOSIS (Blood clot), PERIPHERAL SWELLING (Left leg was swollen, Twice the size of his right leg), MUSCULOSKELETAL STIFFNESS (Really tight), DISCOMFORT (Very uncomfortable), GAIT DISTURBANCE (Can't walk dog), SKIN DISORDER (feels like his skin is going to rip open) and PAIN IN EXTREMITY (arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was not given No concomitant medication 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.; 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Skin disorder, Thrombosis
Clinical narrative: Blood clot; feels like his skin is going to rip open; arm was a little sore; Left leg was swollen, Twice the size of his right leg; Really tight; Very uncomfortable; Can't walk dog; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced PERIPHERAL SWELLING (Left leg was swollen, Twice the size of his right leg), MUSCULOSKELETAL STIFFNESS (Really tight), DISCOMFORT (Very uncomfortable) and GAIT DISTURBANCE (Can't walk dog). On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant), SKIN DISORDER (feels like his skin is going to rip open) and PAIN IN EXTREMITY (arm was a little sore). At the time of the report, THROMBOSIS (Blood clot), PERIPHERAL SWELLING (Left leg was swollen, Twice the size of his right leg), MUSCULOSKELETAL STIFFNESS (Really tight), DISCOMFORT (Very uncomfortable), GAIT DISTURBANCE (Can't walk dog), SKIN DISORDER (feels like his skin is going to rip open) and PAIN IN EXTREMITY (arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was not given No concomitant medication 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.; 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: U
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Pain in extremity, Peripheral swelling, Skin tightness
Clinical narrative: Nurse knows someone who got a blood clot from the vaccine.; little sore in arm; left leg was swollen; feels like his skin is going to rip open; leg is really tight; very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Nurse knows someone who got a blood clot from the vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Nurse knows someone who got a blood clot from the vaccine.) (seriousness criterion medically significant), PAIN IN EXTREMITY (little sore in arm), PERIPHERAL SWELLING (left leg was swollen), FEELING ABNORMAL (feels like his skin is going to rip open), SKIN TIGHTNESS (leg is really tight) and DISCOMFORT (very uncomfortable). At the time of the report, THROMBOSIS (Nurse knows someone who got a blood clot from the vaccine.), PAIN IN EXTREMITY (little sore in arm), PERIPHERAL SWELLING (left leg was swollen), FEELING ABNORMAL (feels like his skin is going to rip open), SKIN TIGHTNESS (leg is really tight) and DISCOMFORT (very uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the patient experienced blood clots and was given with blood thinners. the concomitant history was not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-114494 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Nurse knows someone who got a blood clot from the vaccine.; little sore in arm; left leg was swollen; feels like his skin is going to rip open; leg is really tight; very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Nurse knows someone who got a blood clot from the vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Nurse knows someone who got a blood clot from the vaccine.) (seriousness criterion medically significant), PAIN IN EXTREMITY (little sore in arm), PERIPHERAL SWELLING (left leg was swollen), FEELING ABNORMAL (feels like his skin is going to rip open), SKIN TIGHTNESS (leg is really tight) and DISCOMFORT (very uncomfortable). At the time of the report, THROMBOSIS (Nurse knows someone who got a blood clot from the vaccine.), PAIN IN EXTREMITY (little sore in arm), PERIPHERAL SWELLING (left leg was swollen), FEELING ABNORMAL (feels like his skin is going to rip open), SKIN TIGHTNESS (leg is really tight) and DISCOMFORT (very uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the patient experienced blood clots and was given with blood thinners. the concomitant history was not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-114494 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: I started to have Rheumatoid Arthritis flare ups; This spontaneous case was reported by an other and describes the occurrence of RHEUMATOID ARTHRITIS (I started to have Rheumatoid Arthritis flare ups) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (I started to have Rheumatoid Arthritis flare ups) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (I started to have Rheumatoid Arthritis flare ups) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by the reporter.  Very limited information regarding this case. However, based on the current available information from the case narrative; and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-114592 (E2B Linked Report).; Sender's Comments: Very limited information regarding this case. However, based on the current available information from the case narrative; and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD-2021-114592:MOD21-114592 (Cross-linked)
Sex: U
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: I am experiencing a loss of vision; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (I am experiencing a loss of vision) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLINDNESS (I am experiencing a loss of vision) (seriousness criterion medically significant). At the time of the report, BLINDNESS (I am experiencing a loss of vision) outcome was unknown.            No treatment information and no concomitant information was provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Very limited information regarding the event has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-231563 (Patient Link).; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Received the Moderna Shot and within 7-8 weeks after passed away; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Received the Moderna Shot and within 7-8 weeks after passed away) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported by reporter.  Patient died on an unknown date approximately 7 to 8 weeks after receiving vaccination.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown casuse of death
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Myocarditis, Panic attack, Tachycardia
Clinical narrative: Racing heart-tachycardia in the mornings only; Myocarditis; Panic attack; Anxiety; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant), PANIC ATTACK (Panic attack), ANXIETY (Anxiety) and CHEST PAIN (Chest pain). On 22-Jun-2021, the patient experienced TACHYCARDIA (Racing heart-tachycardia in the mornings only). The patient was treated with ALPRAZOLAM (XANAX) (oral) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Myocarditis), PANIC ATTACK (Panic attack), ANXIETY (Anxiety), CHEST PAIN (Chest pain) and TACHYCARDIA (Racing heart-tachycardia in the mornings only) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.    Caller received the Moderna vaccine series and experienced adverse events including myocarditis, panic attack, anxiety and chest pain and consulted emergency room and primary care physician. Patient had EKG.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-231677 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.