chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue
Clinical narrative: MORE PERSISTENT FATIGUE THAN NORMAL; This spontaneous report received from a patient via a company representative concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included major stroke, and concurrent conditions included aortic st. jude valve, cholesterol, thyroid, hypertension, low blood pressure, extremes of heat, and cold weather effec.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included warfarin for cholesterol. On 06-JUN-2021, the subject experienced more persistent fatigue than normal. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Often below 120/70. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of more persistent fatigue than normal was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Pyrexia
Clinical narrative: SORE BACK; BARELY WALK STRAIGHT; SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:Unknown ,expiry:unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced sore back, barely walk straight, and slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever, sore back and barely walk straight was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Muscle discomfort, Muscle strain, Muscular weakness
Clinical narrative: PAIN; MUSCLE SENSITIVITY; CANT BEAR WEIGHT ON FOOT; LEG MUSCULAR STRAIN; TIREDNESS; RIGHT LEG NUMBNESS GOES FROM GLUTEUS TO ANKLE THAT STARTED A WEEK AFTER INNOCULATION; This spontaneous report received from a patient concerned a 50 year old male. The patient's weight was 195 pounds, and height was 180 centimeters. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced right leg numbness goes from gluteus to ankle that started a week after innoculation. On 03-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced leg muscular strain. On an unspecified date, the subject experienced pain, muscle sensitivity, and cant bear weight on foot. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness on 03-APR-2021, had not recovered from leg muscular strain, right leg numbness goes from gluteus to ankle that started a week after innoculation, pain, and muscle sensitivity, and the outcome of cant bear weight on foot was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: PAIN; MUSCLE SENSITIVITY; CANT BEAR WEIGHT ON FOOT; LEG MUSCULAR STRAIN; TIREDNESS; RIGHT LEG NUMBNESS GOES FROM GLUTEUS TO ANKLE THAT STARTED A WEEK AFTER INNOCULATION; This spontaneous report received from a patient concerned a 50 year old male. The patient's weight was 195 pounds, and height was 180 centimeters. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced right leg numbness goes from gluteus to ankle that started a week after innoculation. On 03-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced leg muscular strain. On an unspecified date, the subject experienced pain, muscle sensitivity, and cant bear weight on foot. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness on 03-APR-2021, had not recovered from leg muscular strain, right leg numbness goes from gluteus to ankle that started a week after innoculation, pain, and muscle sensitivity, and the outcome of cant bear weight on foot was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Fatigue, Gait inability, Muscular weakness
Clinical narrative: UNABLE TO WALK; UNABLE TO GET OUT OF BED; BLURRED VISION; LEFT ARM PAIN; LEFT ARM WEAKNESS; FEVER; MUSCLE PAIN/ACHES; WEAKNESS; TIREDNESS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included ulcers in mouth due to medication, and concurrent conditions included psoriasis, psoriatic arthritis, high blood pressure, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with terbinafine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: 28-JUL-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included hydrocodone for pain, alprazolam, amlodipine, cyclobenzaprine, folic acid, hydrochlorothiazide, methotrexate, metoprolol succinate, secukinumab, sulfasalazine, and trazodone. On 24-MAR-2021, the subject experienced unable to walk. On 24-MAR-2021, the subject experienced unable to get out of bed. On 24-MAR-2021, the subject experienced blurred vision. On 24-MAR-2021, the subject experienced left arm pain. On 24-MAR-2021, the subject experienced left arm weakness. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced muscle pain/aches. On 24-MAR-2021, the subject experienced weakness. On 24-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to walk, unable to get out of bed, fever, muscle pain/aches, and weakness on 24-MAR-2021, and had not recovered from blurred vision, left arm pain, left arm weakness, and tiredness. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Vision blurred
Clinical narrative: UNABLE TO WALK; UNABLE TO GET OUT OF BED; BLURRED VISION; LEFT ARM PAIN; LEFT ARM WEAKNESS; FEVER; MUSCLE PAIN/ACHES; WEAKNESS; TIREDNESS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included ulcers in mouth due to medication, and concurrent conditions included psoriasis, psoriatic arthritis, high blood pressure, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with terbinafine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: 28-JUL-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included hydrocodone for pain, alprazolam, amlodipine, cyclobenzaprine, folic acid, hydrochlorothiazide, methotrexate, metoprolol succinate, secukinumab, sulfasalazine, and trazodone. On 24-MAR-2021, the subject experienced unable to walk. On 24-MAR-2021, the subject experienced unable to get out of bed. On 24-MAR-2021, the subject experienced blurred vision. On 24-MAR-2021, the subject experienced left arm pain. On 24-MAR-2021, the subject experienced left arm weakness. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced muscle pain/aches. On 24-MAR-2021, the subject experienced weakness. On 24-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to walk, unable to get out of bed, fever, muscle pain/aches, and weakness on 24-MAR-2021, and had not recovered from blurred vision, left arm pain, left arm weakness, and tiredness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING SENSATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced tingling sensation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tingling sensation was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE STORED AT OUTSIDE OF RECOMMENDED STORAGE CONDITION; VACCINE GIVEN OUTSIDE OF RECOMMENDED STORAGE CONDITION; This spontaneous report received from a physician concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, high blood pressure, diabetes, and sjogren's. The patient experienced drug allergy when treated with cefaclor, chlorhexidine, clindamycin, doxycycline, and sulfamethoxazole/trimethoprim. 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 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced vaccine given outside of recommended storage condition. On an unspecified date, the subject experienced vaccine stored at outside of recommended storage condition. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given outside of recommended storage condition and vaccine stored at outside of recommended storage condition was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: NUMBNESS IN THE ARMS AND LEGS; TINGLING OF LEFT ARM; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: 07-AUG-2021) dose was not reported, administered on 06-JUL-2021 15:15 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced tingling of left arm. On 06-JUL-2021, the subject experienced numbness in the arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in the arms and legs, and the outcome of tingling of left arm was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: RINGING IN THE LEFT EAR; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient did not took any medications, no known allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced ringing in the left ear. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing in the left ear on 09-JUL-2021. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Fatigue, Pyrexia
Clinical narrative: Covid; Chills; Slight fever 100&99; Very Tired; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Slight fever 100&99) and FATIGUE (Very Tired). On 11-Apr-2021, the patient experienced COVID-19 (Covid) (seriousness criterion hospitalization). The patient was hospitalized from 11-Apr-2021 to 23-Apr-2021 due to COVID-19. The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 23-Apr-2021, COVID-19 (Covid) had resolved. At the time of the report, CHILLS (Chills), PYREXIA (Slight fever 100&99) and FATIGUE (Very Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 100-99 (High) 100 to 99. On 08-Jan-2021, Body temperature: 100-99 (High) 100 to 99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  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: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Musculoskeletal disorder
Clinical narrative: Could not get out of bed; Again could not get out of bed, legs would not work; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISORDER (Again could not get out of bed, legs would not work) and BEDRIDDEN (Could not get out of bed) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISORDER (Again could not get out of bed, legs would not work) (seriousness criteria hospitalization and medically significant) and BEDRIDDEN (Could not get out of bed) (seriousness criterion hospitalization). The patient was hospitalized from 07-Jan-2021 to 09-Jan-2021 due to MUSCULOSKELETAL DISORDER. At the time of the report, MUSCULOSKELETAL DISORDER (Again could not get out of bed, legs would not work) was resolving and BEDRIDDEN (Could not get out of bed) outcome was unknown.            Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-027194 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: Upon internal medical review on 29 Jun 2021, case was 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 events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Insomnia, Photopsia
Clinical narrative: stroke; Flashers in her eyes that continue; Woke up in the middle of the night several times; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) 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 ATENOLOL, LEVOTHYROXINE, CHLORTHALIDONE, SIMVASTATIN, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and ACETYLSALICYLIC ACID, CAFFEINE, CHLORPHENAMINE MALEATE (CORICIDIN [ACETYLSALICYLIC ACID;CAFFEINE;CHLORPHENAMINE MALEATE]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PHOTOPSIA (Flashers in her eyes that continue) and INSOMNIA (Woke up in the middle of the night several times). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Migraine and Headache, at a dose of 1 dosage form four times per day. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), PHOTOPSIA (Flashers in her eyes that continue) and INSOMNIA (Woke up in the middle of the night several times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CEREBROVASCULAR ACCIDENT (stroke) to be not related. No further causality assessments were provided for PHOTOPSIA (Flashers in her eyes that continue) and INSOMNIA (Woke up in the middle of the night several times).    Based on the current available information and temporal association between the use of the product and the start date of the events of photopsia and insomnia, a causal relationship cannot be excluded.  Based on reporter's causality the event of cerebrovascular accident is assessed as unlikely related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant follow received and the initial diagnosis of ocular migraine was wrong and is confirmed to be a stroke.  Reporter causality was updated to unrelated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of photopsia and insomnia, a causal relationship cannot be excluded.  Based on reporter's causality the event of cerebrovascular accident is assessed as unlikely related to mRNA-1273.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Myocardial infarction
Clinical narrative: Heart attack; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.  Company comment: This case concerns a 65-year-old male with a serious unexpected event of myocardial infarction, and nonserious diarrhea. Event latency 1 day after 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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Added new adverse event myocardial infarction and upgraded the case to serious.; Sender's Comments: This case concerns a 65-year-old male with a serious unexpected event of myocardial infarction, and nonserious diarrhea. Event latency 1 day after 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.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Stool analysis
Clinical narrative: Diarrhoea; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Diarrhoea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Diarrhea from 12-Mar-2021 to 07-Jul-2021. Concurrent medical conditions included Cardiac disorder NOS and Drug allergy (allergy to oxycodone). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN, B COMPLEX WITH C, FUROSEMIDE, IRON, LEVOTHYROXINE, MECLIZINE [MECLOZINE], METOPROLOL, OMEGA-3 FATTY ACIDS, OMEPRAZOLE, PYRIDOXINE, SERTRALINE, TAMSULOSIN, THERAGRAN-M [ASCORBIC ACID;CALCIUM CARBONATE;COPPER;CYANOCOBALAMIN;ERGOCALCIFEROL;IODINE;IRON;MAGNESIUM;MANGANESE;NICOTINIC ACID;PANTOTHENIC ACID;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHEROL;ZINC], OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT) and WARFARIN for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Diarrhoea) (seriousness criterion hospitalization). The patient was hospitalized on 29-Mar-2021 due to DIARRHOEA. The patient was treated with COLESTIPOL for Diarrhoea, at a dose of UNK, qd and PLANTAGO OVATA (METAMUCIL CITRON) for Diarrhoea, at a dose of UNK, qd, 10-15 tabs. At the time of the report, DIARRHOEA (Diarrhoea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Stool analysis: negative (Negative) 3 different stool samples are submitted.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is experiencing constant 6-7 time diarrhea.  The patient underwent colonoscopy and blood test results unknown.  Company comment: 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 07-Jul-2021: Follow up received on 7-Jul-2021 Updated patient demographics- occupation changed from consumer to physician , medical history, lab data, added concomitant medicines and treatment medicines, event diarrhea updated(non-serious to serious) , patient admitted to hospital; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactoid reaction
Clinical narrative: Anaphylactoid Reaction; This spontaneous case was reported by a health care professional and describes the occurrence of ANAPHYLACTOID REACTION (Anaphylactoid Reaction) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mast cell aggregation. Concurrent medical conditions included Asthma. Concomitant products included OMALIZUMAB (XOLAIR), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTOID REACTION (Anaphylactoid Reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTOID REACTION (Anaphylactoid Reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Haemoptysis, Muscle strain, Oxygen saturation
Clinical narrative: Blood clots in both their lungs; though they had covid-19; Difficulty breathing; Sharp pain in chest; Though they have pulled a muscle; Spiting up blood; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Blood clots in both their lungs), DYSPNOEA (Difficulty breathing), CHEST PAIN (Sharp pain in chest), MUSCLE STRAIN (Though they have pulled a muscle), HAEMOPTYSIS (Spiting up blood) and SUSPECTED COVID-19 (though they had covid-19) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization), CHEST PAIN (Sharp pain in chest) (seriousness criterion hospitalization), MUSCLE STRAIN (Though they have pulled a muscle) (seriousness criterion hospitalization) and HAEMOPTYSIS (Spiting up blood) (seriousness criterion hospitalization). On 04-Jul-2021, the patient experienced SUSPECTED COVID-19 (though they had covid-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY THROMBOSIS (Blood clots in both their lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 04-Jul-2021 to 05-Jul-2021 due to CHEST PAIN, DYSPNOEA, HAEMOPTYSIS, MUSCLE STRAIN, PULMONARY THROMBOSIS and SUSPECTED COVID-19. At the time of the report, PULMONARY THROMBOSIS (Blood clots in both their lungs), CHEST PAIN (Sharp pain in chest), MUSCLE STRAIN (Though they have pulled a muscle), HAEMOPTYSIS (Spiting up blood) and SUSPECTED COVID-19 (though they had covid-19) outcome was unknown and DYSPNOEA (Difficulty breathing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2021, Oxygen saturation: unknown (abnormal) unable to have a good oxygen level.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included High blood pressure medication and cholesterol medication.  Treatment medications included antibiotics and pain medication.  Reportedly, the patient was scheduled to get the second dose on 20-Jul-2021.  Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Suspected COVID-19
Clinical narrative: Blood clots in both their lungs; though they had covid-19; Difficulty breathing; Sharp pain in chest; Though they have pulled a muscle; Spiting up blood; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Blood clots in both their lungs), DYSPNOEA (Difficulty breathing), CHEST PAIN (Sharp pain in chest), MUSCLE STRAIN (Though they have pulled a muscle), HAEMOPTYSIS (Spiting up blood) and SUSPECTED COVID-19 (though they had covid-19) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization), CHEST PAIN (Sharp pain in chest) (seriousness criterion hospitalization), MUSCLE STRAIN (Though they have pulled a muscle) (seriousness criterion hospitalization) and HAEMOPTYSIS (Spiting up blood) (seriousness criterion hospitalization). On 04-Jul-2021, the patient experienced SUSPECTED COVID-19 (though they had covid-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY THROMBOSIS (Blood clots in both their lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 04-Jul-2021 to 05-Jul-2021 due to CHEST PAIN, DYSPNOEA, HAEMOPTYSIS, MUSCLE STRAIN, PULMONARY THROMBOSIS and SUSPECTED COVID-19. At the time of the report, PULMONARY THROMBOSIS (Blood clots in both their lungs), CHEST PAIN (Sharp pain in chest), MUSCLE STRAIN (Though they have pulled a muscle), HAEMOPTYSIS (Spiting up blood) and SUSPECTED COVID-19 (though they had covid-19) outcome was unknown and DYSPNOEA (Difficulty breathing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2021, Oxygen saturation: unknown (abnormal) unable to have a good oxygen level.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included High blood pressure medication and cholesterol medication.  Treatment medications included antibiotics and pain medication.  Reportedly, the patient was scheduled to get the second dose on 20-Jul-2021.  Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Fatigue, Gait disturbance, Headache
Clinical narrative: Severe pain in the left side of his chest; Pain in calf; Had to use a cane to walk; Severe pain in the left side of hip and knee; First dose drained him; Nerve root disorder; The first dose drained him, and he made his whole right side numb; Severe pain in the left side of his temple; It feels like he had a mini stroke; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (It feels like he had a mini stroke) and NERVE ROOT INJURY (Nerve root disorder) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (It feels like he had a mini stroke) (seriousness criterion medically significant). On 25-Jun-2021, the patient experienced HEADACHE (Severe pain in the left side of his temple). On 27-Jun-2021, the patient experienced HYPOAESTHESIA (The first dose drained him, and he made his whole right side numb). On 05-Jul-2021, the patient experienced NERVE ROOT INJURY (Nerve root disorder) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (Severe pain in the left side of his chest), PAIN IN EXTREMITY (Pain in calf), GAIT DISTURBANCE (Had to use a cane to walk), ARTHRALGIA (Severe pain in the left side of hip and knee) and FATIGUE (First dose drained him). The patient was treated with PREDNISONE at a dose of 20 mg. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (It feels like he had a mini stroke), NERVE ROOT INJURY (Nerve root disorder), HYPOAESTHESIA (The first dose drained him, and he made his whole right side numb), CHEST PAIN (Severe pain in the left side of his chest), PAIN IN EXTREMITY (Pain in calf), GAIT DISTURBANCE (Had to use a cane to walk), ARTHRALGIA (Severe pain in the left side of hip and knee), FATIGUE (First dose drained him) and HEADACHE (Severe pain in the left side of his temple) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nerve root injury, Pain in extremity, Transient ischaemic attack
Clinical narrative: Severe pain in the left side of his chest; Pain in calf; Had to use a cane to walk; Severe pain in the left side of hip and knee; First dose drained him; Nerve root disorder; The first dose drained him, and he made his whole right side numb; Severe pain in the left side of his temple; It feels like he had a mini stroke; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (It feels like he had a mini stroke) and NERVE ROOT INJURY (Nerve root disorder) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (It feels like he had a mini stroke) (seriousness criterion medically significant). On 25-Jun-2021, the patient experienced HEADACHE (Severe pain in the left side of his temple). On 27-Jun-2021, the patient experienced HYPOAESTHESIA (The first dose drained him, and he made his whole right side numb). On 05-Jul-2021, the patient experienced NERVE ROOT INJURY (Nerve root disorder) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (Severe pain in the left side of his chest), PAIN IN EXTREMITY (Pain in calf), GAIT DISTURBANCE (Had to use a cane to walk), ARTHRALGIA (Severe pain in the left side of hip and knee) and FATIGUE (First dose drained him). The patient was treated with PREDNISONE at a dose of 20 mg. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (It feels like he had a mini stroke), NERVE ROOT INJURY (Nerve root disorder), HYPOAESTHESIA (The first dose drained him, and he made his whole right side numb), CHEST PAIN (Severe pain in the left side of his chest), PAIN IN EXTREMITY (Pain in calf), GAIT DISTURBANCE (Had to use a cane to walk), ARTHRALGIA (Severe pain in the left side of hip and knee), FATIGUE (First dose drained him) and HEADACHE (Severe pain in the left side of his temple) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment.
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Facial paralysis; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Facial paralysis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (Facial paralysis) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Facial paralysis) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.  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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Incorrect dose administered, Pyrexia, Rash, Seizure
Clinical narrative: Had a rash on her left arm; Her left arm itched from the inside out; Ser left arm was swollen up; She had 101F temperature; she almost had a seizure; Her body was shaking from head to feet; she received 2nd dose 49 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (she almost had a seizure) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) for an unknown indication.    On 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced INCORRECT DOSE ADMINISTERED (she received 2nd dose 49 days after the 1st dose). On 01-Jul-2021, the patient experienced SEIZURE (she almost had a seizure) (seriousness criterion medically significant), TREMOR (Her body was shaking from head to feet), RASH (Had a rash on her left arm), VACCINATION SITE PRURITUS (Her left arm itched from the inside out), VACCINATION SITE SWELLING (Ser left arm was swollen up) and PYREXIA (She had 101F temperature). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. On 01-Jul-2021, SEIZURE (she almost had a seizure), TREMOR (Her body was shaking from head to feet) and PYREXIA (She had 101F temperature) had resolved. At the time of the report, INCORRECT DOSE ADMINISTERED (she received 2nd dose 49 days after the 1st dose), RASH (Had a rash on her left arm), VACCINATION SITE PRURITUS (Her left arm itched from the inside out) and VACCINATION SITE SWELLING (Ser left arm was swollen up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2021, Body temperature: high (High) Body temperature was 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not go to her doctor during the events but does plan to see her PCP.  No treatment medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-175840 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Had a rash on her left arm; Her left arm itched from the inside out; Ser left arm was swollen up; She had 101F temperature; she almost had a seizure; Her body was shaking from head to feet; she received 2nd dose 49 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (she almost had a seizure) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) for an unknown indication.    On 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced INCORRECT DOSE ADMINISTERED (she received 2nd dose 49 days after the 1st dose). On 01-Jul-2021, the patient experienced SEIZURE (she almost had a seizure) (seriousness criterion medically significant), TREMOR (Her body was shaking from head to feet), RASH (Had a rash on her left arm), VACCINATION SITE PRURITUS (Her left arm itched from the inside out), VACCINATION SITE SWELLING (Ser left arm was swollen up) and PYREXIA (She had 101F temperature). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. On 01-Jul-2021, SEIZURE (she almost had a seizure), TREMOR (Her body was shaking from head to feet) and PYREXIA (She had 101F temperature) had resolved. At the time of the report, INCORRECT DOSE ADMINISTERED (she received 2nd dose 49 days after the 1st dose), RASH (Had a rash on her left arm), VACCINATION SITE PRURITUS (Her left arm itched from the inside out) and VACCINATION SITE SWELLING (Ser left arm was swollen up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2021, Body temperature: high (High) Body temperature was 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not go to her doctor during the events but does plan to see her PCP.  No treatment medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-175840 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Thrombosis
Clinical narrative: heart attacks; blood clots from vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (heart attacks) and THROMBOSIS (blood clots from vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attacks) (seriousness criteria hospitalization and medically significant) and THROMBOSIS (blood clots from vaccine) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (heart attacks) and THROMBOSIS (blood clots from vaccine) outcome was unknown.            No concomitant medication information was mentioned. No treatment medication information was mentioned  Additional information was mentioned patient had a vitals and internal bleeding  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.  Thrombosis is an adverse event of special  interest.  Further information is expected.; 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.  Thrombosis is an adverse event of special  interest.  Further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart Attack one day after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack one day after vaccine) 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 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jul-2021, the patient experienced MYOCARDIAL INFARCTION (Heart Attack one day after vaccine) (seriousness criteria medically significant and life threatening). At the time of the report, MYOCARDIAL INFARCTION (Heart Attack one day after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not reported.  Treatment details was not reported.  Patient had a bad experience with the vaccine as had a heart attack one day after vaccine.  Company Comment Very limited information regarding this event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.