chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Peripheral swelling, Rash, Testicular swelling, Urticaria
Clinical narrative: bad welts everywhere; hard time breathing; his hands, arms,swollen; testicles are swollen; a full-blown rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (bad welts everywhere), DYSPNOEA (hard time breathing), PERIPHERAL SWELLING (his hands, arms,swollen), TESTICULAR SWELLING (testicles are swollen) and RASH (a full-blown rash) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-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 URTICARIA (bad welts everywhere), DYSPNOEA (hard time breathing), PERIPHERAL SWELLING (his hands, arms,swollen), TESTICULAR SWELLING (testicles are swollen) and RASH (a full-blown rash). At the time of the report, URTICARIA (bad welts everywhere), DYSPNOEA (hard time breathing), PERIPHERAL SWELLING (his hands, arms,swollen), TESTICULAR SWELLING (testicles are swollen) and RASH (a full-blown rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist noted that it was a severe allergic reaction and did not recommend patients to receive the second dose. The pharmacist recommended the patient to go to urgent care to receive a corticosteroid injection as his hands and arms were still swollen at the time of reporting.  No concomitant drug information provided.  No treatment drug information provided.  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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Dehydration, Diarrhoea, Weight decreased
Clinical narrative: dehydration; turning on his autoimmune system to where his body is fighting itself. He states his body is fighting his intestines; lost 15 pounds; diarrhea for over 2 months; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (dehydration) and AUTOIMMUNE DISORDER (turning on his autoimmune system to where his body is fighting itself. He states his body is fighting his intestines) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Colonoscopy on 12-Aug-2021. Concurrent medical conditions included Autoimmune disorder.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced DIARRHOEA (diarrhea for over 2 months). On an unknown date, the patient experienced DEHYDRATION (dehydration) (seriousness criterion hospitalization), AUTOIMMUNE DISORDER (turning on his autoimmune system to where his body is fighting itself. He states his body is fighting his intestines) (seriousness criterion medically significant) and WEIGHT DECREASED (lost 15 pounds). At the time of the report, DEHYDRATION (dehydration), AUTOIMMUNE DISORDER (turning on his autoimmune system to where his body is fighting itself. He states his body is fighting his intestines), DIARRHOEA (diarrhea for over 2 months) and WEIGHT DECREASED (lost 15 pounds) outcome was unknown.            The doctors were thinking that it caused by the shot, turning on his autoimmune system to where his body is fighting itself. Patient states that his body is fighting his intestines. Patient called to report this that he has been hospitalized 4 times for dehydration; one time he was there for 6 days. Concomitant medications was not provided by the reporter. Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine from a vial that was expired, greater than 12 hours after initial vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from a vial that was expired, greater than 12 hours after initial vial puncture) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from a vial that was expired, greater than 12 hours after initial vial puncture). On 25-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from a vial that was expired, greater than 12 hours after initial vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. The vial expired at 4:55 AM this morning. patient received their at least 4 hours past expiration. After each withdrawal the vial was put back in the fridge No treatment details were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Thirst, Weight decreased
Clinical narrative: anxiety state, unspecified; chest and neck feel intense which comes and goes; patient received intravenous migraine medication; not herself; lost 5 pounds; lower left back pain which feels internal; chest and neck feel intense which comes and goes; pressure tingly feeling in her head; weak; thirsty; food aversion, couldn't eat, felt hungry, tasted disgusting; headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (patient received intravenous migraine medication) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced ASTHENIA (weak), THIRST (thirsty), FOOD AVERSION (food aversion, couldn't eat, felt hungry, tasted disgusting), PARAESTHESIA (pressure tingly feeling in her head) and HEADACHE (headache). On 18-Aug-2021, the patient experienced CHEST DISCOMFORT (chest and neck feel intense which comes and goes). On an unknown date, the patient experienced MIGRAINE (patient received intravenous migraine medication) (seriousness criterion medically significant), FEELING ABNORMAL (not herself), WEIGHT DECREASED (lost 5 pounds), BACK PAIN (lower left back pain which feels internal), MUSCULOSKELETAL DISCOMFORT (chest and neck feel intense which comes and goes) and ANXIETY (anxiety state, unspecified). The patient was treated with IBUPROFEN ongoing from 18-Aug-2021 for Head pressure, at a dose of 1 dosage form. At the time of the report, MIGRAINE (patient received intravenous migraine medication), ASTHENIA (weak), THIRST (thirsty), FOOD AVERSION (food aversion, couldn't eat, felt hungry, tasted disgusting), FEELING ABNORMAL (not herself), PARAESTHESIA (pressure tingly feeling in her head), WEIGHT DECREASED (lost 5 pounds), BACK PAIN (lower left back pain which feels internal), CHEST DISCOMFORT (chest and neck feel intense which comes and goes), MUSCULOSKELETAL DISCOMFORT (chest and neck feel intense which comes and goes), ANXIETY (anxiety state, unspecified) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Computerised tomogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant information was provided by reporter. They gave her an IV of a migraine medication. she thinks it was Toradol but was unsure.   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: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Death, Palpitations, Product administered to patient of inappropriate age
Clinical narrative: death; teenager got palpitation; her heart enlarged; teenager got a covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (death), PALPITATIONS (teenager got palpitation), CARDIOMEGALY (her heart enlarged) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (teenager got a covid-19 vaccine.) in a female 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEATH (death) (seriousness criteria death and medically significant), PALPITATIONS (teenager got palpitation) (seriousness criterion death), CARDIOMEGALY (her heart enlarged) (seriousness criterion death) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (teenager got a covid-19 vaccine.) (seriousness criterion death). The reported cause of death was teenager got palpitation, her heart enlarged and teenager got a covid-19 vaccine.. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.    No treatment information was provided.  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.; Reported Cause(s) of Death: teenager got palpitation; her heart enlarged; teenager got a covid-19 vaccine.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered more that 24 hours after the vial was first punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered more that 24 hours after the vial was first punctured) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021 at 2:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021 at 2:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered more that 24 hours after the vial was first punctured). On 25-Aug-2021 at 2:40 PM, EXPIRED PRODUCT ADMINISTERED (dose administered more that 24 hours after the vial was first punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported by reporter Treatment information was not provided by reporter
Sex: F
Vaccine: COVID19
Symptoms: Precancerous condition, Smear cervix, Smear cervix abnormal
Clinical narrative: Pre-cancerous condition; abnormal pap smear one month after getting both Moderna doses,abnormal PRE-cancerous pap smear now; This spontaneous case was reported by a consumer and describes the occurrence of SMEAR CERVIX ABNORMAL (abnormal pap smear one month after getting both Moderna doses, abnormal PRE-cancerous pap smear now) and PRECANCEROUS CONDITION (Pre-cancerous condition) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 086B21A and O37A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SMEAR CERVIX ABNORMAL (abnormal pap smear one month after getting both Moderna doses,abnormal PRE-cancerous pap smear now) (seriousness criterion medically significant) and PRECANCEROUS CONDITION (Pre-cancerous condition) (seriousness criterion medically significant). At the time of the report, SMEAR CERVIX ABNORMAL (abnormal pap smear one month after getting both Moderna doses,abnormal PRE-cancerous pap smear now) and PRECANCEROUS CONDITION (Pre-cancerous condition) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Smear cervix: abnormal (abnormal) abnormal PRE-cancerous pap smear now.         No relevant concomitant and treatment medications were reported  Patient has to have a double-mastectomy  Company Comment: Very limited information regarding the events Abnormal PAP smear and Precancerous condition has been provided at this time.  Further information has been requested.  The event Breast cancer seems to have occurred in another patient. Currently, there is no information available about the drug involved. Additional information has been requested.    Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow up received :This report contains no new information; Sender's Comments: Very limited information regarding the events Abnormal PAP smear and Precancerous condition has been provided at this time.  Further information has been requested.  The event Breast cancer seems to have occurred in another patient. Currently, there is no information available about the drug involved. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Vaccination complication, Vaccination site pain
Clinical narrative: Very mild malaise type of feeling; A little bit out of it; Feeling of tiredness; Soreness at the injection; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Very mild malaise type of feeling), FEELING ABNORMAL (A little bit out of it), FATIGUE (Feeling of tiredness) and VACCINATION SITE PAIN (Soreness at the injection) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Hypothyroidism, BPH, Sleep apnea, Monoclonal B-cell lymphocytosis (MBL (Monoclonal B-cell Leukocytosis) which he sees a hematologist for) and Atrial fibrillation. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), FLECAINIDE, AMLODIPINE BESILATE (NORVASC), TADALAFIL (CIALIS), HYDROCHLOROTHIAZIDE and NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for an unknown indication.    On 21-Jan-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 VACCINATION COMPLICATION (Very mild malaise type of feeling). an unknown date, the patient experienced FEELING ABNORMAL (A little bit out of it), FATIGUE (Feeling of tiredness) and VACCINATION SITE PAIN (Soreness at the injection). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Very mild malaise type of feeling), FEELING ABNORMAL (A little bit out of it), FATIGUE (Feeling of tiredness) and VACCINATION SITE PAIN (Soreness at the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included put some hydrocortisone cream on it and some CBD cream.  The lot number for the first dose was 025J20A OR 02C120A.   This case was linked to MOD-2021-297029, MOD-2021-297112 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis, Palpitations, Product dose omission issue
Clinical narrative: Chest pain; Palpitations; Acute myocarditis; First dose in January, terrified to get the second dose; This spontaneous case was reported by a physician and describes the occurrence of CHEST PAIN (Chest pain), PALPITATIONS (Palpitations) and MYOCARDITIS (Acute myocarditis) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to metals and Drug allergy (Allergic to medications).    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization), PALPITATIONS (Palpitations) (seriousness criterion hospitalization) and MYOCARDITIS (Acute myocarditis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose in January, terrified to get the second dose). At the time of the report, CHEST PAIN (Chest pain), PALPITATIONS (Palpitations), MYOCARDITIS (Acute myocarditis) and PRODUCT DOSE OMISSION ISSUE (First dose in January, terrified to get the second dose) had resolved.        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.   No relevant concomitant and treatment medications were reported.  Company Comment : This report refers to a case of product dose omission for mRNA-1273 (lot # unknown) with associated AE reported of myocarditis, palpitations and chest pain. 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: This report refers to a case of product dose omission for mRNA-1273 (lot # unknown) with associated AE reported of myocarditis, palpitations and chest pain. 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: got tested  positive for  covid-19; got tested positive for covid-19; Second dose after 38 days; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got tested  positive for  covid-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 38 days) and DRUG INEFFECTIVE (got tested positive for covid-19) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 38 days). On 24-Aug-2021, the patient experienced COVID-19 (got tested  positive for  covid-19) and DRUG INEFFECTIVE (got tested positive for covid-19). On 22-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 38 days) had resolved. On 24-Aug-2021, DRUG INEFFECTIVE (got tested positive for covid-19) had resolved. At the time of the report, COVID-19 (got tested  positive for  covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, SARS-CoV-2 test positive: positive (Positive) Positive.         No Concomitant medications were provided.  No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow-up information included no new information.; 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. This is a case of lack of effect despite the patient had 2 doses of Moderna vaccine in an inappropriate interval (25-35 days).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Influenza like illness, Nausea, Pain in extremity
Clinical narrative: Sore arm (left); Retinal detachment  (right eye); Flu like symptoms; Loss of appetite; Weakness; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL DETACHMENT (Retinal detachment  (right eye)) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (Loss of appetite), ASTHENIA (Weakness) and NAUSEA (Nausea). On 10-Jul-2021, the patient experienced RETINAL DETACHMENT (Retinal detachment  (right eye)) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm (left)). At the time of the report, RETINAL DETACHMENT (Retinal detachment  (right eye)) had not resolved, INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (Loss of appetite), ASTHENIA (Weakness) and NAUSEA (Nausea) had resolved and PAIN IN EXTREMITY (Sore arm (left)) outcome was unknown.            Patient underwent Retina repair on 11-Jul-2021 and was prescribed with eye drops.  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-2021-297474 (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.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Retinal detachment
Clinical narrative: Sore arm (left); Retinal detachment  (right eye); Flu like symptoms; Loss of appetite; Weakness; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL DETACHMENT (Retinal detachment  (right eye)) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (Loss of appetite), ASTHENIA (Weakness) and NAUSEA (Nausea). On 10-Jul-2021, the patient experienced RETINAL DETACHMENT (Retinal detachment  (right eye)) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm (left)). At the time of the report, RETINAL DETACHMENT (Retinal detachment  (right eye)) had not resolved, INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (Loss of appetite), ASTHENIA (Weakness) and NAUSEA (Nausea) had resolved and PAIN IN EXTREMITY (Sore arm (left)) outcome was unknown.            Patient underwent Retina repair on 11-Jul-2021 and was prescribed with eye drops.  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-2021-297474 (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.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Heart rate, Mobility decreased, Pain in extremity
Clinical narrative: Palpitations; Received 1st dose 3Jul2021 and has not received his 2nd dose; Couldn't walk for about 2 weeks after leaving the hospital; Dizziness; leg pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion hospitalization), PRODUCT DOSE OMISSION ISSUE (Received 1st dose 3Jul2021 and has not received his 2nd dose), MOBILITY DECREASED (Couldn't walk for about 2 weeks after leaving the hospital), DIZZINESS (Dizziness), PAIN IN EXTREMITY (leg pain) and ARTHRALGIA (Joint pain). At the time of the report, PALPITATIONS (Palpitations), MOBILITY DECREASED (Couldn't walk for about 2 weeks after leaving the hospital), DIZZINESS (Dizziness), PAIN IN EXTREMITY (leg pain) and ARTHRALGIA (Joint pain) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Received 1st dose 3Jul2021 and has not received his 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 170 (High) 170 and 116-120 (High) 116-120.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  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 events, a causal relationship cannot be excluded. Product dose omission issue is assessed as not applicable for causality.; 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. Product dose omission issue is assessed as not applicable for causality.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Product dose omission issue
Clinical narrative: Palpitations; Received 1st dose 3Jul2021 and has not received his 2nd dose; Couldn't walk for about 2 weeks after leaving the hospital; Dizziness; leg pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion hospitalization), PRODUCT DOSE OMISSION ISSUE (Received 1st dose 3Jul2021 and has not received his 2nd dose), MOBILITY DECREASED (Couldn't walk for about 2 weeks after leaving the hospital), DIZZINESS (Dizziness), PAIN IN EXTREMITY (leg pain) and ARTHRALGIA (Joint pain). At the time of the report, PALPITATIONS (Palpitations), MOBILITY DECREASED (Couldn't walk for about 2 weeks after leaving the hospital), DIZZINESS (Dizziness), PAIN IN EXTREMITY (leg pain) and ARTHRALGIA (Joint pain) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Received 1st dose 3Jul2021 and has not received his 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 170 (High) 170 and 116-120 (High) 116-120.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  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 events, a causal relationship cannot be excluded. Product dose omission issue is assessed as not applicable for causality.; 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. Product dose omission issue is assessed as not applicable for causality.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: couldn't use her arm from the shoulder to her finger tips; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (couldn't use her arm from the shoulder to her finger tips) in a 21-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (couldn't use her arm from the shoulder to her finger tips). At the time of the report, MOBILITY DECREASED (couldn't use her arm from the shoulder to her finger tips) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient can't guarantee it was the Moderna vaccine she got. No concomitant medication was reported. No treatment medication use was reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Right moderate stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Right moderate stroke) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Depression.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Right moderate stroke) (seriousness criterion medically significant). The patient was treated with Physical therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Right moderate stroke) outcome was unknown.            The patient received second dose in June. Concomitant medications Includes medication for cholesterol and for depression. The patient was receiving physical therapy and there were sequels in the left arm and leg. No treatment medications were provided.  Company Comment: Based on current available information and patient's advanced age and medical history of cholesterol as plausible confounders for the event, causality is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on current available information and patient's advanced age and medical history of cholesterol as plausible confounders for the event, causality is assessed as unlikely related to mRNA-1273.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Blood test, Burning sensation, Chapped lips, Dehydration
Clinical narrative: Can't swallow; Her tongue is dry; Her lips are cracked; Can't sleep at night because her tongue is dry/keeps up 6-8 times at night; Burning sensation; Big red tongue; Dehydration; Lost a lot of weight; Dry mouth bothers her especially in the morning; Caused her to lose her taste of food; Big, fat, red, swollen tongue is from the COVID19 virus; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Can't swallow), TONGUE DRY (Her tongue is dry), CHAPPED LIPS (Her lips are cracked), SLEEP DISORDER (Can't sleep at night because her tongue is dry/keeps up 6-8 times at night) and BURNING SENSATION (Burning sensation) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPHAGIA (Can't swallow), TONGUE DRY (Her tongue is dry), CHAPPED LIPS (Her lips are cracked), SLEEP DISORDER (Can't sleep at night because her tongue is dry/keeps up 6-8 times at night), BURNING SENSATION (Burning sensation), TONGUE ERYTHEMA (Big red tongue), DEHYDRATION (Dehydration), WEIGHT DECREASED (Lost a lot of weight), DRY MOUTH (Dry mouth bothers her especially in the morning), AGEUSIA (Caused her to lose her taste of food) and TONGUE OEDEMA (Big, fat, red, swollen tongue is from the COVID19 virus). At the time of the report, DYSPHAGIA (Can't swallow), TONGUE DRY (Her tongue is dry), CHAPPED LIPS (Her lips are cracked), SLEEP DISORDER (Can't sleep at night because her tongue is dry/keeps up 6-8 times at night), BURNING SENSATION (Burning sensation), TONGUE ERYTHEMA (Big red tongue), DEHYDRATION (Dehydration), WEIGHT DECREASED (Lost a lot of weight), DRY MOUTH (Dry mouth bothers her especially in the morning), AGEUSIA (Caused her to lose her taste of food) and TONGUE OEDEMA (Big, fat, red, swollen tongue is from the COVID19 virus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal.         Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company comment: Considering current available information and plausible temporal relationship between product use and onset date of the event, causal role cannot be excluded. Other possible confounder is patient's advanced age.; Sender's Comments: Considering current available information and plausible temporal relationship between product use and onset date of the event, causal role cannot be excluded. Other possible confounder is patient's advanced age.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysphagia, Sleep disorder, Tongue dry, Tongue erythema
Clinical narrative: Can't swallow; Her tongue is dry; Her lips are cracked; Can't sleep at night because her tongue is dry/keeps up 6-8 times at night; Burning sensation; Big red tongue; Dehydration; Lost a lot of weight; Dry mouth bothers her especially in the morning; Caused her to lose her taste of food; Big, fat, red, swollen tongue is from the COVID19 virus; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Can't swallow), TONGUE DRY (Her tongue is dry), CHAPPED LIPS (Her lips are cracked), SLEEP DISORDER (Can't sleep at night because her tongue is dry/keeps up 6-8 times at night) and BURNING SENSATION (Burning sensation) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPHAGIA (Can't swallow), TONGUE DRY (Her tongue is dry), CHAPPED LIPS (Her lips are cracked), SLEEP DISORDER (Can't sleep at night because her tongue is dry/keeps up 6-8 times at night), BURNING SENSATION (Burning sensation), TONGUE ERYTHEMA (Big red tongue), DEHYDRATION (Dehydration), WEIGHT DECREASED (Lost a lot of weight), DRY MOUTH (Dry mouth bothers her especially in the morning), AGEUSIA (Caused her to lose her taste of food) and TONGUE OEDEMA (Big, fat, red, swollen tongue is from the COVID19 virus). At the time of the report, DYSPHAGIA (Can't swallow), TONGUE DRY (Her tongue is dry), CHAPPED LIPS (Her lips are cracked), SLEEP DISORDER (Can't sleep at night because her tongue is dry/keeps up 6-8 times at night), BURNING SENSATION (Burning sensation), TONGUE ERYTHEMA (Big red tongue), DEHYDRATION (Dehydration), WEIGHT DECREASED (Lost a lot of weight), DRY MOUTH (Dry mouth bothers her especially in the morning), AGEUSIA (Caused her to lose her taste of food) and TONGUE OEDEMA (Big, fat, red, swollen tongue is from the COVID19 virus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal.         Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company comment: Considering current available information and plausible temporal relationship between product use and onset date of the event, causal role cannot be excluded. Other possible confounder is patient's advanced age.; Sender's Comments: Considering current available information and plausible temporal relationship between product use and onset date of the event, causal role cannot be excluded. Other possible confounder is patient's advanced age.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue oedema, Weight decreased
Clinical narrative: Can't swallow; Her tongue is dry; Her lips are cracked; Can't sleep at night because her tongue is dry/keeps up 6-8 times at night; Burning sensation; Big red tongue; Dehydration; Lost a lot of weight; Dry mouth bothers her especially in the morning; Caused her to lose her taste of food; Big, fat, red, swollen tongue is from the COVID19 virus; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Can't swallow), TONGUE DRY (Her tongue is dry), CHAPPED LIPS (Her lips are cracked), SLEEP DISORDER (Can't sleep at night because her tongue is dry/keeps up 6-8 times at night) and BURNING SENSATION (Burning sensation) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPHAGIA (Can't swallow), TONGUE DRY (Her tongue is dry), CHAPPED LIPS (Her lips are cracked), SLEEP DISORDER (Can't sleep at night because her tongue is dry/keeps up 6-8 times at night), BURNING SENSATION (Burning sensation), TONGUE ERYTHEMA (Big red tongue), DEHYDRATION (Dehydration), WEIGHT DECREASED (Lost a lot of weight), DRY MOUTH (Dry mouth bothers her especially in the morning), AGEUSIA (Caused her to lose her taste of food) and TONGUE OEDEMA (Big, fat, red, swollen tongue is from the COVID19 virus). At the time of the report, DYSPHAGIA (Can't swallow), TONGUE DRY (Her tongue is dry), CHAPPED LIPS (Her lips are cracked), SLEEP DISORDER (Can't sleep at night because her tongue is dry/keeps up 6-8 times at night), BURNING SENSATION (Burning sensation), TONGUE ERYTHEMA (Big red tongue), DEHYDRATION (Dehydration), WEIGHT DECREASED (Lost a lot of weight), DRY MOUTH (Dry mouth bothers her especially in the morning), AGEUSIA (Caused her to lose her taste of food) and TONGUE OEDEMA (Big, fat, red, swollen tongue is from the COVID19 virus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal.         Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company comment: Considering current available information and plausible temporal relationship between product use and onset date of the event, causal role cannot be excluded. Other possible confounder is patient's advanced age.; Sender's Comments: Considering current available information and plausible temporal relationship between product use and onset date of the event, causal role cannot be excluded. Other possible confounder is patient's advanced age.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Hypoaesthesia, Palpitations
Clinical narrative: it went up to her neck; she was still feeling weak; numbness of her left arm (injection site) and it went up to her neck numbness of her left arm (injection site); heart palpitations; lightheadedness; short of breath; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ANAESTHESIA (numbness of her left arm (injection site) and it went up to her neck numbness of her left arm (injection site)), PALPITATIONS (heart palpitations), DIZZINESS (lightheadedness), DYSPNOEA (short of breath) and HYPOAESTHESIA (it went up to her neck) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A-1) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Wheezing (for 7-8 months), Productive cough (for 7-8 months) and Weakness (for 7-8 months). Concurrent medical conditions included Familial mediterranean fever.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced VACCINATION SITE ANAESTHESIA (numbness of her left arm (injection site) and it went up to her neck numbness of her left arm (injection site)), PALPITATIONS (heart palpitations), DIZZINESS (lightheadedness) and DYSPNOEA (short of breath). On an unknown date, the patient experienced HYPOAESTHESIA (it went up to her neck) and ASTHENIA (she was still feeling weak). On 20-Aug-2021, VACCINATION SITE ANAESTHESIA (numbness of her left arm (injection site) and it went up to her neck numbness of her left arm (injection site)) outcome was unknown. At the time of the report, PALPITATIONS (heart palpitations), DIZZINESS (lightheadedness), DYSPNOEA (short of breath), HYPOAESTHESIA (it went up to her neck) and ASTHENIA (she was still feeling weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Laboratory data was mentioned as   ECG was normal, BP was 125 , heart rate was 120, Troponin level was  normal. No concomitant medications were provided by the reporter. Treatment information was mentioned  as IV fluid , Corvalol 30 drops 2 doses, Valeriana pills -3, Colchicine.  Company Comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Events are not medically significant and case is non-serious.  While patient states a systolic BP of 125 is high for them, this is not an abnormally high reading and no event captured for it.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Events are not medically significant and case is non-serious.  While patient states a systolic BP of 125 is high for them, this is not an abnormally high reading and no event captured for it