chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram, Gait disturbance, Headache, Inappropriate schedule of product administration
Clinical narrative: passed out; can't walk very well without assistance; Sleepy; Very weak; headache; In appropriate doses interval, more than 35 days; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (Taking asthma medication as concomitant).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (In appropriate doses interval, more than 35 days). On 20-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), GAIT DISTURBANCE (can't walk very well without assistance), SOMNOLENCE (Sleepy), ASTHENIA (Very weak) and HEADACHE (headache). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), GAIT DISTURBANCE (can't walk very well without assistance), SOMNOLENCE (Sleepy), ASTHENIA (Very weak) and HEADACHE (headache) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (In appropriate doses interval, more than 35 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Computerised tomogram: (Negative) negative. On 23-Apr-2021, X-ray: (Negative) negative.         No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient's heart was checked but no abnormal results. Company comment: This report refers to a case of  Inappropriate schedule of vaccine administered  for mRNA-1273, lot # 013M20A with associated AEs(loss of consciousness, gait disturbance, somnolence, asthenia and headache). 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  Inappropriate schedule of vaccine administered  for mRNA-1273, lot # 013M20A with associated AEs(loss of consciousness, gait disturbance, somnolence, asthenia and headache). 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Somnolence, X-ray
Clinical narrative: passed out; can't walk very well without assistance; Sleepy; Very weak; headache; In appropriate doses interval, more than 35 days; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (Taking asthma medication as concomitant).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (In appropriate doses interval, more than 35 days). On 20-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), GAIT DISTURBANCE (can't walk very well without assistance), SOMNOLENCE (Sleepy), ASTHENIA (Very weak) and HEADACHE (headache). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), GAIT DISTURBANCE (can't walk very well without assistance), SOMNOLENCE (Sleepy), ASTHENIA (Very weak) and HEADACHE (headache) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (In appropriate doses interval, more than 35 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Computerised tomogram: (Negative) negative. On 23-Apr-2021, X-ray: (Negative) negative.         No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient's heart was checked but no abnormal results. Company comment: This report refers to a case of  Inappropriate schedule of vaccine administered  for mRNA-1273, lot # 013M20A with associated AEs(loss of consciousness, gait disturbance, somnolence, asthenia and headache). 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  Inappropriate schedule of vaccine administered  for mRNA-1273, lot # 013M20A with associated AEs(loss of consciousness, gait disturbance, somnolence, asthenia and headache). 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: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Head injury, Hypotension, Syncope
Clinical narrative: fainted twice; hypotensive; head injury; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted twice) in a 22-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.     Concurrent medical conditions included Autism.    On 31-Mar-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 SYNCOPE (fainted twice) (seriousness criterion medically significant), HYPOTENSION (hypotensive) and HEAD INJURY (head injury). At the time of the report, SYNCOPE (fainted twice), HYPOTENSION (hypotensive) and HEAD INJURY (head injury) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       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. However, Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Further information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Fatigue, Hypoacusis, Hypoaesthesia, Vaccination site pain
Clinical narrative: Hearing loss persists; Cannot hear correctly; Right ear feels numb; Soreness in injected right arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss persists) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (Soreness in injected right arm) and FATIGUE (Fatigue). On 20-Apr-2021, the patient experienced HYPOACUSIS (Cannot hear correctly) and HYPOAESTHESIA (Right ear feels numb). On 27-Apr-2021, the patient experienced DEAFNESS (Hearing loss persists) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Hearing loss persists), HYPOACUSIS (Cannot hear correctly), HYPOAESTHESIA (Right ear feels numb), VACCINATION SITE PAIN (Soreness in injected right arm) and FATIGUE (Fatigue) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Treatment information included paracetamol.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-092179 (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 these events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Hypertonic bladder, Renal impairment
Clinical narrative: kidneys and bladder overworking; kidneys and bladder overworking; yeast infection due to "kidneys and bladder overworking; This spontaneous case was reported by a consumer and describes the occurrence of RENAL IMPAIRMENT (kidneys and bladder overworking) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0171B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), EMPAGLIFLOZIN (JARDIANCE) and SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Apr-2021, the patient experienced RENAL IMPAIRMENT (kidneys and bladder overworking) (seriousness criterion medically significant), HYPERTONIC BLADDER (kidneys and bladder overworking) and FUNGAL INFECTION (yeast infection due to "kidneys and bladder overworking). At the time of the report, RENAL IMPAIRMENT (kidneys and bladder overworking), HYPERTONIC BLADDER (kidneys and bladder overworking) and FUNGAL INFECTION (yeast infection due to "kidneys and bladder overworking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication includes unknown once weekly injection.  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. Diabetes could have played a causative factor on the event renal impairment; 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. Diabetes could have played a causative factor on the event renal impairment
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: A female patient received her first dose of the vaccine and developed Bells Palsy twelve days later; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (A female patient received her first dose of the vaccine and developed Bells Palsy twelve days later) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BELL'S PALSY (A female patient received her first dose of the vaccine and developed Bells Palsy twelve days later) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (A female patient received her first dose of the vaccine and developed Bells Palsy twelve days later) 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.   Patient was treated with antivirals and steroids  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.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Angina pectoris, Blood pressure increased, Blood pressure measurement, Chest pain
Clinical narrative: stabbing chest pains; chest pain; really bloated; blood pressure incresed; cannot eat very well; body aches; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANGINA PECTORIS (stabbing chest pains) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-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 ANGINA PECTORIS (stabbing chest pains) (seriousness criterion hospitalization), CHEST PAIN (chest pain), ABDOMINAL DISTENSION (really bloated), BLOOD PRESSURE INCREASED (blood pressure incresed), DECREASED APPETITE (cannot eat very well), MYALGIA (body aches) and PYREXIA (fever). The patient was hospitalized from 01-Apr-2021 to 03-Apr-2021 due to ANGINA PECTORIS. At the time of the report, ANGINA PECTORIS (stabbing chest pains), CHEST PAIN (chest pain), ABDOMINAL DISTENSION (really bloated) and DECREASED APPETITE (cannot eat very well) had not resolved and BLOOD PRESSURE INCREASED (blood pressure incresed), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) high.         No concomitant medications were reported. The reporter states that the patient was given metoprolol in the hospital which was discontinued by her primary care physician,lorazepam by one physician who suggested that she may be having anxiety and was prescribed omeprazole by a gastroenterologist. Action taken with mRNA-1273 in response to the event was not applicable.  This case concerns a 72-year-old male with a serious unexpected event of herpes zoster. Event onset 8 days after first dose mRNA-1273. Event resolved with dexpanthenol and chlorhexidine. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 72-year-old male with a serious unexpected event of herpes zoster. Event onset 8 days after first dose mRNA-1273. Event resolved with dexpanthenol and chlorhexidine. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Myalgia, Pyrexia
Clinical narrative: stabbing chest pains; chest pain; really bloated; blood pressure incresed; cannot eat very well; body aches; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANGINA PECTORIS (stabbing chest pains) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-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 ANGINA PECTORIS (stabbing chest pains) (seriousness criterion hospitalization), CHEST PAIN (chest pain), ABDOMINAL DISTENSION (really bloated), BLOOD PRESSURE INCREASED (blood pressure incresed), DECREASED APPETITE (cannot eat very well), MYALGIA (body aches) and PYREXIA (fever). The patient was hospitalized from 01-Apr-2021 to 03-Apr-2021 due to ANGINA PECTORIS. At the time of the report, ANGINA PECTORIS (stabbing chest pains), CHEST PAIN (chest pain), ABDOMINAL DISTENSION (really bloated) and DECREASED APPETITE (cannot eat very well) had not resolved and BLOOD PRESSURE INCREASED (blood pressure incresed), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) high.         No concomitant medications were reported. The reporter states that the patient was given metoprolol in the hospital which was discontinued by her primary care physician,lorazepam by one physician who suggested that she may be having anxiety and was prescribed omeprazole by a gastroenterologist. Action taken with mRNA-1273 in response to the event was not applicable.  This case concerns a 72-year-old male with a serious unexpected event of herpes zoster. Event onset 8 days after first dose mRNA-1273. Event resolved with dexpanthenol and chlorhexidine. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 72-year-old male with a serious unexpected event of herpes zoster. Event onset 8 days after first dose mRNA-1273. Event resolved with dexpanthenol and chlorhexidine. 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blindness, Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: stroke at vision site; partial sight lost in left eye; feeling weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke at vision site) and BLINDNESS (partial sight lost in left eye) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Implantable cardioverter defibrillator insertion.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke at vision site) (seriousness criteria hospitalization and medically significant), BLINDNESS (partial sight lost in left eye) (seriousness criteria hospitalization, disability and medically significant) and ASTHENIA (feeling weak). The patient was hospitalized from 20-Apr-2021 to 21-Apr-2021 due to BLINDNESS and CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke at vision site), BLINDNESS (partial sight lost in left eye) and ASTHENIA (feeling weak) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Computerised tomogram: (abnormal) Stroke at vision site. On 20-Apr-2021, Magnetic resonance imaging: (abnormal) Stroke at vision site.         No concomitant medication were reported.  The reporter stated that the patient was taking medicines but doctor changed her medication and she did not want to talk so she did not give names.; 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: Deafness
Clinical narrative: Have experienced hearing loss after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Have experienced hearing loss after vaccination) in a female 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Have experienced hearing loss after vaccination) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Have experienced hearing loss after vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient is a part of a group of over 1000 patients (all vaccines, not just Moderna).  No treatment information was provided.  Company Comment : Very limited information regarding the events has been provided at this time. Additional information regarding date of onset, date of vaccination, medical history and concomitant medications are required for further evaluation.   This case was linked to US-MODERNATX, INC.-MOD-2021-091898, US-MODERNATX, INC.-MOD-2021-092733 (E2B Linked Report).; Sender's Comments: Very limited information regarding the events has been provided at this time. Additional information regarding date of onset, date of vaccination, medical history and concomitant medications are required for further evaluation. US-MODERNATX, INC.-MOD-2021-091898:Crosslinked (MOD21-082668) US-MODERNATX, INC.-MOD-2021-092733:Crosslinked (MOD21-082695)
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Cough, Influenza like illness, Pneumonia
Clinical narrative: Congestive heart failure exacerbation; pneumonia; flu like symptoms; Coughing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE CONGESTIVE (Congestive heart failure exacerbation) and PNEUMONIA (pneumonia) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030-M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Congestive heart failure. Concomitant products included CARVEDILOL, THIAMINE (VITAMIN B1 [THIAMINE]), AMLODIPINE, LOSARTAN, FOLIC ACID, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), FUROSEMIDE and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) 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 05-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and COUGH (Coughing). On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure exacerbation) (seriousness criterion hospitalization) and PNEUMONIA (pneumonia) (seriousness criterion hospitalization). The patient was hospitalized from 09-Apr-2021 to 13-Apr-2021 due to CARDIAC FAILURE CONGESTIVE and PNEUMONIA. On 13-Apr-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) and COUGH (Coughing) had resolved. At the time of the report, CARDIAC FAILURE CONGESTIVE (Congestive heart failure exacerbation) and PNEUMONIA (pneumonia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Multiple inhalers.  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: Neoplasm malignant, Product dose omission issue
Clinical narrative: emergency cancer treatment; has not gotten second dose in 42+ days; This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (emergency cancer treatment) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced NEOPLASM MALIGNANT (emergency cancer treatment) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (has not gotten second dose in 42+ days). On 02-Jan-2021, PRODUCT DOSE OMISSION ISSUE (has not gotten second dose in 42+ days) had resolved. At the time of the report, NEOPLASM MALIGNANT (emergency cancer treatment) 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.   No concomitant details were provided. No treatment details were provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Portal hypertension
Clinical narrative: Portal hypertension; Inappropriate schedule of product administration; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PORTAL HYPERTENSION (Portal hypertension) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Liver cirrhosis (Patient had liver cirrhosis since 8 years.), Diabetes mellitus, Portal hypertension, BPH, Hyperlipidemia and Kidney disorder. Concomitant products included MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for BPH, INSULIN for Diabetes mellitus, SIMVASTATIN for Hyperlipidemia, FUROSEMIDE (LASILIX [FUROSEMIDE]) for Portal hypertension, POTASSIUM for Renal disorder.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). On 08-Apr-2021, the patient experienced PORTAL HYPERTENSION (Portal hypertension) (seriousness criterion hospitalization). The patient was hospitalized from 08-Apr-2021 to 24-Apr-2021 due to PORTAL HYPERTENSION. On 18-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) had resolved. At the time of the report, PORTAL HYPERTENSION (Portal hypertension) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient missed his second dose of Moderna Covid -19 vaccine, which was scheduled on 15-April-2021. It had been 42 days passed since his first dose of vaccine. No treatment information was provided by the reporter.  Company comment: This report refers to a case of  Inappropriate schedule of vaccine administered  for mRNA-1273, lot # 027A21A  with associated interval hospitalization for portal hypertension. 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. The portal hypertension is a cofounder; Sender's Comments: This report refers to a case of  Inappropriate schedule of vaccine administered  for mRNA-1273, lot # 027A21A  with associated interval hospitalization for portal hypertension. 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. The portal hypertension is a cofounder
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Epilepsy, Headache, Nausea
Clinical narrative: Epileptic Feed; Dizziness; Chills; Fever; Vomiting; Feel like vomiting (Nausea); Headache; Pain at the injection site; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of EPILEPSY (Epileptic Feed) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mitral valve prolapse. Concurrent medical conditions included Hypertension and Thyroid disorder.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). On 27-Apr-2021, the patient experienced DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (Fever), VOMITING (Vomiting), NAUSEA (Feel like vomiting (Nausea)) and HEADACHE (Headache). On 28-Apr-2021, the patient experienced EPILEPSY (Epileptic Feed) (seriousness criterion medically significant). At the time of the report, EPILEPSY (Epileptic Feed), DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (Fever), VOMITING (Vomiting), NAUSEA (Feel like vomiting (Nausea)), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She also developed dizziness headache, felt bad and today 28Apr2021 she developed an epileptic feed about 3 hours ago. She has never had an epileptic feed before. She has a history of mitral valve prolapse and was currently on treatment for hypertension of thyroid disease. She wanted to know what she can do to treat these symptoms.  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. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: Epileptic Feed; Dizziness; Chills; Fever; Vomiting; Feel like vomiting (Nausea); Headache; Pain at the injection site; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of EPILEPSY (Epileptic Feed) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mitral valve prolapse. Concurrent medical conditions included Hypertension and Thyroid disorder.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). On 27-Apr-2021, the patient experienced DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (Fever), VOMITING (Vomiting), NAUSEA (Feel like vomiting (Nausea)) and HEADACHE (Headache). On 28-Apr-2021, the patient experienced EPILEPSY (Epileptic Feed) (seriousness criterion medically significant). At the time of the report, EPILEPSY (Epileptic Feed), DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (Fever), VOMITING (Vomiting), NAUSEA (Feel like vomiting (Nausea)), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She also developed dizziness headache, felt bad and today 28Apr2021 she developed an epileptic feed about 3 hours ago. She has never had an epileptic feed before. She has a history of mitral valve prolapse and was currently on treatment for hypertension of thyroid disease. She wanted to know what she can do to treat these symptoms.  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. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling face, Wheezing
Clinical narrative: Wheezing; Swelling of her face; Swelling of her hands and feet; Swelling of her hands and feet; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing), SWELLING FACE (Swelling of her face), the first episode of PERIPHERAL SWELLING (Swelling of her hands and feet) and the second episode of PERIPHERAL SWELLING (Swelling of her hands and feet) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced WHEEZING (Wheezing) (seriousness criterion life threatening), SWELLING FACE (Swelling of her face) (seriousness criterion life threatening), the first episode of PERIPHERAL SWELLING (Swelling of her hands and feet) (seriousness criterion life threatening) and the second episode of PERIPHERAL SWELLING (Swelling of her hands and feet) (seriousness criterion life threatening). At the time of the report, WHEEZING (Wheezing), SWELLING FACE (Swelling of her face) and the last episode of PERIPHERAL SWELLING (Swelling of her hands and feet) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  The patient took 2 doses of diphenhydramine hydrochloride, cetirizine, and famotidine. On 28-Apr-2021, the patient was feeling better.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Back pain, Deep vein thrombosis, Drug eruption
Clinical narrative: Back pain have been severely bad after she took both doses; Arthritis have been severely bad after she took both doses; Drug Rash; Diagnosed with DVT; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (Diagnosed with DVT) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 11020A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis, Migraine and Back pain. Concomitant products included GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for Migraine.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced DEEP VEIN THROMBOSIS (Diagnosed with DVT) (seriousness criterion medically significant). On an unknown date, the patient experienced BACK PAIN (Back pain have been severely bad after she took both doses), ARTHRITIS (Arthritis have been severely bad after she took both doses) and DRUG ERUPTION (Drug Rash). At the time of the report, DEEP VEIN THROMBOSIS (Diagnosed with DVT), BACK PAIN (Back pain have been severely bad after she took both doses), ARTHRITIS (Arthritis have been severely bad after she took both doses) and DRUG ERUPTION (Drug Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After getting the first shot on 16 Jan2021, she was diagnosed with DVT on 18 Jan 2021 and has been on blood thinner ever since then. She also takes Emgality, a migraine injection every month. She states that ever since she received the vaccine and has been put on blood thinner, she gets rash every month when she take Emgality injection. She also reported that her underlying conditions like back pain and arthritis have been severely bad after she took both doses of the vaccine. Patient is going to speak with her doctor first thing in the morning tomorrow.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Palsy) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient noticed symptoms of Bell's Palsy on 27 Apr 2021 and diagnosed through emergency room visit on 28 Apr 2021.  Treatment for the event included oral prednisone for 7 days by emergency room provider.  The patient advised to hold off second dose of Moderna COVID19 vaccine.  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. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Arrhythmia; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) since an unknown date.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant). On 22-Apr-2021, ARRHYTHMIA (Arrhythmia) 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 product use was reported.  Treatment details included Metoprolol.; 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. However, patient's history of pacemaker is a confounding factor which may play a possible contributory role.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Loss of consciousness, Taste disorder
Clinical narrative: Passed out; Felt dizzy; Nasty taste in mouth; was feeling tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced TASTE DISORDER (Nasty taste in mouth) and FATIGUE (was feeling tired). On 26-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and DIZZINESS (Felt dizzy). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Felt dizzy), TASTE DISORDER (Nasty taste in mouth) and FATIGUE (was feeling tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient had acetaminophen for the events. Action taken with mRNA-1273 in response to the drug was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested Dose 1 case
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Ear discomfort, Tinnitus
Clinical narrative: Hearing loss in right ear; Blocking of both the ears; Sounds as of ocean in right ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in right ear) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-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 DEAFNESS UNILATERAL (Hearing loss in right ear) (seriousness criterion medically significant), EAR DISCOMFORT (Blocking of both the ears) and TINNITUS (Sounds as of ocean in right ear). At the time of the report, DEAFNESS UNILATERAL (Hearing loss in right ear) and TINNITUS (Sounds as of ocean in right ear) outcome was unknown and EAR DISCOMFORT (Blocking of both the ears) had resolved.            Treatment medications included flu nose, allergy pill, nasal spray and prednisone.  Company Comment: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-098399 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-098399:First Dose Case