chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Insomnia, Psychotic disorder, Wheezing
Clinical narrative: Continued to have wheezing; Could not sleep at night/unable to sleep; Having a hard time working; Felt fatigued/ chronic fatigue and slept constantly; Heart rate elevated; Blood pressure elevated; That night he had another psychotic episode; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOTIC DISORDER (That night he had another psychotic episode), WHEEZING (Continued to have wheezing), INSOMNIA (Could not sleep at night/unable to sleep), IMPAIRED WORK ABILITY (Having a hard time working) and HEART RATE INCREASED (Heart rate elevated) in a 44-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 Asthma (had asthma as a child).    On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced PSYCHOTIC DISORDER (That night he had another psychotic episode). On 31-Jul-2021, the patient experienced HEART RATE INCREASED (Heart rate elevated). 31-Jul-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure elevated). On an unknown date, the patient experienced WHEEZING (Continued to have wheezing), INSOMNIA (Could not sleep at night/unable to sleep), IMPAIRED WORK ABILITY (Having a hard time working) and FATIGUE (Felt fatigued/ chronic fatigue and slept constantly). The patient was treated with SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PSYCHOTIC DISORDER (That night he had another psychotic episode), INSOMNIA (Could not sleep at night/unable to sleep), IMPAIRED WORK ABILITY (Having a hard time working), HEART RATE INCREASED (Heart rate elevated), BLOOD PRESSURE INCREASED (Blood pressure elevated) and FATIGUE (Felt fatigued/ chronic fatigue and slept constantly) outcome was unknown and WHEEZING (Continued to have wheezing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, Blood pressure measurement: high (High) High. On 31-Jul-2021, Heart rate: high (High) High.         Concomitant medications were not reported.  Patient went to emergency room on 31-july-2021 and had more X-rays and breathing treatments. They suggested he had either asthma or pulmonary hypertension but not yet confirmed. On 02-Aug-2021 patient went to a pulmonologist who said it look like asthma and started breathing treatments but not the albuterol. Patient had still albuterol inhaler during night which caused him to be unable to sleep. He had blood work done on 19-Aug-2021   This case was linked to MOD-2021-293168 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Lethargy, Pyrexia, SARS-CoV-2 test
Clinical narrative: Lethargic; Got COVID; Tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), COVID-19 (Got COVID), FATIGUE (Tired) and PYREXIA (Fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027D21A and 939902) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals (Sulphur), Shellfish allergy and Fruit allergy (Avocado).   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced LETHARGY (Lethargic), COVID-19 (Got COVID) and PYREXIA (Fever). 30-Jul-2021, the patient experienced FATIGUE (Tired). The patient was treated with VITAMIN C [ASCORBIC ACID] for Adverse event, at an unspecified dose and frequency; VITAMIN D [VITAMIN D NOS] for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 06-Aug-2021, PYREXIA (Fever) had resolved. On 08-Aug-2021, COVID-19 (Got COVID) had resolved. At the time of the report, LETHARGY (Lethargic) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         Relevant concomitant medications were not reported.  Patient went to urgent care on 8-Aug-2021.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Coordination abnormal, Gait disturbance, Hypoaesthesia, Muscle twitching
Clinical narrative: lower leg numbness from hips down; nerve damage on legs; muscle weakness; coordination problems; he is tripping; experiencing imbalance; uncontrollable muscle twitching all over body; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (nerve damage on legs), MUSCULAR WEAKNESS (muscle weakness), COORDINATION ABNORMAL (coordination problems), GAIT DISTURBANCE (he is tripping) and BALANCE DISORDER (experiencing imbalance) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced NERVE INJURY (nerve damage on legs), MUSCULAR WEAKNESS (muscle weakness), COORDINATION ABNORMAL (coordination problems), GAIT DISTURBANCE (he is tripping), BALANCE DISORDER (experiencing imbalance) and MUSCLE TWITCHING (uncontrollable muscle twitching all over body). On an unknown date, the patient experienced HYPOAESTHESIA (lower leg numbness from hips down). At the time of the report, NERVE INJURY (nerve damage on legs), MUSCULAR WEAKNESS (muscle weakness), COORDINATION ABNORMAL (coordination problems), GAIT DISTURBANCE (he is tripping), BALANCE DISORDER (experiencing imbalance), MUSCLE TWITCHING (uncontrollable muscle twitching all over body) and HYPOAESTHESIA (lower leg numbness from hips down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported he was taking blood pressure medication.  No treatment medication was reported by patient.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Nerve injury
Clinical narrative: lower leg numbness from hips down; nerve damage on legs; muscle weakness; coordination problems; he is tripping; experiencing imbalance; uncontrollable muscle twitching all over body; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (nerve damage on legs), MUSCULAR WEAKNESS (muscle weakness), COORDINATION ABNORMAL (coordination problems), GAIT DISTURBANCE (he is tripping) and BALANCE DISORDER (experiencing imbalance) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced NERVE INJURY (nerve damage on legs), MUSCULAR WEAKNESS (muscle weakness), COORDINATION ABNORMAL (coordination problems), GAIT DISTURBANCE (he is tripping), BALANCE DISORDER (experiencing imbalance) and MUSCLE TWITCHING (uncontrollable muscle twitching all over body). On an unknown date, the patient experienced HYPOAESTHESIA (lower leg numbness from hips down). At the time of the report, NERVE INJURY (nerve damage on legs), MUSCULAR WEAKNESS (muscle weakness), COORDINATION ABNORMAL (coordination problems), GAIT DISTURBANCE (he is tripping), BALANCE DISORDER (experiencing imbalance), MUSCLE TWITCHING (uncontrollable muscle twitching all over body) and HYPOAESTHESIA (lower leg numbness from hips down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported he was taking blood pressure medication.  No treatment medication was reported by patient.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Neck pain, Tinnitus
Clinical narrative: pain in her neck and ears at times; pain in her neck and ears at times; a clicking in her head; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (pain in her neck and ears at times), NECK PAIN (pain in her neck and ears at times) and TINNITUS (a clicking in her head) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-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 EAR PAIN (pain in her neck and ears at times), NECK PAIN (pain in her neck and ears at times) and TINNITUS (a clicking in her head). At the time of the report, EAR PAIN (pain in her neck and ears at times), NECK PAIN (pain in her neck and ears at times) and TINNITUS (a clicking in her head) had not resolved.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inappropriate schedule of product administration, Myalgia, Peripheral swelling, Pruritus
Clinical narrative: Itchiness; Arm Swelling (right); Tenderness (right); Arm pinkish in color; Rashes on elbow (right); Arm soreness  (right); Third dose given more than 35 days from second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS, PERIPHERAL SWELLING (right arm), TENDERNESS, ERYTHEMA, and RASH (right elbow) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced PRURITUS, PERIPHERAL SWELLING (right arm), TENDERNESS, ERYTHEMA, RASH (right elbow), MYALGIA (right arm), and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose given more than 35 days from second dose). At the time of the report, PRURITUS, PERIPHERAL SWELLING (right arm), TENDERNESS, ERYTHEMA, RASH (right elbow), MYALGIA (right arm), and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose given more than 35 days from second dose) had resolved.            No concomitant medication were provided by the reporter.  No treatment medication were provided by the reporter.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tenderness
Clinical narrative: Itchiness; Arm Swelling (right); Tenderness (right); Arm pinkish in color; Rashes on elbow (right); Arm soreness  (right); Third dose given more than 35 days from second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS, PERIPHERAL SWELLING (right arm), TENDERNESS, ERYTHEMA, and RASH (right elbow) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced PRURITUS, PERIPHERAL SWELLING (right arm), TENDERNESS, ERYTHEMA, RASH (right elbow), MYALGIA (right arm), and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose given more than 35 days from second dose). At the time of the report, PRURITUS, PERIPHERAL SWELLING (right arm), TENDERNESS, ERYTHEMA, RASH (right elbow), MYALGIA (right arm), and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose given more than 35 days from second dose) had resolved.            No concomitant medication were provided by the reporter.  No treatment medication were provided by the reporter.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Adhesive tape allergy (Allergic to tapes.) and Adhesive tape allergy (Allergic to Band aids.).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave a vaccine to two patients that was past the 12hr window; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave a vaccine to two patients that was past the 12hr window) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 091D21A) for COVID-19 vaccination.     Concurrent medical conditions included Adhesive tape allergy (tape), Allergy to antibiotic (Amoxicillin) and Allergy to antibiotic (Erythromycin).   On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave a vaccine to two patients that was past the 12hr window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave a vaccine to two patients that was past the 12hr window) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow up received on 23 Aug 2021 include reporter first name updated. On 25-Aug-2021: Follow up received on 25 Aug 2021 include no new information. On 25-Aug-2021: Follow-up received on 25 Aug 2021 include patient demographics.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Product dose omission issue
Clinical narrative: Different sensation on his left arm up to his neck; Facial numbness; First dose 10March2021 - Overdue second dose; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Different sensation on his left arm up to his neck), HYPOAESTHESIA (Facial numbness) and PRODUCT DOSE OMISSION ISSUE (First dose 10March2021 - Overdue second dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     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 10-Mar-2021, the patient experienced PARAESTHESIA (Different sensation on his left arm up to his neck), HYPOAESTHESIA (Facial numbness) and PRODUCT DOSE OMISSION ISSUE (First dose 10March2021 - Overdue second dose). At the time of the report, PARAESTHESIA (Different sensation on his left arm up to his neck) and HYPOAESTHESIA (Facial numbness) had not resolved and PRODUCT DOSE OMISSION ISSUE (First dose 10March2021 - Overdue second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Incorrect dose administered
Clinical narrative: Administered invalid dose; she tried to administer a dose to a patient, certain dose leaked out of the syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Administered invalid dose) and ACCIDENTAL EXPOSURE TO PRODUCT (she tried to administer a dose to a patient, certain dose leaked out of the syringe) in a 30-year-old female patient who received mRNA-1273 (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Administered invalid dose) and ACCIDENTAL EXPOSURE TO PRODUCT (she tried to administer a dose to a patient, certain dose leaked out of the syringe). At the time of the report, INCORRECT DOSE ADMINISTERED (Administered invalid dose) and ACCIDENTAL EXPOSURE TO PRODUCT (she tried to administer a dose to a patient, certain dose leaked out of the syringe) outcome was unknown.        For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Reporter said that after she tried to administer a dose to a patient, certain dose leaked out of the syringe.   No concomitant medication was reported.                   No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: From point of puncture, the vial was stored at room temperature between 66 degree Fahrenheit and 68 degree Fahrenheit for 20 hours then administered as a 1st dose to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (From point of puncture, the vial was stored at room temperature between 66 degree Fahrenheit and 68 degree Fahrenheit for 20 hours then administered as a 1st dose to a patient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (From point of puncture, the vial was stored at room temperature between 66 degree Fahrenheit and 68 degree Fahrenheit for 20 hours then administered as a 1st dose to a patient). On 20-Aug-2021, PRODUCT STORAGE ERROR (From point of puncture, the vial was stored at room temperature between 66 degree Fahrenheit and 68 degree Fahrenheit for 20 hours then administered as a 1st dose to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. The patient wanted to know if the case stands valid or not.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow-up received on 25-AUG-2021 contains updated narrative
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: frequent dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (frequent dizzy spells) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (frequent dizzy spells). At the time of the report, DIZZINESS (frequent dizzy spells) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Feeling sick as hell after taking the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Feeling sick as hell after taking the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 ILLNESS (Feeling sick as hell after taking the vaccine). At the time of the report, ILLNESS (Feeling sick as hell after taking the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not reported   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Sinus disorder, Upper-airway cough syndrome
Clinical narrative: Prior to getting the 1st dose she has always had sinus problem but since receiving the 1st dose it is a little bit more; Prior to getting the 1st dose she has always had sinus problem but since receiving the 1st dose it is a little bit more; Stuff comes from her nose (up to her eyes) then goes into her throat; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (Prior to getting the 1st dose she has always had sinus problem but since receiving the 1st dose it is a little bit more), CONDITION AGGRAVATED (Prior to getting the 1st dose she has always had sinus problem but since receiving the 1st dose it is a little bit more) and UPPER-AIRWAY COUGH SYNDROME (Stuff comes from her nose (up to her eyes) then goes into her throat) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Sinus infection. Concomitant products included MONTELUKAST and LEVOCETIRIZINE for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUS DISORDER (Prior to getting the 1st dose she has always had sinus problem but since receiving the 1st dose it is a little bit more), CONDITION AGGRAVATED (Prior to getting the 1st dose she has always had sinus problem but since receiving the 1st dose it is a little bit more) and UPPER-AIRWAY COUGH SYNDROME (Stuff comes from her nose (up to her eyes) then goes into her throat). At the time of the report, SINUS DISORDER (Prior to getting the 1st dose she has always had sinus problem but since receiving the 1st dose it is a little bit more), CONDITION AGGRAVATED (Prior to getting the 1st dose she has always had sinus problem but since receiving the 1st dose it is a little bit more) and UPPER-AIRWAY COUGH SYNDROME (Stuff comes from her nose (up to her eyes) then goes into her throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days from first vaccination, not able to get second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days from first vaccination, not able to get second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Removal of kidney stone (kidney stone removed, not related to vaccine). Concurrent medical conditions included Respiratory syncytial virus infection NOS (RSV, not related to vaccine) and UTI (not related to vaccine).    On 01-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 PRODUCT DOSE OMISSION ISSUE (More than 36 days from first vaccination, not able to get second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days from first vaccination, not able to get second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided.  No treatment information was mentioned.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Myalgia
Clinical narrative: Confusion; Back muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion) and MYALGIA (Back muscle pain) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C2A1) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was Covid positive back in April of 2021) in April 2021. Concurrent medical conditions included Allergy to nuts, Allergy to animals and Penicillin allergy.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced CONFUSIONAL STATE (Confusion) and MYALGIA (Back muscle pain). At the time of the report, CONFUSIONAL STATE (Confusion) and MYALGIA (Back muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Dose administered to a 14 year old/Moderna COVID-19 vaccine was administered to a consumer under the age of 18; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose administered to a 14 year old/Moderna COVID-19 vaccine was administered to a consumer under the age of 18) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.   No Medical History information was reported.   On 18-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose administered to a 14 year old/Moderna COVID-19 vaccine was administered to a consumer under the age of 18). On 18-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose administered to a 14 year old/Moderna COVID-19 vaccine was administered to a consumer under the age of 18) 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 concomitant medications were provided. Treatment information was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired driving ability, Pain in extremity
Clinical narrative: Sense of direction was off kilter while driving, felt so turned around when trying to come home; Arm hurt but after a few hours it went away; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED DRIVING ABILITY (Sense of direction was off kilter while driving, felt so turned around when trying to come home) and PAIN IN EXTREMITY (Arm hurt but after a few hours it went away) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bladder infection. Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) for Bladder infection.   On 22-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) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt but after a few hours it went away). On 22-Aug-2021, the patient experienced IMPAIRED DRIVING ABILITY (Sense of direction was off kilter while driving, felt so turned around when trying to come home). On 19-Apr-2021, PAIN IN EXTREMITY (Arm hurt but after a few hours it went away) had resolved. At the time of the report, IMPAIRED DRIVING ABILITY (Sense of direction was off kilter while driving, felt so turned around when trying to come home) outcome was unknown.            The patient stated that he received first dose of Moderna vaccine on 22 March 2021 and did not experience any symptoms post-vaccination.  The patient stated that he received second dose of Moderna vaccine on 19 April 2021 and had arm hurt, which went away after a few hours.  On 22 August 2021, the patient reported that his sense of direction was off kilter, while driven home from a family members house. The patient also reported that he drive that route a lot and have never felt so turned around when trying to come home.  The patient stated that he is taking sulfamethoxazole and trimethoprim for a bladder infection since three weeks. No treatment medications were reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, SARS-CoV-2 test
Clinical narrative: really bad headache/doctors think I am having a reaction to the vaccine, The headache is getting worse, it is not responding to medication; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (really bad headache/doctors think I am having a reaction to the vaccine, The headache is getting worse, it is not responding to medication) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (really bad headache/doctors think I am having a reaction to the vaccine, The headache is getting worse, it is not responding to medication). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at an unspecified dose and frequency; ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) ongoing since an unknown date for Headache, at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (really bad headache/doctors think I am having a reaction to the vaccine, The headache is getting worse, it is not responding to medication) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: clear (normal) The CT scan was clear. On an unknown date, SARS-CoV-2 test: normal (Negative) A COVID test came back negative.     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.   It was reported that the headache was not responding to medication and was  getting worse.  Relevant concomitant medications were not provided.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: patient got a first dose of the Pfizer vaccine and a second dose of the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient got a first dose of the Pfizer vaccine and a second dose of the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No medical history information was provided.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient got a first dose of the Pfizer vaccine and a second dose of the Moderna vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (patient got a first dose of the Pfizer vaccine and a second dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received a Pfizer vaccine for the first dose; patient came to the pharmacy and requested a Moderna vaccine for the second dose. Pharmacist did not follow protocol and administer the Moderna vaccine for the second dose.  Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I had a mild/moderate reaction to the vaccine with the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had a mild/moderate reaction to the vaccine with the first 2 doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had a mild/moderate reaction to the vaccine with the first 2 doses). At the time of the report, VACCINATION COMPLICATION (I had a mild/moderate reaction to the vaccine with the first 2 doses) outcome was unknown.      Concomitants were not provided. Treatment was not given.   This case was linked to MOD-2021-294219 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Off label use
Clinical narrative: arm hurt like crazy; patient got the booster vaccine and is not if are considered immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm hurt like crazy) and OFF LABEL USE (patient got the booster vaccine and is not if are considered immunocompromised) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 010A21A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, the patient experienced MYALGIA (arm hurt like crazy) and OFF LABEL USE (patient got the booster vaccine and is not if are considered immunocompromised). At the time of the report, MYALGIA (arm hurt like crazy) and OFF LABEL USE (patient got the booster vaccine and is not if are considered immunocompromised) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided. patient 1 informs that  the Patient 2 is  in a high risk patient due to having diabetes, asthma, a heart condition and had kidney cancer, but  they are not sure if patient 2 is immunocompromised.   This case was linked to MOD-2021-294284 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Nausea
Clinical narrative: A serious increase in the frequency of heartburn; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (A serious increase in the frequency of heartburn) and NAUSEA (Nausea) 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 12-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 DYSPEPSIA (A serious increase in the frequency of heartburn) and NAUSEA (Nausea). At the time of the report, DYSPEPSIA (A serious increase in the frequency of heartburn) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: sore arm; headache; more than 35 days from first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days from first vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days from first vaccination). At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days from first vaccination) had resolved.            Concomitant medication was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-245767 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-245767:Dose 1 case
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Swelling
Clinical narrative: Possible neck swelling; Possible difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Possible neck swelling) and DYSPNOEA (Possible difficulty breathing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Possible neck swelling) and DYSPNOEA (Possible difficulty breathing). At the time of the report, SWELLING (Possible neck swelling) and DYSPNOEA (Possible difficulty breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain) in an adult male patient 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 VACCINATION SITE PAIN (Arm pain). At the time of the report, VACCINATION SITE PAIN (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenal neoplasm
Clinical narrative: Now, they found one in the adrenal gland and it is not a good one so they have to remove it; This spontaneous case was reported by a consumer and describes the occurrence of ADRENAL NEOPLASM (Now, they found one in the adrenal gland and it is not a good one so they have to remove it) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Kidney tumor (Doctors found a tumor on the kidney last year in September) in September 2020.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-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 ADRENAL NEOPLASM (Now, they found one in the adrenal gland and it is not a good one so they have to remove it). At the time of the report, ADRENAL NEOPLASM (Now, they found one in the adrenal gland and it is not a good one so they have to remove it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment history was reported.  Patient wanted to get the booster shot.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: only one dose received so far; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only one dose received so far) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-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 PRODUCT DOSE OMISSION ISSUE (only one dose received so far). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only one dose received so far) outcome was unknown.            No concomitant medication details were provided. No treatment information was mentioned.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported  No treatment medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Follow-up received included No New Information
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in her arm that lasted a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm that lasted a few days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Platelet disorder (platelet disorder that requires a daily chemotherapy pill.).    On 15-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 PAIN IN EXTREMITY (soreness in her arm that lasted a few days). At the time of the report, PAIN IN EXTREMITY (soreness in her arm that lasted a few days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant or treatment information  were reported.   This case was linked to MOD-2021-294231, MOD-2021-294229 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old patient received the moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old patient received the moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old patient received the moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old patient received the moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.                   No treatment medication was reported.