chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Feeding disorder, Vaccination complication, Vertigo
Clinical narrative: health ruined; can't work or read a computer screen; ear thumping; vertigo; can't eat; extremely dizzy / dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (health ruined), VISUAL IMPAIRMENT (can't work or read a computer screen), EAR DISCOMFORT (ear thumping), VERTIGO (vertigo) and FEEDING DISORDER (can't eat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 COMPLICATION (health ruined), VISUAL IMPAIRMENT (can't work or read a computer screen), EAR DISCOMFORT (ear thumping), VERTIGO (vertigo), FEEDING DISORDER (can't eat) and DIZZINESS (extremely dizzy / dizziness). At the time of the report, VACCINATION COMPLICATION (health ruined), VISUAL IMPAIRMENT (can't work or read a computer screen), EAR DISCOMFORT (ear thumping), VERTIGO (vertigo), FEEDING DISORDER (can't eat) and DIZZINESS (extremely dizzy / dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: health ruined; can't work or read a computer screen; ear thumping; vertigo; can't eat; extremely dizzy / dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (health ruined), VISUAL IMPAIRMENT (can't work or read a computer screen), EAR DISCOMFORT (ear thumping), VERTIGO (vertigo) and FEEDING DISORDER (can't eat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 COMPLICATION (health ruined), VISUAL IMPAIRMENT (can't work or read a computer screen), EAR DISCOMFORT (ear thumping), VERTIGO (vertigo), FEEDING DISORDER (can't eat) and DIZZINESS (extremely dizzy / dizziness). At the time of the report, VACCINATION COMPLICATION (health ruined), VISUAL IMPAIRMENT (can't work or read a computer screen), EAR DISCOMFORT (ear thumping), VERTIGO (vertigo), FEEDING DISORDER (can't eat) and DIZZINESS (extremely dizzy / dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site swelling
Clinical narrative: red bumps on palm; redness on injection site; swelling at injection site; This spontaneous case was reported by a patient and describes the occurrence of RASH (red bumps on palm), VACCINATION SITE ERYTHEMA (redness on injection site) and VACCINATION SITE SWELLING (swelling at injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 RASH (red bumps on palm), VACCINATION SITE ERYTHEMA (redness on injection site) and VACCINATION SITE SWELLING (swelling at injection site). At the time of the report, RASH (red bumps on palm), VACCINATION SITE ERYTHEMA (redness on injection site) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided. Treatment information not provided.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16-year-old received the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received the Moderna vaccine) in a 16-year-old patient of an unknown 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided by reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Feeling abnormal, Gait disturbance, Insomnia
Clinical narrative: left arm pain/right arm pain; neck pain; back pain; trouble sleeping; Pain near scapula; pain to elbow; felt like something hit her; could not walk straight; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like something hit her), GAIT DISTURBANCE (could not walk straight), PAIN IN EXTREMITY (left arm pain/right arm pain), NECK PAIN (neck pain) and BACK PAIN (back pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In June 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced FEELING ABNORMAL (felt like something hit her) and GAIT DISTURBANCE (could not walk straight). On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm pain/right arm pain), NECK PAIN (neck pain), BACK PAIN (back pain), INSOMNIA (trouble sleeping), PAIN (Pain near scapula) and ARTHRALGIA (pain to elbow). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at a dose of 1 dosage form; PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL EXTRA STRENGTH) for Pain, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (felt like something hit her), GAIT DISTURBANCE (could not walk straight), PAIN IN EXTREMITY (left arm pain/right arm pain), NECK PAIN (neck pain), BACK PAIN (back pain), INSOMNIA (trouble sleeping), PAIN (Pain near scapula) and ARTHRALGIA (pain to elbow) outcome was unknown.            No concomitant medication were reported    This case was linked to MOD-2021-262385 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: TCR Received on 10-Sep-2021,Contain Non Significant Information
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: left arm pain/right arm pain; neck pain; back pain; trouble sleeping; Pain near scapula; pain to elbow; felt like something hit her; could not walk straight; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like something hit her), GAIT DISTURBANCE (could not walk straight), PAIN IN EXTREMITY (left arm pain/right arm pain), NECK PAIN (neck pain) and BACK PAIN (back pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In June 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced FEELING ABNORMAL (felt like something hit her) and GAIT DISTURBANCE (could not walk straight). On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm pain/right arm pain), NECK PAIN (neck pain), BACK PAIN (back pain), INSOMNIA (trouble sleeping), PAIN (Pain near scapula) and ARTHRALGIA (pain to elbow). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at a dose of 1 dosage form; PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL EXTRA STRENGTH) for Pain, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (felt like something hit her), GAIT DISTURBANCE (could not walk straight), PAIN IN EXTREMITY (left arm pain/right arm pain), NECK PAIN (neck pain), BACK PAIN (back pain), INSOMNIA (trouble sleeping), PAIN (Pain near scapula) and ARTHRALGIA (pain to elbow) outcome was unknown.            No concomitant medication were reported    This case was linked to MOD-2021-262385 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: TCR Received on 10-Sep-2021,Contain Non Significant Information
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral coldness, Vaccination site erythema, Vaccination site induration
Clinical narrative: a little numbness in pinky finger; pinky finger is colder than the rest of her fingers; day of vaccination her arm was sore/tender; knot; site of vaccination was itchy (for about half day); site of vaccination had some reddens; site of vaccination was swollen; site of vaccination was warm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (a little numbness in pinky finger), PERIPHERAL COLDNESS (pinky finger is colder than the rest of her fingers), PAIN IN EXTREMITY (day of vaccination her arm was sore/tender), VACCINATION SITE WARMTH (site of vaccination was warm) and VACCINATION SITE INDURATION (knot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included COLECALCIFEROL (VIT D3), ASCORBIC ACID (VIT C), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced VACCINATION SITE WARMTH (site of vaccination was warm), VACCINATION SITE ERYTHEMA (site of vaccination had some reddens) and VACCINATION SITE SWELLING (site of vaccination was swollen). On 08-Jul-2021, the patient experienced HYPOAESTHESIA (a little numbness in pinky finger), PERIPHERAL COLDNESS (pinky finger is colder than the rest of her fingers), PAIN IN EXTREMITY (day of vaccination her arm was sore/tender), VACCINATION SITE INDURATION (knot) and VACCINATION SITE PRURITUS (site of vaccination was itchy (for about half day)). On 09-Jul-2021, PERIPHERAL COLDNESS (pinky finger is colder than the rest of her fingers), PAIN IN EXTREMITY (day of vaccination her arm was sore/tender), VACCINATION SITE WARMTH (site of vaccination was warm), VACCINATION SITE PRURITUS (site of vaccination was itchy (for about half day)), VACCINATION SITE ERYTHEMA (site of vaccination had some reddens) and VACCINATION SITE SWELLING (site of vaccination was swollen) had resolved. At the time of the report, HYPOAESTHESIA (a little numbness in pinky finger) outcome was unknown and VACCINATION SITE INDURATION (knot) had resolved.        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.   Concomitant medications included blood pressure medication, Thyroid medication.  Treatment information was not provided.  Second dose is on 31-Jul-2021.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: a little numbness in pinky finger; pinky finger is colder than the rest of her fingers; day of vaccination her arm was sore/tender; knot; site of vaccination was itchy (for about half day); site of vaccination had some reddens; site of vaccination was swollen; site of vaccination was warm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (a little numbness in pinky finger), PERIPHERAL COLDNESS (pinky finger is colder than the rest of her fingers), PAIN IN EXTREMITY (day of vaccination her arm was sore/tender), VACCINATION SITE WARMTH (site of vaccination was warm) and VACCINATION SITE INDURATION (knot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included COLECALCIFEROL (VIT D3), ASCORBIC ACID (VIT C), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced VACCINATION SITE WARMTH (site of vaccination was warm), VACCINATION SITE ERYTHEMA (site of vaccination had some reddens) and VACCINATION SITE SWELLING (site of vaccination was swollen). On 08-Jul-2021, the patient experienced HYPOAESTHESIA (a little numbness in pinky finger), PERIPHERAL COLDNESS (pinky finger is colder than the rest of her fingers), PAIN IN EXTREMITY (day of vaccination her arm was sore/tender), VACCINATION SITE INDURATION (knot) and VACCINATION SITE PRURITUS (site of vaccination was itchy (for about half day)). On 09-Jul-2021, PERIPHERAL COLDNESS (pinky finger is colder than the rest of her fingers), PAIN IN EXTREMITY (day of vaccination her arm was sore/tender), VACCINATION SITE WARMTH (site of vaccination was warm), VACCINATION SITE PRURITUS (site of vaccination was itchy (for about half day)), VACCINATION SITE ERYTHEMA (site of vaccination had some reddens) and VACCINATION SITE SWELLING (site of vaccination was swollen) had resolved. At the time of the report, HYPOAESTHESIA (a little numbness in pinky finger) outcome was unknown and VACCINATION SITE INDURATION (knot) had resolved.        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.   Concomitant medications included blood pressure medication, Thyroid medication.  Treatment information was not provided.  Second dose is on 31-Jul-2021.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna dose was given to a patient on Monday July 19, 2021 after storage in the refrigerator for 37 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose was given to a patient on Monday July 19, 2021 after storage in the refrigerator for 37 days) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose was given to a patient on Monday July 19, 2021 after storage in the refrigerator for 37 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose was given to a patient on Monday July 19, 2021 after storage in the refrigerator for 37 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: No new information reported
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Nausea, SARS-CoV-2 test
Clinical narrative: vertigo; dizziness; nausea; soreness in injection arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (dizziness), MYALGIA (soreness in injection arm), HEADACHE (headache) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05CD214) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced MYALGIA (soreness in injection arm) and HEADACHE (headache). On 16-Jul-2021, the patient experienced VERTIGO (vertigo), DIZZINESS (dizziness) and NAUSEA (nausea). At the time of the report, VERTIGO (vertigo), DIZZINESS (dizziness), MYALGIA (soreness in injection arm), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: other (Positive) other.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; dizziness; nausea; soreness in injection arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (dizziness), MYALGIA (soreness in injection arm), HEADACHE (headache) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05CD214) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced MYALGIA (soreness in injection arm) and HEADACHE (headache). On 16-Jul-2021, the patient experienced VERTIGO (vertigo), DIZZINESS (dizziness) and NAUSEA (nausea). At the time of the report, VERTIGO (vertigo), DIZZINESS (dizziness), MYALGIA (soreness in injection arm), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: other (Positive) other.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reaction to the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the Moderna 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to the Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (reaction to the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-062134 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: spot where I had the shot, is red; spot where I had the shot, is hard; spot where I had the shot, is itchy; spot where I had the shot, is swollen; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (spot where I had the shot, is red), VACCINATION SITE INDURATION (spot where I had the shot, is hard), VACCINATION SITE PRURITUS (spot where I had the shot, is itchy) and VACCINATION SITE SWELLING (spot where I had the shot, is swollen) 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 VACCINATION SITE ERYTHEMA (spot where I had the shot, is red), VACCINATION SITE INDURATION (spot where I had the shot, is hard), VACCINATION SITE PRURITUS (spot where I had the shot, is itchy) and VACCINATION SITE SWELLING (spot where I had the shot, is swollen). At the time of the report, VACCINATION SITE ERYTHEMA (spot where I had the shot, is red), VACCINATION SITE INDURATION (spot where I had the shot, is hard), VACCINATION SITE PRURITUS (spot where I had the shot, is itchy) and VACCINATION SITE SWELLING (spot where I had the shot, is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was received by the patient No Treatment was received by the patient.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects from the first moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects from the first moderna shot) 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 VACCINATION COMPLICATION (side effects from the first moderna shot). At the time of the report, VACCINATION COMPLICATION (side effects from the first moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up information received on 24-JUL-2021 ,contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Can I get a second shot if my first shot was 6 months ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Can I get a second shot if my first shot was 6 months ago) 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 PRODUCT DOSE OMISSION ISSUE (Can I get a second shot if my first shot was 6 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Can I get a second shot if my first shot was 6 months ago) outcome was unknown.            No concomitant medication were reported.  No treatment medication was reported.   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Memory impairment, Myalgia, Nausea, Product dose omission issue
Clinical narrative: nausea sensation subsided; for the first three days her brain was lit up; Postponed second dose due to vertigo (16 weeks since first dose); patient woke up with an immense feeling of vertigo, which intensity lasted that entire week. She couldn't get up without spinning; Arm hurt all day (vaccinated one); Little fever; Her brain was lit up, couldn't stop, it was very hard to sleep; Memory issue, it's difficult for her to recall info quickly/ Can see a picture but can't pull up words for that; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (patient woke up with an immense feeling of vertigo, which intensity lasted that entire week. She couldn't get up without spinning), MYALGIA (Arm hurt all day (vaccinated one)), PYREXIA (Little fever), SLEEP DISORDER (Her brain was lit up, couldn't stop, it was very hard to sleep) and MEMORY IMPAIRMENT (Memory issue, it's difficult for her to recall info quickly/ Can see a picture but can't pull up words for that) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced VERTIGO (patient woke up with an immense feeling of vertigo, which intensity lasted that entire week. She couldn't get up without spinning), MYALGIA (Arm hurt all day (vaccinated one)), PYREXIA (Little fever), SLEEP DISORDER (Her brain was lit up, couldn't stop, it was very hard to sleep) and MEMORY IMPAIRMENT (Memory issue, it's difficult for her to recall info quickly/ Can see a picture but can't pull up words for that). On 21-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Postponed second dose due to vertigo (16 weeks since first dose)). On an unknown date, the patient experienced NAUSEA (nausea sensation subsided) and FEELING ABNORMAL (for the first three days her brain was lit up). In April 2021, MYALGIA (Arm hurt all day (vaccinated one)), PYREXIA (Little fever) and SLEEP DISORDER (Her brain was lit up, couldn't stop, it was very hard to sleep) had resolved. On 21-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Postponed second dose due to vertigo (16 weeks since first dose)) had resolved. At the time of the report, VERTIGO (patient woke up with an immense feeling of vertigo, which intensity lasted that entire week. She couldn't get up without spinning), MEMORY IMPAIRMENT (Memory issue, it's difficult for her to recall info quickly/ Can see a picture but can't pull up words for that), NAUSEA (nausea sensation subsided) and FEELING ABNORMAL (for the first three days her brain was lit up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder, Vertigo
Clinical narrative: nausea sensation subsided; for the first three days her brain was lit up; Postponed second dose due to vertigo (16 weeks since first dose); patient woke up with an immense feeling of vertigo, which intensity lasted that entire week. She couldn't get up without spinning; Arm hurt all day (vaccinated one); Little fever; Her brain was lit up, couldn't stop, it was very hard to sleep; Memory issue, it's difficult for her to recall info quickly/ Can see a picture but can't pull up words for that; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (patient woke up with an immense feeling of vertigo, which intensity lasted that entire week. She couldn't get up without spinning), MYALGIA (Arm hurt all day (vaccinated one)), PYREXIA (Little fever), SLEEP DISORDER (Her brain was lit up, couldn't stop, it was very hard to sleep) and MEMORY IMPAIRMENT (Memory issue, it's difficult for her to recall info quickly/ Can see a picture but can't pull up words for that) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced VERTIGO (patient woke up with an immense feeling of vertigo, which intensity lasted that entire week. She couldn't get up without spinning), MYALGIA (Arm hurt all day (vaccinated one)), PYREXIA (Little fever), SLEEP DISORDER (Her brain was lit up, couldn't stop, it was very hard to sleep) and MEMORY IMPAIRMENT (Memory issue, it's difficult for her to recall info quickly/ Can see a picture but can't pull up words for that). On 21-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Postponed second dose due to vertigo (16 weeks since first dose)). On an unknown date, the patient experienced NAUSEA (nausea sensation subsided) and FEELING ABNORMAL (for the first three days her brain was lit up). In April 2021, MYALGIA (Arm hurt all day (vaccinated one)), PYREXIA (Little fever) and SLEEP DISORDER (Her brain was lit up, couldn't stop, it was very hard to sleep) had resolved. On 21-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Postponed second dose due to vertigo (16 weeks since first dose)) had resolved. At the time of the report, VERTIGO (patient woke up with an immense feeling of vertigo, which intensity lasted that entire week. She couldn't get up without spinning), MEMORY IMPAIRMENT (Memory issue, it's difficult for her to recall info quickly/ Can see a picture but can't pull up words for that), NAUSEA (nausea sensation subsided) and FEELING ABNORMAL (for the first three days her brain was lit up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Dizziness, Malaise, Musculoskeletal discomfort, Rash
Clinical narrative: Could not move his neck side to side; Was not feeling well/not his normal self; Rash on his foot/Rash on his head; Neck swelling; Getting dizzy/got so dizzy at work that he had to sit down; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Neck swelling), DIZZINESS (Getting dizzy/got so dizzy at work that he had to sit down), MUSCULOSKELETAL DISCOMFORT (Could not move his neck side to side), MALAISE (Was not feeling well/not his normal self) and RASH (Rash on his foot/Rash on his head) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Diabetes.    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced SWELLING (Neck swelling) and DIZZINESS (Getting dizzy/got so dizzy at work that he had to sit down). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Could not move his neck side to side), MALAISE (Was not feeling well/not his normal self) and RASH (Rash on his foot/Rash on his head). At the time of the report, SWELLING (Neck swelling), DIZZINESS (Getting dizzy/got so dizzy at work that he had to sit down), MUSCULOSKELETAL DISCOMFORT (Could not move his neck side to side), MALAISE (Was not feeling well/not his normal self) and RASH (Rash on his foot/Rash on his head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: went way up than normal (High) went way up than normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. Treatment included some antibiotic cream   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received had no new information recorded
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Could not move his neck side to side; Was not feeling well/not his normal self; Rash on his foot/Rash on his head; Neck swelling; Getting dizzy/got so dizzy at work that he had to sit down; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Neck swelling), DIZZINESS (Getting dizzy/got so dizzy at work that he had to sit down), MUSCULOSKELETAL DISCOMFORT (Could not move his neck side to side), MALAISE (Was not feeling well/not his normal self) and RASH (Rash on his foot/Rash on his head) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Diabetes.    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced SWELLING (Neck swelling) and DIZZINESS (Getting dizzy/got so dizzy at work that he had to sit down). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Could not move his neck side to side), MALAISE (Was not feeling well/not his normal self) and RASH (Rash on his foot/Rash on his head). At the time of the report, SWELLING (Neck swelling), DIZZINESS (Getting dizzy/got so dizzy at work that he had to sit down), MUSCULOSKELETAL DISCOMFORT (Could not move his neck side to side), MALAISE (Was not feeling well/not his normal self) and RASH (Rash on his foot/Rash on his head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: went way up than normal (High) went way up than normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. Treatment included some antibiotic cream   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received had no new information recorded
Sex: U
Vaccine: COVID19
Symptoms: Bursitis, Pain in extremity
Clinical narrative: Atypical bursitis in the shoulder; The arm but it is painful; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of BURSITIS (Atypical bursitis in the shoulder) and PAIN IN EXTREMITY (The arm but it is painful) 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 BURSITIS (Atypical bursitis in the shoulder) and PAIN IN EXTREMITY (The arm but it is painful). At the time of the report, BURSITIS (Atypical bursitis in the shoulder) and PAIN IN EXTREMITY (The arm but it is painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Headache, Intentional product use issue
Clinical narrative: Patient has family member who are with COVID-19 infection; did not receive the second shot/pharmacist referred it´s being too long/vaccine after 42 days/unable to take the 2nd dose since it's longer than 42 days; 1 month of headache, like someone hit on top of her head; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Patient has family member who are with COVID-19 infection), INTENTIONAL PRODUCT USE ISSUE (did not receive the second shot/pharmacist referred it´s being too long/vaccine after 42 days/unable to take the 2nd dose since it's longer than 42 days) and HEADACHE (1 month of headache, like someone hit on top of her head) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No medication history information was reported.  Concomitant products included CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Depression.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (1 month of headache, like someone hit on top of her head). On 05-Jun-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (did not receive the second shot/pharmacist referred it´s being too long/vaccine after 42 days/unable to take the 2nd dose since it's longer than 42 days). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Patient has family member who are with COVID-19 infection). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 UNK. In May 2021, HEADACHE (1 month of headache, like someone hit on top of her head) had resolved. On 05-Jun-2021, INTENTIONAL PRODUCT USE ISSUE (did not receive the second shot/pharmacist referred it´s being too long/vaccine after 42 days/unable to take the 2nd dose since it's longer than 42 days) had resolved. At the time of the report, EXPOSURE TO SARS-COV-2 (Patient has family member who are with COVID-19 infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received and contains no new information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Felt weak; Muscle ache; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak), MYALGIA (Muscle ache), PYREXIA (Fever) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022c21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included MONOCLONAL ANTIBODIES for COVID-19.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Felt weak), MYALGIA (Muscle ache), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, ASTHENIA (Felt weak), MYALGIA (Muscle ache), PYREXIA (Fever) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dizziness, Vaccination complication
Clinical narrative: Taste buds are off; Feeling dizzy; Similar side effects as mine; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Taste buds are off), DIZZINESS (Feeling dizzy) and VACCINATION COMPLICATION (Similar side effects as mine) 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 AGEUSIA (Taste buds are off), DIZZINESS (Feeling dizzy) and VACCINATION COMPLICATION (Similar side effects as mine). At the time of the report, AGEUSIA (Taste buds are off), DIZZINESS (Feeling dizzy) and VACCINATION COMPLICATION (Similar side effects as mine) 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.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Translation document received on 11-Sep-2021 contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 42 days since first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (42 days since first dose) 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 PRODUCT DOSE OMISSION ISSUE (42 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (42 days since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported by reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: redness at vaccination site/measured 6" long by 4 " wide; itchy reaction at the injection site; the injection site that was warm to the touch; raised at injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at vaccination site/measured 6" long by 4 " wide), VACCINATION SITE PRURITUS (itchy reaction at the injection site), VACCINATION SITE WARMTH (the injection site that was warm to the touch) and VACCINATION SITE SWELLING (raised at injection site) 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 VACCINATION SITE ERYTHEMA (redness at vaccination site/measured 6" long by 4 " wide), VACCINATION SITE PRURITUS (itchy reaction at the injection site), VACCINATION SITE WARMTH (the injection site that was warm to the touch) and VACCINATION SITE SWELLING (raised at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness at vaccination site/measured 6" long by 4 " wide), VACCINATION SITE PRURITUS (itchy reaction at the injection site), VACCINATION SITE WARMTH (the injection site that was warm to the touch) and VACCINATION SITE SWELLING (raised at injection site) 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 medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product were reported  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss) 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 ALOPECIA (Hair loss). At the time of the report, ALOPECIA (Hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter. No Treatment medications were provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness) 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 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced DIZZINESS (Dizziness) and NAUSEA (Nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Nausea, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Non-Significant follow up received on 26-JUL-2021 - AE contact information updated. On 27-Jul-2021: Non-Significant Follow up received on 27-JUL-2021