chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Feeling abnormal
Clinical narrative: Once he started driving but he didn't why he was driving; One week after 2nd dose, patient reports that he started dreaming strange; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (One week after 2nd dose, patient reports that he started dreaming strange) and FEELING ABNORMAL (Once he started driving but he didn't why he was driving) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 01-May-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) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced ABNORMAL DREAMS (One week after 2nd dose, patient reports that he started dreaming strange). On an unknown date, the patient experienced FEELING ABNORMAL (Once he started driving but he didn't why he was driving). At the time of the report, ABNORMAL DREAMS (One week after 2nd dose, patient reports that he started dreaming strange) and FEELING ABNORMAL (Once he started driving but he didn't why he was driving) was resolving.            No treatment medication was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: TCR form was added, and event outcome was updated in recent follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: magnet and keys stick to my arm; 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 SITE REACTION (magnet and keys stick to my arm) 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 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 REACTION (magnet and keys stick to my arm). At the time of the report, VACCINATION SITE REACTION (magnet and keys stick to my arm) 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: Heart rate increased
Clinical narrative: heart rate is fast after second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (heart rate is fast after second 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 HEART RATE INCREASED (heart rate is fast after second dose). At the time of the report, HEART RATE INCREASED (heart rate is fast after second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination complication
Clinical narrative: experienced a side effect; mild fever; fatigue; 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 (experienced a side effect), PYREXIA (mild fever) and FATIGUE (fatigue) 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 was provided by the reporter .     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (experienced a side effect), PYREXIA (mild fever) and FATIGUE (fatigue). At the time of the report, VACCINATION COMPLICATION (experienced a side effect), PYREXIA (mild fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Cough, Emphysema, Musculoskeletal chest pain, Pyrexia
Clinical narrative: Potentially COPD after 2nd dose; Started to get a cough after 2nd dose/Worsening cough after 2nd dose; Emphysema after 2nd dose; Started hurting under his right rib cage when he sneezed/pain under his right rib cage got stronger; Fever for 2-3 hours the day after 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Potentially COPD after 2nd dose), COUGH (Started to get a cough after 2nd dose/Worsening cough after 2nd dose), EMPHYSEMA (Emphysema after 2nd dose), MUSCULOSKELETAL CHEST PAIN (Started hurting under his right rib cage when he sneezed/pain under his right rib cage got stronger) and PYREXIA (Fever for 2-3 hours the day after 2nd dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045b21a and 018b21a) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included DOXYCYCLINE and IBUPROFEN for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-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 CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Potentially COPD after 2nd dose), COUGH (Started to get a cough after 2nd dose/Worsening cough after 2nd dose), EMPHYSEMA (Emphysema after 2nd dose), MUSCULOSKELETAL CHEST PAIN (Started hurting under his right rib cage when he sneezed/pain under his right rib cage got stronger) and PYREXIA (Fever for 2-3 hours the day after 2nd dose). At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Potentially COPD after 2nd dose), COUGH (Started to get a cough after 2nd dose/Worsening cough after 2nd dose), EMPHYSEMA (Emphysema after 2nd dose), MUSCULOSKELETAL CHEST PAIN (Started hurting under his right rib cage when he sneezed/pain under his right rib cage got stronger) and PYREXIA (Fever for 2-3 hours the day after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) detected emphysema and potentially COPD..         Action taken with mRNA-1273 in response to the drug was not applicable. No treatment information reported.   This case was linked to MOD-2021-103566 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Potentially COPD after 2nd dose; Started to get a cough after 2nd dose/Worsening cough after 2nd dose; Emphysema after 2nd dose; Started hurting under his right rib cage when he sneezed/pain under his right rib cage got stronger; Fever for 2-3 hours the day after 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Potentially COPD after 2nd dose), COUGH (Started to get a cough after 2nd dose/Worsening cough after 2nd dose), EMPHYSEMA (Emphysema after 2nd dose), MUSCULOSKELETAL CHEST PAIN (Started hurting under his right rib cage when he sneezed/pain under his right rib cage got stronger) and PYREXIA (Fever for 2-3 hours the day after 2nd dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045b21a and 018b21a) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included DOXYCYCLINE and IBUPROFEN for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-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 CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Potentially COPD after 2nd dose), COUGH (Started to get a cough after 2nd dose/Worsening cough after 2nd dose), EMPHYSEMA (Emphysema after 2nd dose), MUSCULOSKELETAL CHEST PAIN (Started hurting under his right rib cage when he sneezed/pain under his right rib cage got stronger) and PYREXIA (Fever for 2-3 hours the day after 2nd dose). At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Potentially COPD after 2nd dose), COUGH (Started to get a cough after 2nd dose/Worsening cough after 2nd dose), EMPHYSEMA (Emphysema after 2nd dose), MUSCULOSKELETAL CHEST PAIN (Started hurting under his right rib cage when he sneezed/pain under his right rib cage got stronger) and PYREXIA (Fever for 2-3 hours the day after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) detected emphysema and potentially COPD..         Action taken with mRNA-1273 in response to the drug was not applicable. No treatment information reported.   This case was linked to MOD-2021-103566 (Patient Link).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient who was16 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient who was16 years of age) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient who was16 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient who was16 years of age) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Product administered to patient of inappropriate age
Clinical narrative: My 16 daughter still has a headache after receiving her second vaccine; still has a headache after receiving her second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My 16 daughter still has a headache after receiving her second vaccine) and HEADACHE (still has a headache after receiving her second vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second 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 (My 16 daughter still has a headache after receiving her second vaccine) and HEADACHE (still has a headache after receiving her second vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My 16 daughter still has a headache after receiving her second vaccine) outcome was unknown and HEADACHE (still has a headache after receiving her second vaccine) had not resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort
Clinical narrative: like something stuck in throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (like something stuck in throat) 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) at an unspecified dose. On an unknown date, the patient experienced OROPHARYNGEAL DISCOMFORT (like something stuck in throat). At the time of the report, OROPHARYNGEAL DISCOMFORT (like something stuck in throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant Medications were Provided By the reporter. No Treatment History was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: "Report a side effect.; Is it normal where you got your vaccine to be hurting for three days?; 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 ("Report a side effect.) and VACCINATION SITE PAIN (Is it normal where you got your vaccine to be hurting for three days?) 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 ("Report a side effect.) and VACCINATION SITE PAIN (Is it normal where you got your vaccine to be hurting for three days?). At the time of the report, VACCINATION COMPLICATION ("Report a side effect.) and VACCINATION SITE PAIN (Is it normal where you got your vaccine to be hurting for three days?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication included.  No treatment medication included.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Malaise, Petechiae, Vaccination site rash
Clinical narrative: 4 months between first and second dose; feeling sick; petechias on lower abdomen and legs; swollen limph nodes under the arm; rash at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of PETECHIAE (petechias on lower abdomen and legs), LYMPHADENOPATHY (swollen limph nodes under the arm), VACCINATION SITE RASH (rash at injection site), MALAISE (feeling sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months between first and second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PETECHIAE (petechias on lower abdomen and legs), LYMPHADENOPATHY (swollen limph nodes under the arm) and VACCINATION SITE RASH (rash at injection site). On 23-May-2021, the patient experienced MALAISE (feeling sick). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months between first and second dose). At the time of the report, PETECHIAE (petechias on lower abdomen and legs), LYMPHADENOPATHY (swollen limph nodes under the arm), VACCINATION SITE RASH (rash at injection site), MALAISE (feeling sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months between first and second dose) 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 medication was provided.  No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I got my first vaccine but I missed my 2 one; 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 (I got my first vaccine but I missed my 2 one) 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 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 (I got my first vaccine but I missed my 2 one). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I got my first vaccine but I missed my 2 one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: blood in urine; 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 BLOOD URINE PRESENT (blood in urine) 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 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 BLOOD URINE PRESENT (blood in urine). At the time of the report, BLOOD URINE PRESENT (blood in urine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported via chat bot and asked if anyone reported having blood in urine after taking the vaccine. No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.   Reporter did not allow further contact
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Influenza like illness
Clinical narrative: flue like for about two days; feet are having extreme cold flashes left one; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flue like for about two days) and FEELING COLD (feet are having extreme cold flashes left one) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flue like for about two days) and FEELING COLD (feet are having extreme cold flashes left one). At the time of the report, INFLUENZA LIKE ILLNESS (flue like for about two days) and FEELING COLD (feet are having extreme cold flashes left one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant product use was not provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling very tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (feeling very tired) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (feeling very tired). At the time of the report, FATIGUE (feeling very tired) 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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test
Clinical narrative: COVID-19; Cough; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and COUGH (Cough) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) 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 COVID-19 (COVID-19) and COUGH (Cough). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) and COUGH (Cough) outcome was unknown.      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) (Unknown) was unknown.       The patient's concomitant medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: arm still red; arm still swollen; body aches; 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 SITE ERYTHEMA (arm still red), VACCINATION SITE SWELLING (arm still swollen) and MYALGIA (body aches) 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 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm still red), VACCINATION SITE SWELLING (arm still swollen) and MYALGIA (body aches). At the time of the report, VACCINATION SITE ERYTHEMA (arm still red), VACCINATION SITE SWELLING (arm still swollen) and MYALGIA (body aches) outcome was unknown.            Concomitant product use was not provided by the reported.  Treatment information was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Bitter taste in mouth; Sore arm; Fisrt dose (15-jan-2021) , second dose (21-feb-2021); This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Fisrt dose (15-jan-2021) , second dose (21-feb-2021)), DYSGEUSIA (Bitter taste in mouth) and PAIN IN EXTREMITY (Sore arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included MULTIVITAMINS;MINERALS, VITAMIN C [ASCORBIC ACID] and APIUM GRAVEOLENS SEED EXTRACT (CELERY SEED [APIUM GRAVEOLENS SEED EXTRACT]) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Fisrt dose (15-jan-2021) , second dose (21-feb-2021)) and PAIN IN EXTREMITY (Sore arm). On 17-May-2021, the patient experienced DYSGEUSIA (Bitter taste in mouth). On 21-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Fisrt dose (15-jan-2021) , second dose (21-feb-2021)) had resolved. On 23-Feb-2021, PAIN IN EXTREMITY (Sore arm) outcome was unknown. At the time of the report, DYSGEUSIA (Bitter taste in mouth) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.     Treatment medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Vision blurred
Clinical narrative: Taste metal; Vision is blurry; Feeling dizzy; 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 DIZZINESS (Feeling dizzy), DYSGEUSIA (Taste metal) and VISION BLURRED (Vision is blurry) 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 was provided by the reporter.     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 DIZZINESS (Feeling dizzy), DYSGEUSIA (Taste metal) and VISION BLURRED (Vision is blurry). At the time of the report, DIZZINESS (Feeling dizzy), DYSGEUSIA (Taste metal) and VISION BLURRED (Vision is blurry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information regarding treatment or concomitant medication was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: leg pain; 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 PAIN IN EXTREMITY (leg pain) 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, 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 PAIN IN EXTREMITY (leg pain). At the time of the report, PAIN IN EXTREMITY (leg pain) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (have an allergy on the local of the vaccine with some bubbles), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (My arm was bigger where I had the vaccine,have an allergy on the local of the vaccine with some bubbles) and VACCINATION SITE PAIN (hurting a lot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO MEDICAL HISTORY REPORTED.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (have an allergy on the local of the vaccine with some bubbles), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (My arm was bigger where I had the vaccine,have an allergy on the local of the vaccine with some bubbles) and VACCINATION SITE PAIN (hurting a lot). At the time of the report, ALLERGY TO VACCINE (have an allergy on the local of the vaccine with some bubbles), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (My arm was bigger where I had the vaccine,have an allergy on the local of the vaccine with some bubbles) and VACCINATION SITE PAIN (hurting a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter no treatment information reported by the reporter   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash on arm; 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 SITE RASH (rash on arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 RASH (rash on arm). At the time of the report, VACCINATION SITE RASH (rash on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Gait disturbance, Illness, Nervousness
Clinical narrative: Arm was swollen like the size of a coin/ arms look bad/ arm continued to swell up bigger; Very sick; She felt bad; Nervous; Cannot walk straight; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen like the size of a coin/ arms look bad/ arm continued to swell up bigger), ILLNESS (Very sick), FEELING ABNORMAL (She felt bad), NERVOUSNESS (Nervous) and GAIT DISTURBANCE (Cannot walk straight) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. In May 2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen like the size of a coin/ arms look bad/ arm continued to swell up bigger), ILLNESS (Very sick), FEELING ABNORMAL (She felt bad), NERVOUSNESS (Nervous), GAIT DISTURBANCE (Cannot walk straight), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm was swollen like the size of a coin/ arms look bad/ arm continued to swell up bigger), ILLNESS (Very sick), FEELING ABNORMAL (She felt bad), NERVOUSNESS (Nervous), GAIT DISTURBANCE (Cannot walk straight), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication includes antibiotics.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Arm was swollen like the size of a coin/ arms look bad/ arm continued to swell up bigger; Very sick; She felt bad; Nervous; Cannot walk straight; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen like the size of a coin/ arms look bad/ arm continued to swell up bigger), ILLNESS (Very sick), FEELING ABNORMAL (She felt bad), NERVOUSNESS (Nervous) and GAIT DISTURBANCE (Cannot walk straight) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. In May 2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen like the size of a coin/ arms look bad/ arm continued to swell up bigger), ILLNESS (Very sick), FEELING ABNORMAL (She felt bad), NERVOUSNESS (Nervous), GAIT DISTURBANCE (Cannot walk straight), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm was swollen like the size of a coin/ arms look bad/ arm continued to swell up bigger), ILLNESS (Very sick), FEELING ABNORMAL (She felt bad), NERVOUSNESS (Nervous), GAIT DISTURBANCE (Cannot walk straight), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication includes antibiotics.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I don't feel good; 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 FEELING ABNORMAL (I don't feel good) 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 FEELING ABNORMAL (I don't feel good). At the time of the report, FEELING ABNORMAL (I don't feel good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Paraesthesia
Clinical narrative: tingling from knee to foot mainly in the foot; left foot tingling and numbness like the foot went to sleep with pins and needle feeling 24 hours later; muscle spasms that occur around knee near the side and back of the knee; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling from knee to foot mainly in the foot), HYPOAESTHESIA (left foot tingling and numbness like the foot went to sleep with pins and needle feeling 24 hours later) and MUSCLE SPASMS (muscle spasms that occur around knee near the side and back of the knee) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included AMITRIPTYLINE for an unknown indication.    On 17-May-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced HYPOAESTHESIA (left foot tingling and numbness like the foot went to sleep with pins and needle feeling 24 hours later). 18-May-2021, the patient experienced MUSCLE SPASMS (muscle spasms that occur around knee near the side and back of the knee). On 18-May-2021 at 9:00 PM, the patient experienced PARAESTHESIA (tingling from knee to foot mainly in the foot). At the time of the report, PARAESTHESIA (tingling from knee to foot mainly in the foot), HYPOAESTHESIA (left foot tingling and numbness like the foot went to sleep with pins and needle feeling 24 hours later) and MUSCLE SPASMS (muscle spasms that occur around knee near the side and back of the knee) had not 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.   No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up information received on 07-Jul-2021 contains added event of muscle spasm and event outcome updated to not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain in the shot arm, I am still having pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscle pain in the shot arm, I am still having pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.     On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced MYALGIA (muscle pain in the shot arm, I am still having pain). At the time of the report, MYALGIA (muscle pain in the shot arm, I am still having pain) had not resolved.            No other concomitant medical  provided by the reporter. No treatment information provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: break out in welts; 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 URTICARIA (break out in welts) 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 URTICARIA (break out in welts). At the time of the report, URTICARIA (break out in welts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Running a slight fever; Chiling; 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 PYREXIA (Running a slight fever) and CHILLS (Chiling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced PYREXIA (Running a slight fever) and CHILLS (Chiling). At the time of the report, PYREXIA (Running a slight fever) and CHILLS (Chiling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; 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 VERTIGO (Vertigo) 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 VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Erythema, Fatigue, Feeling abnormal
Clinical narrative: face was red, left arm becoming red; they became foggy; tired; a mild fever with a temperature of 102.5; working heard to breath; Left arm hot to touch; Flulike symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (working heard to breath), FEELING HOT (Left arm hot to touch), INFLUENZA LIKE ILLNESS (Flulike symptoms), ERYTHEMA (face was red, left arm becoming red) and FEELING ABNORMAL (they became foggy) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flulike symptoms). On 28-Apr-2021, the patient experienced DYSPNOEA (working heard to breath), FEELING HOT (Left arm hot to touch), ERYTHEMA (face was red, left arm becoming red), FEELING ABNORMAL (they became foggy), FATIGUE (tired) and PYREXIA (a mild fever with a temperature of 102.5). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (working heard to breath), FEELING HOT (Left arm hot to touch), INFLUENZA LIKE ILLNESS (Flulike symptoms), ERYTHEMA (face was red, left arm becoming red), FEELING ABNORMAL (they became foggy), FATIGUE (tired) and PYREXIA (a mild fever with a temperature of 102.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 102.5 (High) 102.5 F. On 28-Apr-2021, Heart rate: high (High) more than 100 beats per minute. On 28-Apr-2021, Respiratory rate: high (High) Respiratory rate increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate, Influenza like illness, Pyrexia, Respiratory rate
Clinical narrative: face was red, left arm becoming red; they became foggy; tired; a mild fever with a temperature of 102.5; working heard to breath; Left arm hot to touch; Flulike symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (working heard to breath), FEELING HOT (Left arm hot to touch), INFLUENZA LIKE ILLNESS (Flulike symptoms), ERYTHEMA (face was red, left arm becoming red) and FEELING ABNORMAL (they became foggy) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flulike symptoms). On 28-Apr-2021, the patient experienced DYSPNOEA (working heard to breath), FEELING HOT (Left arm hot to touch), ERYTHEMA (face was red, left arm becoming red), FEELING ABNORMAL (they became foggy), FATIGUE (tired) and PYREXIA (a mild fever with a temperature of 102.5). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (working heard to breath), FEELING HOT (Left arm hot to touch), INFLUENZA LIKE ILLNESS (Flulike symptoms), ERYTHEMA (face was red, left arm becoming red), FEELING ABNORMAL (they became foggy), FATIGUE (tired) and PYREXIA (a mild fever with a temperature of 102.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 102.5 (High) 102.5 F. On 28-Apr-2021, Heart rate: high (High) more than 100 beats per minute. On 28-Apr-2021, Respiratory rate: high (High) Respiratory rate increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Body aches) 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 MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurts; 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 PAIN IN EXTREMITY (arm hurts) 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 21-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurts). At the time of the report, PAIN IN EXTREMITY (arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       it was reported that patient has artritus
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling
Clinical narrative: pain; swelling; redness of arm; 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 PAIN (pain), SWELLING (swelling) and ERYTHEMA (redness of arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 PAIN (pain), SWELLING (swelling) and ERYTHEMA (redness of arm). At the time of the report, PAIN (pain), SWELLING (swelling) and ERYTHEMA (redness of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: arm is red; arm is swollen; 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 ERYTHEMA (arm is red) and PERIPHERAL SWELLING (arm is swollen) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced ERYTHEMA (arm is red) and PERIPHERAL SWELLING (arm is swollen). At the time of the report, ERYTHEMA (arm is red) and PERIPHERAL SWELLING (arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.