chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Vaccination site pain
Clinical narrative: Rapid heartbeat; Soreness on her injection arm that last for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heartbeat) and VACCINATION SITE PAIN (Soreness on her injection arm that last for a couple of days) 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 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced HEART RATE INCREASED (Rapid heartbeat) and VACCINATION SITE PAIN (Soreness on her injection arm that last for a couple of days). At the time of the report, HEART RATE INCREASED (Rapid heartbeat) and VACCINATION SITE PAIN (Soreness on her injection arm that last for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs and Treatment details, if any, not provided.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eczema, Headache, Malaise, Pruritus, Rash
Clinical narrative: Eczema; Developed a measles like rash throughout his body covering chest, arm leg and groin area; I feel itchy, rash is overwhelming; Measles like rash; Rash covering my body; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema), MALAISE (Developed a measles like rash throughout his body covering chest, arm leg and groin area), PRURITUS (I feel itchy, rash is overwhelming), RASH MORBILLIFORM (Measles like rash) and RASH (Rash covering my body) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was reported.  Concomitant products included SIMVASTATIN, COLECALCIFEROL (VITAMIN D3), LEVOCETIRIZINE, ALPRAZOLAM, ATENOLOL and DICYCLOMINE [DICYCLOVERINE] for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema), MALAISE (Developed a measles like rash throughout his body covering chest, arm leg and groin area), PRURITUS (I feel itchy, rash is overwhelming), RASH MORBILLIFORM (Measles like rash), RASH (Rash covering my body) and HEADACHE (Headaches). At the time of the report, ECZEMA (Eczema), MALAISE (Developed a measles like rash throughout his body covering chest, arm leg and groin area), PRURITUS (I feel itchy, rash is overwhelming), RASH MORBILLIFORM (Measles like rash) and HEADACHE (Headaches) outcome was unknown and RASH (Rash covering my body) had not resolved.            Other medications include  Probiotic.  No treatments were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Patient Date of birth and Outcome of an event rash was updated.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash morbilliform
Clinical narrative: Eczema; Developed a measles like rash throughout his body covering chest, arm leg and groin area; I feel itchy, rash is overwhelming; Measles like rash; Rash covering my body; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema), MALAISE (Developed a measles like rash throughout his body covering chest, arm leg and groin area), PRURITUS (I feel itchy, rash is overwhelming), RASH MORBILLIFORM (Measles like rash) and RASH (Rash covering my body) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was reported.  Concomitant products included SIMVASTATIN, COLECALCIFEROL (VITAMIN D3), LEVOCETIRIZINE, ALPRAZOLAM, ATENOLOL and DICYCLOMINE [DICYCLOVERINE] for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema), MALAISE (Developed a measles like rash throughout his body covering chest, arm leg and groin area), PRURITUS (I feel itchy, rash is overwhelming), RASH MORBILLIFORM (Measles like rash), RASH (Rash covering my body) and HEADACHE (Headaches). At the time of the report, ECZEMA (Eczema), MALAISE (Developed a measles like rash throughout his body covering chest, arm leg and groin area), PRURITUS (I feel itchy, rash is overwhelming), RASH MORBILLIFORM (Measles like rash) and HEADACHE (Headaches) outcome was unknown and RASH (Rash covering my body) had not resolved.            Other medications include  Probiotic.  No treatments were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Patient Date of birth and Outcome of an event rash was updated.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eczema, Rash
Clinical narrative: Eczema; Developed a measles like rash throughout his body covering chest, arm leg and groin area; I feel itchy, rash is overwhelming; Measles like rash; Rash covering my body; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema), MALAISE (Developed a measles like rash throughout his body covering chest, arm leg and groin area), PRURITUS (I feel itchy, rash is overwhelming), RASH MORBILLIFORM (Measles like rash) and RASH (Rash covering my body) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was reported.  Concomitant products included SIMVASTATIN, COLECALCIFEROL (VITAMIN D3), LEVOCETIRIZINE, ALPRAZOLAM, ATENOLOL and DICYCLOMINE [DICYCLOVERINE] for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema), MALAISE (Developed a measles like rash throughout his body covering chest, arm leg and groin area), PRURITUS (I feel itchy, rash is overwhelming), RASH MORBILLIFORM (Measles like rash), RASH (Rash covering my body) and HEADACHE (Headaches). At the time of the report, ECZEMA (Eczema), MALAISE (Developed a measles like rash throughout his body covering chest, arm leg and groin area), PRURITUS (I feel itchy, rash is overwhelming), RASH MORBILLIFORM (Measles like rash) and HEADACHE (Headaches) outcome was unknown and RASH (Rash covering my body) had not resolved.            Other medications include  Probiotic.  No treatments were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Patient Date of birth and Outcome of an event rash was updated.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: other people who got their Moderna Covid-19 Vaccine and  experiencing  the same  symptoms of  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 FATIGUE (other people who got their Moderna Covid-19 Vaccine and  experiencing  the same  symptoms of  fatigue) 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 FATIGUE (other people who got their Moderna Covid-19 Vaccine and  experiencing  the same  symptoms of  fatigue). At the time of the report, FATIGUE (other people who got their Moderna Covid-19 Vaccine and  experiencing  the same  symptoms of  fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Experiencing tiredness; 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 FATIGUE (Experiencing tiredness) 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 26-May-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 an unknown date, the patient experienced FATIGUE (Experiencing tiredness). At the time of the report, FATIGUE (Experiencing tiredness) had not resolved.            No concomitant medication were reported. No treatment medication were reported.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Piloerection, Pruritus, Thermal burn
Clinical narrative: heat makes it burn; broke out in hives; painful; itchy; hundred bumps; very tender and heat makes it burn; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out in hives), PAIN IN EXTREMITY (painful), PRURITUS (itchy), PILOERECTION (hundred bumps) and THERMAL BURN (very tender and heat makes it burn) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced URTICARIA (broke out in hives), PAIN IN EXTREMITY (painful), PRURITUS (itchy), PILOERECTION (hundred bumps) and THERMAL BURN (very tender and heat makes it burn). On an unknown date, the patient experienced BURNING SENSATION (heat makes it burn). The patient was treated with PREDNISONE at an unspecified dose and frequency and CALAMINE, ZINC OXIDE (CALADRYL [CALAMINE;ZINC OXIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (broke out in hives), PAIN IN EXTREMITY (painful), PRURITUS (itchy), PILOERECTION (hundred bumps), THERMAL BURN (very tender and heat makes it burn) and BURNING SENSATION (heat makes it burn) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the Reporter. The treatment information were oat milk baths (Aveeno 100% oat milk), using ice packs, lotion.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: heat makes it burn; broke out in hives; painful; itchy; hundred bumps; very tender and heat makes it burn; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out in hives), PAIN IN EXTREMITY (painful), PRURITUS (itchy), PILOERECTION (hundred bumps) and THERMAL BURN (very tender and heat makes it burn) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced URTICARIA (broke out in hives), PAIN IN EXTREMITY (painful), PRURITUS (itchy), PILOERECTION (hundred bumps) and THERMAL BURN (very tender and heat makes it burn). On an unknown date, the patient experienced BURNING SENSATION (heat makes it burn). The patient was treated with PREDNISONE at an unspecified dose and frequency and CALAMINE, ZINC OXIDE (CALADRYL [CALAMINE;ZINC OXIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (broke out in hives), PAIN IN EXTREMITY (painful), PRURITUS (itchy), PILOERECTION (hundred bumps), THERMAL BURN (very tender and heat makes it burn) and BURNING SENSATION (heat makes it burn) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the Reporter. The treatment information were oat milk baths (Aveeno 100% oat milk), using ice packs, lotion.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Rash
Clinical narrative: Upper arm down to the elbow was red; Upper arm down to the elbow was red,hot rash; Upper arm down to the elbow was red,hot rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (upper arm down to the elbow was red,), BURNING SENSATION (Upper arm down to the elbow was red,hot) and RASH (Upper arm down to the elbow was red,hot rash) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Osteopenia and Colon cancer stage II. Concurrent medical conditions included Hiatal hernia, Hypothyroidism, Blood pressure high, Triglycerides high and Heartburn.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced ERYTHEMA (upper arm down to the elbow was red,), BURNING SENSATION (Upper arm down to the elbow was red,hot) and RASH (Upper arm down to the elbow was red,hot rash). At the time of the report, ERYTHEMA (upper arm down to the elbow was red,), BURNING SENSATION (Upper arm down to the elbow was red,hot) and RASH (Upper arm down to the elbow was red,hot rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, General physical health deterioration, Illness, Vaccination site pain
Clinical narrative: feeling sick/ has not been feeling well at all; health is declining/body has started failing; lost 50 lbs; has no energy; can barely walk across the road; He has excruciating pain on his left arm where the injection was/ and he can't even lay on his left arm or touch it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (feeling sick/ has not been feeling well at all), GENERAL PHYSICAL HEALTH DETERIORATION (health is declining/body has started failing), WEIGHT DECREASED (lost 50 lbs), ASTHENIA (has no energy) and GAIT DISTURBANCE (can barely walk across the road) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    In February 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 an unknown date, the patient experienced ILLNESS (feeling sick/ has not been feeling well at all), GENERAL PHYSICAL HEALTH DETERIORATION (health is declining/body has started failing), WEIGHT DECREASED (lost 50 lbs), ASTHENIA (has no energy), GAIT DISTURBANCE (can barely walk across the road) and VACCINATION SITE PAIN (He has excruciating pain on his left arm where the injection was/ and he can't even lay on his left arm or touch it). The patient was treated with ACETAMINOPHEN for Pain, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (feeling sick/ has not been feeling well at all), GENERAL PHYSICAL HEALTH DETERIORATION (health is declining/body has started failing), WEIGHT DECREASED (lost 50 lbs), ASTHENIA (has no energy), GAIT DISTURBANCE (can barely walk across the road) and VACCINATION SITE PAIN (He has excruciating pain on his left arm where the injection was/ and he can't even lay on his left arm or touch it) outcome was unknown.            Concomitant medication included thyroid medication. Patient went through lab data but results were not provided.  Patient consulted with his doctor but they did not provide any treatment, they were not able to figure out what was going on with patient and they do not knowhow to treat the reaction to COVID shot, especially for the ones dying like him.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: feeling sick/ has not been feeling well at all; health is declining/body has started failing; lost 50 lbs; has no energy; can barely walk across the road; He has excruciating pain on his left arm where the injection was/ and he can't even lay on his left arm or touch it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (feeling sick/ has not been feeling well at all), GENERAL PHYSICAL HEALTH DETERIORATION (health is declining/body has started failing), WEIGHT DECREASED (lost 50 lbs), ASTHENIA (has no energy) and GAIT DISTURBANCE (can barely walk across the road) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    In February 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 an unknown date, the patient experienced ILLNESS (feeling sick/ has not been feeling well at all), GENERAL PHYSICAL HEALTH DETERIORATION (health is declining/body has started failing), WEIGHT DECREASED (lost 50 lbs), ASTHENIA (has no energy), GAIT DISTURBANCE (can barely walk across the road) and VACCINATION SITE PAIN (He has excruciating pain on his left arm where the injection was/ and he can't even lay on his left arm or touch it). The patient was treated with ACETAMINOPHEN for Pain, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (feeling sick/ has not been feeling well at all), GENERAL PHYSICAL HEALTH DETERIORATION (health is declining/body has started failing), WEIGHT DECREASED (lost 50 lbs), ASTHENIA (has no energy), GAIT DISTURBANCE (can barely walk across the road) and VACCINATION SITE PAIN (He has excruciating pain on his left arm where the injection was/ and he can't even lay on his left arm or touch it) outcome was unknown.            Concomitant medication included thyroid medication. Patient went through lab data but results were not provided.  Patient consulted with his doctor but they did not provide any treatment, they were not able to figure out what was going on with patient and they do not knowhow to treat the reaction to COVID shot, especially for the ones dying like him.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered after more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after more than 30 days in the refrigerator) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 009C21A) for COVID-19 vaccination.     No medical history is provided by reporter.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-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 PRODUCT STORAGE ERROR (Vaccine administered after more than 30 days in the refrigerator). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was administered vaccine which had been in the refrigerator for greater than 30 days. Patient did not experienced any symptoms after receiving the vaccine.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose not administered and it has been more than 37 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not administered and it has been more than 37 days) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C12A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not administered and it has been more than 37 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not administered and it has been more than 37 days) 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.   Patient refused to take the second dose 28 days later.  No relevant concomitant medications were reported.  No treatment information was provided.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: sore arm; when your body's kicking up some immune; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (when your body's kicking up some immune) and FATIGUE (fatigued) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced FATIGUE (fatigued). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (when your body's kicking up some immune). At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (when your body's kicking up some immune) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-280154 (Patient Link).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: flu like symptoms; sweating; fever; chills; body ache; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient experienced HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 02-Jul-2021, HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved.            Concomitant medications include birth control. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-280149 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Headache, Somnolence
Clinical narrative: I fall asleep constantly; have no energy; I have brain fog / I feel as though I have been injected with poison; slight headche; fatigue / tired; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (I fall asleep constantly), ASTHENIA (have no energy), FEELING ABNORMAL (I have brain fog / I feel as though I have been injected with poison), HEADACHE (slight headche) and FATIGUE (fatigue / tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (allergic to Sulfa).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced SOMNOLENCE (I fall asleep constantly), ASTHENIA (have no energy), FEELING ABNORMAL (I have brain fog / I feel as though I have been injected with poison), HEADACHE (slight headche) and FATIGUE (fatigue / tired). At the time of the report, SOMNOLENCE (I fall asleep constantly), ASTHENIA (have no energy), FEELING ABNORMAL (I have brain fog / I feel as though I have been injected with poison), HEADACHE (slight headche) and FATIGUE (fatigue / tired) had not resolved.            No concomitant or treatment medication has been reported.   This case was linked to MOD-2021-079362 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: after I got the shot my right thum went num; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (after I got the shot my right thum went num) 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 HYPOAESTHESIA (after I got the shot my right thum went num). At the time of the report, HYPOAESTHESIA (after I got the shot my right thum went num) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.   Reporter did not allow further contact
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of product storage error (vaccine administered after more than 30 days in the refrigerator), and administered expired product (vaccine administered after more than 30 days in the refrigerator) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 009C21A) for COVID-19 immunization. No medical history reported. On Jun 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Aug 6, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Aug 6, 2021, patient experienced product storage error (vaccine administered after more than 30 days in the refrigerator), and administered expired product (vaccine administered after more than 30 days in the refrigerator). At the time of the report, product storage error (vaccine administered after more than 30 days in the refrigerator), and administered expired product (vaccine administered after more than 30 days in the refrigerator): resolved. The reporter did not provide any causality assessments, or concomitant medication. Patient did not experience any symptoms after receiving the vaccine, and has not received any treatments.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Got the first Moderna vaccine in Apr/2021 and was scheduled for second vaccine today; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got the first Moderna vaccine in Apr/2021 and was scheduled for second vaccine today) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got the first Moderna vaccine in Apr/2021 and was scheduled for second vaccine today). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got the first Moderna vaccine in Apr/2021 and was scheduled for second vaccine today) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication information was provided. No concomitant medication information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Administered a third dose to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Administered a third dose to patients) 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. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Administered a third dose to patients). At the time of the report, EXTRA DOSE ADMINISTERED (Administered a third dose to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant medications were reported No treatment medications were reported
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered after more than 30 days in the refrigerator; Vaccine administered after more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Vaccine administered after more than 30 days in the refrigerator) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Vaccine administered after more than 30 days in the refrigerator). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Vaccine administered after more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medication was provided. No treatment  was provided.   This case was linked to MOD-2021-279679 (Patient Link).   Reporter did not allow further contact
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Outside recommended dosing window; Vaccine administered after more than 30 days in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside recommended dosing window) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside recommended dosing window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside recommended dosing window) 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.   No concomitant medications were reported.  No treatment information was provided
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: flu like symptoms; Very sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN (Very sore) 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 INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN (Very sore). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN (Very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) 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 (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was reported. No treatment medication was provided by reporter. Reporter did not allow further contact
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated with a vial that had been in the refrigerator past the 30 days; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with a vial that had been in the refrigerator past the 30 days) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with a vial that had been in the refrigerator past the 30 days). On 25-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with a vial that had been in the refrigerator past the 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Product administration error; 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 ADMINISTRATION ERROR (Product administration error) 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 ADMINISTRATION ERROR (Product administration error). At the time of the report, PRODUCT ADMINISTRATION ERROR (Product administration error) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose > 35 days ago / The patient received her first dose of Moderna COVID19 Vaccine on 15Jun2021 and was supposed to receive her second dose today 06Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago / The patient received her first dose of Moderna COVID19 Vaccine on 15Jun2021 and was supposed to receive her second dose today 06Aug2021) 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 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago / The patient received her first dose of Moderna COVID19 Vaccine on 15Jun2021 and was supposed to receive her second dose today 06Aug2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago / The patient received her first dose of Moderna COVID19 Vaccine on 15Jun2021 and was supposed to receive her second dose today 06Aug2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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 (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No treatment medications were provided by reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Feeling abnormal, Vaccination site erythema, Vaccination site pruritus, Vaccination site vesicles
Clinical narrative: Redness in that area as well; Wednesday morning, I felt it and it felt weird; A blister on the back side of her arm; It's still a little warm to touch after 2 weeks; Itching on back side of arm where I got injection/ it was still itching the next day; thought it was a mosquito bite; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPOD BITE (thought it was a mosquito bite), FEELING ABNORMAL (Wednesday morning, I felt it and it felt weird), VACCINATION SITE VESICLES (A blister on the back side of her arm), VACCINATION SITE WARMTH (It's still a little warm to touch after 2 weeks) and VACCINATION SITE ERYTHEMA (Redness in that area as well) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (EUTHYROX), TELMISARTAN, HYDROCHLOROTHIAZIDE and METOPROLOL for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced ARTHROPOD BITE (thought it was a mosquito bite) and VACCINATION SITE PRURITUS (Itching on back side of arm where I got injection/ it was still itching the next day). On 04-Aug-2021, the patient experienced FEELING ABNORMAL (Wednesday morning, I felt it and it felt weird), VACCINATION SITE VESICLES (A blister on the back side of her arm) and VACCINATION SITE WARMTH (It's still a little warm to touch after 2 weeks). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness in that area as well). At the time of the report, ARTHROPOD BITE (thought it was a mosquito bite), FEELING ABNORMAL (Wednesday morning, I felt it and it felt weird), VACCINATION SITE VESICLES (A blister on the back side of her arm), VACCINATION SITE WARMTH (It's still a little warm to touch after 2 weeks), VACCINATION SITE ERYTHEMA (Redness in that area as well) and VACCINATION SITE PRURITUS (Itching on back side of arm where I got injection/ it was still itching the next day) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Redness in that area as well; Wednesday morning, I felt it and it felt weird; A blister on the back side of her arm; It's still a little warm to touch after 2 weeks; Itching on back side of arm where I got injection/ it was still itching the next day; thought it was a mosquito bite; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPOD BITE (thought it was a mosquito bite), FEELING ABNORMAL (Wednesday morning, I felt it and it felt weird), VACCINATION SITE VESICLES (A blister on the back side of her arm), VACCINATION SITE WARMTH (It's still a little warm to touch after 2 weeks) and VACCINATION SITE ERYTHEMA (Redness in that area as well) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (EUTHYROX), TELMISARTAN, HYDROCHLOROTHIAZIDE and METOPROLOL for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced ARTHROPOD BITE (thought it was a mosquito bite) and VACCINATION SITE PRURITUS (Itching on back side of arm where I got injection/ it was still itching the next day). On 04-Aug-2021, the patient experienced FEELING ABNORMAL (Wednesday morning, I felt it and it felt weird), VACCINATION SITE VESICLES (A blister on the back side of her arm) and VACCINATION SITE WARMTH (It's still a little warm to touch after 2 weeks). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness in that area as well). At the time of the report, ARTHROPOD BITE (thought it was a mosquito bite), FEELING ABNORMAL (Wednesday morning, I felt it and it felt weird), VACCINATION SITE VESICLES (A blister on the back side of her arm), VACCINATION SITE WARMTH (It's still a little warm to touch after 2 weeks), VACCINATION SITE ERYTHEMA (Redness in that area as well) and VACCINATION SITE PRURITUS (Itching on back side of arm where I got injection/ it was still itching the next day) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported by the reporter.