chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Myalgia, Nausea, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (had reaction after second dose), CHILLS (Chills), PAIN (body aches), HEADACHE (very terrible headache.Very very bad headache) and BEDRIDDEN (2 days she was in bed) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026120A - 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Blood pressure med, LISINOPRIL, carvedilol                                                     Heart, ezetimibe                                                      Cholesterol, ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, RETINOL, TOCOPHEROL, VITAMIN B NOS (MULTIPLE VITAMINS) and ESZOPICLONE (8 HORAS) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (had reaction after second dose), CHILLS (Chills), PAIN (body aches), HEADACHE (very terrible headache.Very very bad headache), BEDRIDDEN (2 days she was in bed), TINNITUS (ringing earing and tinnitus.they never gone away, almost 2 month ago), INSOMNIA (preventing her from sleeping), DIZZINESS (Dizziness), BALANCE DISORDER (balance issue), NAUSEA (Nausea), MALAISE (Today is in bed again feeling is going to been sick again), MYALGIA (muscle pain) and VOMITING (Vomitting). At the time of the report, UNEVALUABLE EVENT (had reaction after second dose), CHILLS (Chills), PAIN (body aches), HEADACHE (very terrible headache.Very very bad headache), BEDRIDDEN (2 days she was in bed), TINNITUS (ringing earing and tinnitus.they never gone away, almost 2 month ago), INSOMNIA (preventing her from sleeping), DIZZINESS (Dizziness), BALANCE DISORDER (balance issue), NAUSEA (Nausea), MALAISE (Today is in bed again feeling is going to been sick again), MYALGIA (muscle pain) and VOMITING (Vomitting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon internal review on 04-Aug-2021, the age units corrected to years.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Unevaluable event, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (had reaction after second dose), CHILLS (Chills), PAIN (body aches), HEADACHE (very terrible headache.Very very bad headache) and BEDRIDDEN (2 days she was in bed) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026120A - 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Blood pressure med, LISINOPRIL, carvedilol                                                     Heart, ezetimibe                                                      Cholesterol, ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, RETINOL, TOCOPHEROL, VITAMIN B NOS (MULTIPLE VITAMINS) and ESZOPICLONE (8 HORAS) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (had reaction after second dose), CHILLS (Chills), PAIN (body aches), HEADACHE (very terrible headache.Very very bad headache), BEDRIDDEN (2 days she was in bed), TINNITUS (ringing earing and tinnitus.they never gone away, almost 2 month ago), INSOMNIA (preventing her from sleeping), DIZZINESS (Dizziness), BALANCE DISORDER (balance issue), NAUSEA (Nausea), MALAISE (Today is in bed again feeling is going to been sick again), MYALGIA (muscle pain) and VOMITING (Vomitting). At the time of the report, UNEVALUABLE EVENT (had reaction after second dose), CHILLS (Chills), PAIN (body aches), HEADACHE (very terrible headache.Very very bad headache), BEDRIDDEN (2 days she was in bed), TINNITUS (ringing earing and tinnitus.they never gone away, almost 2 month ago), INSOMNIA (preventing her from sleeping), DIZZINESS (Dizziness), BALANCE DISORDER (balance issue), NAUSEA (Nausea), MALAISE (Today is in bed again feeling is going to been sick again), MYALGIA (muscle pain) and VOMITING (Vomitting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon internal review on 04-Aug-2021, the age units corrected to years.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: second dose more than the recommendeed time interval/gap; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (second dose more than the recommendeed time interval/gap) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012MZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (second dose more than the recommendeed time interval/gap). At the time of the report, OFF LABEL USE (second dose more than the recommendeed time interval/gap) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided  No treatment medication was provided
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness
Clinical narrative: chest tightness; Feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest tightness) and DIZZINESS (Feeling dizzy) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (chest tightness) and DIZZINESS (Feeling dizzy). At the time of the report, CHEST DISCOMFORT (chest tightness) and DIZZINESS (Feeling dizzy) outcome was unknown. Not Provided
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rash erythematous
Clinical narrative: Headaches; feeling little more tired; rashes all over body(elbows, hands,feet and a little bit onchest)/ rashes turned from red to purple; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (rashes all over body(elbows, hands,feet and a little bit onchest)/ rashes turned from red to purple), HEADACHE (Headaches) and FATIGUE (feeling little more tired) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced RASH ERYTHEMATOUS (rashes all over body(elbows, hands,feet and a little bit onchest)/ rashes turned from red to purple). On an unknown date, the patient experienced HEADACHE (Headaches) and FATIGUE (feeling little more tired). At the time of the report, RASH ERYTHEMATOUS (rashes all over body(elbows, hands,feet and a little bit onchest)/ rashes turned from red to purple) had resolved and HEADACHE (Headaches) and FATIGUE (feeling little more tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea, Neck pain
Clinical narrative: Pain includes achiness in neck; Pain in shoulder; Nausea; Headache; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (Pain includes achiness in neck), ARTHRALGIA (Pain in shoulder), NAUSEA (Nausea) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-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) (Intramuscular) 1 dosage form. In April 2021, the patient experienced NECK PAIN (Pain includes achiness in neck), ARTHRALGIA (Pain in shoulder), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, NECK PAIN (Pain includes achiness in neck), ARTHRALGIA (Pain in shoulder), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.            Concomitant product information was not provided.  Treatment information was not included but patient want to know to take Acetaminophen
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Rhinorrhoea
Clinical narrative: Loss of taste; loss of smell; A little runny nose; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), ANOSMIA (loss of smell) and RHINORRHOEA (A little runny nose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced AGEUSIA (Loss of taste), ANOSMIA (loss of smell) and RHINORRHOEA (A little runny nose). At the time of the report, AGEUSIA (Loss of taste), ANOSMIA (loss of smell) and RHINORRHOEA (A little runny nose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: swelling under the arm size of tennis ball; rash, little patch of rash spreading in arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling under the arm size of tennis ball) and RASH (rash, little patch of rash spreading in arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003BZ1A and 001A21A) for COVID-19 vaccination.     No concomitant medications reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced RASH (rash, little patch of rash spreading in arm). On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling under the arm size of tennis ball). At the time of the report, PERIPHERAL SWELLING (swelling under the arm size of tennis ball) and RASH (rash, little patch of rash spreading in arm) outcome was unknown.            patient states that after second dose in 06April2021, he noticed rash that appeared, saw little patch of rash spreading in arm. The patient states that one week later, he states that rash went to top of shoulder to elbow and to arm and lower arm. The patient states that this week he developed swelling under the arm size of tennis ball. The patient states that this morning he was seen by his doctor. The patient states that rash has gotten slowly better. The patient states that swelling is little disturbing last three days. The patient also reports history of lymphoma   This case was linked to US-MODERNATX, INC.-MOD-2021-079406 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079406:Cross link with Dose 1
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: LARGE AND SMALL RASH SHOWING AROUND LEGS , BACK ,ARMS
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Rash, Scratch
Clinical narrative: Started thinking it was either a bug bite  or scratch, then thought poison ivy rash but has progressed steadily over both legs and little on arms.  Was prescribed prednisone and cephalexin to treat has steadily worsened over 2 weeks.  Have an appt with dermatologist scheduled on 8/26/21.  Not totally sure if this is related to vaccine but was encouraged to report.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Pruritus, Rash
Clinical narrative: rash all over body -arms, legs, back and scalp; dry skin; intense itching and redness; intense itching and redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash all over body -arms, legs, back and scalp), DRY SKIN (dry skin), PRURITUS (intense itching and redness) and ERYTHEMA (intense itching and redness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) and METOPROLOL for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash all over body -arms, legs, back and scalp), DRY SKIN (dry skin), PRURITUS (intense itching and redness) and ERYTHEMA (intense itching and redness). At the time of the report, RASH (rash all over body -arms, legs, back and scalp), DRY SKIN (dry skin), PRURITUS (intense itching and redness) and ERYTHEMA (intense itching and redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   1st week in April saw dermatologist - said use dry skin cream for treatment
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeding disorder, Feeling hot, Headache
Clinical narrative: I could not eat; I'm really hot; yesterday, it was worse than today; I felt like throwing up; I got a little dizzy; Fatigue; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (I could not eat), FEELING HOT (I'm really hot; yesterday, it was worse than today), MALAISE (I felt like throwing up), DIZZINESS (I got a little dizzy) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced FEEDING DISORDER (I could not eat), FEELING HOT (I'm really hot; yesterday, it was worse than today), MALAISE (I felt like throwing up), DIZZINESS (I got a little dizzy), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, FEEDING DISORDER (I could not eat), FEELING HOT (I'm really hot; yesterday, it was worse than today), MALAISE (I felt like throwing up), DIZZINESS (I got a little dizzy), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow-up received on 26-May-2021 and verbatim events are updated. On 19-Apr-2021: Non-Significant Follow up appended.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: I could not eat; I'm really hot; yesterday, it was worse than today; I felt like throwing up; I got a little dizzy; Fatigue; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (I could not eat), FEELING HOT (I'm really hot; yesterday, it was worse than today), MALAISE (I felt like throwing up), DIZZINESS (I got a little dizzy) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced FEEDING DISORDER (I could not eat), FEELING HOT (I'm really hot; yesterday, it was worse than today), MALAISE (I felt like throwing up), DIZZINESS (I got a little dizzy), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, FEEDING DISORDER (I could not eat), FEELING HOT (I'm really hot; yesterday, it was worse than today), MALAISE (I felt like throwing up), DIZZINESS (I got a little dizzy), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow-up received on 26-May-2021 and verbatim events are updated. On 19-Apr-2021: Non-Significant Follow up appended.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore Arm). At the time of the report, VACCINATION SITE PAIN (Sore Arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by Reporter.   This case was linked to MOD-2021-080080, MOD-2021-080342 (Patient Link).   Reporter did not allow further contact
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0183214 and 0403214) for COVID-19 vaccination.     No medical history was provided by reporter. No concomitant medication reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-080498 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080498:2nd dose of vaccine
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Discomfort, Fatigue, Gait disturbance
Clinical narrative: very weak; bones and body started to ache a lot; slight fever; she couldn't even walk, now she can't walk; pain in her left leg, it burns like fire; shoulder hurts, her neck; extremely exhausted; sensation; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), MYALGIA (bones and body started to ache a lot), PYREXIA (slight fever), GAIT DISTURBANCE (she couldn't even walk, now she can't walk) and PAIN IN EXTREMITY (pain in her left leg, it burns like fire) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. 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 ASTHENIA (very weak), MYALGIA (bones and body started to ache a lot), PYREXIA (slight fever), GAIT DISTURBANCE (she couldn't even walk, now she can't walk), PAIN IN EXTREMITY (pain in her left leg, it burns like fire), ARTHRALGIA (shoulder hurts, her neck), FATIGUE (extremely exhausted) and DISCOMFORT (sensation). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: very weak; bones and body started to ache a lot; slight fever; she couldn't even walk, now she can't walk; pain in her left leg, it burns like fire; shoulder hurts, her neck; extremely exhausted; sensation; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), MYALGIA (bones and body started to ache a lot), PYREXIA (slight fever), GAIT DISTURBANCE (she couldn't even walk, now she can't walk) and PAIN IN EXTREMITY (pain in her left leg, it burns like fire) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. 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 ASTHENIA (very weak), MYALGIA (bones and body started to ache a lot), PYREXIA (slight fever), GAIT DISTURBANCE (she couldn't even walk, now she can't walk), PAIN IN EXTREMITY (pain in her left leg, it burns like fire), ARTHRALGIA (shoulder hurts, her neck), FATIGUE (extremely exhausted) and DISCOMFORT (sensation). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Illness, Overdose
Clinical narrative: 15 minutes after receiving this second dose a healthcare professional administered another shot (3rd dose); violently Ill; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (15 minutes after receiving this second dose a healthcare professional administered another shot (3rd dose)) and ILLNESS (violently Ill) 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 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 16-Apr-2021, the patient experienced OVERDOSE (15 minutes after receiving this second dose a healthcare professional administered another shot (3rd dose)) and ILLNESS (violently Ill). At the time of the report, OVERDOSE (15 minutes after receiving this second dose a healthcare professional administered another shot (3rd dose)) and ILLNESS (violently Ill) outcome was unknown.            The action taken with events, overdose, violently ill is not applicable. No concomitant medications reported. No treatment reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Feeling abnormal, Illness, Palpitations
Clinical narrative: Racing heart; Chillswent back and forth all day; brain fog; stayed all day in bed; sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), PALPITATIONS (Racing heart), CHILLS (Chillswent back and forth all day), FEELING ABNORMAL (brain fog) and DISCOMFORT (stayed all day in bed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic obstructive pulmonary disease. Concomitant products included FLUOXETINE and VITAMINS NOS for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ILLNESS (sick). On 12-Apr-2021, the patient experienced PALPITATIONS (Racing heart), CHILLS (Chillswent back and forth all day), FEELING ABNORMAL (brain fog) and DISCOMFORT (stayed all day in bed). At the time of the report, ILLNESS (sick), PALPITATIONS (Racing heart), CHILLS (Chillswent back and forth all day), FEELING ABNORMAL (brain fog) and DISCOMFORT (stayed all day in bed) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   AB negative blood type. No treatment drugs were reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), was not applicable.   This case was linked to MOD-2021-081268 (E2B Linked Report).; Sender's Comments:  MOD-2021-081268:First dose case
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Severe allergic reaction after 2 weeks of 1st shot; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Severe allergic reaction after 2 weeks of 1st shot) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Severe allergic reaction after 2 weeks of 1st shot). At the time of the report, HYPERSENSITIVITY (Severe allergic reaction after 2 weeks of 1st shot) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Email
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash macular, Skin burning sensation, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: rash is blotchy; believes it to be "Covid Arm"; rash is burning; feels hot; rash is itchy; rash; (rash) red; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (rash is blotchy), VACCINATION SITE REACTION (believes it to be "Covid Arm"), SKIN BURNING SENSATION (rash is burning), FEELING HOT (feels hot) and VACCINATION SITE PRURITUS (rash is itchy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced RASH MACULAR (rash is blotchy), VACCINATION SITE REACTION (believes it to be "Covid Arm"), SKIN BURNING SENSATION (rash is burning), FEELING HOT (feels hot), VACCINATION SITE PRURITUS (rash is itchy), VACCINATION SITE RASH (rash) and VACCINATION SITE ERYTHEMA ((rash) red). At the time of the report, RASH MACULAR (rash is blotchy), VACCINATION SITE REACTION (believes it to be "Covid Arm"), SKIN BURNING SENSATION (rash is burning), FEELING HOT (feels hot), VACCINATION SITE PRURITUS (rash is itchy), VACCINATION SITE RASH (rash) and VACCINATION SITE ERYTHEMA ((rash) red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Patient took ibuprofen to treat her symptoms   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site reaction
Clinical narrative: rash is blotchy; believes it to be "Covid Arm"; rash is burning; feels hot; rash is itchy; rash; (rash) red; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (rash is blotchy), VACCINATION SITE REACTION (believes it to be "Covid Arm"), SKIN BURNING SENSATION (rash is burning), FEELING HOT (feels hot) and VACCINATION SITE PRURITUS (rash is itchy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced RASH MACULAR (rash is blotchy), VACCINATION SITE REACTION (believes it to be "Covid Arm"), SKIN BURNING SENSATION (rash is burning), FEELING HOT (feels hot), VACCINATION SITE PRURITUS (rash is itchy), VACCINATION SITE RASH (rash) and VACCINATION SITE ERYTHEMA ((rash) red). At the time of the report, RASH MACULAR (rash is blotchy), VACCINATION SITE REACTION (believes it to be "Covid Arm"), SKIN BURNING SENSATION (rash is burning), FEELING HOT (feels hot), VACCINATION SITE PRURITUS (rash is itchy), VACCINATION SITE RASH (rash) and VACCINATION SITE ERYTHEMA ((rash) red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Patient took ibuprofen to treat her symptoms   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Limb discomfort, Pain, Rash
Clinical narrative: blisters around the injection side; sensitive move up and down, is between elbow and the shot; almost feel like a sun burn and touch it and hurts; blister in different areas; redness; high pressure sensitivity on her arm; development a rash and had bruise that went down to her hand and now is on her finger; development a rash and had bruise that went down to her hand and now is on her finger; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (high pressure sensitivity on her arm), RASH (development a rash and had bruise that went down to her hand and now is on her finger), VACCINATION SITE BRUISING (development a rash and had bruise that went down to her hand and now is on her finger), VACCINATION SITE VESICLES (blisters around the injection side) and BLISTER (blister in different areas) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     "No medical history was provided by the reporter.".  Concomitant products included DESVENLAFAXINE SUCCINATE (PRISTIQ) for Antidepressant therapy, POTASSIUM CITRATE for Kidney stone.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced LIMB DISCOMFORT (high pressure sensitivity on her arm), RASH (development a rash and had bruise that went down to her hand and now is on her finger) and VACCINATION SITE BRUISING (development a rash and had bruise that went down to her hand and now is on her finger). On 20-Apr-2021, the patient experienced BLISTER (blister in different areas) and ERYTHEMA (redness). On an unknown date, the patient experienced VACCINATION SITE VESICLES (blisters around the injection side), VACCINATION SITE MOVEMENT IMPAIRMENT (sensitive move up and down, is between elbow and the shot) and PAIN (almost feel like a sun burn and touch it and hurts). At the time of the report, LIMB DISCOMFORT (high pressure sensitivity on her arm), RASH (development a rash and had bruise that went down to her hand and now is on her finger), VACCINATION SITE BRUISING (development a rash and had bruise that went down to her hand and now is on her finger), VACCINATION SITE VESICLES (blisters around the injection side), BLISTER (blister in different areas), ERYTHEMA (redness), VACCINATION SITE MOVEMENT IMPAIRMENT (sensitive move up and down, is between elbow and the shot) and PAIN (almost feel like a sun burn and touch it and hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include Thyroid medicines in the morning.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site movement impairment, Vaccination site vesicles
Clinical narrative: blisters around the injection side; sensitive move up and down, is between elbow and the shot; almost feel like a sun burn and touch it and hurts; blister in different areas; redness; high pressure sensitivity on her arm; development a rash and had bruise that went down to her hand and now is on her finger; development a rash and had bruise that went down to her hand and now is on her finger; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (high pressure sensitivity on her arm), RASH (development a rash and had bruise that went down to her hand and now is on her finger), VACCINATION SITE BRUISING (development a rash and had bruise that went down to her hand and now is on her finger), VACCINATION SITE VESICLES (blisters around the injection side) and BLISTER (blister in different areas) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     "No medical history was provided by the reporter.".  Concomitant products included DESVENLAFAXINE SUCCINATE (PRISTIQ) for Antidepressant therapy, POTASSIUM CITRATE for Kidney stone.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced LIMB DISCOMFORT (high pressure sensitivity on her arm), RASH (development a rash and had bruise that went down to her hand and now is on her finger) and VACCINATION SITE BRUISING (development a rash and had bruise that went down to her hand and now is on her finger). On 20-Apr-2021, the patient experienced BLISTER (blister in different areas) and ERYTHEMA (redness). On an unknown date, the patient experienced VACCINATION SITE VESICLES (blisters around the injection side), VACCINATION SITE MOVEMENT IMPAIRMENT (sensitive move up and down, is between elbow and the shot) and PAIN (almost feel like a sun burn and touch it and hurts). At the time of the report, LIMB DISCOMFORT (high pressure sensitivity on her arm), RASH (development a rash and had bruise that went down to her hand and now is on her finger), VACCINATION SITE BRUISING (development a rash and had bruise that went down to her hand and now is on her finger), VACCINATION SITE VESICLES (blisters around the injection side), BLISTER (blister in different areas), ERYTHEMA (redness), VACCINATION SITE MOVEMENT IMPAIRMENT (sensitive move up and down, is between elbow and the shot) and PAIN (almost feel like a sun burn and touch it and hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include Thyroid medicines in the morning.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Inflammation, Myalgia, Myositis
Clinical narrative: looked weird; slightly itched; It's rather pink.; "my left leg started to bother me"; inflammation of the muscle in left leg; inflammation of the nerves in left leg; "it is still hurting"/ sore leg/ it doesn't seem to get any better/"it's just strange/; tired/ been calling people to help me/ it is making life difficult; it was hurting pretty good; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (looked weird), VACCINATION SITE PRURITUS (slightly itched), VACCINATION SITE ERYTHEMA (It's rather pink.), GAIT DISTURBANCE ("my left leg started to bother me") and MYOSITIS (inflammation of the muscle in left leg) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DENOSUMAB (PROLIA) for Bone disorder (NOS), LEVOTHYROXINE for Thyroid disorder.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced PAIN (it was hurting pretty good). On an unknown date, the patient experienced SKIN DISORDER (looked weird), VACCINATION SITE PRURITUS (slightly itched), VACCINATION SITE ERYTHEMA (It's rather pink.), GAIT DISTURBANCE ("my left leg started to bother me"), MYOSITIS (inflammation of the muscle in left leg), INFLAMMATION (inflammation of the nerves in left leg), MYALGIA ("it is still hurting"/ sore leg/ it doesn't seem to get any better/"it's just strange/) and FATIGUE (tired/ been calling people to help me/ it is making life difficult). The patient was treated with ARNICA MONTANA (ARNICARE) for Pain and Inflammation, at an unspecified dose and frequency and MELOXICAM for Pain and Inflammation, at an unspecified dose and frequency. At the time of the report, SKIN DISORDER (looked weird), VACCINATION SITE PRURITUS (slightly itched), VACCINATION SITE ERYTHEMA (It's rather pink.), GAIT DISTURBANCE ("my left leg started to bother me"), MYOSITIS (inflammation of the muscle in left leg), INFLAMMATION (inflammation of the nerves in left leg), MYALGIA ("it is still hurting"/ sore leg/ it doesn't seem to get any better/"it's just strange/), FATIGUE (tired/ been calling people to help me/ it is making life difficult) and PAIN (it was hurting pretty good) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other events include Moderna COVID arm. concomitant product usage were  putting ice on her arm when she got it after both doses,  Arnicare.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Significant follow up appended - new events added, concomitant medications were added.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin disorder, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: looked weird; slightly itched; It's rather pink.; "my left leg started to bother me"; inflammation of the muscle in left leg; inflammation of the nerves in left leg; "it is still hurting"/ sore leg/ it doesn't seem to get any better/"it's just strange/; tired/ been calling people to help me/ it is making life difficult; it was hurting pretty good; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (looked weird), VACCINATION SITE PRURITUS (slightly itched), VACCINATION SITE ERYTHEMA (It's rather pink.), GAIT DISTURBANCE ("my left leg started to bother me") and MYOSITIS (inflammation of the muscle in left leg) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DENOSUMAB (PROLIA) for Bone disorder (NOS), LEVOTHYROXINE for Thyroid disorder.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced PAIN (it was hurting pretty good). On an unknown date, the patient experienced SKIN DISORDER (looked weird), VACCINATION SITE PRURITUS (slightly itched), VACCINATION SITE ERYTHEMA (It's rather pink.), GAIT DISTURBANCE ("my left leg started to bother me"), MYOSITIS (inflammation of the muscle in left leg), INFLAMMATION (inflammation of the nerves in left leg), MYALGIA ("it is still hurting"/ sore leg/ it doesn't seem to get any better/"it's just strange/) and FATIGUE (tired/ been calling people to help me/ it is making life difficult). The patient was treated with ARNICA MONTANA (ARNICARE) for Pain and Inflammation, at an unspecified dose and frequency and MELOXICAM for Pain and Inflammation, at an unspecified dose and frequency. At the time of the report, SKIN DISORDER (looked weird), VACCINATION SITE PRURITUS (slightly itched), VACCINATION SITE ERYTHEMA (It's rather pink.), GAIT DISTURBANCE ("my left leg started to bother me"), MYOSITIS (inflammation of the muscle in left leg), INFLAMMATION (inflammation of the nerves in left leg), MYALGIA ("it is still hurting"/ sore leg/ it doesn't seem to get any better/"it's just strange/), FATIGUE (tired/ been calling people to help me/ it is making life difficult) and PAIN (it was hurting pretty good) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other events include Moderna COVID arm. concomitant product usage were  putting ice on her arm when she got it after both doses,  Arnicare.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Significant follow up appended - new events added, concomitant medications were added.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin haemorrhage, Skin irritation
Clinical narrative: feeling of weird skin irritation; a little bit of sore arm; noticed blood after receiving second dose; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (feeling of weird skin irritation), PAIN IN EXTREMITY (a little bit of sore arm) and SKIN HAEMORRHAGE (noticed blood after receiving 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. On 16-Apr-2021, the patient experienced SKIN IRRITATION (feeling of weird skin irritation), PAIN IN EXTREMITY (a little bit of sore arm) and SKIN HAEMORRHAGE (noticed blood after receiving second dose). At the time of the report, SKIN IRRITATION (feeling of weird skin irritation), PAIN IN EXTREMITY (a little bit of sore arm) and SKIN HAEMORRHAGE (noticed blood after receiving second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081500 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081500:2nd  dose
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Myalgia, Pyrexia, Vein disorder
Clinical narrative: Her eyesight was burning; Developed like ¨some ball of veins and swelling on the back of her left feet, of about 4 or 5 cm, that lasted 2 or 3 days; Cough; body aches; fever; Was tired; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Her eyesight was burning), VEIN DISORDER (Developed like ¨some ball of veins and swelling on the back of her left feet, of about 4 or 5 cm, that lasted 2 or 3 days), COUGH (Cough), MYALGIA (body aches) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040AMA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VISUAL IMPAIRMENT (Her eyesight was burning), VEIN DISORDER (Developed like ¨some ball of veins and swelling on the back of her left feet, of about 4 or 5 cm, that lasted 2 or 3 days), COUGH (Cough), MYALGIA (body aches), PYREXIA (fever) and FATIGUE (Was tired). The patient was treated with NAPROXEN SODIUM (NAPROXEN [NAPROXEN SODIUM]) on 24-Mar-2021 at a dose of 500 mg. On 25-Mar-2021, VISUAL IMPAIRMENT (Her eyesight was burning), COUGH (Cough), MYALGIA (body aches), PYREXIA (fever) and FATIGUE (Was tired) outcome was unknown. At the time of the report, VEIN DISORDER (Developed like ¨some ball of veins and swelling on the back of her left feet, of about 4 or 5 cm, that lasted 2 or 3 days) outcome was unknown. Not Provided      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.    Patient concomitant medications was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up information received on 20-APR-2021 HCP Information , patient details , Events were added .