chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Night sweats, Paraesthesia, Paraesthesia oral
Clinical narrative: tingling and numbness in body especially lips; numbness in body especially lips; tingling; numbness in body; grogginess; night sweats; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (grogginess), NIGHT SWEATS (night sweats), PARAESTHESIA ORAL (tingling and numbness in body especially lips), HYPOAESTHESIA ORAL (numbness in body especially lips) and PARAESTHESIA (tingling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced SOMNOLENCE (grogginess) and NIGHT SWEATS (night sweats). On 06-May-2021, the patient experienced PARAESTHESIA ORAL (tingling and numbness in body especially lips), HYPOAESTHESIA ORAL (numbness in body especially lips), PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness in body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-May-2021, SOMNOLENCE (grogginess) and NIGHT SWEATS (night sweats) had resolved. At the time of the report, PARAESTHESIA ORAL (tingling and numbness in body especially lips), HYPOAESTHESIA ORAL (numbness in body especially lips), PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness in body) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was treated with PARACETAMOL (TYLENOL).   This case was linked to MOD-2021-110021 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: tingling and numbness in body especially lips; numbness in body especially lips; tingling; numbness in body; grogginess; night sweats; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (grogginess), NIGHT SWEATS (night sweats), PARAESTHESIA ORAL (tingling and numbness in body especially lips), HYPOAESTHESIA ORAL (numbness in body especially lips) and PARAESTHESIA (tingling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced SOMNOLENCE (grogginess) and NIGHT SWEATS (night sweats). On 06-May-2021, the patient experienced PARAESTHESIA ORAL (tingling and numbness in body especially lips), HYPOAESTHESIA ORAL (numbness in body especially lips), PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness in body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-May-2021, SOMNOLENCE (grogginess) and NIGHT SWEATS (night sweats) had resolved. At the time of the report, PARAESTHESIA ORAL (tingling and numbness in body especially lips), HYPOAESTHESIA ORAL (numbness in body especially lips), PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness in body) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was treated with PARACETAMOL (TYLENOL).   This case was linked to MOD-2021-110021 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Migraine, Myalgia, Swelling
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DYSAESTHESIA (sensitivity at a 3 inch by 5 inch area around the injection site), the first episode of HYPERSENSITIVITY (allergic reaction), VACCINATION SITE ERYTHEMA (Vaccination site redness/ redness migrated to an area 3 inches below and 3 inches above her elbow with a darker color), VACCINATION SITE SWELLING (Vaccination site swelling/ Swelling migrated to an area 3 inches below and 3 inches above her elbow with a darker color) and MYALGIA (deep muscle aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 20-Apr-2021 at 4:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site redness/ redness migrated to an area 3 inches below and 3 inches above her elbow with a darker color), VACCINATION SITE SWELLING (Vaccination site swelling/ Swelling migrated to an area 3 inches below and 3 inches above her elbow with a darker color), MYALGIA (deep muscle aches), VACCINATION SITE PAIN (skin level pain), SWELLING (swelling) and ERYTHEMA (redness). On an unknown date, the patient experienced VACCINATION SITE DYSAESTHESIA (sensitivity at a 3 inch by 5 inch area around the injection site), the first episode of HYPERSENSITIVITY (allergic reaction), MIGRAINE (migraine) and the second episode of HYPERSENSITIVITY (allergic reaction). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 24-Apr-2021, MYALGIA (deep muscle aches) had resolved. On 04-May-2021, VACCINATION SITE PAIN (skin level pain) outcome was unknown. At the time of the report, VACCINATION SITE DYSAESTHESIA (sensitivity at a 3 inch by 5 inch area around the injection site), VACCINATION SITE ERYTHEMA (Vaccination site redness/ redness migrated to an area 3 inches below and 3 inches above her elbow with a darker color), VACCINATION SITE SWELLING (Vaccination site swelling/ Swelling migrated to an area 3 inches below and 3 inches above her elbow with a darker color), SWELLING (swelling), ERYTHEMA (redness), MIGRAINE (migraine) and the last episode of HYPERSENSITIVITY (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. Patient took Benadryl for the symptoms.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site dysaesthesia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DYSAESTHESIA (sensitivity at a 3 inch by 5 inch area around the injection site), the first episode of HYPERSENSITIVITY (allergic reaction), VACCINATION SITE ERYTHEMA (Vaccination site redness/ redness migrated to an area 3 inches below and 3 inches above her elbow with a darker color), VACCINATION SITE SWELLING (Vaccination site swelling/ Swelling migrated to an area 3 inches below and 3 inches above her elbow with a darker color) and MYALGIA (deep muscle aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 20-Apr-2021 at 4:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site redness/ redness migrated to an area 3 inches below and 3 inches above her elbow with a darker color), VACCINATION SITE SWELLING (Vaccination site swelling/ Swelling migrated to an area 3 inches below and 3 inches above her elbow with a darker color), MYALGIA (deep muscle aches), VACCINATION SITE PAIN (skin level pain), SWELLING (swelling) and ERYTHEMA (redness). On an unknown date, the patient experienced VACCINATION SITE DYSAESTHESIA (sensitivity at a 3 inch by 5 inch area around the injection site), the first episode of HYPERSENSITIVITY (allergic reaction), MIGRAINE (migraine) and the second episode of HYPERSENSITIVITY (allergic reaction). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 24-Apr-2021, MYALGIA (deep muscle aches) had resolved. On 04-May-2021, VACCINATION SITE PAIN (skin level pain) outcome was unknown. At the time of the report, VACCINATION SITE DYSAESTHESIA (sensitivity at a 3 inch by 5 inch area around the injection site), VACCINATION SITE ERYTHEMA (Vaccination site redness/ redness migrated to an area 3 inches below and 3 inches above her elbow with a darker color), VACCINATION SITE SWELLING (Vaccination site swelling/ Swelling migrated to an area 3 inches below and 3 inches above her elbow with a darker color), SWELLING (swelling), ERYTHEMA (redness), MIGRAINE (migraine) and the last episode of HYPERSENSITIVITY (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. Patient took Benadryl for the symptoms.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Decreased appetite, Fatigue, Feeling hot
Clinical narrative: Body hurt all over; Felt like she was in a dream sequence; Slept all day; Lost appetite; Got really hot; Temaparature 102 F; Fatigued; Chills; Sore arm / muscle aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 06-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lost appetite), PAIN (Body hurt all over), FEELING HOT (Got really hot), SOMNOLENCE (Slept all day) and ABNORMAL DREAMS (Felt like she was in a dream sequence) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 23-Apr-2021, the patient experienced MYALGIA (Sore arm / muscle aches). On 24-Apr-2021, the patient experienced DECREASED APPETITE (Lost appetite), FEELING HOT (Got really hot), PYREXIA (Temaparature 102 F), FATIGUE (Fatigued) and CHILLS (Chills). On 25-Apr-2021, the patient experienced SOMNOLENCE (Slept all day). On an unknown date, the patient experienced PAIN (Body hurt all over) and ABNORMAL DREAMS (Felt like she was in a dream sequence). At the time of the report, DECREASED APPETITE (Lost appetite), PAIN (Body hurt all over), FEELING HOT (Got really hot), SOMNOLENCE (Slept all day), ABNORMAL DREAMS (Felt like she was in a dream sequence), PYREXIA (Temaparature 102 F), FATIGUE (Fatigued), CHILLS (Chills) and MYALGIA (Sore arm / muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment medication were provided   concomitants were provided
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Somnolence
Clinical narrative: Body hurt all over; Felt like she was in a dream sequence; Slept all day; Lost appetite; Got really hot; Temaparature 102 F; Fatigued; Chills; Sore arm / muscle aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 06-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lost appetite), PAIN (Body hurt all over), FEELING HOT (Got really hot), SOMNOLENCE (Slept all day) and ABNORMAL DREAMS (Felt like she was in a dream sequence) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 23-Apr-2021, the patient experienced MYALGIA (Sore arm / muscle aches). On 24-Apr-2021, the patient experienced DECREASED APPETITE (Lost appetite), FEELING HOT (Got really hot), PYREXIA (Temaparature 102 F), FATIGUE (Fatigued) and CHILLS (Chills). On 25-Apr-2021, the patient experienced SOMNOLENCE (Slept all day). On an unknown date, the patient experienced PAIN (Body hurt all over) and ABNORMAL DREAMS (Felt like she was in a dream sequence). At the time of the report, DECREASED APPETITE (Lost appetite), PAIN (Body hurt all over), FEELING HOT (Got really hot), SOMNOLENCE (Slept all day), ABNORMAL DREAMS (Felt like she was in a dream sequence), PYREXIA (Temaparature 102 F), FATIGUE (Fatigued), CHILLS (Chills) and MYALGIA (Sore arm / muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment medication were provided   concomitants were provided
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Soreness in her arm; Soreness in her body; Pain and throbbing inside her arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm), PAIN (Soreness in her body) and PAIN (Pain and throbbing inside her arm) 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 05-May-2021, the patient experienced PAIN (Pain and throbbing inside her arm). On 06-May-2021, the patient experienced PAIN (Soreness in her body). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in her arm). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm) and PAIN (Pain and throbbing inside her arm) outcome was unknown and PAIN (Soreness in her body) 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 reported.  No treatment information was provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Depressed mood, Hyperhidrosis, Limb discomfort, Pain in extremity
Clinical narrative: arm pain was really bad/pain was extreme; sweats; I couldn't raise my arm; I didn't feel like myself; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain was really bad/pain was extreme), HYPERHIDROSIS (sweats), LIMB DISCOMFORT (I couldn't raise my arm) and DEPRESSED MOOD (I didn't feel like myself) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain was really bad/pain was extreme), HYPERHIDROSIS (sweats), LIMB DISCOMFORT (I couldn't raise my arm) and DEPRESSED MOOD (I didn't feel like myself). On 13-Apr-2021, DEPRESSED MOOD (I didn't feel like myself) had resolved. On 14-Apr-2021, PAIN IN EXTREMITY (arm pain was really bad/pain was extreme) and LIMB DISCOMFORT (I couldn't raise my arm) had resolved. On 15-Apr-2021, HYPERHIDROSIS (sweats) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-109895 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109895:Husband case
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasticity, Myalgia, Pain, Vaccination site pain
Clinical narrative: Tenderness at site of injection, right arm; Pain in non-injected left arm,Pain in non-injected left shoulder; Pain down left chest,Pain down left back; Cannot move non-injected left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness at site of injection, right arm), MYALGIA (Pain in non-injected left arm,Pain in non-injected left shoulder), PAIN (Pain down left chest,Pain down left back) and MUSCLE SPASTICITY (Cannot move non-injected left arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Gabapentin) and Drug allergy (Phenergan).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced VACCINATION SITE PAIN (Tenderness at site of injection, right arm), PAIN (Pain down left chest,Pain down left back) and MUSCLE SPASTICITY (Cannot move non-injected left arm). 05-May-2021, the patient experienced MYALGIA (Pain in non-injected left arm,Pain in non-injected left shoulder). At the time of the report, VACCINATION SITE PAIN (Tenderness at site of injection, right arm), MYALGIA (Pain in non-injected left arm,Pain in non-injected left shoulder), PAIN (Pain down left chest,Pain down left back) and MUSCLE SPASTICITY (Cannot move non-injected left arm) outcome was unknown. Not Provided          concomitant medications include anti depressant medications, anti anxiety medications and pain medications.   This case was linked to MOD-2021-110036 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Illness, Influenza like illness
Clinical narrative: Severe flu like illness; NOT to have my 2nd. scheduled shot; Bruise on arm at injection site/Huge area of bruising; Diarrhea; Very Sick; Side effects; Vomiting; Chills; Body aches; Fever; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise on arm at injection site/Huge area of bruising), DIARRHOEA (Diarrhea), ILLNESS (Very Sick), VACCINATION COMPLICATION (Side effects) and INFLUENZA LIKE ILLNESS (Severe flu like illness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Was hospitalized with serious symptoms.) on 01-Feb-2021 and Infusion (Infusion of BAM, a monoclonal antibody.) on 02-Feb-2021.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DIARRHOEA (Diarrhea), ILLNESS (Very Sick), VACCINATION COMPLICATION (Side effects), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Body aches), PYREXIA (Fever) and FATIGUE (Exhaustion). On 05-May-2021, the patient experienced VACCINATION SITE BRUISING (Bruise on arm at injection site/Huge area of bruising). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Severe flu like illness) and INTENTIONAL DOSE OMISSION (NOT to have my 2nd. scheduled shot). At the time of the report, VACCINATION SITE BRUISING (Bruise on arm at injection site/Huge area of bruising), DIARRHOEA (Diarrhea), ILLNESS (Very Sick), VACCINATION COMPLICATION (Side effects), INFLUENZA LIKE ILLNESS (Severe flu like illness), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Body aches), PYREXIA (Fever) and FATIGUE (Exhaustion) outcome was unknown and INTENTIONAL DOSE OMISSION (NOT to have my 2nd. scheduled shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, SARS-CoV-2 test: (Positive) Postive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received included medical history details of the patient and new adverse events.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional dose omission, Myalgia, Pyrexia, SARS-CoV-2 test, Vaccination complication
Clinical narrative: Severe flu like illness; NOT to have my 2nd. scheduled shot; Bruise on arm at injection site/Huge area of bruising; Diarrhea; Very Sick; Side effects; Vomiting; Chills; Body aches; Fever; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise on arm at injection site/Huge area of bruising), DIARRHOEA (Diarrhea), ILLNESS (Very Sick), VACCINATION COMPLICATION (Side effects) and INFLUENZA LIKE ILLNESS (Severe flu like illness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Was hospitalized with serious symptoms.) on 01-Feb-2021 and Infusion (Infusion of BAM, a monoclonal antibody.) on 02-Feb-2021.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DIARRHOEA (Diarrhea), ILLNESS (Very Sick), VACCINATION COMPLICATION (Side effects), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Body aches), PYREXIA (Fever) and FATIGUE (Exhaustion). On 05-May-2021, the patient experienced VACCINATION SITE BRUISING (Bruise on arm at injection site/Huge area of bruising). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Severe flu like illness) and INTENTIONAL DOSE OMISSION (NOT to have my 2nd. scheduled shot). At the time of the report, VACCINATION SITE BRUISING (Bruise on arm at injection site/Huge area of bruising), DIARRHOEA (Diarrhea), ILLNESS (Very Sick), VACCINATION COMPLICATION (Side effects), INFLUENZA LIKE ILLNESS (Severe flu like illness), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Body aches), PYREXIA (Fever) and FATIGUE (Exhaustion) outcome was unknown and INTENTIONAL DOSE OMISSION (NOT to have my 2nd. scheduled shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, SARS-CoV-2 test: (Positive) Postive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received included medical history details of the patient and new adverse events.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vomiting
Clinical narrative: Severe flu like illness; NOT to have my 2nd. scheduled shot; Bruise on arm at injection site/Huge area of bruising; Diarrhea; Very Sick; Side effects; Vomiting; Chills; Body aches; Fever; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise on arm at injection site/Huge area of bruising), DIARRHOEA (Diarrhea), ILLNESS (Very Sick), VACCINATION COMPLICATION (Side effects) and INFLUENZA LIKE ILLNESS (Severe flu like illness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Was hospitalized with serious symptoms.) on 01-Feb-2021 and Infusion (Infusion of BAM, a monoclonal antibody.) on 02-Feb-2021.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DIARRHOEA (Diarrhea), ILLNESS (Very Sick), VACCINATION COMPLICATION (Side effects), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Body aches), PYREXIA (Fever) and FATIGUE (Exhaustion). On 05-May-2021, the patient experienced VACCINATION SITE BRUISING (Bruise on arm at injection site/Huge area of bruising). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Severe flu like illness) and INTENTIONAL DOSE OMISSION (NOT to have my 2nd. scheduled shot). At the time of the report, VACCINATION SITE BRUISING (Bruise on arm at injection site/Huge area of bruising), DIARRHOEA (Diarrhea), ILLNESS (Very Sick), VACCINATION COMPLICATION (Side effects), INFLUENZA LIKE ILLNESS (Severe flu like illness), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Body aches), PYREXIA (Fever) and FATIGUE (Exhaustion) outcome was unknown and INTENTIONAL DOSE OMISSION (NOT to have my 2nd. scheduled shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, SARS-CoV-2 test: (Positive) Postive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received included medical history details of the patient and new adverse events.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Tinnitus, Vaccination site reaction
Clinical narrative: 2nd dose received on: 04Apr2021; Reaction; Developed tinnitus (ringing in the ears); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Reaction), TINNITUS (Developed tinnitus (ringing in the ears)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on: 04Apr2021) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE REACTION (Reaction) and TINNITUS (Developed tinnitus (ringing in the ears)). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on: 04Apr2021). At the time of the report, VACCINATION SITE REACTION (Reaction), TINNITUS (Developed tinnitus (ringing in the ears)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on: 04Apr2021) outcome was unknown. Not Provided      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.   Treatment and concomitant medicines were not reported Action taken with mRNA-1273 in response to the event was unknown
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling cold, Malaise, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Not feeling well; Cold; Cough; Stuffiness; Fever; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Not feeling well), FEELING COLD (Cold), COUGH (Cough), MUSCULOSKELETAL STIFFNESS (Stuffiness) and PYREXIA (Fever) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced MALAISE (Not feeling well), FEELING COLD (Cold), COUGH (Cough), MUSCULOSKELETAL STIFFNESS (Stuffiness) and PYREXIA (Fever). At the time of the report, MALAISE (Not feeling well), FEELING COLD (Cold), COUGH (Cough), MUSCULOSKELETAL STIFFNESS (Stuffiness) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information included Tylenol. Action taken with mRNA-1273 in response to the event was unknown
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site rash
Clinical narrative: Arm is painful; red itchy Rash on injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm is painful) and VACCINATION SITE RASH (red itchy Rash on injection site arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Arm is painful) and VACCINATION SITE RASH (red itchy Rash on injection site arm). At the time of the report, MYALGIA (Arm is painful) and VACCINATION SITE RASH (red itchy Rash on injection site arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicine include Eczema cream  Concomitant medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Coronavirus test, Dyspnoea, Fatigue, Somnolence
Clinical narrative: Tested covid-19 positive after first dose; Breathing messed/Have to catch my breath while talking/Too short of breathing; Sleep a lot; Fatigue; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested covid-19 positive after first dose), DYSPNOEA (Breathing messed/Have to catch my breath while talking/Too short of breathing), SOMNOLENCE (Sleep a lot) and FATIGUE (Fatigue) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included Difficulty breathing (Patient pre-existing condition includes breathing complication.). Concurrent medical conditions included HIV positive, Asthma and Hypertension.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced COVID-19 (Tested covid-19 positive after first dose), DYSPNOEA (Breathing messed/Have to catch my breath while talking/Too short of breathing), SOMNOLENCE (Sleep a lot) and FATIGUE (Fatigue). At the time of the report, COVID-19 (Tested covid-19 positive after first dose) had resolved and DYSPNOEA (Breathing messed/Have to catch my breath while talking/Too short of breathing), SOMNOLENCE (Sleep a lot) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Coronavirus test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not provided. The patient had recovered from COVID-19 at the time of reporting.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start  date of the events dyspnea, somnolence and fatigue, a causal relationship cannot be excluded. Patient's history of asthma and HIV are confounding factors that may play a possible contributory role. Further information has been requested. Based on the mechanism of action of mRNA 1273, it is unlikely to cause Covid 19.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: A little tired,fatigued; Soreness (left arm); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (A little tired,fatigued) and VACCINATION SITE PAIN (Soreness (left arm)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PIOGLITAZONE for Diabetes, INSULIN GLARGINE (BASAGLAR), METFORMIN, LISINOPRIL, VITAMIN D3, IRON, HYDROCHLOROTHIAZIDE, POTASSIUM and ROSUVASTATIN for an unknown indication.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced FATIGUE (A little tired,fatigued) and VACCINATION SITE PAIN (Soreness (left arm)). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FATIGUE (A little tired,fatigued) and VACCINATION SITE PAIN (Soreness (left arm)) outcome was unknown. Not Provided          Treatment drug include Tylenol Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-033851 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Headache, Insomnia
Clinical narrative: dizziness; difficulty in sleep; headache for 2 months; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-May-2021 and was forwarded to Moderna on 06-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), INSOMNIA (difficulty in sleep) and HEADACHE (headache for 2 months) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    No medical history was provided by the reporter.  Concomitant products included QUETIAPINE FUMARATE (SEROQUEL), ROPINIROLE, PRAZOSIN, CLONAZEPAM, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and VALACICLOVIR HYDROCHLORIDE (PRO-VALACYCLOVIR) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (dizziness), INSOMNIA (difficulty in sleep) and HEADACHE (headache for 2 months). At the time of the report, DIZZINESS (dizziness), INSOMNIA (difficulty in sleep) and HEADACHE (headache for 2 months) 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.   Treatment medicines include Aspirin and lavender oil for headaches Action taken with mRNA-1273 in response to the event was unknown
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feeling druggy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling druggy) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling druggy). At the time of the report, FEELING ABNORMAL (Feeling druggy) was resolving.            Treatment and concomitant medicines were not provided Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-110132 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Outcome of event updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-110132:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Rash
Clinical narrative: rash got worsen; Rash on both arms/Rash spread to chest, back and legs; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (rash got worsen) and RASH (Rash on both arms/Rash spread to chest, back and legs) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-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 CONDITION AGGRAVATED (rash got worsen) and RASH (Rash on both arms/Rash spread to chest, back and legs). At the time of the report, CONDITION AGGRAVATED (rash got worsen) and RASH (Rash on both arms/Rash spread to chest, back and legs) outcome was unknown.            No concomitant medications were provided. Treatment medications was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Myalgia
Clinical narrative: bowel movement changes; Aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of BOWEL MOVEMENT IRREGULARITY (bowel movement changes) and MYALGIA (Aches and pains) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BOWEL MOVEMENT IRREGULARITY (bowel movement changes) and MYALGIA (Aches and pains). At the time of the report, BOWEL MOVEMENT IRREGULARITY (bowel movement changes) outcome was unknown and MYALGIA (Aches and pains) had resolved.            Treatment and concomitant list were not provided Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-109579 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound scan vagina
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 29-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003CZ1A and 033B21A) for COVID-19 vaccination.     The patient's past medical history included Iron deficiency (managed with mult-vitamin) on 11-May-2019, Carotid body tumor (none - followed by ENT surgeon. will repeat MRI in December after delivery) on 01-Jul-2020, Alcohol use (prior use,4 drinks/ month) on 31-Dec-2019, Postpartum hemorrhage (live, full-term birth complications-postpartum hemorrhage (mother)) on 31-Dec-2015 and Postpartum hemorrhage (live, full-term birth complications-precipitous delivery; postpartum hemorrhage (mother)) on 11-Feb-2017. Concomitant products included PRENATAL MULTIVITAMIN + DHA for Pregnancy.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 16-Dec-2020 and the estimated date of delivery was 22-Sep-2021. On 05-May-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 05-May-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Pregnancy test: positive (Positive) Positive. On 19-Feb-2021, Ultrasound scan vagina: pregnancy positive (normal) Single live intrauterine pregnancy confirmed.         The patient had an Anatomy scan on 05/05/2021 and were WNL. The patient had Maternal Serum AFP on 04/02/2021 and the results were  WNL.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: patient demographics updated, historical conditions ,lab data  updated,2 nd dose added, concomitant medications added
Age: 68.0
Sex: F
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 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. CV19-0162272) for COVID-19 vaccination.     Concurrent medical conditions included Wheezing since 30-Dec-2019, Cough on 30-Dec-2019, Weakness since 25-Mar-2020, Tiredness since 25-Mar-2020, Muscle pain since 25-Mar-2020, Pain in arm since 31-Mar-2021, Loss of smell on 24-May-2021, Loss of taste on 24-May-2021, Drug allergy (Allergy to Amoxicillin), Food allergy (Allergy to Banana), Food allergy (Allergy to Becan) and Ragweed allergy. Concomitant products included DOXYCYCLINE from 14-Jan-2021 to an unknown date for Antibiotic therapy, PREDNISONE from 26-May-2021 to an unknown date for Steroid therapy NOS, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), SPRING VALLEY B100 COMPLEX from 31-May-2021 to an unknown date and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-110178 (E2B Linked Report). This case was linked to MOD-2021-110178 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Medical history, concomitants, patient information, allergies, vaccination facility information are added. On 07-Jul-2021: Follow-up information received on 07-jul-2021 contains No new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-110178:Dose 2
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feeling druggy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling druggy) in a 42-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling druggy). At the time of the report, FEELING ABNORMAL (Feeling druggy) had resolved. Not Provided          Patient was feeling druggy since receiving the vaccine.  Concomitant medications were not reported.  No treatment details were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-110112 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-110112:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeding disorder, Gastrooesophageal reflux disease, Headache, Insomnia
Clinical narrative: taste issues; doesn't eat or sleep well; doesn't eat or sleep well; Chills; muscle ache; low-grade fever; headache; surge of acid in my mouth; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (surge of acid in my mouth), TASTE DISORDER (taste issues), FEEDING DISORDER (doesn't eat or sleep well), INSOMNIA (doesn't eat or sleep well) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (surge of acid in my mouth). On an unknown date, the patient experienced TASTE DISORDER (taste issues), FEEDING DISORDER (doesn't eat or sleep well), INSOMNIA (doesn't eat or sleep well), CHILLS (Chills), MYALGIA (muscle ache), PYREXIA (low-grade fever) and HEADACHE (headache). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (surge of acid in my mouth), TASTE DISORDER (taste issues), FEEDING DISORDER (doesn't eat or sleep well), INSOMNIA (doesn't eat or sleep well), CHILLS (Chills), MYALGIA (muscle ache), PYREXIA (low-grade fever) and HEADACHE (headache) 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 treatment medications were provided. No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-109904 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109904:Husband case