chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Fast heartbeat; Chest pain; Sore neck; Sore arm; Bad headaches; fever; Swollen glands; Achy joints; achy muscles; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heartbeat), CHEST PAIN (Chest pain), NECK PAIN (Sore neck), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Bad headaches) 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 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 HEART RATE INCREASED (Fast heartbeat), CHEST PAIN (Chest pain), NECK PAIN (Sore neck), PAIN IN EXTREMITY (Sore arm), HEADACHE (Bad headaches), PYREXIA (fever), LYMPHADENOPATHY (Swollen glands), ARTHRALGIA (Achy joints) and MYALGIA (achy muscles). At the time of the report, HEART RATE INCREASED (Fast heartbeat), CHEST PAIN (Chest pain), NECK PAIN (Sore neck), PAIN IN EXTREMITY (Sore arm), HEADACHE (Bad headaches), PYREXIA (fever), LYMPHADENOPATHY (Swollen glands), ARTHRALGIA (Achy joints) and MYALGIA (achy muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information provided was Tylenol.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Headache, Myalgia, Pyrexia, Tenderness
Clinical narrative: tender to touch; size of the redness is 5cm; headache; body aches is severe; had high fever 102; This spontaneous case was reported by a physician and describes the occurrence of TENDERNESS (tender to touch), ERYTHEMA (size of the redness is 5cm), HEADACHE (headache), MYALGIA (body aches is severe) and PYREXIA (had high fever 102) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tender to touch), ERYTHEMA (size of the redness is 5cm), HEADACHE (headache), MYALGIA (body aches is severe) and PYREXIA (had high fever 102). At the time of the report, TENDERNESS (tender to touch), ERYTHEMA (size of the redness is 5cm), HEADACHE (headache), MYALGIA (body aches is severe) and PYREXIA (had high fever 102) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included Tylenol A Liter of IV fluid. No concomitant medication was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-094833 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discharge, Breast pain, Breast swelling, Breast tenderness, Chills
Clinical narrative: Breast swelling in left breast, Left breast still swollen; Left breast implant ruptured; 500cc of fluid taken off left breast; Slept all day; Left breast is tender; Left breast has some pain/streteched; mild fever; Chills; injection site tenderness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BREAST SWELLING (Breast swelling in left breast, Left breast still swollen), DEVICE BREAKAGE (Left breast implant ruptured), BREAST DISCHARGE (500cc of fluid taken off left breast), SOMNOLENCE (Slept all day) and BREAST TENDERNESS (Left breast is tender) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast implant user.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site tenderness). On 12-Feb-2021, the patient experienced BREAST SWELLING (Breast swelling in left breast, Left breast still swollen), DEVICE BREAKAGE (Left breast implant ruptured), BREAST DISCHARGE (500cc of fluid taken off left breast), SOMNOLENCE (Slept all day), BREAST TENDERNESS (Left breast is tender), BREAST PAIN (Left breast has some pain/streteched), PYREXIA (mild fever) and CHILLS (Chills). At the time of the report, BREAST SWELLING (Breast swelling in left breast, Left breast still swollen), BREAST TENDERNESS (Left breast is tender) and BREAST PAIN (Left breast has some pain/streteched) had not resolved and DEVICE BREAKAGE (Left breast implant ruptured), BREAST DISCHARGE (500cc of fluid taken off left breast), SOMNOLENCE (Slept all day), VACCINATION SITE PAIN (injection site tenderness), PYREXIA (mild fever) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient consulted the doctor and advised for diagnostic mammogram . Concomitant product use was not provided by the reporter.  It was reported that patient had surgery to take care of breast to remove the breast implants and allowed them to heal.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Device breakage, Pyrexia, Somnolence, Vaccination site pain
Clinical narrative: Breast swelling in left breast, Left breast still swollen; Left breast implant ruptured; 500cc of fluid taken off left breast; Slept all day; Left breast is tender; Left breast has some pain/streteched; mild fever; Chills; injection site tenderness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BREAST SWELLING (Breast swelling in left breast, Left breast still swollen), DEVICE BREAKAGE (Left breast implant ruptured), BREAST DISCHARGE (500cc of fluid taken off left breast), SOMNOLENCE (Slept all day) and BREAST TENDERNESS (Left breast is tender) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast implant user.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site tenderness). On 12-Feb-2021, the patient experienced BREAST SWELLING (Breast swelling in left breast, Left breast still swollen), DEVICE BREAKAGE (Left breast implant ruptured), BREAST DISCHARGE (500cc of fluid taken off left breast), SOMNOLENCE (Slept all day), BREAST TENDERNESS (Left breast is tender), BREAST PAIN (Left breast has some pain/streteched), PYREXIA (mild fever) and CHILLS (Chills). At the time of the report, BREAST SWELLING (Breast swelling in left breast, Left breast still swollen), BREAST TENDERNESS (Left breast is tender) and BREAST PAIN (Left breast has some pain/streteched) had not resolved and DEVICE BREAKAGE (Left breast implant ruptured), BREAST DISCHARGE (500cc of fluid taken off left breast), SOMNOLENCE (Slept all day), VACCINATION SITE PAIN (injection site tenderness), PYREXIA (mild fever) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient consulted the doctor and advised for diagnostic mammogram . Concomitant product use was not provided by the reporter.  It was reported that patient had surgery to take care of breast to remove the breast implants and allowed them to heal.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Feeling hot, Injection site pain
Clinical narrative: she started feeling tired 4 days ago; After 1 week, she started with swollen left arm and it was hard; hot to touch; red; very itchy; It went from injection site to the elbow and She went to urgent care; doctor diagnosed it as a covid arm; Next day she discomfort on her left arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Next day she discomfort on her left arm), CHILLS (Chills), PERIPHERAL SWELLING (After 1 week, she started with swollen left arm and it was hard), FEELING HOT (hot to touch) and ERYTHEMA (red) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was reported.     On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LIMB DISCOMFORT (Next day she discomfort on her left arm) and CHILLS (Chills). On 13-Apr-2021, the patient experienced PERIPHERAL SWELLING (After 1 week, she started with swollen left arm and it was hard), FEELING HOT (hot to touch), ERYTHEMA (red), PRURITUS (very itchy), INJECTION SITE PAIN (It went from injection site to the elbow and She went to urgent care) and VACCINATION SITE REACTION (doctor diagnosed it as a covid arm). On 24-Apr-2021, the patient experienced FATIGUE (she started feeling tired 4 days ago). At the time of the report, LIMB DISCOMFORT (Next day she discomfort on her left arm), CHILLS (Chills), PERIPHERAL SWELLING (After 1 week, she started with swollen left arm and it was hard), FEELING HOT (hot to touch), ERYTHEMA (red), PRURITUS (very itchy), INJECTION SITE PAIN (It went from injection site to the elbow and She went to urgent care), VACCINATION SITE REACTION (doctor diagnosed it as a covid arm) and FATIGUE (she started feeling tired 4 days ago) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling, Pruritus, Vaccination site reaction
Clinical narrative: she started feeling tired 4 days ago; After 1 week, she started with swollen left arm and it was hard; hot to touch; red; very itchy; It went from injection site to the elbow and She went to urgent care; doctor diagnosed it as a covid arm; Next day she discomfort on her left arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Next day she discomfort on her left arm), CHILLS (Chills), PERIPHERAL SWELLING (After 1 week, she started with swollen left arm and it was hard), FEELING HOT (hot to touch) and ERYTHEMA (red) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was reported.     On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LIMB DISCOMFORT (Next day she discomfort on her left arm) and CHILLS (Chills). On 13-Apr-2021, the patient experienced PERIPHERAL SWELLING (After 1 week, she started with swollen left arm and it was hard), FEELING HOT (hot to touch), ERYTHEMA (red), PRURITUS (very itchy), INJECTION SITE PAIN (It went from injection site to the elbow and She went to urgent care) and VACCINATION SITE REACTION (doctor diagnosed it as a covid arm). On 24-Apr-2021, the patient experienced FATIGUE (she started feeling tired 4 days ago). At the time of the report, LIMB DISCOMFORT (Next day she discomfort on her left arm), CHILLS (Chills), PERIPHERAL SWELLING (After 1 week, she started with swollen left arm and it was hard), FEELING HOT (hot to touch), ERYTHEMA (red), PRURITUS (very itchy), INJECTION SITE PAIN (It went from injection site to the elbow and She went to urgent care), VACCINATION SITE REACTION (doctor diagnosed it as a covid arm) and FATIGUE (she started feeling tired 4 days ago) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm at injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 007B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm at injection site). On 04-Mar-2021, PAIN IN EXTREMITY (sore arm at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-094935 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) 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.   No concomitant medications were provided. No treatment drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-095360 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095360:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Headache, Lethargy
Clinical narrative: Slept for three days; Lethergic; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Slept for three days), LETHARGY (Lethergic) and HEADACHE (Headache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPROPION for Antidepressant therapy, LOSARTAN for Hypertension, LEVOTHYROXINE for Hypothyroidism.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced BEDRIDDEN (Slept for three days), LETHARGY (Lethergic) and HEADACHE (Headache). On 27-Apr-2021, BEDRIDDEN (Slept for three days), LETHARGY (Lethergic) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-095733 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Lymphadenopathy, Myalgia
Clinical narrative: Swollen lymph nodes left arm; Body aches; Chills; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), LYMPHADENOPATHY (Swollen lymph nodes left arm), MYALGIA (Body aches) and CHILLS (Chills) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath), MYALGIA (Body aches) and CHILLS (Chills). On 28-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Apr-2021, DYSPNOEA (Shortness of breath), MYALGIA (Body aches) and CHILLS (Chills) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.   This case was linked to MOD-2021-094812 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Product dose omission issue
Clinical narrative: Missed the appointment of the second dose/ 42 days period had passed; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the appointment of the second dose/ 42 days period had passed) and PERIPHERAL SWELLING (Swollen arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN, TOPIRAMATE (TOPAMAX) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the appointment of the second dose/ 42 days period had passed). 07-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm). On 07-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed the appointment of the second dose/ 42 days period had passed) had resolved. On 09-Mar-2021, PERIPHERAL SWELLING (Swollen arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included Claritin, Motrin. No treatment medications were taken by the patient.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Feeling abnormal, Pain in extremity, Rash erythematous
Clinical narrative: Metallic taste in mouth; Red, itchy rash on her chest, neck area; Red rash on her chest, neck area; Mouth felt weird (tongue and throat); Itchy rash on the vaccination site; Felt fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DYSGEUSIA (Metallic taste in mouth), RASH PRURITIC (Red, itchy rash on her chest, neck area), RASH ERYTHEMATOUS (Red rash on her chest, neck area) and FEELING ABNORMAL (Mouth felt weird (tongue and throat)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke. Concomitant products included CLOBETASOL PROPIONATE (CLOBETASOL 0.05%) for Psoriasis, FOLIC ACID, METHOTREXATE SODIUM, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), SIMVASTATIN, MONTELUKAST SODIUM (SINGULAIR), LISINOPRIL, DULOXETINE HYDROCHLORIDE (CYMBALTA), LORATADINE (CLARITIN [LORATADINE]), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and BETAMETHASONE DIPROPIONATE, CALCIPOTRIOL (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt fatigue). On 10-Apr-2021, the patient experienced DYSGEUSIA (Metallic taste in mouth), RASH PRURITIC (Red, itchy rash on her chest, neck area), RASH ERYTHEMATOUS (Red rash on her chest, neck area), FEELING ABNORMAL (Mouth felt weird (tongue and throat)) and VACCINATION SITE RASH (Itchy rash on the vaccination site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Apr-2021, DYSGEUSIA (Metallic taste in mouth) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH PRURITIC (Red, itchy rash on her chest, neck area), RASH ERYTHEMATOUS (Red rash on her chest, neck area), FEELING ABNORMAL (Mouth felt weird (tongue and throat)), VACCINATION SITE RASH (Itchy rash on the vaccination site) and FATIGUE (Felt fatigue) outcome was unknown.        The action taken with 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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site rash
Clinical narrative: Metallic taste in mouth; Red, itchy rash on her chest, neck area; Red rash on her chest, neck area; Mouth felt weird (tongue and throat); Itchy rash on the vaccination site; Felt fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DYSGEUSIA (Metallic taste in mouth), RASH PRURITIC (Red, itchy rash on her chest, neck area), RASH ERYTHEMATOUS (Red rash on her chest, neck area) and FEELING ABNORMAL (Mouth felt weird (tongue and throat)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke. Concomitant products included CLOBETASOL PROPIONATE (CLOBETASOL 0.05%) for Psoriasis, FOLIC ACID, METHOTREXATE SODIUM, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), SIMVASTATIN, MONTELUKAST SODIUM (SINGULAIR), LISINOPRIL, DULOXETINE HYDROCHLORIDE (CYMBALTA), LORATADINE (CLARITIN [LORATADINE]), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and BETAMETHASONE DIPROPIONATE, CALCIPOTRIOL (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt fatigue). On 10-Apr-2021, the patient experienced DYSGEUSIA (Metallic taste in mouth), RASH PRURITIC (Red, itchy rash on her chest, neck area), RASH ERYTHEMATOUS (Red rash on her chest, neck area), FEELING ABNORMAL (Mouth felt weird (tongue and throat)) and VACCINATION SITE RASH (Itchy rash on the vaccination site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Apr-2021, DYSGEUSIA (Metallic taste in mouth) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH PRURITIC (Red, itchy rash on her chest, neck area), RASH ERYTHEMATOUS (Red rash on her chest, neck area), FEELING ABNORMAL (Mouth felt weird (tongue and throat)), VACCINATION SITE RASH (Itchy rash on the vaccination site) and FATIGUE (Felt fatigue) outcome was unknown.        The action taken with 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hot flush
Clinical narrative: dizziness; hot flashes; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness) and HOT FLUSH (hot flashes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) and HOT FLUSH (hot flashes). At the time of the report, DIZZINESS (dizziness) and HOT FLUSH (hot flashes) 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.   no treatment information was provided  no concomitant medication were reported   This case was linked to US-MODERNATX, INC.-MOD-2021-095209, US-MODERNATX, INC.-MOD-2021-095268 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095209: US-MODERNATX, INC.-MOD-2021-095268:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: Neck is a little bit stiff, like when you are having a massage; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Neck is a little bit stiff, like when you are having a massage) and HEADACHE (Bad headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck is a little bit stiff, like when you are having a massage) and HEADACHE (Bad headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Neck is a little bit stiff, like when you are having a massage) and HEADACHE (Bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Taste disorder
Clinical narrative: Loss of taste; Loss of smell; She tastes burnt onion; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and TASTE DISORDER (She tastes burnt onion) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and TASTE DISORDER (She tastes burnt onion). At the time of the report, AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and TASTE DISORDER (She tastes burnt onion) outcome was unknown. Not Provided          Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-094912 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and MYALGIA (Body aches) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021 at 3:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown. Not Provided          No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Start experiencing hives, intermittently was experiencing hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Start experiencing hives, intermittently was experiencing hives) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced URTICARIA (Start experiencing hives, intermittently was experiencing hives). At the time of the report, URTICARIA (Start experiencing hives, intermittently was experiencing hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow up received on 02-Jun-2021 as email address of the reporter was added.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest X-ray, Chills, Decreased appetite, Myalgia
Clinical narrative: loss of appetite; Chills; joint pain; leg muscles are aching; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), CHILLS (Chills), ARTHRALGIA (joint pain) and MYALGIA (leg muscles are aching) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced DECREASED APPETITE (loss of appetite), CHILLS (Chills), ARTHRALGIA (joint pain) and MYALGIA (leg muscles are aching). At the time of the report, DECREASED APPETITE (loss of appetite), CHILLS (Chills), ARTHRALGIA (joint pain) and MYALGIA (leg muscles are aching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Chest X-ray: normal (normal) normal.     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.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non significant follow up received on 28-MAY-2021, no new information
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: worst side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (worst side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (worst side effects). At the time of the report, VACCINATION COMPLICATION (worst side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Follow-up  received on 12-Jun-2021, contains no new information.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Inappropriate schedule of product administration, Peripheral swelling
Clinical narrative: Swollen and red hands; Swollen and red hands; Late for the second dose; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (Swollen and red hands), ERYTHEMA (Swollen and red hands) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for the second dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen and red hands), ERYTHEMA (Swollen and red hands) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for the second dose). At the time of the report, PERIPHERAL SWELLING (Swollen and red hands) and ERYTHEMA (Swollen and red hands) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for the second dose) had resolved. 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.   No concomitant medications reported. No treatment information provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Lymphadenopathy, Pain in extremity, Pallor
Clinical narrative: dont feel like themselves; lymph node in the right arm, looks prominent like an egg; temperature came back; lymph node in the left arm; pale looking in the face; temperature of 101.3 for three days; arm was sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), PALLOR (pale looking in the face), FEELING ABNORMAL (dont feel like themselves), PYREXIA (temperature of 101.3 for three days) and LYMPHADENOPATHY (lymph node in the right arm, looks prominent like an egg) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, LISINOPRIL, CARVEDILOL, ATORVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 27-Feb-2021, the patient experienced PYREXIA (temperature of 101.3 for three days). On 02-Mar-2021, the patient experienced PALLOR (pale looking in the face). On an unknown date, the patient experienced FEELING ABNORMAL (dont feel like themselves), LYMPHADENOPATHY (lymph node in the right arm, looks prominent like an egg), PYREXIA (temperature came back) and LYMPHADENOPATHY (lymph node in the left arm). On 02-Mar-2021, PYREXIA (temperature of 101.3 for three days) had resolved. On 03-Mar-2021, PALLOR (pale looking in the face) had resolved, LYMPHADENOPATHY (lymph node in the right arm, looks prominent like an egg) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (arm was sore), FEELING ABNORMAL (dont feel like themselves), PYREXIA (temperature came back) and LYMPHADENOPATHY (lymph node in the left arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 101.3 (High) fever- 101.3.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included paracetamol.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 30 April 2021 NNI
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: dont feel like themselves; lymph node in the right arm, looks prominent like an egg; temperature came back; lymph node in the left arm; pale looking in the face; temperature of 101.3 for three days; arm was sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), PALLOR (pale looking in the face), FEELING ABNORMAL (dont feel like themselves), PYREXIA (temperature of 101.3 for three days) and LYMPHADENOPATHY (lymph node in the right arm, looks prominent like an egg) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, LISINOPRIL, CARVEDILOL, ATORVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 27-Feb-2021, the patient experienced PYREXIA (temperature of 101.3 for three days). On 02-Mar-2021, the patient experienced PALLOR (pale looking in the face). On an unknown date, the patient experienced FEELING ABNORMAL (dont feel like themselves), LYMPHADENOPATHY (lymph node in the right arm, looks prominent like an egg), PYREXIA (temperature came back) and LYMPHADENOPATHY (lymph node in the left arm). On 02-Mar-2021, PYREXIA (temperature of 101.3 for three days) had resolved. On 03-Mar-2021, PALLOR (pale looking in the face) had resolved, LYMPHADENOPATHY (lymph node in the right arm, looks prominent like an egg) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (arm was sore), FEELING ABNORMAL (dont feel like themselves), PYREXIA (temperature came back) and LYMPHADENOPATHY (lymph node in the left arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 101.3 (High) fever- 101.3.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included paracetamol.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 30 April 2021 NNI
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) and CHILLS (Chills) 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 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches) and CHILLS (Chills). At the time of the report, PAIN (Body aches) and CHILLS (Chills) outcome was unknown.            No concomitant medications provided. No treatment information provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue
Clinical narrative: not want to get out of bed; blood pressure increased; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure increased) and FATIGUE (not want to get out of bed) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018L32A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Blood pressure (High blood pressure). Concomitant products included DILTIAZEM for Hypertension.   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. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLOOD PRESSURE INCREASED (blood pressure increased). On an unknown date, the patient experienced FATIGUE (not want to get out of bed). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure increased) had not resolved and FATIGUE (not want to get out of bed) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood pressure measurement: (High) High.         Concomitant medication included high blood pressure medications.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-094869 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow-up added on 28-APR-2021, Vaccine date and batch no. added, concomitant medication added and event date updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-094869:Daughter's case
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapeutic product ineffective
Clinical narrative: Tested negative for antibodies; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT INEFFECTIVE (Tested negative for antibodies) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure increased since 2008, Anxiety since 2008, ADHD since 2003 and Shoulder injury since 2008. Concomitant products included COLECALCIFEROL (ADDERA D3) for ADHD, LORAZEPAM (ATIVAN) for Anxiety, LISINOPRIL for Hypertension, TIZANIDINE for Injury.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced THERAPEUTIC PRODUCT INEFFECTIVE (Tested negative for antibodies). At the time of the report, THERAPEUTIC PRODUCT INEFFECTIVE (Tested negative for antibodies) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, SARS-CoV-2 antibody test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.  This report refers to a case of therapeutic product ineffective for mRNA-1273, ( lot # not provided) with no associated AEs.   This case was linked to US-MODERNATX, INC.-MOD-2021-094824 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Concomitant medication information and historical condition was updated; Sender's Comments: This report refers to a case of therapeutic product ineffective for mRNA-1273, ( lot # not provided) with no associated AEs. US-MODERNATX, INC.-MOD-2021-094824:Wife Case
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: injecion site swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (injecion site swollen) 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 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced INJECTION SITE SWELLING (injecion site swollen). At the time of the report, INJECTION SITE SWELLING (injecion site swollen) outcome was unknown. Not Provided          No concomitant medications were provided.  Treatment with ice packs pertained to the events, was provided by the patient.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for Covid-19) in a 76-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.     On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced COVID-19 (Tested positive for Covid-19). At the time of the report, COVID-19 (Tested positive for Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, SARS-CoV-2 test: Positive.     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.   Concomitants include High blood pressure medicine, Medicine for high cholesterol, Diabetes medication and Heart medicine.  No treatment medication included.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non significant follow up received, No new information
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: she got her first shot on 19th march( more that 36 days have passed); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she got her first shot on 19th march( more that 36 days have passed)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she got her first shot on 19th march( more that 36 days have passed)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she got her first shot on 19th march( more that 36 days have passed)) outcome was unknown. Not Provided          No concomitant medication was reported.  Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Nonsignificant Follow-up
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: patient 17 years of age received first dose; This spontaneous case was reported by a physician and describes the occurrence of UNEVALUABLE EVENT (patient 17 years of age received first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced UNEVALUABLE EVENT (patient 17 years of age received first dose). At the time of the report, UNEVALUABLE EVENT (patient 17 years of age received first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.