chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body was achy; Arm was extremely sore; 103.5 degree fever; Dizziness/wooziness.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness/wooziness.), PAIN (Body was achy), PAIN IN EXTREMITY (Arm was extremely sore) and PYREXIA (103.5 degree fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic rhinitis, Penicillin allergy, Sulfonamide allergy and Drug allergy (Patient is allergic to erythromycin.). Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) from 01-Jan-2018 to an unknown date for Allergic rhinitis.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (Dizziness/wooziness.) and PYREXIA (103.5 degree fever). On an unknown date, the patient experienced PAIN (Body was achy) and PAIN IN EXTREMITY (Arm was extremely sore). On 14-Mar-2021, PYREXIA (103.5 degree fever) had resolved. On 18-Mar-2021, DIZZINESS (Dizziness/wooziness.) had resolved. At the time of the report, PAIN (Body was achy) and PAIN IN EXTREMITY (Arm was extremely sore) outcome was unknown.            Patient took Advil and Tylenol to reduce the fever. Tylenol was more effective so he just took that after his first dose of Advil.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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, a causal relationship cannot be excluded.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Product dose omission issue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of hypoesthesia (numbness in arms and hands from elbow down in both hands), pain (like carpel tunnel pain) and product dose omission issue (missed dose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 021B21A) for COVID-19 immunization. No medical history provided. Concomitant products included atenolol, losartan, potassium and amlodipine for an unknown indication. On Apr 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced hypoesthesia (numbness in arms and hands from elbow down in both hands), pain (like carpel tunnel pain) and product dose omission issue (missed dose). At the time of the report, hypoesthesia (numbness in arms and hands from elbow down in both hands) and pain (like carpel tunnel pain): resolving; and product dose omission issue (missed dose) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The patient noted he also had back surgery. Reporter did not allow further contact.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain (soreness), myalgia (muscle aches) and chills in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pain (soreness), myalgia (muscle aches) and chills. At the time of the report, pain (soreness), myalgia (muscle aches) and chills outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided. Reporter did not allow further contact.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fall, Tremor
Clinical narrative: legs were shaking; Needs to take baby steps, Wall support; Tripping; Fall 4-5 times; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (legs were shaking), BALANCE DISORDER (Needs to take baby steps, Wall support), DIZZINESS (Tripping) and FALL (Fall 4-5 times) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Insomnia, Schizophrenia and Mania.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced TREMOR (legs were shaking), BALANCE DISORDER (Needs to take baby steps, Wall support), DIZZINESS (Tripping) and FALL (Fall 4-5 times). The patient was treated with MECLIZINE [MECLOZINE] at a dose of 12 milligram once a day. On 11-Apr-2021, FALL (Fall 4-5 times) had resolved. At the time of the report, TREMOR (legs were shaking), BALANCE DISORDER (Needs to take baby steps, Wall support) and DIZZINESS (Tripping) outcome was unknown.        Concomitant products included Unspecified Anxiolytics, Unspecified Sleep aids, Unspecified Antipsychotics.  For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to INC.-MOD-2021-117963 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-117963:Friend
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Patient experienced only chills; Fever; Soreness in her arms; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Patient experienced only chills), PYREXIA (Fever) and MYALGIA (Soreness in her arms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 CHILLS (Patient experienced only chills), PYREXIA (Fever) and MYALGIA (Soreness in her arms). At the time of the report, CHILLS (Patient experienced only chills), PYREXIA (Fever) and MYALGIA (Soreness in her arms) had not resolved.            Patient states that she had extreme symptoms worse than when she had COVID-19 for 2 days after getting the first dose.  The action taken with response to the drug is not applicable.  No concomitant medication was reported.  It was not reported if the patient was received any corrective treatment for the event.   This case was linked to MOD-2021-030492 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine given more than 6 hours after first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given more than 6 hours after first vial puncture) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given more than 6 hours after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given more than 6 hours after first vial puncture) 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 relevant concomitant medications were reported. No treatment information was provided.  Pharmacist called to report 5 patients were given Moderna vaccine more than 6 hours after first vial puncture.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Head discomfort, Myalgia, Vaccination site pain
Clinical narrative: Warm to touch; Heaviness, head feels heavy; Body aches; Pain in arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warm to touch), HEAD DISCOMFORT (Heaviness, head feels heavy), MYALGIA (Body aches) and VACCINATION SITE PAIN (Pain in arm at the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Warm to touch), HEAD DISCOMFORT (Heaviness, head feels heavy), MYALGIA (Body aches) and VACCINATION SITE PAIN (Pain in arm at the injection site). At the time of the report, FEELING HOT (Warm to touch), HEAD DISCOMFORT (Heaviness, head feels heavy), MYALGIA (Body aches) and VACCINATION SITE PAIN (Pain in arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Fatigue, Pyrexia
Clinical narrative: Soreness in chest area where she has scar tissue after 2nd dose; Joints hurt; exteremely tired; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Soreness in chest area where she has scar tissue after 2nd dose), ARTHRALGIA (Joints hurt), FATIGUE (exteremely tired) and PYREXIA (fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021c21a) for COVID-19 vaccination.     The patient's past medical history included Hodgkin's lymphoma (Had scar tissue at chest area).   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 CHEST PAIN (Soreness in chest area where she has scar tissue after 2nd dose), ARTHRALGIA (Joints hurt), FATIGUE (exteremely tired) and PYREXIA (fever). At the time of the report, CHEST PAIN (Soreness in chest area where she has scar tissue after 2nd dose), ARTHRALGIA (Joints hurt), FATIGUE (exteremely tired) and PYREXIA (fever) had resolved.            Concomitant product use was not provided by the reporter.   ? No treatment information was provided.   This case was linked to MOD-2021-075323 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: No new information On 27-Jul-2021: significant follow up appended : outcome resolved
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (swollen arm), erythema (red arm), chills, headache (woke up in night with massive headache) and pyrexia (felt feverish but did not have fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025C21A and 040B21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history provided. On Apr 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On May 6, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 8, 2021, patient experienced vaccination site pain (tenderness at vaccination site). On May 6, 2021, patient experienced peripheral swelling (swollen arm), erythema (red arm), chills, headache (woke up in night with massive headache), pyrexia (felt feverish but did not have fever) and myalgia (arm very sore for 2 and half days). On May 7, 2021, patient experienced fatigue (on next day extremely exhausted). At the time of the report, peripheral swelling (swollen arm), erythema (red arm), headache (woke up in night with massive headache) and myalgia (arm very sore for 2 and half days): resolving; chills, fatigue (on next day extremely exhausted) and vaccination site pain (tenderness at vaccination site): not resolved; and pyrexia (felt feverish but did not have fever) resolved. Patient took Advil to treat the symptoms. No concomitant medication provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (swollen arm), erythema (red arm), chills, headache (woke up in night with massive headache) and pyrexia (felt feverish but did not have fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025C21A and 040B21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history provided. On Apr 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On May 6, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 8, 2021, patient experienced vaccination site pain (tenderness at vaccination site). On May 6, 2021, patient experienced peripheral swelling (swollen arm), erythema (red arm), chills, headache (woke up in night with massive headache), pyrexia (felt feverish but did not have fever) and myalgia (arm very sore for 2 and half days). On May 7, 2021, patient experienced fatigue (on next day extremely exhausted). At the time of the report, peripheral swelling (swollen arm), erythema (red arm), headache (woke up in night with massive headache) and myalgia (arm very sore for 2 and half days): resolving; chills, fatigue (on next day extremely exhausted) and vaccination site pain (tenderness at vaccination site): not resolved; and pyrexia (felt feverish but did not have fever) resolved. Patient took Advil to treat the symptoms. No concomitant medication provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: chills; generalised body aches; tiredness; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (tiredness), CHILLS (chills) and MYALGIA (generalised body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20a) for COVID-19 vaccination.     Concurrent medical conditions included GERD. Concomitant products included ASA for Analgesia, OMEPRAZOLE.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced FATIGUE (tiredness). On an unknown date, the patient experienced CHILLS (chills) and MYALGIA (generalised body aches). On 11-Jan-2021, FATIGUE (tiredness) had resolved. At the time of the report, CHILLS (chills) and MYALGIA (generalised body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient had shingles vaccine 1month prior to Moderna covid-19 vaccine at her right arm through route on 30-11-2020. patient using osteo bi flex
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given Moderna vaccine more than 6 hours after first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given Moderna vaccine more than 6 hours after first vial puncture) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given Moderna vaccine more than 6 hours after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given Moderna vaccine more than 6 hours after first vial puncture) 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.   The patient's concomitant medication was not reported. No treatment information was provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Feeling abnormal, Lip disorder, Myalgia
Clinical narrative: There is bumps in perimeter of my tongue; There is bumps in perimeter of my lips; Swollen cheek; Head was foggy; Dry mouth; Muscle soreness; Tiredness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Head was foggy), DRY MOUTH (Dry mouth), LIP DISORDER (There is bumps in perimeter of my lips), SWELLING FACE (Swollen cheek) and TONGUE DISORDER (There is bumps in perimeter of my tongue) in a 29-year-old male 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.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced PYREXIA (Fever). On 09-May-2021, the patient experienced FEELING ABNORMAL (Head was foggy), DRY MOUTH (Dry mouth), MYALGIA (Muscle soreness) and FATIGUE (Tiredness). On 11-May-2021, the patient experienced LIP DISORDER (There is bumps in perimeter of my lips) and SWELLING FACE (Swollen cheek). On an unknown date, the patient experienced TONGUE DISORDER (There is bumps in perimeter of my tongue). On 10-May-2021, FEELING ABNORMAL (Head was foggy), DRY MOUTH (Dry mouth), PYREXIA (Fever), MYALGIA (Muscle soreness) and FATIGUE (Tiredness) had resolved. At the time of the report, LIP DISORDER (There is bumps in perimeter of my lips), SWELLING FACE (Swollen cheek) and TONGUE DISORDER (There is bumps in perimeter of my tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face, Tongue disorder
Clinical narrative: There is bumps in perimeter of my tongue; There is bumps in perimeter of my lips; Swollen cheek; Head was foggy; Dry mouth; Muscle soreness; Tiredness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Head was foggy), DRY MOUTH (Dry mouth), LIP DISORDER (There is bumps in perimeter of my lips), SWELLING FACE (Swollen cheek) and TONGUE DISORDER (There is bumps in perimeter of my tongue) in a 29-year-old male 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.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced PYREXIA (Fever). On 09-May-2021, the patient experienced FEELING ABNORMAL (Head was foggy), DRY MOUTH (Dry mouth), MYALGIA (Muscle soreness) and FATIGUE (Tiredness). On 11-May-2021, the patient experienced LIP DISORDER (There is bumps in perimeter of my lips) and SWELLING FACE (Swollen cheek). On an unknown date, the patient experienced TONGUE DISORDER (There is bumps in perimeter of my tongue). On 10-May-2021, FEELING ABNORMAL (Head was foggy), DRY MOUTH (Dry mouth), PYREXIA (Fever), MYALGIA (Muscle soreness) and FATIGUE (Tiredness) had resolved. At the time of the report, LIP DISORDER (There is bumps in perimeter of my lips), SWELLING FACE (Swollen cheek) and TONGUE DISORDER (There is bumps in perimeter of my tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient hasn't received her 2nd dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received her 2nd dose yet) 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-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received her 2nd dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received her 2nd dose yet) 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 relevant concomitant medications were reported. No treatment information was provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose given 21 days after 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 21 days after 1st dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not known by caller) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 21 days after 1st dose). On 11-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 21 days after 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose greater than 28 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose greater than 28 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose greater than 28 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose greater than 28 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Dyspnoea, Parosmia, Taste disorder
Clinical narrative: Good smells become bad; Slight taste changes; Shortness of breath; Sense of smell has gone completely off the charts; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Good smells become bad), TASTE DISORDER (Slight taste changes), DYSPNOEA (Shortness of breath) and ANOSMIA (Sense of smell has gone completely off the charts) in a 53-year-old male 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 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) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAROSMIA (Good smells become bad), TASTE DISORDER (Slight taste changes), DYSPNOEA (Shortness of breath) and ANOSMIA (Sense of smell has gone completely off the charts). At the time of the report, PAROSMIA (Good smells become bad), TASTE DISORDER (Slight taste changes), DYSPNOEA (Shortness of breath) and ANOSMIA (Sense of smell has gone completely off the charts) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was  not applicable HCP information documented. Provided consent to follow-up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Gait disturbance, Loss of personal independence in daily activities, Tendonitis
Clinical narrative: I figured out it was knee bursitis; Limit my activities; irritate when she walk; had to use a walker when forced to move around the house; Tendinitis on left thigh up to left knee; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (irritate when she walk; had to use a walker when forced to move around the house), TENDONITIS (Tendinitis on left thigh up to left knee), BURSITIS (I figured out it was knee bursitis) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Limit my activities) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TENDONITIS (Tendinitis on left thigh up to left knee). On 18-Apr-2021, the patient experienced GAIT DISTURBANCE (irritate when she walk; had to use a walker when forced to move around the house). On an unknown date, the patient experienced BURSITIS (I figured out it was knee bursitis) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Limit my activities). The patient was treated with CELECOXIB ongoing since an unknown date for Bursitis, at a dose of 200 milligram twice a day; DICLOFENAC SODIUM (topical) ongoing since an unknown date for Bursitis, at a dose of 1 % four times per day and IBUPROFEN for Bursitis, at a dose of 1 dosage form. At the time of the report, GAIT DISTURBANCE (irritate when she walk; had to use a walker when forced to move around the house) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Limit my activities) had not resolved, TENDONITIS (Tendinitis on left thigh up to left knee) was resolving and BURSITIS (I figured out it was knee bursitis) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  On 26MAY2021, the patient went to her primary care doctor who confirmed the diagnosis of bursitis.  Concomitant product use was not provided. Treatment also included ice packs.   This case was linked to MOD-2021-117892 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Completed ADR Form: Updated reporter's address, patient demographics, second dose details, added treatment medications and one additional event "Bursitis" and the outcome of the event tendonitis change from unknown to recovering.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Oral candidiasis, Swollen tongue, Tongue coated
Clinical narrative: tongue coated by fungus; Oral thrush; tongue swollen up; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE COATED (tongue coated by fungus), ORAL CANDIDIASIS (Oral thrush) and SWOLLEN TONGUE (tongue swollen up) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient tested positive for COVID-19, but symptoms were very mild.) in November 2020. Concurrent medical conditions included Blood pressure. Concomitant products included TAMSULOSIN, FINASTERIDE, ATORVASTATIN and VITAMINS NOS for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced TONGUE COATED (tongue coated by fungus), ORAL CANDIDIASIS (Oral thrush) and SWOLLEN TONGUE (tongue swollen up). The patient was treated with NYSTATIN (oral) at a dose of 1 milliliter once a day and FLUCONAZOLE at a dose of 2 pills on the 1st day, followed by 1 pill for next 6 days. At the time of the report, TONGUE COATED (tongue coated by fungus) outcome was unknown and ORAL CANDIDIASIS (Oral thrush) and SWOLLEN TONGUE (tongue swollen up) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taking concomitant medications for Prostate. Patient was back on nystatin oral antifungal suspension just a few days ago.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative, SARS-CoV-2 antibody test
Clinical narrative: Covid-19 antibody test done at about 4 weeks after completing vaccine series show no COVID-19 antibodies; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (Covid-19 antibody test done at about 4 weeks after completing vaccine series show no COVID-19 antibodies) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 045A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  .  Concomitant products included AMIODARONE, METOPROLOL TARTRATE, APIXABAN (ELIQUIS), ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), LISINOPRIL, MELATONIN, VITAMIN D [VITAMIN D NOS] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-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 ANTIBODY TEST NEGATIVE (Covid-19 antibody test done at about 4 weeks after completing vaccine series show no COVID-19 antibodies). At the time of the report, ANTIBODY TEST NEGATIVE (Covid-19 antibody test done at about 4 weeks after completing vaccine series show no COVID-19 antibodies) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative Negative.         No relevant concomitant medications were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and DIZZINESS (Severe Dizziness) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 23-Apr-2021, the patient experienced DIZZINESS (Severe Dizziness). On 23-Apr-2021, PAIN IN EXTREMITY (Sore Arm) and DIZZINESS (Severe Dizziness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Heart rate: increased (High) Rapid Heart Rate which lasted only a few minutes.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was provided by the reporter.  At the time of this report it was reported that second shot was scheduled for 19-May-2021.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is only 16 and she is here for her second dose of the vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is only 16 and she is here for her second dose of the vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is only 16 and she is here for her second dose of the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is only 16 and she is here for her second dose of the vaccine) 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 relevant concomitant medications were reported. No treatment information was provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old receive their first Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receive their first Moderna vaccine) in a 16-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 first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receive their first Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receive their first Moderna vaccine) 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 relevant concomitant medications were reported.  Pharmacist asked should the 16 year old receive their second Moderna vaccine.  No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Pain, Pruritus, Rash
Clinical narrative: Whole body hurting me; Didn't wanna do anything; Itchiness between shoulder and elbowbetween , "Popey muscle"; Redness between shoulder and elbowbetween , "Popey muscle"; Tiny pink-ish spot; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Whole body hurting me), FEELING ABNORMAL (Didn't wanna do anything), PRURITUS (Itchiness between shoulder and elbowbetween , "Popey muscle"), ERYTHEMA (Redness between shoulder and elbowbetween , "Popey muscle") and RASH (Tiny pink-ish spot) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031-A21A) for COVID-19 vaccination.     The patient's past medical history included Broken bones in 2013. Concomitant products included METFORMIN, ENALAPRIL, OMEPRAZOLE, FENOFIBRATE, THEOPHYLLINE, GABAPENTIN, COLECALCIFEROL (VITAMIN D3), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), Proair and latanoprost eye drops.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN (Whole body hurting me), FEELING ABNORMAL (Didn't wanna do anything), PRURITUS (Itchiness between shoulder and elbowbetween , "Popey muscle"), ERYTHEMA (Redness between shoulder and elbowbetween , "Popey muscle") and RASH (Tiny pink-ish spot). On 24-Apr-2021, PAIN (Whole body hurting me) and FEELING ABNORMAL (Didn't wanna do anything) had resolved. At the time of the report, PRURITUS (Itchiness between shoulder and elbowbetween , "Popey muscle"), ERYTHEMA (Redness between shoulder and elbowbetween , "Popey muscle") and RASH (Tiny pink-ish spot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment Tyleno
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Low grade fever of 99 to 100.4 degrees for eleven days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever of 99 to 100.4 degrees for eleven days after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Back pain. Concomitant products included FENTANYL CITRATE (NARCO) for Back pain.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (Low grade fever of 99 to 100.4 degrees for eleven days after first dose). On 15-Mar-2021, PYREXIA (Low grade fever of 99 to 100.4 degrees for eleven days after first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 99 to 100.4 (High) 99 to 100.4 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Decreased appetite, Illness, Mobility decreased, Rash macular
Clinical narrative: got sick; lost my appetite; legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger; Skin is peeling off; legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger; didn't move about 3-4 days; throw up easily; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick), DECREASED APPETITE (lost my appetite), BLISTER (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger), SKIN EXFOLIATION (Skin is peeling off) and RASH MACULAR (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ILLNESS (got sick), DECREASED APPETITE (lost my appetite), BLISTER (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger), SKIN EXFOLIATION (Skin is peeling off), RASH MACULAR (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger), MOBILITY DECREASED (didn't move about 3-4 days) and VOMITING (throw up easily). At the time of the report, ILLNESS (got sick), DECREASED APPETITE (lost my appetite), BLISTER (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger), SKIN EXFOLIATION (Skin is peeling off), RASH MACULAR (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger), MOBILITY DECREASED (didn't move about 3-4 days) and VOMITING (throw up easily) outcome was unknown.            Concomitant product use was not provided by the reporter.  After the second shot, he got sick and didn't move for about 3-4 days. He lost his appetite and had vomiting. His legs had red marks all over until his waist and now they're bumps. It has fluid in them and they started bursting. Skin is peeling off. They're getting bigger.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Skin exfoliation, Vomiting
Clinical narrative: got sick; lost my appetite; legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger; Skin is peeling off; legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger; didn't move about 3-4 days; throw up easily; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick), DECREASED APPETITE (lost my appetite), BLISTER (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger), SKIN EXFOLIATION (Skin is peeling off) and RASH MACULAR (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ILLNESS (got sick), DECREASED APPETITE (lost my appetite), BLISTER (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger), SKIN EXFOLIATION (Skin is peeling off), RASH MACULAR (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger), MOBILITY DECREASED (didn't move about 3-4 days) and VOMITING (throw up easily). At the time of the report, ILLNESS (got sick), DECREASED APPETITE (lost my appetite), BLISTER (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger), SKIN EXFOLIATION (Skin is peeling off), RASH MACULAR (legs had red marks all over until my waist,now they're bumps, has fluid in them, started bursting, getting bigger), MOBILITY DECREASED (didn't move about 3-4 days) and VOMITING (throw up easily) outcome was unknown.            Concomitant product use was not provided by the reporter.  After the second shot, he got sick and didn't move for about 3-4 days. He lost his appetite and had vomiting. His legs had red marks all over until his waist and now they're bumps. It has fluid in them and they started bursting. Skin is peeling off. They're getting bigger.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm tenderness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included Hives. Concurrent medical conditions included Allergy NOS. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy NOS.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced TENDERNESS (Arm tenderness). On 11-Apr-2021, TENDERNESS (Arm tenderness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient would normally take Benadryl to treat  allergies, but hasn't taken any due to caring for patient's child. No treatment medication was provided.   This case was linked to MOD-2021-117951 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm was sore; Little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and FATIGUE (Little tired) in a 71-year-old female patient who received mRNA-1273 (batch no. 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Lyme disease.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore) and FATIGUE (Little tired). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and FATIGUE (Little tired) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       The concomitant medication include Hypothyroid medication.  No treatment information was provided.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, Taste disorder
Clinical narrative: Lost taste; Next day her taste changed; Food tastes bitter/water tastes sweet; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost taste), TASTE DISORDER (Next day her taste changed) and DYSGEUSIA (Food tastes bitter/water tastes sweet) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced AGEUSIA (Lost taste), TASTE DISORDER (Next day her taste changed) and DYSGEUSIA (Food tastes bitter/water tastes sweet). At the time of the report, AGEUSIA (Lost taste), TASTE DISORDER (Next day her taste changed) and DYSGEUSIA (Food tastes bitter/water tastes sweet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.