chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: dose leaked out of the syringe during administration and the full dose was not administered; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (dose leaked out of the syringe during administration and the full dose was not administered) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced UNDERDOSE (dose leaked out of the syringe during administration and the full dose was not administered). On 12-May-2021, UNDERDOSE (dose leaked out of the syringe during administration and the full dose was not administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. No relevant concomitant medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial). On 11-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was stored at the facility on 07-Apr-2021 and kept in their fridge past the expiration date of 07-May-2021. The doses were received on 11May2021.   This case was linked to MOD21-089564, MOD21-089636, MOD21-089642, MOD21-089644, MOD21-089646, MOD21-089650, MOD21-089653, MOD21-089658, MOD21-089660, US-MODERNATX, INC.-MOD-2021-123137 (E2B Linked Report).; Sender's Comments:  MOD21-089564:Same reporter MOD21-089636:Same reporter MOD21-089642:Same reporter MOD21-089644:Same reporter MOD21-089646:Same reporter MOD21-089650:Same reporter MOD21-089653:Same reporter MOD21-089658:Same reporter MOD21-089660:Same reporter US-MODERNATX, INC.-MOD-2021-123137:crosslinked
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Fatigue, Feeling cold
Clinical narrative: Lost appetite; Upset stomach; sore throat; Felt like a cold; Fatigue; Chills; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lost appetite), ABDOMINAL DISCOMFORT (Upset stomach), OROPHARYNGEAL PAIN (sore throat), FEELING COLD (Felt like a cold) and FATIGUE (Fatigue) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced DECREASED APPETITE (Lost appetite), ABDOMINAL DISCOMFORT (Upset stomach), OROPHARYNGEAL PAIN (sore throat), FEELING COLD (Felt like a cold), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Bad headache). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DECREASED APPETITE (Lost appetite), ABDOMINAL DISCOMFORT (Upset stomach), OROPHARYNGEAL PAIN (sore throat), FEELING COLD (Felt like a cold), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medicines were reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: Lost appetite; Upset stomach; sore throat; Felt like a cold; Fatigue; Chills; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lost appetite), ABDOMINAL DISCOMFORT (Upset stomach), OROPHARYNGEAL PAIN (sore throat), FEELING COLD (Felt like a cold) and FATIGUE (Fatigue) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced DECREASED APPETITE (Lost appetite), ABDOMINAL DISCOMFORT (Upset stomach), OROPHARYNGEAL PAIN (sore throat), FEELING COLD (Felt like a cold), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Bad headache). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DECREASED APPETITE (Lost appetite), ABDOMINAL DISCOMFORT (Upset stomach), OROPHARYNGEAL PAIN (sore throat), FEELING COLD (Felt like a cold), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medicines were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site induration, Vaccination site movement impairment, Vaccination site swelling
Clinical narrative: "can't move my arm at all"; "hard in the middle and then jellified on the outside"; arm of injection swollen the size of a tennis ball, "hard in the middle and then jellified on the outside"; "severe headaches"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT ("can't move my arm at all"), VACCINATION SITE INDURATION ("hard in the middle and then jellified on the outside"), VACCINATION SITE SWELLING (arm of injection swollen the size of a tennis ball, "hard in the middle and then jellified on the outside") and HEADACHE ("severe headaches") in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No history was provided by the reporter.  Concomitant products included LINACLOTIDE (LINZESS), POTASSIUM CHLORIDE, SODIUM BICARBONATE, TRAZODONE, CLONAZEPAM, SEVELAMER CARBONATE and OMEPRAZOLE for an unknown indication.   On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT ("can't move my arm at all"), VACCINATION SITE INDURATION ("hard in the middle and then jellified on the outside"), VACCINATION SITE SWELLING (arm of injection swollen the size of a tennis ball, "hard in the middle and then jellified on the outside") and HEADACHE ("severe headaches"). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT ("can't move my arm at all"), VACCINATION SITE INDURATION ("hard in the middle and then jellified on the outside"), VACCINATION SITE SWELLING (arm of injection swollen the size of a tennis ball, "hard in the middle and then jellified on the outside") and HEADACHE ("severe headaches") outcome was unknown.            No laboratory details was given. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Headache, Heart rate, Lymphadenopathy
Clinical narrative: Felt dizzy; Headache when I bends over/bad headache; lymph node of neck on left side was swollen; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy), LYMPHADENOPATHY (lymph node of neck on left side was swollen) and HEADACHE (Headache when I bends over/bad headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included Parathyroid gland operation (mentioned doctor took out her parathyroid gland 5 years back) in 2016. Concurrent medical conditions included Drug allergy (Statin:HMG-CoA reductase inhibitors), Allergic reaction to analgesics (Ibuprofen), Drug allergy (Synthroid), Allergic reaction to antibiotics (Doxycycline), High cholesterol (genetic as per the endocrinologist) since 1985 and Drug allergy. Concomitant products included FISH OIL for High cholesterol, CALCIUM, TURMERIC [CURCUMA LONGA RHIZOME] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 28-Apr-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021 at 8:00 AM, the patient experienced LYMPHADENOPATHY (lymph node of neck on left side was swollen). On an unknown date, the patient experienced DIZZINESS (Felt dizzy) and HEADACHE (Headache when I bends over/bad headache). On 09-May-2021, LYMPHADENOPATHY (lymph node of neck on left side was swollen) had resolved. At the time of the report, DIZZINESS (Felt dizzy) and HEADACHE (Headache when I bends over/bad headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Heart rate: low (Low) Low heart rate. On 10-May-2021, Blood pressure measurement: 119/71 Low. On 10-May-2021, Heart rate: 44 Low. On 12-May-2021, Blood pressure measurement: 120/77 (Low) after running errands she monitored it again and it was 124/73, pulse rate 55.. On 12-May-2021, Heart rate: 44 (Low) after running errands she monitored it again and it was 124/73, pulse rate 55..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported   This case was linked to MOD-2021-221135 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Updated patient demographics[Height, Weight, Race], Updated Medical History: allergy[HMG-CoA reductase inhibitors], current condition: high cholesterol.  Updated outcome of event Swollen lymph node on left side from Unknown to recovered. On 06-Aug-2021: Follow up received and it contains no new information.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No medical history.     On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-122634, US-MODERNATX, INC.-MOD-2021-122456, MOD21-089636, MOD21-089642, MOD21-089644, MOD21-089646, MOD21-089650, MOD21-089655, US-MODERNATX, INC.-MOD-2021-123137 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-122634: US-MODERNATX, INC.-MOD-2021-122456: MOD21-089636: MOD21-089642: MOD21-089644: MOD21-089646: MOD21-089650: MOD21-089655: US-MODERNATX, INC.-MOD-2021-123137:crosslinked
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Intentional dose omission, Rash, Vaccination complication, Vaccination site pruritus
Clinical narrative: Not received his second dose; Rash/Rash on his arm, leg, and back; bad reaction on arm/rash; Itchy; Blisters/"big bubbles with fluid in them"; Bad reaction on the arm where he got the shot; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters/"big bubbles with fluid in them"), VACCINATION COMPLICATION (Bad reaction on the arm where he got the shot), INTENTIONAL DOSE OMISSION (Not received his second dose), VACCINATION SITE PRURITUS (Itchy) and RASH (Rash/Rash on his arm, leg, and back) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced BLISTER (Blisters/"big bubbles with fluid in them"), VACCINATION COMPLICATION (Bad reaction on the arm where he got the shot), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (bad reaction on arm/rash). On 12-May-2021, the patient experienced RASH (Rash/Rash on his arm, leg, and back). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Not received his second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, BLISTER (Blisters/"big bubbles with fluid in them"), VACCINATION COMPLICATION (Bad reaction on the arm where he got the shot), VACCINATION SITE PRURITUS (Itchy), RASH (Rash/Rash on his arm, leg, and back) and VACCINATION SITE RASH (bad reaction on arm/rash) outcome was unknown and INTENTIONAL DOSE OMISSION (Not received his second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter. Treatment for the event included antibiotic cream.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Not received his second dose; Rash/Rash on his arm, leg, and back; bad reaction on arm/rash; Itchy; Blisters/"big bubbles with fluid in them"; Bad reaction on the arm where he got the shot; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters/"big bubbles with fluid in them"), VACCINATION COMPLICATION (Bad reaction on the arm where he got the shot), INTENTIONAL DOSE OMISSION (Not received his second dose), VACCINATION SITE PRURITUS (Itchy) and RASH (Rash/Rash on his arm, leg, and back) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced BLISTER (Blisters/"big bubbles with fluid in them"), VACCINATION COMPLICATION (Bad reaction on the arm where he got the shot), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (bad reaction on arm/rash). On 12-May-2021, the patient experienced RASH (Rash/Rash on his arm, leg, and back). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Not received his second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, BLISTER (Blisters/"big bubbles with fluid in them"), VACCINATION COMPLICATION (Bad reaction on the arm where he got the shot), VACCINATION SITE PRURITUS (Itchy), RASH (Rash/Rash on his arm, leg, and back) and VACCINATION SITE RASH (bad reaction on arm/rash) outcome was unknown and INTENTIONAL DOSE OMISSION (Not received his second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter. Treatment for the event included antibiotic cream.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive for covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced COVID-19 (positive for covid-19). On 09-May-2021, COVID-19 (positive for covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, SARS-CoV-2 test: positive (Positive) positive. On 09-May-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.  Patient tested positive for covid-19 on 21Apr2021 and turned negative on 9May2021 and went for the second dose and was denied and was advised to call us for guidance on how to proceed.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: itchiness of the left shoulder; redness of left shoulder; swollenness of left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itchiness of the left shoulder), INJECTION SITE ERYTHEMA (redness of left shoulder) and INJECTION SITE SWELLING (swollenness of left shoulder) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C4A) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced INJECTION SITE PRURITUS (itchiness of the left shoulder), INJECTION SITE ERYTHEMA (redness of left shoulder) and INJECTION SITE SWELLING (swollenness of left shoulder). At the time of the report, INJECTION SITE PRURITUS (itchiness of the left shoulder), INJECTION SITE ERYTHEMA (redness of left shoulder) and INJECTION SITE SWELLING (swollenness of left shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose of a vaccine from an expired vial) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose of a vaccine from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose of a vaccine from an expired vial) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medicines were not reported   This case was linked to US-MODERNATX, INC.-MOD-2021-122781, MOD21-089636, MOD21-089642, MOD21-089644, MOD21-089646, MOD21-089650, MOD21-089653, MOD21-089655, MOD21-089658 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-122781: MOD21-089636: MOD21-089642: MOD21-089644: MOD21-089646: MOD21-089650: MOD21-089653: MOD21-089655: MOD21-089658:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Pain in extremity, Somnolence
Clinical narrative: Pain that went down my leg to my foot, feeling it going down my thighs and knees; Sleepy; I have lack of appetite, lost 17 pounds; I have lack of appetite, lost 17 pounds; Tired; Started with one side of the hip then both; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), SOMNOLENCE (Sleepy), DECREASED APPETITE (I have lack of appetite, lost 17 pounds), WEIGHT DECREASED (I have lack of appetite, lost 17 pounds) and FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, 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 (Pain that went down my leg to my foot, feeling it going down my thighs and knees), SOMNOLENCE (Sleepy), DECREASED APPETITE (I have lack of appetite, lost 17 pounds), WEIGHT DECREASED (I have lack of appetite, lost 17 pounds), FATIGUE (Tired) and ARTHRALGIA (Started with one side of the hip then both). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and GABAPENTIN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), SOMNOLENCE (Sleepy), DECREASED APPETITE (I have lack of appetite, lost 17 pounds), WEIGHT DECREASED (I have lack of appetite, lost 17 pounds), FATIGUE (Tired) and ARTHRALGIA (Started with one side of the hip then both) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Pain that went down my leg to my foot, feeling it going down my thighs and knees; Sleepy; I have lack of appetite, lost 17 pounds; I have lack of appetite, lost 17 pounds; Tired; Started with one side of the hip then both; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), SOMNOLENCE (Sleepy), DECREASED APPETITE (I have lack of appetite, lost 17 pounds), WEIGHT DECREASED (I have lack of appetite, lost 17 pounds) and FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, 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 (Pain that went down my leg to my foot, feeling it going down my thighs and knees), SOMNOLENCE (Sleepy), DECREASED APPETITE (I have lack of appetite, lost 17 pounds), WEIGHT DECREASED (I have lack of appetite, lost 17 pounds), FATIGUE (Tired) and ARTHRALGIA (Started with one side of the hip then both). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and GABAPENTIN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain that went down my leg to my foot, feeling it going down my thighs and knees), SOMNOLENCE (Sleepy), DECREASED APPETITE (I have lack of appetite, lost 17 pounds), WEIGHT DECREASED (I have lack of appetite, lost 17 pounds), FATIGUE (Tired) and ARTHRALGIA (Started with one side of the hip then both) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis
Clinical narrative: Cold; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) and FATIGUE (Fatigue) in a 19-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 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced FATIGUE (Fatigue). On 12-May-2021, the patient experienced NASOPHARYNGITIS (Cold). On 15-Apr-2021, FATIGUE (Fatigue) had resolved. At the time of the report, NASOPHARYNGITIS (Cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications mentioned.  No treatment information mentioned.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Red; whole bicep was puffy; Losing sleep; Itching whichworse at night; Rash; Small bump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Losing sleep), VACCINATION SITE PRURITUS (Itching whichworse at night), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (whole bicep was puffy) and VACCINATION SITE RASH (Rash) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) for Diabetes.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Small bump at the injection site). On 29-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itching whichworse at night) and VACCINATION SITE RASH (Rash). On 12-May-2021, the patient experienced INSOMNIA (Losing sleep) and VACCINATION SITE SWELLING (whole bicep was puffy). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red). At the time of the report, INSOMNIA (Losing sleep), VACCINATION SITE SWELLING (whole bicep was puffy), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Small bump at the injection site) outcome was unknown and VACCINATION SITE PRURITUS (Itching whichworse at night) and VACCINATION SITE ERYTHEMA (Red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was not reported.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Interchange of vaccine products
Clinical narrative: ras the second dose / she was able to receive her second scheduled dose of Astra Zeneca.; This spontaneous case was reported by a health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS  as the second dose / she was able to receive her second scheduled dose of Astra Zeneca.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ASTRA ZENECA COMPOUND 677 for an unknown indication.    No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient received second dose of ASTRA ZENECA COMPOUND 677 (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS / she was able to receive her second scheduled dose of Astra Zeneca.). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS she was able to receive her second scheduled dose of Astra Zeneca.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment or adverse event information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant follow up appended to AER
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Paraesthesia, Rash, Scratch, Skin exfoliation
Clinical narrative: Fingers had minor peeling skin; Hypersensitivity reaction; Rash; Itchy red circular patch at injection site (left arm); Itchy red circular patch at injection site (left arm); red, itchy hive-like spots on right hand (mainly 3 fingers) and the next day on couple fingers of left hand; Tingly feeling on fingers; Scratching left arm w/ right hand; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Fingers had minor peeling skin), URTICARIA (red, itchy hive-like spots on right hand (mainly 3 fingers) and the next day on couple fingers of left hand), PARAESTHESIA (Tingly feeling on fingers), SCRATCH (Scratching left arm w/ right hand) and HYPERSENSITIVITY (Hypersensitivity reaction) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B212A and 034C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-May-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021 at 1:20 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced URTICARIA (red, itchy hive-like spots on right hand (mainly 3 fingers) and the next day on couple fingers of left hand), SCRATCH (Scratching left arm w/ right hand) and RASH (Rash). 09-May-2021, the patient experienced PARAESTHESIA (Tingly feeling on fingers). 09-May-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy red circular patch at injection site (left arm)) and VACCINATION SITE ERYTHEMA (Itchy red circular patch at injection site (left arm)). On 09-May-2021 at 1:00 PM, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced SKIN EXFOLIATION (Fingers had minor peeling skin). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 12-May-2021 to 13-May-2021 for Adverse event, at an unspecified dose and frequency. On 19-May-2021, SKIN EXFOLIATION (Fingers had minor peeling skin), URTICARIA (red, itchy hive-like spots on right hand (mainly 3 fingers) and the next day on couple fingers of left hand), PARAESTHESIA (Tingly feeling on fingers), HYPERSENSITIVITY (Hypersensitivity reaction), RASH (Rash), VACCINATION SITE PRURITUS (Itchy red circular patch at injection site (left arm)) and VACCINATION SITE ERYTHEMA (Itchy red circular patch at injection site (left arm)) had resolved. At the time of the report, SCRATCH (Scratching left arm w/ right hand) outcome was unknown.            Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Events added, outcome and reporter causality updated.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Fingers had minor peeling skin; Hypersensitivity reaction; Rash; Itchy red circular patch at injection site (left arm); Itchy red circular patch at injection site (left arm); red, itchy hive-like spots on right hand (mainly 3 fingers) and the next day on couple fingers of left hand; Tingly feeling on fingers; Scratching left arm w/ right hand; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Fingers had minor peeling skin), URTICARIA (red, itchy hive-like spots on right hand (mainly 3 fingers) and the next day on couple fingers of left hand), PARAESTHESIA (Tingly feeling on fingers), SCRATCH (Scratching left arm w/ right hand) and HYPERSENSITIVITY (Hypersensitivity reaction) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B212A and 034C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-May-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021 at 1:20 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced URTICARIA (red, itchy hive-like spots on right hand (mainly 3 fingers) and the next day on couple fingers of left hand), SCRATCH (Scratching left arm w/ right hand) and RASH (Rash). 09-May-2021, the patient experienced PARAESTHESIA (Tingly feeling on fingers). 09-May-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy red circular patch at injection site (left arm)) and VACCINATION SITE ERYTHEMA (Itchy red circular patch at injection site (left arm)). On 09-May-2021 at 1:00 PM, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced SKIN EXFOLIATION (Fingers had minor peeling skin). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 12-May-2021 to 13-May-2021 for Adverse event, at an unspecified dose and frequency. On 19-May-2021, SKIN EXFOLIATION (Fingers had minor peeling skin), URTICARIA (red, itchy hive-like spots on right hand (mainly 3 fingers) and the next day on couple fingers of left hand), PARAESTHESIA (Tingly feeling on fingers), HYPERSENSITIVITY (Hypersensitivity reaction), RASH (Rash), VACCINATION SITE PRURITUS (Itchy red circular patch at injection site (left arm)) and VACCINATION SITE ERYTHEMA (Itchy red circular patch at injection site (left arm)) had resolved. At the time of the report, SCRATCH (Scratching left arm w/ right hand) outcome was unknown.            Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Events added, outcome and reporter causality updated.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hair growth abnormal, Therapeutic response unexpected
Clinical narrative: started growing hair on the top of otherwise bald head; potential AE of hair growth; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (started growing hair on the top of otherwise bald head) and HAIR GROWTH ABNORMAL (potential AE of hair growth) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. W1A21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pre-diabetic, Urination abnormal NOS and Cholesterol. Concomitant products included SIMVASTATIN and ATORVASTATIN for Cholesterol, METFORMIN for Pre-diabetes, FESOTERODINE FUMARATE (TOVIAZ) for Urination abnormal NOS, LISINOPRIL, ASCORBIC ACID (VITAMIN-C), VITAMIN D NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and SAW PALMETTO [SERENOA REPENS] for an unknown indication.   On 20-Feb-2021 at 9:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021 at 9:20 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (started growing hair on the top of otherwise bald head) and HAIR GROWTH ABNORMAL (potential AE of hair growth). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (started growing hair on the top of otherwise bald head) and HAIR GROWTH ABNORMAL (potential AE of hair growth) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered THERAPEUTIC RESPONSE UNEXPECTED (started growing hair on the top of otherwise bald head) and HAIR GROWTH ABNORMAL (potential AE of hair growth) to be possibly related.    No treatment medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow up was received and it includes Patient demographics and Concomitant medications were added. On 08-Jul-2021: Follow up was received contains no new information. On 28-Jul-2021: follow-up received contain no new information.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Influenza like illness, Pain, Pain in extremity
Clinical narrative: rapid COVID-19 antigen test Positive; Soreness of the left arm/extreme pain on the left arm; drained out; Fever 99.5-99.7 F; Body aches; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), INFLUENZA LIKE ILLNESS (Flu like symptoms), COVID-19 (rapid COVID-19 antigen test Positive), PAIN IN EXTREMITY (Soreness of the left arm/extreme pain on the left arm) and FATIGUE (drained out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) 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) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PAIN (Body aches), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Soreness of the left arm/extreme pain on the left arm), FATIGUE (drained out) and PYREXIA (Fever 99.5-99.7 F). On 11-May-2021, the patient experienced COVID-19 (rapid COVID-19 antigen test Positive). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-May-2021, PAIN (Body aches), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Soreness of the left arm/extreme pain on the left arm), FATIGUE (drained out) and PYREXIA (Fever 99.5-99.7 F) had resolved. At the time of the report, COVID-19 (rapid COVID-19 antigen test Positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: rapid COVID-19 antigen test Positive; Soreness of the left arm/extreme pain on the left arm; drained out; Fever 99.5-99.7 F; Body aches; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), INFLUENZA LIKE ILLNESS (Flu like symptoms), COVID-19 (rapid COVID-19 antigen test Positive), PAIN IN EXTREMITY (Soreness of the left arm/extreme pain on the left arm) and FATIGUE (drained out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) 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) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PAIN (Body aches), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Soreness of the left arm/extreme pain on the left arm), FATIGUE (drained out) and PYREXIA (Fever 99.5-99.7 F). On 11-May-2021, the patient experienced COVID-19 (rapid COVID-19 antigen test Positive). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-May-2021, PAIN (Body aches), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Soreness of the left arm/extreme pain on the left arm), FATIGUE (drained out) and PYREXIA (Fever 99.5-99.7 F) had resolved. At the time of the report, COVID-19 (rapid COVID-19 antigen test Positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Eye swelling, Inappropriate schedule of product administration, Rhinorrhoea, Sinusitis
Clinical narrative: Nose was running like a faucet; Eyes hurt because of swollen sinus; swollen sinus; CHILLS; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Nose was running like a faucet), EYE SWELLING (Eyes hurt because of swollen sinus), SINUSITIS (swollen sinus), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and CHILLS (CHILLS) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 31-Mar-2021, the patient experienced CHILLS (CHILLS). On an unknown date, the patient experienced RHINORRHOEA (Nose was running like a faucet), EYE SWELLING (Eyes hurt because of swollen sinus) and SINUSITIS (swollen sinus). On 30-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 01-Apr-2021, CHILLS (CHILLS) had resolved. At the time of the report, RHINORRHOEA (Nose was running like a faucet), EYE SWELLING (Eyes hurt because of swollen sinus) and SINUSITIS (swollen sinus) had resolved.            No concomitant medication was not reported. No treatment medication was not reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-122979 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Patient received the second dose Pfizer and the first dose was Moderna; 1st dose of Moderna vaccine 8 Jan 2021. 124 days since first dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received the second dose Pfizer and the first dose was Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna vaccine 8 Jan 2021. 124 days since first dose.) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna vaccine 8 Jan 2021. 124 days since first dose.). On 12-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received the second dose Pfizer and the first dose was Moderna). On 08-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna vaccine 8 Jan 2021. 124 days since first dose.) had resolved. On 12-May-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient received the second dose Pfizer and the first dose was Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Nausea, Pain
Clinical narrative: Shortness of breath, feels like esophagus is closing in; Weakness; Aches; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath, feels like esophagus is closing in), ASTHENIA (Weakness), PAIN (Aches), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (Nausea). On 12-May-2021, the patient experienced DYSPNOEA (Shortness of breath, feels like esophagus is closing in), ASTHENIA (Weakness), PAIN (Aches) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath, feels like esophagus is closing in), ASTHENIA (Weakness), PAIN (Aches), FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved.            No relevant concomitant medications were provided.  The action taken for mRNA-1273 was not applicable.