chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis since an unknown date. Concomitant products included METHYLPREDNISOLONE for Arthritis, FLUTICASONE PROPIONATE and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Nasal congestion, TOFACITINIB CITRATE (XELJANZ) from 01-Feb-2019 to an unknown date for Rheumatoid arthritis, KETOTIFEN FUMARATE, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), ACYCLOVIR [ACICLOVIR], VITAMIN D3, SALBUTAMOL SULFATE (VENTOLIN HFA), ALBUTEROL SULFATE and RANITIDINE HCL for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            This case was linked to MOD-2021-102454, MOD-2021-102454 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: Weakness; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PYREXIA (Fever) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, ASTHENIA (Weakness), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            No treatment medication were provided. No concomitant medication were provided. Action taken for Moderna COVID-19 Vaccine was not applicable.   This case was linked to MOD-2021-042439 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fall
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak) and FALL (fell) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.  On an unknown date, the patient received 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 ASTHENIA (weak) and FALL (fell). At the time of the report, ASTHENIA (weak) and FALL (fell) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The treatment medicines relevant to events were not reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling abnormal, Myalgia, Nausea
Clinical narrative: Weak; Felt awful the rest of the night; Nausea; Slightly red; Fever; Chills; Aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), FEELING ABNORMAL (Felt awful the rest of the night), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Slightly red) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036AZ1A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included drug allergy (Aspirin, Daypro).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced ASTHENIA (Weak), FEELING ABNORMAL (Felt awful the rest of the night), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Slightly red), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches). On 28-Mar-2021, ASTHENIA (Weak), FEELING ABNORMAL (Felt awful the rest of the night), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Slightly red), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ASTHENIA (Weak), FEELING ABNORMAL (Felt awful the rest of the night), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Slightly red), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches) to be related.    No concomitant medications were reported.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to MOD-2021-040652, MOD-2021-040652 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema
Clinical narrative: Weak; Felt awful the rest of the night; Nausea; Slightly red; Fever; Chills; Aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), FEELING ABNORMAL (Felt awful the rest of the night), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Slightly red) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036AZ1A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included drug allergy (Aspirin, Daypro).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced ASTHENIA (Weak), FEELING ABNORMAL (Felt awful the rest of the night), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Slightly red), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches). On 28-Mar-2021, ASTHENIA (Weak), FEELING ABNORMAL (Felt awful the rest of the night), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Slightly red), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ASTHENIA (Weak), FEELING ABNORMAL (Felt awful the rest of the night), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Slightly red), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches) to be related.    No concomitant medications were reported.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to MOD-2021-040652, MOD-2021-040652 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: constant headache; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (constant headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ROSUVASTATIN for an unknown indication.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced HEADACHE (constant headache). At the time of the report, HEADACHE (constant headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided   This case was linked to MOD-2021-105150 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Injection site pain, Myalgia, Night sweats, Pyrexia
Clinical narrative: Fever 100.2-100.3F; chills/rigors; left arm pain; Fever >101F; chills/rigors,; night sweats; myalgias; right arm pain; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever >101F), CHILLS (chills/rigors,), NIGHT SWEATS (night sweats), MYALGIA (myalgias) and INJECTION SITE PAIN (right arm pain) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.    The patient's past medical history included COVID-19 from 23-Jan-2021 to 13-Feb-2021.   On 02-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 at an unspecified dose. On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Fever >101F), CHILLS (chills/rigors,), NIGHT SWEATS (night sweats), MYALGIA (myalgias) and INJECTION SITE PAIN (right arm pain). On 31-Mar-2021, the patient experienced PYREXIA (Fever 100.2-100.3F), CHILLS (chills/rigors) and INJECTION SITE PAIN (left arm pain). On 06-Mar-2021, PYREXIA (Fever >101F), CHILLS (chills/rigors,), NIGHT SWEATS (night sweats), MYALGIA (myalgias) and INJECTION SITE PAIN (right arm pain) had resolved. On 02-Apr-2021, PYREXIA (Fever 100.2-100.3F), CHILLS (chills/rigors) and INJECTION SITE PAIN (left arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and 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. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treated with over the counter NSAID (Motrin and Tylenol).   This case was linked to MOD-2021-035957 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension
Clinical narrative: headache  was persisting; Felling constant headache that does not go away; high blood pressure; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (headache  was persisting), HYPERTENSION (high blood pressure) and HEADACHE (Felling constant headache that does not go away) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and ROSUVASTATIN for an unknown indication.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced HYPERTENSION (high blood pressure). On an unknown date, the patient experienced HEADACHE (headache  was persisting) and HEADACHE (Felling constant headache that does not go away). The patient was treated with IBUPROFEN (oral) for Symptomatic treatment, at a dose of 200 mg twice a day; PARACETAMOL (TYLENOL) (oral) for Symptomatic treatment, at a dose of 500 mg once a day; LOSARTAN (oral) for Symptomatic treatment, at a dose of 25 mg once a day and BACLOFEN (oral) for Symptomatic treatment, at a dose of 20 mg once a day. At the time of the report, HEADACHE (headache  was persisting), HYPERTENSION (high blood pressure) and HEADACHE (Felling constant headache that does not go away) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-105107 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Inappropriate schedule of product administration, Maternal exposure during pregnancy
Clinical narrative: Dizzy; Weakness; Arm Pain; She also states that in the place are saying that the 2nd dose is given 45 dayes after; Pregnant; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weakness), PAIN IN EXTREMITY (Arm Pain), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She also states that in the place are saying that the 2nd dose is given 45 dayes after) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 10-Nov-2020 and the estimated date of delivery was 18-Aug-2021. On 28-Apr-2021, the patient experienced DIZZINESS (Dizzy), ASTHENIA (Weakness), PAIN IN EXTREMITY (Arm Pain), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She also states that in the place are saying that the 2nd dose is given 45 dayes after), MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and HEADACHE (Headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 28-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, DIZZINESS (Dizzy), ASTHENIA (Weakness), PAIN IN EXTREMITY (Arm Pain) and HEADACHE (Headache) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She also states that in the place are saying that the 2nd dose is given 45 dayes after) had resolved. Not Provided          Treatment information was not provided   This case was linked to MOD-2021-098416 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Dizzy; Weakness; Arm Pain; She also states that in the place are saying that the 2nd dose is given 45 dayes after; Pregnant; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weakness), PAIN IN EXTREMITY (Arm Pain), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She also states that in the place are saying that the 2nd dose is given 45 dayes after) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 10-Nov-2020 and the estimated date of delivery was 18-Aug-2021. On 28-Apr-2021, the patient experienced DIZZINESS (Dizzy), ASTHENIA (Weakness), PAIN IN EXTREMITY (Arm Pain), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She also states that in the place are saying that the 2nd dose is given 45 dayes after), MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and HEADACHE (Headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 28-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, DIZZINESS (Dizzy), ASTHENIA (Weakness), PAIN IN EXTREMITY (Arm Pain) and HEADACHE (Headache) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She also states that in the place are saying that the 2nd dose is given 45 dayes after) had resolved. Not Provided          Treatment information was not provided   This case was linked to MOD-2021-098416 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Hypersomnia
Clinical narrative: Felt generally  bad; Sick enough systemically went to bed for 36 hours; substantial joint pain in hips, knees, hands; Headache; Slight nausea; Fatigue; VACCINATION SITE RASH; VACCINATION SITE ERYTHEMA; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (Felt generally  bad), HYPERSOMNIA (Sick enough systemically went to bed for 36 hours), ARTHRALGIA (substantial joint pain in hips, knees, hands), HEADACHE (Headache) and NAUSEA (Slight nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Low sodium diet (Low Na DASH), Mitral valve prolapse (mitral prolapse), Premature atrial contraction (PAC) and Hypertension (high BP).   On 17-Jan-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt generally  bad), HYPERSOMNIA (Sick enough systemically went to bed for 36 hours), ARTHRALGIA (substantial joint pain in hips, knees, hands), HEADACHE (Headache), NAUSEA (Slight nausea), FATIGUE (Fatigue), VACCINATION SITE RASH (VACCINATION SITE RASH) and VACCINATION SITE ERYTHEMA (VACCINATION SITE ERYTHEMA). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Felt generally  bad), HYPERSOMNIA (Sick enough systemically went to bed for 36 hours), ARTHRALGIA (substantial joint pain in hips, knees, hands), HEADACHE (Headache), NAUSEA (Slight nausea), FATIGUE (Fatigue), VACCINATION SITE RASH (VACCINATION SITE RASH) and VACCINATION SITE ERYTHEMA (VACCINATION SITE ERYTHEMA) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Ibuprofen for treatment.  No concomitant medications were reported.   This case was linked to MOD-2021-014403.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Initial Additional-1 : AE outcome
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site erythema, Vaccination site rash
Clinical narrative: Felt generally  bad; Sick enough systemically went to bed for 36 hours; substantial joint pain in hips, knees, hands; Headache; Slight nausea; Fatigue; VACCINATION SITE RASH; VACCINATION SITE ERYTHEMA; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (Felt generally  bad), HYPERSOMNIA (Sick enough systemically went to bed for 36 hours), ARTHRALGIA (substantial joint pain in hips, knees, hands), HEADACHE (Headache) and NAUSEA (Slight nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Low sodium diet (Low Na DASH), Mitral valve prolapse (mitral prolapse), Premature atrial contraction (PAC) and Hypertension (high BP).   On 17-Jan-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt generally  bad), HYPERSOMNIA (Sick enough systemically went to bed for 36 hours), ARTHRALGIA (substantial joint pain in hips, knees, hands), HEADACHE (Headache), NAUSEA (Slight nausea), FATIGUE (Fatigue), VACCINATION SITE RASH (VACCINATION SITE RASH) and VACCINATION SITE ERYTHEMA (VACCINATION SITE ERYTHEMA). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Felt generally  bad), HYPERSOMNIA (Sick enough systemically went to bed for 36 hours), ARTHRALGIA (substantial joint pain in hips, knees, hands), HEADACHE (Headache), NAUSEA (Slight nausea), FATIGUE (Fatigue), VACCINATION SITE RASH (VACCINATION SITE RASH) and VACCINATION SITE ERYTHEMA (VACCINATION SITE ERYTHEMA) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Ibuprofen for treatment.  No concomitant medications were reported.   This case was linked to MOD-2021-014403.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Initial Additional-1 : AE outcome
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine, Off label use
Clinical narrative: Patient not going to take 2nd shot; Chronic,daily migraine headaches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Patient not going to take 2nd shot), MIGRAINE (Chronic,daily migraine headaches) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 OFF LABEL USE (Patient not going to take 2nd shot), MIGRAINE (Chronic,daily migraine headaches) and HEADACHE (Headache). At the time of the report, OFF LABEL USE (Patient not going to take 2nd shot), MIGRAINE (Chronic,daily migraine headaches) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Description:  1st communication was on 2021-05-03 20:05 2nd communication was on 2021-05-03 19:56 3rd communication was on 2021-05-04 07:54 4th communication was on 2021-05-04 10:00 5th communication was on 2021-05-04 09:33 Patient clearly stated that he is not going to take the second shot. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product was not provided. treatment was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: NNI On 21-May-2021: NNI
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Dysstasia
Clinical narrative: Was unable to stand up on her own legs; Other minor side effects; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (Was unable to stand up on her own legs) and ADVERSE REACTION (Other minor side effects) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016m20A) for COVID-19 vaccination.     Concurrent medical conditions included Gout, Diabetes, Thyroid disorder and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, METFORMIN for Diabetes, ALLOPURINOL for Gout, LEVOTHYROXINE for Thyroid disorder.    On 30-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 DYSSTASIA (Was unable to stand up on her own legs) and ADVERSE REACTION (Other minor side effects). At the time of the report, DYSSTASIA (Was unable to stand up on her own legs) and ADVERSE REACTION (Other minor side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include diabetes drug that starts with C. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: But I am a mother to a 33 month old who still breastfeeds; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (But I am a mother to a 33 month old who still breastfeeds) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    MEDICAL HISTORY (Patient): Concurrent medical conditions included Breast feeding.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 24-Mar-2021, the patient experienced EXPOSURE VIA BREAST MILK (But I am a mother to a 33 month old who still breastfeeds). At the time of the report, EXPOSURE VIA BREAST MILK (But I am a mother to a 33 month old who still breastfeeds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication details were provided. No treatment medication information were provided   This case was linked to MOD-2021-105471 (Parent-Child Link).   See case MOD-2021-105471 for details regarding the child case.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain in extremity, Rash, Ultrasound scan, Vaccination site pain
Clinical narrative: Rash on her torso, right arm; burning in left arm; horrible left shoulder and arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (horrible left shoulder and arm pain), VACCINATION SITE PAIN (burning in left arm) and RASH (Rash on her torso, right arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (horrible left shoulder and arm pain). On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (burning in left arm). On an unknown date, the patient experienced RASH (Rash on her torso, right arm). The patient was treated with IBUPROFEN ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (horrible left shoulder and arm pain), VACCINATION SITE PAIN (burning in left arm) and RASH (Rash on her torso, right arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Magnetic resonance imaging: (Inconclusive) MRI of the neck.. On 09-Apr-2021, Ultrasound scan: normal (normal) NO BLOOD CLOT DETECTED.         The concomitant medication was not provided.  The treatment information was not provided.   This case was linked to MOD-2021-100566, MOD-2021-100566 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Additional significant follow up received on 2 June 2021 contains NNI On 03-Jun-2021: Non-significant follow up appended
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Mother to a 33 month old who still breastfeeds; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Mother to a 33 month old who still breastfeeds) in a 33-month-old child of an unknown gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Maternal exposure during breast feeding.     No Medical History information was reported.    On 24-Mar-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 24-Mar-2021, the child was diagnosed with EXPOSURE VIA BREAST MILK (Mother to a 33 month old who still breastfeeds). At the time of the report, EXPOSURE VIA BREAST MILK (Mother to a 33 month old who still breastfeeds) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment medications were not provided.   This case was linked to MOD-2021-105429 (Parent-Child Link).   See case MOD-2021-105429 for details regarding the Parent case.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This spontaneous case was reported by an other and describes the occurrence of MIGRAINE (Migraine) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) outcome was unknown.            NO concomitant medication details were not provided. NO treatment medication details were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-103955 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103955:first dose case
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills) and FATIGUE (Tiredness) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and FATIGUE (Tiredness). At the time of the report, CHILLS (Chills) and FATIGUE (Tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CHILLS (Chills) and FATIGUE (Tiredness) to be possibly related.    concomitant medication were not provided.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Axillary pain, Contusion, Fatigue, Injection site haemorrhage
Clinical narrative: Injection site bleeding; Injection site nodule; Bruised and sore under the arm; Felt groggy; Bruised and sore under the arm; Lymph node was swollen; Tired fatigued; Joints hurt; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE HAEMORRHAGE (Injection site bleeding), INJECTION SITE NODULE (Injection site nodule), CONTUSION (Bruised and sore under the arm), SOMNOLENCE (Felt groggy) and AXILLARY PAIN (Bruised and sore under the arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE HAEMORRHAGE (Injection site bleeding), INJECTION SITE NODULE (Injection site nodule), CONTUSION (Bruised and sore under the arm), SOMNOLENCE (Felt groggy), AXILLARY PAIN (Bruised and sore under the arm), LYMPHADENOPATHY (Lymph node was swollen), FATIGUE (Tired fatigued) and ARTHRALGIA (Joints hurt). At the time of the report, INJECTION SITE HAEMORRHAGE (Injection site bleeding), INJECTION SITE NODULE (Injection site nodule), CONTUSION (Bruised and sore under the arm), SOMNOLENCE (Felt groggy), AXILLARY PAIN (Bruised and sore under the arm), LYMPHADENOPATHY (Lymph node was swollen), FATIGUE (Tired fatigued) and ARTHRALGIA (Joints hurt) 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.   No concomitant medication and treatment information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site nodule, Lymphadenopathy, Somnolence
Clinical narrative: Injection site bleeding; Injection site nodule; Bruised and sore under the arm; Felt groggy; Bruised and sore under the arm; Lymph node was swollen; Tired fatigued; Joints hurt; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE HAEMORRHAGE (Injection site bleeding), INJECTION SITE NODULE (Injection site nodule), CONTUSION (Bruised and sore under the arm), SOMNOLENCE (Felt groggy) and AXILLARY PAIN (Bruised and sore under the arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE HAEMORRHAGE (Injection site bleeding), INJECTION SITE NODULE (Injection site nodule), CONTUSION (Bruised and sore under the arm), SOMNOLENCE (Felt groggy), AXILLARY PAIN (Bruised and sore under the arm), LYMPHADENOPATHY (Lymph node was swollen), FATIGUE (Tired fatigued) and ARTHRALGIA (Joints hurt). At the time of the report, INJECTION SITE HAEMORRHAGE (Injection site bleeding), INJECTION SITE NODULE (Injection site nodule), CONTUSION (Bruised and sore under the arm), SOMNOLENCE (Felt groggy), AXILLARY PAIN (Bruised and sore under the arm), LYMPHADENOPATHY (Lymph node was swollen), FATIGUE (Tired fatigued) and ARTHRALGIA (Joints hurt) 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.   No concomitant medication and treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm  pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm  pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, ROSUVASTATIN, METFORMIN, OMEPRAZOLE and OMEGA-3 FATTY ACIDS for an unknown indication, TAMSULOSIN.    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, the patient experienced PAIN IN EXTREMITY (arm  pain). At the time of the report, PAIN IN EXTREMITY (arm  pain) had resolved. Second Dose AE      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: TCR received. Second dose event reported.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Scab
Clinical narrative: rash for him looks like "as if been scratching" and it is itchy; rash for him looks like "as if been scratching" and it is itchy and scabs over; skin rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash for him looks like "as if been scratching" and it is itchy), SCAB (rash for him looks like "as if been scratching" and it is itchy and scabs over) and RASH (skin rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (rash for him looks like "as if been scratching" and it is itchy), SCAB (rash for him looks like "as if been scratching" and it is itchy and scabs over) and RASH (skin rash). At the time of the report, RASH PRURITIC (rash for him looks like "as if been scratching" and it is itchy), SCAB (rash for him looks like "as if been scratching" and it is itchy and scabs over) and RASH (skin rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Follow-up received does not contain any significant information, reporter's email address updated.
Age: 62.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Malaise
Clinical narrative: Feeling unwell; This spontaneous case was reported by an other and describes the occurrence of MALAISE (Feeling unwell) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On 29-Apr-2021, the patient experienced MALAISE (Feeling unwell). At the time of the report, MALAISE (Feeling unwell) was resolving.            Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SWELLING (swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced SWELLING (swelling). At the time of the report, SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Feels tired; Arm is very sore like someone gave her a punch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very sore like someone gave her a punch) and FATIGUE (Feels tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PAIN IN EXTREMITY (Arm is very sore like someone gave her a punch). On an unknown date, the patient experienced FATIGUE (Feels tired). At the time of the report, PAIN IN EXTREMITY (Arm is very sore like someone gave her a punch) and FATIGUE (Feels tired) had not resolved.            The patient took the 2nd shot on 04-May-2021 and reported that their arm was very sore, like someone gave them a punch. The patient also reported that they felt tired.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-076227 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Headache, Vaccination site pain
Clinical narrative: feels weak; doesn't feel good at the moment; tired; headache; soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels weak), FEELING ABNORMAL (doesn't feel good at the moment), FATIGUE (tired), HEADACHE (headache) and VACCINATION SITE PAIN (soreness in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (feels weak), FEELING ABNORMAL (doesn't feel good at the moment), FATIGUE (tired), HEADACHE (headache) and VACCINATION SITE PAIN (soreness in her arm). At the time of the report, ASTHENIA (feels weak), FEELING ABNORMAL (doesn't feel good at the moment), FATIGUE (tired), HEADACHE (headache) and VACCINATION SITE PAIN (soreness in her arm) outcome was unknown.            No concomitant drugs were reported. No treatment drugs are not provided by reporter.   This case was linked to MOD-2021-075839 (Patient Link).   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a very sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a very sore left arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020821A and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, METHIMAZOLE for Asthma, OMEPRAZOLE for GERD, TRAZODONE for Insomnia, GABAPENTIN for Mood change.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-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 PAIN IN EXTREMITY (a very sore left arm). At the time of the report, PAIN IN EXTREMITY (a very sore left arm) outcome was unknown.            both the vaccines were administered on left shoulder as mentioned.  No treatment product was reported   This case was linked to MOD-2021-035969 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient missed her second dose, it has been more than 42 days since first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 17-Mar-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 PRODUCT DOSE OMISSION ISSUE (patient missed her second dose, it has been more than 42 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient missed her second dose, it has been more than 42 days since first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Possible deviation from the recommended interval between the first and second moderna covid-19; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possible deviation from the recommended interval between the first and second moderna 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 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possible deviation from the recommended interval between the first and second moderna covid-19). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possible deviation from the recommended interval between the first and second moderna covid-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-106417 (Patient Link).   Reporter did not allow further contact