chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Paraesthesia, Peripheral coldness, Pyrexia
Clinical narrative: hands are tingling; Hands cold; little bit of tightness in her chest; a lot of bowel movements; dizziness; short of breath; headaches; body aches; chills; fever (hot n cold); This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (hands are tingling), PERIPHERAL COLDNESS (Hands cold), CHEST DISCOMFORT (little bit of tightness in her chest), FREQUENT BOWEL MOVEMENTS (a lot of bowel movements) and DIZZINESS (dizziness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced HEADACHE (headaches), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever (hot n cold)). On 28-May-2021, the patient experienced PARAESTHESIA (hands are tingling), PERIPHERAL COLDNESS (Hands cold), CHEST DISCOMFORT (little bit of tightness in her chest), FREQUENT BOWEL MOVEMENTS (a lot of bowel movements), DIZZINESS (dizziness) and DYSPNOEA (short of breath). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Adverse event, at a dose of 1 dosage form. On 24-May-2021, HEADACHE (headaches), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever (hot n cold)) had resolved. On 28-May-2021, CHEST DISCOMFORT (little bit of tightness in her chest) had resolved. At the time of the report, PARAESTHESIA (hands are tingling), PERIPHERAL COLDNESS (Hands cold), FREQUENT BOWEL MOVEMENTS (a lot of bowel movements), DIZZINESS (dizziness) and DYSPNOEA (short of breath) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Concomitant medication and treatment medications updated.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness of face mostly eyes and head; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness of face mostly eyes and head) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced HYPOAESTHESIA (Numbness of face mostly eyes and head). On 07-May-2021, HYPOAESTHESIA (Numbness of face mostly eyes and head) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: a sore throat; and congested; experiencing a fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (a sore throat), NASAL CONGESTION (and congested) and PYREXIA (experiencing a fever) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (a sore throat), NASAL CONGESTION (and congested) and PYREXIA (experiencing a fever). At the time of the report, OROPHARYNGEAL PAIN (a sore throat), NASAL CONGESTION (and congested) and PYREXIA (experiencing a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications provided. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: got my first vaccine 17-Apr-2021 and can I still take the second one or I have to start all over; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got my first vaccine 17-Apr-2021 and can I still take the second one or I have to start all over) 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 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (got my first vaccine 17-Apr-2021 and can I still take the second one or I have to start all over). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got my first vaccine 17-Apr-2021 and can I still take the second one or I have to start all over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscular weakness, Pain in extremity
Clinical narrative: Arm pain/ throbbing in arm; Arm feels weak from elbow to shoulder; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain/ throbbing in arm), MUSCULAR WEAKNESS (Arm feels weak from elbow to shoulder) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (Arm pain/ throbbing in arm), MUSCULAR WEAKNESS (Arm feels weak from elbow to shoulder) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm pain/ throbbing in arm), MUSCULAR WEAKNESS (Arm feels weak from elbow to shoulder) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported  No treatment medication was reported
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headaches) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced HEADACHE (severe headaches). At the time of the report, HEADACHE (severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Pump on right arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Pump on right arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Pump on right arm). At the time of the report, PERIPHERAL SWELLING (Pump on right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Lymph node pain, Pyrexia, Vaccination site pain
Clinical narrative: he felt lethargic; headache; low grade fever; lymph nodes under his left arm was very sore; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (he felt lethargic), HEADACHE (headache), PYREXIA (low grade fever), LYMPH NODE PAIN (lymph nodes under his left arm was very sore) and VACCINATION SITE PAIN (soreness at injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K202A and 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ), ACETYLSALICYLIC ACID (ASPIRIN 81), UBIDECARENONE (COQ10 [UBIDECARENONE]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-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 LETHARGY (he felt lethargic), HEADACHE (headache), PYREXIA (low grade fever), LYMPH NODE PAIN (lymph nodes under his left arm was very sore) and VACCINATION SITE PAIN (soreness at injection site). At the time of the report, LETHARGY (he felt lethargic), HEADACHE (headache), PYREXIA (low grade fever), LYMPH NODE PAIN (lymph nodes under his left arm was very sore) and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on 30-JUN-2021. contains no new information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: he felt lethargic; headache; low grade fever; lymph nodes under his left arm was very sore; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (he felt lethargic), HEADACHE (headache), PYREXIA (low grade fever), LYMPH NODE PAIN (lymph nodes under his left arm was very sore) and VACCINATION SITE PAIN (soreness at injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K202A and 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ), ACETYLSALICYLIC ACID (ASPIRIN 81), UBIDECARENONE (COQ10 [UBIDECARENONE]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-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 LETHARGY (he felt lethargic), HEADACHE (headache), PYREXIA (low grade fever), LYMPH NODE PAIN (lymph nodes under his left arm was very sore) and VACCINATION SITE PAIN (soreness at injection site). At the time of the report, LETHARGY (he felt lethargic), HEADACHE (headache), PYREXIA (low grade fever), LYMPH NODE PAIN (lymph nodes under his left arm was very sore) and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on 30-JUN-2021. contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: IS IT NORMAL TO HAVE A HEADACHE FOR OVER 4 DAYS; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (IS IT NORMAL TO HAVE A HEADACHE FOR OVER 4 DAYS) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 HEADACHE (IS IT NORMAL TO HAVE A HEADACHE FOR OVER 4 DAYS). At the time of the report, HEADACHE (IS IT NORMAL TO HAVE A HEADACHE FOR OVER 4 DAYS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I been feeling a little dizzy the last few days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I been feeling a little dizzy the last few days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I been feeling a little dizzy the last few days). At the time of the report, DIZZINESS (I been feeling a little dizzy the last few days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain
Clinical narrative: bone pain; joint pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone pain) and ARTHRALGIA (joint pain) 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 21-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 an unknown date, the patient experienced BONE PAIN (bone pain) and ARTHRALGIA (joint pain). At the time of the report, BONE PAIN (bone pain) and ARTHRALGIA (joint pain) outcome was unknown.            No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-200584 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash macular
Clinical narrative: red blotches; itching (fire ants); arm swelled a little; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotches), PRURITUS (itching (fire ants)) and PERIPHERAL SWELLING (arm swelled a little) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergies to several medications but not severe).    On 30-May-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 RASH MACULAR (red blotches), PRURITUS (itching (fire ants)) and PERIPHERAL SWELLING (arm swelled a little). At the time of the report, RASH MACULAR (red blotches), PRURITUS (itching (fire ants)) and PERIPHERAL SWELLING (arm swelled a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that pharmacist did go over his medication. Patient took b  No relevant concomitant medications were reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Vaccination site pain
Clinical narrative: limited tenderness in the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (limited tenderness in the vaccination site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D44A21A and 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (limited tenderness in the vaccination site). On 17-Mar-2021, VACCINATION SITE PAIN (limited tenderness in the vaccination site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Antibody test: negative (Negative) Antibody test Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Relevant concomitant medications included, immunosuppressant medications for Crohn's disease.   Treatment information was not provided.   This case was linked to MOD-2021-200636 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Myalgia
Clinical narrative: Muscle soreness; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MYALGIA (Muscle soreness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PROGESTERONE (Progesterone suppository to prevent shortening of cervix and but was stopped at 32 weeks.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 23-Apr-2020 and the estimated date of delivery was 26-Jan-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced MYALGIA (Muscle soreness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-sixth week of the pregnancy. The delivery occurred, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. There were no complications, except the baby was in NICU for 3 days for respiratory issue because he swallowed some fluid while he was coming out. On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, MYALGIA (Muscle soreness) outcome was unknown.            No treatment products reported   This case was linked to MOD-2021-202164 (Parent-Child Link). This case was linked to MOD-2021-200726 (Patient Link).   See case MOD-2021-202164 for details regarding the child case.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Covid arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Covid arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Covid arm). At the time of the report, VACCINATION SITE PAIN (Covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.    This case was linked to MOD-2021-200520.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose past day 35 from first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose past day 35 from first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose past day 35 from first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose past day 35 from first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff neck after sever weeks; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck after sever weeks) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck after sever weeks). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck after sever weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given the 2nd moderna shot on day 22 after the 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the 2nd moderna shot on day 22 after the 1st dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 004B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the 2nd moderna shot on day 22 after the 1st dose). On 01-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given the 2nd moderna shot on day 22 after the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable   This case was linked to MOD-2021-200299 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Headache
Clinical narrative: stay hot; keeping headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (stay hot) and HEADACHE (keeping headache) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (stay hot) and HEADACHE (keeping headache). At the time of the report, FEELING HOT (stay hot) and HEADACHE (keeping headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: second dose extended beyond 35 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose extended beyond 35 days) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included General physical health deterioration (unspecified health issues).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose extended beyond 35 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose extended beyond 35 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  The patient was hospitalized after vaccination, but his health care professional thought that it was related to his unspecified health issues.  Treatment medication was not provided by the reporter.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Vaccination site pain
Clinical narrative: limited tenderness in the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (limited tenderness in the vaccination site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (limited tenderness in the vaccination site). On 14-Apr-2021, VACCINATION SITE PAIN (limited tenderness in the vaccination site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Antibody test: negative (Negative) Antibody test negative.         Relevant concomitant medications included, immunosuppressant medications for Crohn's disease.  Treatment information was not provided.   This case was linked to MOD-2021-200567 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Tired; Sore after first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and MYALGIA (Sore after first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-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 FATIGUE (Tired) and MYALGIA (Sore after first dose). The patient was treated with CELECOXIB (CELEBREX) at an unspecified dose and frequency and CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRIN) at an unspecified dose and frequency. At the time of the report, FATIGUE (Tired) and MYALGIA (Sore after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned.
Sex: U
Vaccine: COVID19
Symptoms: Pollakiuria, Vaginal haemorrhage
Clinical narrative: light vaginal bleeding; little of frequent urination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (light vaginal bleeding) and POLLAKIURIA (little of frequent urination) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (light vaginal bleeding) and POLLAKIURIA (little of frequent urination). At the time of the report, VAGINAL HAEMORRHAGE (light vaginal bleeding) and POLLAKIURIA (little of frequent urination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Haematuria, Pollakiuria, Urine analysis, Vaginal haemorrhage
Clinical narrative: Blood in the urine; vaginal bleeding; Frequent urination; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (Blood in the urine), VAGINAL HAEMORRHAGE (vaginal bleeding) and POLLAKIURIA (Frequent urination) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE, LISINOPRIL, ESCITALOPRAM, ATORVASTATIN, LEVOTHYROXINE and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication, ANASTROZOLE.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced HAEMATURIA (Blood in the urine), VAGINAL HAEMORRHAGE (vaginal bleeding) and POLLAKIURIA (Frequent urination). At the time of the report, HAEMATURIA (Blood in the urine), VAGINAL HAEMORRHAGE (vaginal bleeding) and POLLAKIURIA (Frequent urination) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Urine analysis: negative (Negative) negative for UTI infection.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information regarding corrective treatment was reported by the patient. Caller reported patient's doctor's visit is scheduled for the first week of July.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received :New event was added, lab test added, AE outcomes and contact email was updated. Clinical course updated.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: breaking out in little boils, HCP stated it was a swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (breaking out in little boils, HCP stated it was a swollen lymph node) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 031B21A) 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 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (breaking out in little boils, HCP stated it was a swollen lymph node). At the time of the report, LYMPHADENOPATHY (breaking out in little boils, HCP stated it was a swollen lymph node) outcome was unknown.            This case was linked to MOD-2021-101675 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extreme fatigue after first dose but it gradually improved; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue after first dose but it gradually improved) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (extreme fatigue after first dose but it gradually improved). At the time of the report, FATIGUE (extreme fatigue after first dose but it gradually improved) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitants included. No Treatment mentioned.   This case was linked to MOD-2021-200705 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (still have the fatigue) and FATIGUE (After 3/28 2nd dose, 5 days later I again had extreme fatigue times 10/can describe as chemo fatigue which I had after chemotherapy) 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 28-Mar-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 02-Jun-2021, the patient experienced FATIGUE (still have the fatigue). On an unknown date, the patient experienced FATIGUE (After 3/28 2nd dose, 5 days later I again had extreme fatigue times 10/can describe as chemo fatigue which I had after chemotherapy). At the time of the report, FATIGUE (still have the fatigue) and FATIGUE (After 3/28 2nd dose, 5 days later I again had extreme fatigue times 10/can describe as chemo fatigue which I had after chemotherapy) outcome was unknown. No concomitant medication provided. No treatment medication provided. Reporter did not allow further contact.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16-year old patient who received one dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year old patient who received one dose of the Moderna Covid-19 vaccine) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year old patient who received one dose of the Moderna Covid-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year old patient who received one dose of the Moderna Covid-19 vaccine) 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.   No concomitant medications were reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I had a covid tounge reaction to the first Moderna Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had a covid tounge reaction to the first Moderna Vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had a covid tounge reaction to the first Moderna Vaccine). At the time of the report, VACCINATION COMPLICATION (I had a covid tounge reaction to the first Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient enquired about need my second dose, after getting reaction after first dose  Concomitant medication not reported and Treatment medication was not provided   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: feeling abnormal; Muscle aches; Low grade fever; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling abnormal), MYALGIA (Muscle aches) and PYREXIA (Low grade fever) in a 39-year-old female patient (para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PROGESTERONE (suppository to prevent shortening of cervix and but she stopped it at 32 weeks.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 23-Apr-2021 and the estimated date of delivery was 26-Jan-2021. On an unknown date, the patient experienced FEELING ABNORMAL (feeling abnormal), MYALGIA (Muscle aches) and PYREXIA (Low grade fever). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The vaginal delivery occurred on 15-Jan-2021, which was reported as Normal Pregnancy Outcome. For neonate 1, There were no complications, except the baby was in NICU for 3 days for respiratory issue because he swallowed some fluid while he was coming out. At the time of the report, FEELING ABNORMAL (feeling abnormal), MYALGIA (Muscle aches) and PYREXIA (Low grade fever) outcome was unknown.            No treatment information was reported by the reporter   This case was linked to MOD-2021-202164 (Parent-Child Link). This case was linked to MOD-2021-200573 (Patient Link).   See case MOD-2021-202164 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Followup document was received pregnancy details were updated
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received second dose beyond 36 days after the first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose beyond 36 days after the first dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose beyond 36 days after the first dose). On 02-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose beyond 36 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. No treatment medication reported.   Action taken with mRNA-1273 in response to event was not applicable.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Face oedema, Oedema peripheral, Pruritus, Rash macular
Clinical narrative: itchiness; red spots on face/bumps all over the body; swollen face; Swollen legs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), RASH MACULAR (red spots on face/bumps all over the body), FACE OEDEMA (swollen face) and OEDEMA PERIPHERAL (Swollen legs) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced PRURITUS (itchiness), RASH MACULAR (red spots on face/bumps all over the body), FACE OEDEMA (swollen face) and OEDEMA PERIPHERAL (Swollen legs). At the time of the report, PRURITUS (itchiness), RASH MACULAR (red spots on face/bumps all over the body), FACE OEDEMA (swollen face) and OEDEMA PERIPHERAL (Swollen legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case is for a social media group patient is part of, and a group of people ( Not identified) who have same symptoms as his , which is Tinnitus. No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD21-106092, MOD21-106102 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: mild arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (mild arm pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced PAIN IN EXTREMITY (mild arm pain). On 25-Apr-2021, PAIN IN EXTREMITY (mild arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was reported by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Depressed mood, Pyrexia
Clinical narrative: I feel like crap; High fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (I feel like crap) and PYREXIA (High fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (I feel like crap) and PYREXIA (High fever). At the time of the report, DEPRESSED MOOD (I feel like crap) and PYREXIA (High fever) outcome was unknown.            No concomitant medication provided.  No treatment medication provided.   Reporter did not allow further contact
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Head discomfort, Headache, Tinnitus
Clinical narrative: 5 weeks of Tinnitus \ ear ringing \ ear cracking; ear pressure; head pressure; mild headaches in different parts of the head; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (5 weeks of Tinnitus \ ear ringing \ ear cracking), EAR DISCOMFORT (ear pressure), HEAD DISCOMFORT (head pressure) and HEADACHE (mild headaches in different parts of the head) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced EAR DISCOMFORT (ear pressure), HEAD DISCOMFORT (head pressure) and HEADACHE (mild headaches in different parts of the head). On 24-Apr-2021, the patient experienced TINNITUS (5 weeks of Tinnitus \ ear ringing \ ear cracking). At the time of the report, TINNITUS (5 weeks of Tinnitus \ ear ringing \ ear cracking), EAR DISCOMFORT (ear pressure), HEAD DISCOMFORT (head pressure) and HEADACHE (mild headaches in different parts of the head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.   This case was linked to MOD21-106101, MOD21-106102 (E2B Linked Report).; Sender's Comments:  MOD21-106101: MOD21-106102: