chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Photopsia, Vision blurred, Visual impairment, Vitreous floaters
Clinical narrative: Specs or floaters in eyes; Hazed over eye like cateract is returning; flash of light in left eye when looks to right/ flash of light in right eye when looks to left; Vision impaired; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (Specs or floaters in eyes), VISION BLURRED (Hazed over eye like cataract is returning), PHOTOPSIA (flash of light in left eye when looks to right/ flash of light in right eye when looks to left) and VISUAL IMPAIRMENT (Vision impaired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included Cataract (right) (First cataract surgery on right eye) on 10-Dec-2020 and Cataract (left) (Second cataract surgery on left eye) on 05-Jan-2021.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-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 VITREOUS FLOATERS (Specs or floaters in eyes), VISION BLURRED (Hazed over eye like cateract is returning), PHOTOPSIA (flash of light in left eye when looks to right/ flash of light in right eye when looks to left   ) and VISUAL IMPAIRMENT (Vision impaired). At the time of the report, VITREOUS FLOATERS (Specs or floaters in eyes), VISION BLURRED (Hazed over eye like cateract is returning), PHOTOPSIA (flash of light in left eye when looks to right/ flash of light in right eye when looks to left   ) and VISUAL IMPAIRMENT (Vision impaired) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: chronic cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (chronic cough) 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, 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 COUGH (chronic cough). At the time of the report, COUGH (chronic cough) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported.   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anal haemorrhage, Blood iron decreased, Product dose omission issue
Clinical narrative: Patient stated she had red liquid come out with her bowel movement; Caller does not want to receive the second dose; tired blood" or "not enough iron in your blood; This spontaneous case was reported by a consumer and describes the occurrence of ANAL HAEMORRHAGE (Patient stated she had red liquid come out with her bowel movement), PRODUCT DOSE OMISSION ISSUE (Caller does not want to receive the second dose) and BLOOD IRON DECREASED (tired blood" or "not enough iron in your blood) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included Immune system disorder (Weak immune system and frail) and Rash (Rash allergy). Concurrent medical conditions included Leukemia.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAL HAEMORRHAGE (Patient stated she had red liquid come out with her bowel movement), PRODUCT DOSE OMISSION ISSUE (Caller does not want to receive the second dose) and BLOOD IRON DECREASED (tired blood" or "not enough iron in your blood). At the time of the report, ANAL HAEMORRHAGE (Patient stated she had red liquid come out with her bowel movement), PRODUCT DOSE OMISSION ISSUE (Caller does not want to receive the second dose) and BLOOD IRON DECREASED (tired blood" or "not enough iron in your blood) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up received on 17-JUN-2021 contains no new information On 20-Jun-2021: Patient contact information updated and event added
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a study coodinator and describes the occurrence of FATIGUE (Tiredness) in a 51-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) injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Thermal burn
Clinical narrative: Estradiol Transdermal system causing burning; This spontaneous case was reported by a consumer and describes the occurrence of THERMAL BURN (Estradiol Transdermal system causing burning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERMAL BURN (Estradiol Transdermal system causing burning). At the time of the report, THERMAL BURN (Estradiol Transdermal system causing burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to AE-2021-8730 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  AE-2021-8730:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative
Clinical narrative: Did not have antibodies; This spontaneous case was reported by an other and describes the occurrence of ANTIBODY TEST NEGATIVE (Did not have antibodies) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Did not have antibodies). At the time of the report, ANTIBODY TEST NEGATIVE (Did not have antibodies) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment information provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pyrexia
Clinical narrative: She cant move; She has high fever that doesn't want to break; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (She cant move) and PYREXIA (She has high fever that doesn't want to break) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-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 18-May-2021, the patient experienced HYPOKINESIA (She cant move) and PYREXIA (She has high fever that doesn't want to break). At the time of the report, HYPOKINESIA (She cant move) and PYREXIA (She has high fever that doesn't want to break) outcome was unknown.            The action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: vaccine exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk) in a 2-month-old infant of an unknown gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    MEDICAL HISTORY (Patient): No medical history was provided by the reporter.    On 03-Mar-2021, the mother received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, 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 03-Mar-2021, the infant was diagnosed with EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk). At the time of the report, EXPOSURE VIA BREAST MILK (vaccine exposure via breast milk) had resolved.            No Concomitant and Treatment medicines were Reported  Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-032346 (Parent-Child Link).   See case MOD-2021-032346 for details regarding the Parent case.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms for 3 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 INFLUENZA LIKE ILLNESS (flu like symptoms for 3 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   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 INFLUENZA LIKE ILLNESS (flu like symptoms for 3 days). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms for 3 days) had resolved.            No concomitant and treatment medications were provided
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: Platelet count decreased; This spontaneous case was reported by a physician and describes the occurrence of PLATELET COUNT DECREASED (Platelet count decreased) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) tablet for Myelofibrosis.    Concomitant products included CANNABIS, SIMETICONE (ALKA SELTZER ANTI GAS), IBUPROFEN, GABAPENTIN, OMEPRAZOLE, BISACODYL (DULCOLAX [BISACODYL]) and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL AND HYDROCHLOROTHIAZIDE) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram twice a day. On an unknown date, the patient experienced PLATELET COUNT DECREASED (Platelet count decreased). At the time of the report, PLATELET COUNT DECREASED (Platelet count decreased) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 48,000 (Low) Platelet Count decreased from 60,000 to 48,000.     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 Treatment medications was provided by the reporter.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: Vaccine response impaired; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Vaccine response impaired) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In November 2020, the patient started UPADACITINIB (RINVOQ) (unknown route) 15 milligram. In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. In January 2021, the patient experienced VACCINATION FAILURE (Vaccine response impaired). At the time of the report, VACCINATION FAILURE (Vaccine response impaired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 antibody test: negative (Negative) Found that body did not develop antibodies..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.   No treatment information was provided.  Company comment: This report refers to a case of vaccination failure for mRNA-1273, lot # unknown with no associated AEs.; Sender's Comments: This report refers to a case of vaccination failure for mRNA-1273, lot # unknown with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: Joint pain; fever; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), PYREXIA (fever) and MYALGIA (Muscle ache) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SEMAGLUTIDE (OZEMPIC) and INSULIN DEGLUDEC (TRESIBA) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain), PYREXIA (fever) and MYALGIA (Muscle ache). At the time of the report, ARTHRALGIA (Joint pain), PYREXIA (fever) and MYALGIA (Muscle ache) outcome was unknown.            Concomitant medication not provided. Treatment medication not provided
Sex: F
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: Lost sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Lost sense of smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ANOSMIA (Lost sense of smell). At the time of the report, ANOSMIA (Lost sense of smell) outcome was unknown.            No concomitants medications was reported.  No treatments medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Follow-up included no new information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: mild reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (mild reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (mild reaction). At the time of the report, VACCINATION COMPLICATION (mild reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's concomitant medications were not reported.   No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Second shot gave him a bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Second shot gave him a bad 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Second shot gave him a bad headache). At the time of the report, HEADACHE (Second shot gave him a bad headache) had resolved.            Reporter has mentioned, Patient's nephewhad really bad headache after second dose, and lasted for 12 hours and went away.  No relevant Concomitant medications information was given by Reporter.  No Treatment medication information was given by Reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: increased blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (increased blood pressure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced BLOOD PRESSURE INCREASED (increased blood pressure). At the time of the report, BLOOD PRESSURE INCREASED (increased blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood pressure increased: 135/190 (Inconclusive) Patient reported blood pressure increased, from about 135 to 190 systolic..         No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Sputum discoloured
Clinical narrative: Grey phlegm; This spontaneous case was reported by a consumer and describes the occurrence of SPUTUM DISCOLOURED (Grey phlegm) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.   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 SPUTUM DISCOLOURED (Grey phlegm). At the time of the report, SPUTUM DISCOLOURED (Grey phlegm) outcome was unknown.            No concomitant medication were reported. No treatment information was reported  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: got my first shot yesterday and am experiencing chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (got my first shot yesterday and am experiencing chest 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 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced CHEST PAIN (got my first shot yesterday and am experiencing chest pain). At the time of the report, CHEST PAIN (got my first shot yesterday and am experiencing chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Gait inability, Headache
Clinical narrative: Can't walk; Can't bend down; Very dizzy; Fever; the head hurts; feel pain in the right arm/whole body hurts/pain below her hips; Pain below her hips; Patient can't do anything; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Can't walk), HYPOKINESIA (Can't bend down), DIZZINESS (Very dizzy), PYREXIA (Fever) and HEADACHE (the head hurts) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 50AD27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included METOPROLOL, ATORVASTATIN, PROPAFENONE, VITAMIN B12 [VITAMIN B12 NOS], BORAGO OFFICINALIS OIL, FISH OIL, LINUM USITATISSIMUM OIL (TRIPLE OMEGA 3 6 9) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced GAIT INABILITY (Can't walk), HYPOKINESIA (Can't bend down), DIZZINESS (Very dizzy), PYREXIA (Fever), HEADACHE (the head hurts), MYALGIA (feel pain in the right arm/whole body hurts/pain below her hips), ARTHRALGIA (Pain below her hips) and FATIGUE (Patient can't do anything). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, GAIT INABILITY (Can't walk), HYPOKINESIA (Can't bend down), DIZZINESS (Very dizzy), PYREXIA (Fever), HEADACHE (the head hurts), MYALGIA (feel pain in the right arm/whole body hurts/pain below her hips), ARTHRALGIA (Pain below her hips) and FATIGUE (Patient can't do anything) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Additional information included updated outcome.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Myalgia, Pyrexia
Clinical narrative: Can't walk; Can't bend down; Very dizzy; Fever; the head hurts; feel pain in the right arm/whole body hurts/pain below her hips; Pain below her hips; Patient can't do anything; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Can't walk), HYPOKINESIA (Can't bend down), DIZZINESS (Very dizzy), PYREXIA (Fever) and HEADACHE (the head hurts) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 50AD27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included METOPROLOL, ATORVASTATIN, PROPAFENONE, VITAMIN B12 [VITAMIN B12 NOS], BORAGO OFFICINALIS OIL, FISH OIL, LINUM USITATISSIMUM OIL (TRIPLE OMEGA 3 6 9) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced GAIT INABILITY (Can't walk), HYPOKINESIA (Can't bend down), DIZZINESS (Very dizzy), PYREXIA (Fever), HEADACHE (the head hurts), MYALGIA (feel pain in the right arm/whole body hurts/pain below her hips), ARTHRALGIA (Pain below her hips) and FATIGUE (Patient can't do anything). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, GAIT INABILITY (Can't walk), HYPOKINESIA (Can't bend down), DIZZINESS (Very dizzy), PYREXIA (Fever), HEADACHE (the head hurts), MYALGIA (feel pain in the right arm/whole body hurts/pain below her hips), ARTHRALGIA (Pain below her hips) and FATIGUE (Patient can't do anything) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Additional information included updated outcome.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Pretty negative reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Pretty negative reaction) 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) 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 VACCINATION COMPLICATION (Pretty negative reaction). At the time of the report, VACCINATION COMPLICATION (Pretty negative reaction) outcome was unknown.            No concomitant medications were provided No treatment medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: She  had a lot of reactions to the Moderna injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She  had a lot of reactions to the Moderna injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (She  had a lot of reactions to the Moderna injection). At the time of the report, VACCINATION COMPLICATION (She  had a lot of reactions to the Moderna injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 12 hrs of 1st puncture of vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment drug details was included.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: She describe the rash as red and dark; Rash everywhere all over her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (She describe the rash as red and dark) and RASH (Rash everywhere all over her body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) and CLOPIDOGREL for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-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 RASH ERYTHEMATOUS (She describe the rash as red and dark) and RASH (Rash everywhere all over her body). At the time of the report, RASH ERYTHEMATOUS (She describe the rash as red and dark) and RASH (Rash everywhere all over her body) outcome was unknown.            No Treatment Medications were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: A patient received 1st dose 65 days ago and hasn't received 2nd dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (A patient received 1st dose 65 days ago and hasn't received 2nd dose yet) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included BP, COPD and Diabetes.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (A patient received 1st dose 65 days ago and hasn't received 2nd dose yet). On 13-Apr-2021, PRODUCT DOSE OMISSION ISSUE (A patient received 1st dose 65 days ago and hasn't received 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported. Patient took 2nd dose on 17-jun-2021, Batch no. 014C21A, Intramuscular, LEFT DELTOID, with no Event reported in FU-1   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant FU - Patient demographics provided, batch number provided, Reporter location
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema, Pain in extremity, Pruritus, Vaccination site hypersensitivity, Vaccination site swelling
Clinical narrative: pain in arm; allergic reaction in left upper arm; edema; itching; developed bump around shot/progressing bumps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), VACCINATION SITE HYPERSENSITIVITY (allergic reaction in left upper arm), OEDEMA (edema), PRURITUS (itching) and VACCINATION SITE SWELLING (developed bump around shot/progressing bumps) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm), VACCINATION SITE HYPERSENSITIVITY (allergic reaction in left upper arm), OEDEMA (edema), PRURITUS (itching) and VACCINATION SITE SWELLING (developed bump around shot/progressing bumps). The patient was treated with HISTAMINE at a dose of 1 dosage form and DEXAMETHASONE SODIUM PHOSPHATE (CORTICOIDEX) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain in arm), VACCINATION SITE HYPERSENSITIVITY (allergic reaction in left upper arm), OEDEMA (edema), PRURITUS (itching) and VACCINATION SITE SWELLING (developed bump around shot/progressing bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not reported.  Oral Histamine and Corticoid cream were taken as Treatment medications.  Patient was also applying cold compress. Patient scheduled for second dose next week at the time of reporting and the doctor suggested performing adjuvant testing to see if she has some type of allergic reaction.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow up received which contains no new information.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Full body rash/Still experiencing a rash; Sore arm (first dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm (first dose)) and RASH (Full body rash/Still experiencing a rash) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm (first dose)). On 06-Apr-2021, the patient experienced RASH (Full body rash/Still experiencing a rash). On 04-Mar-2021, PAIN IN EXTREMITY (Sore arm (first dose)) had resolved. At the time of the report, RASH (Full body rash/Still experiencing a rash) had not resolved.            No Concomitant medications reported.No treatment medications reported. 3 more biopsy's completed and medical info   This case was linked to MOD-2021-225630 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant follow up- Outcome of event- updated
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue, Urticaria
Clinical narrative: immediately broke out in a rash (hives); First dose in April and still did not the take the second shot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (immediately broke out in a rash (hives)) and PRODUCT DOSE OMISSION ISSUE (First dose in April and still did not the take the second shot) 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 URTICARIA (immediately broke out in a rash (hives)) and PRODUCT DOSE OMISSION ISSUE (First dose in April and still did not the take the second shot). At the time of the report, URTICARIA (immediately broke out in a rash (hives)) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (First dose in April and still did not the take the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose administered  7Apr2021 - 2nd dose not administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose administered  7Apr2021 - 2nd dose not administered) in a 27-year-old male patient 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 an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose administered  7Apr2021 - 2nd dose not administered). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose administered  7Apr2021 - 2nd dose not administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications are provided.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: Sniffles; A cold; 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 RHINORRHOEA (Sniffles) and NASOPHARYNGITIS (A cold) 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.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Sniffles) and NASOPHARYNGITIS (A cold). At the time of the report, RHINORRHOEA (Sniffles) and NASOPHARYNGITIS (A cold) 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 medications were provided. Treatment medications were unknown.    Reporter did not allow further contact
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Limb discomfort, Rash
Clinical narrative: Full body rash/ Still experiencing a rash; Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Sore arm), RASH (Full body rash/ Still experiencing a rash) and CHILLS (Chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced LIMB DISCOMFORT (Sore arm) and CHILLS (Chills). On 06-Apr-2021, the patient experienced RASH (Full body rash/ Still experiencing a rash). The patient was treated with PREDNISONE for Rash, at a dose of UNK, cyclical and FLUOCINONIDE (topical) for Rash, at a dose of 0.05 %. On 01-Apr-2021, LIMB DISCOMFORT (Sore arm) and CHILLS (Chills) had resolved. At the time of the report, RASH (Full body rash/ Still experiencing a rash) outcome was unknown.            Lab data - Biopsy  No concomitant medications provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received contains significant information. One event is not recovered. On 03-Aug-2021: Non-sig follow-up added.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Dysstasia, Fall, Gait disturbance
Clinical narrative: walking difficulty; arthritis; sciatic nerve pain/knees and shoulders are bone on bone; difficulty standing and walking; pain/more pain than she normally had; muscle pain; joint pain/more joint pain; fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fall), GAIT DISTURBANCE (walking difficulty), ARTHRITIS (arthritis), SCIATICA (sciatic nerve pain/knees and shoulders are bone on bone) and DYSSTASIA (difficulty standing and walking) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-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) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced FALL (fall). On an unknown date, the patient experienced GAIT DISTURBANCE (walking difficulty), ARTHRITIS (arthritis), SCIATICA (sciatic nerve pain/knees and shoulders are bone on bone), DYSSTASIA (difficulty standing and walking), PAIN (pain/more pain than she normally had), MYALGIA (muscle pain) and ARTHRALGIA (joint pain/more joint pain). The patient was treated with CORTISONE in July 2021 for Adverse event, at a dose of cortisone injection in both knees. At the time of the report, FALL (fall), GAIT DISTURBANCE (walking difficulty), ARTHRITIS (arthritis), SCIATICA (sciatic nerve pain/knees and shoulders are bone on bone), DYSSTASIA (difficulty standing and walking), PAIN (pain/more pain than she normally had), MYALGIA (muscle pain) and ARTHRALGIA (joint pain/more joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: revealed arthritis (abnormal) revealed arthritis.         Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up contains additional events difficulty in standing, sciatic nerve pain and treatment product.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Sciatica, X-ray
Clinical narrative: walking difficulty; arthritis; sciatic nerve pain/knees and shoulders are bone on bone; difficulty standing and walking; pain/more pain than she normally had; muscle pain; joint pain/more joint pain; fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fall), GAIT DISTURBANCE (walking difficulty), ARTHRITIS (arthritis), SCIATICA (sciatic nerve pain/knees and shoulders are bone on bone) and DYSSTASIA (difficulty standing and walking) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-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) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced FALL (fall). On an unknown date, the patient experienced GAIT DISTURBANCE (walking difficulty), ARTHRITIS (arthritis), SCIATICA (sciatic nerve pain/knees and shoulders are bone on bone), DYSSTASIA (difficulty standing and walking), PAIN (pain/more pain than she normally had), MYALGIA (muscle pain) and ARTHRALGIA (joint pain/more joint pain). The patient was treated with CORTISONE in July 2021 for Adverse event, at a dose of cortisone injection in both knees. At the time of the report, FALL (fall), GAIT DISTURBANCE (walking difficulty), ARTHRITIS (arthritis), SCIATICA (sciatic nerve pain/knees and shoulders are bone on bone), DYSSTASIA (difficulty standing and walking), PAIN (pain/more pain than she normally had), MYALGIA (muscle pain) and ARTHRALGIA (joint pain/more joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: revealed arthritis (abnormal) revealed arthritis.         Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up contains additional events difficulty in standing, sciatic nerve pain and treatment product.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Supposed to have second shot on 6/3 and missed date; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Supposed to have second shot on 6/3 and missed date) 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 PRODUCT DOSE OMISSION ISSUE (Supposed to have second shot on 6/3 and missed date). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Supposed to have second shot on 6/3 and missed date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.  Patient received second dose on 17-JUN-2021 and had sore arm after second shot.   This case was linked to MOD-2021-259904 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Followup received on 16-JUL-2021 contains no new information.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product dispensing error
Clinical narrative: Administered vaccine after 12 hrs of 1st puncture of vial; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DISPENSING ERROR (Administered vaccine after 12 hrs of 1st puncture of vial) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No medical history was reported.     On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced PRODUCT DISPENSING ERROR (Administered vaccine after 12 hrs of 1st puncture of vial). On 16-Jun-2021, PRODUCT DISPENSING ERROR (Administered vaccine after 12 hrs of 1st puncture of vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant  information was  provided. No Treatment information was  provided.