chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Flushing, Myalgia, Pain in extremity
Clinical narrative: hands were shaking; very bad hot and cold flashes; legs was hurting; fever of 101 point five; body aches/belly aches; diarrhea; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (hands were shaking), FLUSHING (very bad hot and cold flashes), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (legs was hurting) and PYREXIA (fever of 101 point five) in a  patient of an unknown age and gender 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 was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced DIARRHOEA (diarrhea). On an unknown date, the patient experienced TREMOR (hands were shaking), FLUSHING (very bad hot and cold flashes), PAIN IN EXTREMITY (legs was hurting), PYREXIA (fever of 101 point five) and MYALGIA (body aches/belly aches). At the time of the report, TREMOR (hands were shaking), FLUSHING (very bad hot and cold flashes), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (legs was hurting), PYREXIA (fever of 101 point five) and MYALGIA (body aches/belly aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature (Unknown-98): 101.5 (Inconclusive) INCONCLUSIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: hands were shaking; very bad hot and cold flashes; legs was hurting; fever of 101 point five; body aches/belly aches; diarrhea; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (hands were shaking), FLUSHING (very bad hot and cold flashes), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (legs was hurting) and PYREXIA (fever of 101 point five) in a  patient of an unknown age and gender 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 was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced DIARRHOEA (diarrhea). On an unknown date, the patient experienced TREMOR (hands were shaking), FLUSHING (very bad hot and cold flashes), PAIN IN EXTREMITY (legs was hurting), PYREXIA (fever of 101 point five) and MYALGIA (body aches/belly aches). At the time of the report, TREMOR (hands were shaking), FLUSHING (very bad hot and cold flashes), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (legs was hurting), PYREXIA (fever of 101 point five) and MYALGIA (body aches/belly aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature (Unknown-98): 101.5 (Inconclusive) INCONCLUSIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st dose of the Moderna Covid-19 vaccine on 18Feb2021 and wants to get the 2nd dose today (19Jul2021); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose of the Moderna Covid-19 vaccine on 18Feb2021 and wants to get the 2nd dose today (19Jul2021)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose of the Moderna Covid-19 vaccine on 18Feb2021 and wants to get the 2nd dose today (19Jul2021)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose of the Moderna Covid-19 vaccine on 18Feb2021 and wants to get the 2nd dose today (19Jul2021)) 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. Treatment information not provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Malaise, SARS-CoV-2 test
Clinical narrative: He had a cough; has not been feeling good; Tested positive for COVID19 after receiving Moderna vaccine/came down with COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID19 after receiving Moderna vaccine/came down with COVID), COUGH (He had a cough) and MALAISE (has not been feeling good) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced COVID-19 (Tested positive for COVID19 after receiving Moderna vaccine/came down with COVID). On an unknown date, the patient experienced COUGH (He had a cough) and MALAISE (has not been feeling good). At the time of the report, COVID-19 (Tested positive for COVID19 after receiving Moderna vaccine/came down with COVID) and MALAISE (has not been feeling good) outcome was unknown and COUGH (He had a cough) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, SARS-CoV-2 test: positive (Positive) tested positive.         Concomitant medications were not reported.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Added Start date for both the doses of Suspect vaccine, New event Feeling unwell was added, Verbatim for the event Covid 19 was updated and outcome of the event Cough updated from unknown to Not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Pharyngeal swelling, Product dose omission issue, Rash
Clinical narrative: Throat swelling; feeling disoriented; Did not receive the 2nd dose within 25-35 days of getting the 1st dose; rash on her forehead; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat swelling), DISORIENTATION (feeling disoriented), PRODUCT DOSE OMISSION ISSUE (Did not receive the 2nd dose within 25-35 days of getting the 1st dose) and RASH (rash on her forehead) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (Throat swelling), DISORIENTATION (feeling disoriented), PRODUCT DOSE OMISSION ISSUE (Did not receive the 2nd dose within 25-35 days of getting the 1st dose) and RASH (rash on her forehead). At the time of the report, PHARYNGEAL SWELLING (Throat swelling), DISORIENTATION (feeling disoriented) and RASH (rash on her forehead) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive the 2nd dose within 25-35 days of getting the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided.  No treatment medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: New event missed dose was added
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Nausea
Clinical narrative: Nausea; Worse GERD; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Worse GERD) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulpha drugs), Hiatus hernia since 2000 and GERD (6 Months of Gerd after prolia injection). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 2015 to an unknown date for Allergy, GLUCOSAMINE HYDROCHLORIDE for Arthritis, AMLODIPINE BESYLATE from 2020 to an unknown date and AZILSARTAN KAMEDOXOMIL (EDARBI) from 2010 to an unknown date for Blood pressure management, FAMOTIDINE (PEPCID AC) from 2020 to an unknown date for GERD.   On 12-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021 at 11:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Worse GERD). On an unknown date, the patient experienced NAUSEA (Nausea). The patient was treated with LANSOPRAZOLE (PREVACID) for Adverse event, at an unspecified dose and frequency; OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Adverse event, at an unspecified dose and frequency and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Adverse event, at an unspecified dose and frequency. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Worse GERD) and NAUSEA (Nausea) had not resolved.            Patient was taking an unspecified proton pump inhibitor (PPI) for a week for hiatal hernia. Two weeks after second vaccine, patient experienced nausea and GERD. It was reported that if the patient would go off the PPI, symptoms worsened. The only other time the patient had this problem for so long was after an injection of Prolia which stayed in the system for 6 months. Patient had GERD the entire 6 months and it abated as the Prolia wore off.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Illness, Myalgia, Oropharyngeal pain
Clinical narrative: had sore throat; pain all over the body; patient was sick; had body pain; patient had lucid and vivid dream; patient was sick; had lucid dream; patient was sick; had vivid and lucid dream; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of ILLNESS (patient was sick), ABNORMAL DREAMS (had vivid and lucid dream), OROPHARYNGEAL PAIN (had sore throat), ABNORMAL DREAMS (had lucid dream) and ABNORMAL DREAMS (patient had lucid and vivid dream) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to molds.   On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced the first episode of ILLNESS (patient was sick) and ABNORMAL DREAMS (had vivid and lucid dream). On 16-Jul-2021, the patient experienced ABNORMAL DREAMS (had lucid dream) and the second episode of ILLNESS (patient was sick). On 17-Jul-2021, the patient experienced ABNORMAL DREAMS (patient had lucid and vivid dream). On 18-Jul-2021, the patient experienced the third episode of ILLNESS (patient was sick) and MYALGIA (had body pain). On 19-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (had sore throat) and MYALGIA (pain all over the body). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; ZINC at a dose of 1 dosage form and COLECALCIFEROL (VITAMIN D 3) at a dose of 1 dosage form. At the time of the report, ABNORMAL DREAMS (had vivid and lucid dream), OROPHARYNGEAL PAIN (had sore throat), ABNORMAL DREAMS (had lucid dream), ABNORMAL DREAMS (patient had lucid and vivid dream), the last episode of ILLNESS (patient was sick), MYALGIA (had body pain) and MYALGIA (pain all over the body) outcome was unknown.            Apart form other treatment medication patient drunk orange juice and water to alleviate the symptoms experienced.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; 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 DIARRHOEA (Diarrhea) 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 DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Large bruise at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE BRUISING (Large bruise at injection site) 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, 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 SITE BRUISING (Large bruise at injection site). At the time of the report, VACCINATION SITE BRUISING (Large bruise at injection site) outcome was unknown.            No concomitant medications reported. No treatment reported
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Musculoskeletal stiffness, Pain, Swelling
Clinical narrative: Pain/Right hand pain when woke up/Left hand affected too; Light headedness; Swelling; Right hand stiffness when woke up/Could not close her hand in morning/Left hand affected too; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Pain/Right hand pain when woke up/Left hand affected too), DIZZINESS (Light headedness), SWELLING (Swelling) and MUSCULOSKELETAL STIFFNESS (Right hand stiffness when woke up/Could not close her hand in morning/Left hand affected too) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain/Right hand pain when woke up/Left hand affected too), DIZZINESS (Light headedness), SWELLING (Swelling) and MUSCULOSKELETAL STIFFNESS (Right hand stiffness when woke up/Could not close her hand in morning/Left hand affected too). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form; HYDROXYCHLOROQUINE for Adverse event, at a dose of 1 dosage form; MELOXICAM for Adverse event, at a dose of 1 UNK and IBUPROFEN for Adverse event, at a dose of 1 UNK. At the time of the report, PAIN (Pain/Right hand pain when woke up/Left hand affected too), DIZZINESS (Light headedness), SWELLING (Swelling) and MUSCULOSKELETAL STIFFNESS (Right hand stiffness when woke up/Could not close her hand in morning/Left hand affected too) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by reporter. for mRNA-1273 (Moderna COVID-19 Vaccine) (ntramuscular), the reporter did not provide any causality assessment.    This case was linked to MOD-2021-260283 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received punctured vial that was left overnight in a light protective box at room temperature; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received punctured vial that was left overnight in a light protective box at room temperature) 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 EXPIRED PRODUCT ADMINISTERED (Received punctured vial that was left overnight in a light protective box at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received punctured vial that was left overnight in a light protective box at room temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication was reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive today for COVID19 says "maybe it is a false positive" patient declines having symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive today for COVID19 says "maybe it is a false positive" patient declines having symptoms) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.    The patient's past medical history included COVID-19 (Patient had COVID 19 in Nov 2020 and has tested negative later) in November 2020 and Surgery (Carpal tunnel surgery).    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive today for COVID19 says "maybe it is a false positive" patient declines having symptoms).      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is taking some prescribed medications details were not provided. Patient was supposed to have elbow replacement surgery.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy) and FATIGUE (Tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 012A21A) for COVID-19 vaccination.     No specified medical history has been reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced MYALGIA (Achy) and FATIGUE (Tired). At the time of the report, MYALGIA (Achy) and FATIGUE (Tired) had resolved.            Treatment information was not provided. Concomitant medications were not provided. on 19-JUL-2021 AE contact information was updated Call was transferred from Moderna Customer Care, case # 00181349 They are inquiring about the potential of needing a booster shot.   This case was linked to MOD-2021-052885 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Insomnia, Malaise, Panic attack, Product dose omission issue
Clinical narrative: Feeling sick 2 days; Problem sleeping; Hands were trembling / Arm were trembling; Panic attack; Anxiety; Did not receive schedule 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick 2 days), INSOMNIA (Problem sleeping), TREMOR (Hands were trembling / Arm were trembling), PANIC ATTACK (Panic attack) and ANXIETY (Anxiety) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling sick 2 days), INSOMNIA (Problem sleeping), TREMOR (Hands were trembling / Arm were trembling), PANIC ATTACK (Panic attack), ANXIETY (Anxiety) and PRODUCT DOSE OMISSION ISSUE (Did not receive schedule 2nd dose). The patient was treated with ESCITALOPRAM OXALATE (LEXAPRO) for Adverse event, at a dose of 1 dosage form and ALPRAZOLAM (XANAX) for Adverse event, at a dose of 1 dosage form. At the time of the report, MALAISE (Feeling sick 2 days), INSOMNIA (Problem sleeping), TREMOR (Hands were trembling / Arm were trembling), PANIC ATTACK (Panic attack), ANXIETY (Anxiety) and PRODUCT DOSE OMISSION ISSUE (Did not receive schedule 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Feeling sick 2 days; Problem sleeping; Hands were trembling / Arm were trembling; Panic attack; Anxiety; Did not receive schedule 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick 2 days), INSOMNIA (Problem sleeping), TREMOR (Hands were trembling / Arm were trembling), PANIC ATTACK (Panic attack) and ANXIETY (Anxiety) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling sick 2 days), INSOMNIA (Problem sleeping), TREMOR (Hands were trembling / Arm were trembling), PANIC ATTACK (Panic attack), ANXIETY (Anxiety) and PRODUCT DOSE OMISSION ISSUE (Did not receive schedule 2nd dose). The patient was treated with ESCITALOPRAM OXALATE (LEXAPRO) for Adverse event, at a dose of 1 dosage form and ALPRAZOLAM (XANAX) for Adverse event, at a dose of 1 dosage form. At the time of the report, MALAISE (Feeling sick 2 days), INSOMNIA (Problem sleeping), TREMOR (Hands were trembling / Arm were trembling), PANIC ATTACK (Panic attack), ANXIETY (Anxiety) and PRODUCT DOSE OMISSION ISSUE (Did not receive schedule 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: left arm with the first one it hurt a lot; swollen under the arm / first dose swollen under the arm on left arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm with the first one it hurt a lot) and LYMPHADENOPATHY (swollen under the arm / first dose swollen under the arm on left arm.) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No medical history were reported.     On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (left arm with the first one it hurt a lot) and LYMPHADENOPATHY (swollen under the arm / first dose swollen under the arm on left arm.). At the time of the report, VACCINATION SITE PAIN (left arm with the first one it hurt a lot) and LYMPHADENOPATHY (swollen under the arm / first dose swollen under the arm on left arm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. treatment medications were not provided. No lab data has been provided by the reporter.   This case was linked to MOD-2021-260321 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Non-Significant Follow-up added on 19-Jul-2021 and contains no new information. On 19-Jul-2021: Non-Significant Follow-up added on 20-Jul-2021 and contains no new information.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: After the second one it got swollen under the right arm.; Started to feel bad; Today is the 4th day and could get out of the bed; Dizzy; Muscle pain; Fever; Chills; Headache; Very very tired/when is making breakfast for the children is like ran 10 kilometers; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Started to feel bad), PERIPHERAL SWELLING (After the second one it got swollen under the right arm.), MOBILITY DECREASED (Today is the 4th day and could get out of the bed), DIZZINESS (Dizzy) and MYALGIA (Muscle pain) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (Started to feel bad). In July 2021, the patient experienced MOBILITY DECREASED (Today is the 4th day and could get out of the bed), DIZZINESS (Dizzy), MYALGIA (Muscle pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Very very tired/when is making breakfast for the children is like ran 10 kilometers). On an unknown date, the patient experienced PERIPHERAL SWELLING (After the second one it got swollen under the right arm.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Started to feel bad), PERIPHERAL SWELLING (After the second one it got swollen under the right arm.), MOBILITY DECREASED (Today is the 4th day and could get out of the bed), DIZZINESS (Dizzy), MYALGIA (Muscle pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Very very tired/when is making breakfast for the children is like ran 10 kilometers) outcome was unknown.            No concomitant products were reported. No treatment medication were reported. The patient stated that she was being told by everyone that symptoms may last for a couple of days.   This case was linked to MOD-2021-260315 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19-Jul-2021 contains non significant information. On 19-Jul-2021: Follow-up received on 19-Jul-2021 contains non significant information.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: After the second one it got swollen under the right arm.; Started to feel bad; Today is the 4th day and could get out of the bed; Dizzy; Muscle pain; Fever; Chills; Headache; Very very tired/when is making breakfast for the children is like ran 10 kilometers; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Started to feel bad), PERIPHERAL SWELLING (After the second one it got swollen under the right arm.), MOBILITY DECREASED (Today is the 4th day and could get out of the bed), DIZZINESS (Dizzy) and MYALGIA (Muscle pain) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (Started to feel bad). In July 2021, the patient experienced MOBILITY DECREASED (Today is the 4th day and could get out of the bed), DIZZINESS (Dizzy), MYALGIA (Muscle pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Very very tired/when is making breakfast for the children is like ran 10 kilometers). On an unknown date, the patient experienced PERIPHERAL SWELLING (After the second one it got swollen under the right arm.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Started to feel bad), PERIPHERAL SWELLING (After the second one it got swollen under the right arm.), MOBILITY DECREASED (Today is the 4th day and could get out of the bed), DIZZINESS (Dizzy), MYALGIA (Muscle pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Very very tired/when is making breakfast for the children is like ran 10 kilometers) outcome was unknown.            No concomitant products were reported. No treatment medication were reported. The patient stated that she was being told by everyone that symptoms may last for a couple of days.   This case was linked to MOD-2021-260315 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19-Jul-2021 contains non significant information. On 19-Jul-2021: Follow-up received on 19-Jul-2021 contains non significant information.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: soreness at right arm injection site; swelling at right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at right arm injection site) and VACCINATION SITE SWELLING (swelling at right arm injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 04FC21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced VACCINATION SITE PAIN (soreness at right arm injection site) and VACCINATION SITE SWELLING (swelling at right arm injection site). On 04-Jun-2021, VACCINATION SITE PAIN (soreness at right arm injection site) and VACCINATION SITE SWELLING (swelling at right arm injection site) 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.   This case was linked to MOD-2021-260340 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: Was so sick for 12 hours; It was like a train ran him over but then ended right away; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was so sick for 12 hours) and FEELING ABNORMAL (It was like a train ran him over but then ended right away) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Was so sick for 12 hours) and FEELING ABNORMAL (It was like a train ran him over but then ended right away). At the time of the report, ILLNESS (Was so sick for 12 hours) and FEELING ABNORMAL (It was like a train ran him over but then ended right away) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Joint stiffness, Somnolence
Clinical narrative: Hip stiffness in both hips; Feeling sleepy; Tiredness/Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Hip stiffness in both hips), SOMNOLENCE (Feeling sleepy) and FATIGUE (Tiredness/Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04FC21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced JOINT STIFFNESS (Hip stiffness in both hips), SOMNOLENCE (Feeling sleepy) and FATIGUE (Tiredness/Fatigue). At the time of the report, JOINT STIFFNESS (Hip stiffness in both hips), SOMNOLENCE (Feeling sleepy) and FATIGUE (Tiredness/Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the Reporter. No Treatment medication was provided by the Reporter.   This case was linked to MOD-2021-260330 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: >42 days since first Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days since first Moderna vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) and MEFENAMIC ACID (ADVIL [MEFENAMIC ACID]) for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days since first Moderna vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days since first Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included Fusion cervical spine (Lumbar 3 and 4) in 2008.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore right injection site arm). On 13-Mar-2021, VACCINATION SITE PAIN (sore right injection site arm) 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 relevant concomitant medication was reported. The treatment information was not provided.   This case was linked to MOD-2021-260351 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals (sulfites), Allergy to antibiotic, Bladder cancer since 2012, Blood pressure high and Enlarged prostate. Concomitant products included FINASTERIDE (PROSCAR) for BPH, ATENOLOL (TENORMIN) for Blood pressure high, MULTIVITAMIN & MINERAL for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for BPH, at an unspecified dose and frequency and ATORVASTATIN CALCIUM (LIPTOR [ATORVASTATIN CALCIUM]) for Cholesterol blood excessive, at an unspecified dose and frequency. On 19-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: other (High) blood pressure is very high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-246742 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: accidentally injected 1600 patients with expired Moderna COVID 19 vaccine/Patient may have received vaccine after 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidentally injected 1600 patients with expired Moderna COVID 19 vaccine/Patient may have received vaccine after 30 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (accidentally injected 1600 patients with expired Moderna COVID 19 vaccine/Patient may have received vaccine after 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (accidentally injected 1600 patients with expired Moderna COVID 19 vaccine/Patient may have received vaccine after 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitants and treatments medications was reported.  The report provided is from a Nurse practitioner, reporting and enquiring regarding the expired vaccine vials. Details regarding dates administered and lot numbers (multiple) are mentioned in the report.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up information received on 20 Jul 2021 contains no significant information.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: key stuck to them like they were a magnet; 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 (key stuck to them like they were a magnet) 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 VACCINATION COMPLICATION (key stuck to them like they were a magnet). At the time of the report, VACCINATION COMPLICATION (key stuck to them like they were a magnet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Drug screen positive
Clinical narrative: Drug screen positive; This spontaneous case was reported by a consumer and describes the occurrence of DRUG SCREEN POSITIVE (Drug screen positive) 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, the patient experienced DRUG SCREEN POSITIVE (Drug screen positive). At the time of the report, DRUG SCREEN POSITIVE (Drug screen positive) outcome was unknown.            In Lab data, Drug screen was conducted on an unknown date with positive results for oxy.  No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Got scared and backed out from getting 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got scared and backed out from getting 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Depression, SIMVASTATIN (ZOCOR), CLONAZEPAM (KLONOPIN), FUROSEMIDE (LASIX [FUROSEMIDE]) and HYDROCODONE for an unknown indication.    On 29-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 PRODUCT DOSE OMISSION ISSUE (Got scared and backed out from getting 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got scared and backed out from getting 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myalgia
Clinical narrative: Dizziness; Soreness in left arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (Dizziness) and MYALGIA (Soreness in left arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE), QUETIAPINE FUMARATE (SEROQUEL), ATORVASTATIN, PANTOPRAZOLE, LITHIUM, GABAPENTIN, TEMAZEPAM, PRAZOSIN and SERTRALINE for an unknown indication.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced DIZZINESS (Dizziness) and MYALGIA (Soreness in left arm). On 27-May-2021, DIZZINESS (Dizziness) had resolved. At the time of the report, MYALGIA (Soreness in left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-260527 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Flu-like symptoms; Body aches; Fever; Soreness in right arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Body aches), VACCINATION SITE PAIN (Soreness in right arm) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No relevant medical history was provided.  Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE), QUETIAPINE FUMARATE (SEROQUEL), ATORVASTATIN, PANTOPRAZOLE, LITHIUM, GABAPENTIN, TEMAZEPAM, PRAZOSIN and SERTRALINE for an unknown indication.    On 18-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced VACCINATION SITE PAIN (Soreness in right arm). On 19-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). 19-Jul-2021, the patient experienced PAIN (Body aches) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Body aches), VACCINATION SITE PAIN (Soreness in right arm) and PYREXIA (Fever) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-260527 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Has not gotten the second dose more than 36 days after getting the first; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not gotten the second dose more than 36 days after getting the first) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not gotten the second dose more than 36 days after getting the first). On 07-May-2021, PRODUCT DOSE OMISSION ISSUE (Has not gotten the second dose more than 36 days after getting the first) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Non significant follow-up appended.