chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Needle came out so the vaccine started dripping on the floor; All of the vaccine did not get into the arm; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE (Needle came out so the vaccine started dripping on the floor) and UNDERDOSE (All of the vaccine did not get into the arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for an unknown indication.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DEVICE CONNECTION ISSUE (Needle came out so the vaccine started dripping on the floor) and UNDERDOSE (All of the vaccine did not get into the arm). On 09-Apr-2021, DEVICE CONNECTION ISSUE (Needle came out so the vaccine started dripping on the floor) and UNDERDOSE (All of the vaccine did not get into the arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the nurse thought that patient did get some vaccine.  No concomitant medications were reported.  No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Joint swelling, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis; Right hand was extremely swollen almost twice the size/Right foot was extremely swollen, not able to wear shoe; Wrist was extremely swollen almost twice the size; Right foot was red; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis), PERIPHERAL SWELLING (Right hand was extremely swollen almost twice the size/Right foot was extremely swollen, not able to wear shoe), JOINT SWELLING (Wrist was extremely swollen almost twice the size) and ERYTHEMA (Right foot was red) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis. Concomitant products included TRAMADOL for Pain, METHOTREXATE for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right hand was extremely swollen almost twice the size/Right foot was extremely swollen, not able to wear shoe), JOINT SWELLING (Wrist was extremely swollen almost twice the size) and ERYTHEMA (Right foot was red). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis), PERIPHERAL SWELLING (Right hand was extremely swollen almost twice the size/Right foot was extremely swollen, not able to wear shoe), JOINT SWELLING (Wrist was extremely swollen almost twice the size) and ERYTHEMA (Right foot was red) outcome was unknown.            Concomitant drug includes Blood pressure medications  Treatment Received 2 Prednisone shot at the inflammatory joint and also taking Prednisone pill and Toradol pill daily.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.  Action taken with mRNA-1273 in response to the events was not Applicable.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Irritability, Pain, Pulmonary pain, Pyrexia, Renal pain
Clinical narrative: pain in kidneys; pain in lungs; body ache and annoyance; body ache and annoyance; fever; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (pain in kidneys), PULMONARY PAIN (pain in lungs), IRRITABILITY (body ache and annoyance), PAIN (body ache and annoyance) and PYREXIA (fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B2IA) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ENALAPRIL for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced RENAL PAIN (pain in kidneys), PULMONARY PAIN (pain in lungs), IRRITABILITY (body ache and annoyance), PAIN (body ache and annoyance) and PYREXIA (fever). On 08-Apr-2021, RENAL PAIN (pain in kidneys), PULMONARY PAIN (pain in lungs), IRRITABILITY (body ache and annoyance), PAIN (body ache and annoyance) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication includes Medication for the knee (meniscus).  Additional information:Second dose will be administered on 05May2021. Patient experienced fever, "calories", pain in kidneys and lungs. Body ache and annoyance were also mentioned. Patient took Tylenol to treat symptoms. Patient is feeling better now.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Contusion, Cough, Feeling abnormal, Feeling jittery
Clinical narrative: Cough; Blowing her nose a lot; Headache; Temperature of 99; arm was sore and bruised, arm was purple that night when she took bandaid off there was bruise, now it's yellow; Just doesn't feel like herself; jittery feeling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONTUSION (arm was sore and bruised, arm was purple that night when she took bandaid off there was bruise, now it's yellow), FEELING ABNORMAL (Just doesn't feel like herself), FEELING JITTERY (jittery feeling), COUGH (Cough) and FEELING ABNORMAL (Blowing her nose a lot) in a 60-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.     The patient's past medical history included COPD, Fibromyalgia, Anxiety, Panic attack and Complex regional pain syndrome.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced CONTUSION (arm was sore and bruised, arm was purple that night when she took bandaid off there was bruise, now it's yellow), FEELING ABNORMAL (Just doesn't feel like herself), FEELING JITTERY (jittery feeling), HEADACHE (Headache) and PYREXIA (Temperature of 99). On an unknown date, the patient experienced COUGH (Cough) and FEELING ABNORMAL (Blowing her nose a lot). On 23-Mar-2021, FEELING JITTERY (jittery feeling) had resolved. At the time of the report, CONTUSION (arm was sore and bruised, arm was purple that night when she took bandaid off there was bruise, now it's yellow), FEELING ABNORMAL (Just doesn't feel like herself), COUGH (Cough), FEELING ABNORMAL (Blowing her nose a lot), HEADACHE (Headache) and PYREXIA (Temperature of 99) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: (High) 99. On 19-Mar-2021, SARS-CoV-2 test negative: 27-feb-2021 Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications provided were for pain, anxiety, 2 inhalers, breathing machine treatments and oxygen.  Treatment medication were not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Cough; Blowing her nose a lot; Headache; Temperature of 99; arm was sore and bruised, arm was purple that night when she took bandaid off there was bruise, now it's yellow; Just doesn't feel like herself; jittery feeling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONTUSION (arm was sore and bruised, arm was purple that night when she took bandaid off there was bruise, now it's yellow), FEELING ABNORMAL (Just doesn't feel like herself), FEELING JITTERY (jittery feeling), COUGH (Cough) and FEELING ABNORMAL (Blowing her nose a lot) in a 60-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.     The patient's past medical history included COPD, Fibromyalgia, Anxiety, Panic attack and Complex regional pain syndrome.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced CONTUSION (arm was sore and bruised, arm was purple that night when she took bandaid off there was bruise, now it's yellow), FEELING ABNORMAL (Just doesn't feel like herself), FEELING JITTERY (jittery feeling), HEADACHE (Headache) and PYREXIA (Temperature of 99). On an unknown date, the patient experienced COUGH (Cough) and FEELING ABNORMAL (Blowing her nose a lot). On 23-Mar-2021, FEELING JITTERY (jittery feeling) had resolved. At the time of the report, CONTUSION (arm was sore and bruised, arm was purple that night when she took bandaid off there was bruise, now it's yellow), FEELING ABNORMAL (Just doesn't feel like herself), COUGH (Cough), FEELING ABNORMAL (Blowing her nose a lot), HEADACHE (Headache) and PYREXIA (Temperature of 99) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: (High) 99. On 19-Mar-2021, SARS-CoV-2 test negative: 27-feb-2021 Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications provided were for pain, anxiety, 2 inhalers, breathing machine treatments and oxygen.  Treatment medication were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), FEELING HOT (Hot), HEADACHE (Bad headache) and FATIGUE (Feels tired) 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 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well), FEELING HOT (Hot), HEADACHE (Bad headache) and FATIGUE (Feels tired). At the time of the report, MALAISE (Not feeling well), FEELING HOT (Hot), HEADACHE (Bad headache) and FATIGUE (Feels tired) outcome was unknown. Concomitant product use was not provided. Treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reporter did not allow further contact.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: sore arm; felt exhausted; out of energy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (felt exhausted) and ASTHENIA (out of energy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 320M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (felt exhausted) and ASTHENIA (out of energy). At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (felt exhausted) and ASTHENIA (out of energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not provided.
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site pain
Clinical narrative: Mild tenderness near injection site when pushed on; Mild pain near injection site when pushed on; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Mild tenderness near injection site when pushed on) and VACCINATION SITE PAIN (Mild pain near injection site when pushed on) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced TENDERNESS (Mild tenderness near injection site when pushed on) and VACCINATION SITE PAIN (Mild pain near injection site when pushed on). On 04-Apr-2021, TENDERNESS (Mild tenderness near injection site when pushed on) and VACCINATION SITE PAIN (Mild pain near injection site when pushed on) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient was scheduled to take Botox injection for migraine on 09-Apr-2021.  Concomitant product use was not provided. Treatment information was not provided.  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 17-Jun-2021: Follow up received on 17-Jun-2021 contains no significant information.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: COVID-19 vaccine second shot three weeks after the first shot; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (COVID-19 vaccine second shot three weeks after the first 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (COVID-19 vaccine second shot three weeks after the first shot). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (COVID-19 vaccine second shot three weeks after the first shot) outcome was unknown. Not Provided          No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity, Urticaria, Vertigo
Clinical narrative: Sore arm; hives on the chest, neck, arm; Dizziness; feels like vertigo; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), URTICARIA (hives on the chest, neck, arm), DIZZINESS (Dizziness), VERTIGO (feels like vertigo) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), URTICARIA (hives on the chest, neck, arm), DIZZINESS (Dizziness), VERTIGO (feels like vertigo) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Sore arm), URTICARIA (hives on the chest, neck, arm), DIZZINESS (Dizziness), VERTIGO (feels like vertigo) and NAUSEA (Nausea) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Palpitations, Vaccination site erythema, Vaccination site induration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing), VACCINATION SITE REACTION (covid arm), VACCINATION SITE WARMTH (Injection felt hot to the touch), VACCINATION SITE INDURATION (Injection site hardness) and VACCINATION SITE RASH (Injection site rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PALPITATIONS (heart racing), MYALGIA (muscle pain) and FATIGUE (Fatigue). On 21-Mar-2021, the patient experienced VACCINATION SITE REACTION (covid arm), VACCINATION SITE WARMTH (Injection felt hot to the touch), VACCINATION SITE INDURATION (Injection site hardness), VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Injection site redness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PALPITATIONS (heart racing), VACCINATION SITE REACTION (covid arm), VACCINATION SITE WARMTH (Injection felt hot to the touch), VACCINATION SITE INDURATION (Injection site hardness), VACCINATION SITE RASH (Injection site rash), MYALGIA (muscle pain), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Non significant follow up received on 17-JUN-2021, no new information
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site reaction, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing), VACCINATION SITE REACTION (covid arm), VACCINATION SITE WARMTH (Injection felt hot to the touch), VACCINATION SITE INDURATION (Injection site hardness) and VACCINATION SITE RASH (Injection site rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PALPITATIONS (heart racing), MYALGIA (muscle pain) and FATIGUE (Fatigue). On 21-Mar-2021, the patient experienced VACCINATION SITE REACTION (covid arm), VACCINATION SITE WARMTH (Injection felt hot to the touch), VACCINATION SITE INDURATION (Injection site hardness), VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Injection site redness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PALPITATIONS (heart racing), VACCINATION SITE REACTION (covid arm), VACCINATION SITE WARMTH (Injection felt hot to the touch), VACCINATION SITE INDURATION (Injection site hardness), VACCINATION SITE RASH (Injection site rash), MYALGIA (muscle pain), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Non significant follow up received on 17-JUN-2021, no new information
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Sore skin; Arm is sore and hurting terribly.; Bad chills; Bad headache; Sore muscles; Fever running pretty hot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN OF SKIN (Sore skin), PAIN IN EXTREMITY (Arm is sore and hurting terribly.), CHILLS (Bad chills), HEADACHE (Bad headache) and MYALGIA (Sore muscles) in a 36-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 08-Apr-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 08-Apr-2021, the patient experienced PAIN OF SKIN (Sore skin), PAIN IN EXTREMITY (Arm is sore and hurting terribly.), CHILLS (Bad chills), HEADACHE (Bad headache), MYALGIA (Sore muscles) and PYREXIA (Fever running pretty hot). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN OF SKIN (Sore skin), PAIN IN EXTREMITY (Arm is sore and hurting terribly.), CHILLS (Bad chills), HEADACHE (Bad headache), MYALGIA (Sore muscles) and PYREXIA (Fever running pretty hot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Body temperature: 103.5 (High) 103.5 F and 102 (High) 102 F.         Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pyrexia
Clinical narrative: Sore skin; Arm is sore and hurting terribly.; Bad chills; Bad headache; Sore muscles; Fever running pretty hot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN OF SKIN (Sore skin), PAIN IN EXTREMITY (Arm is sore and hurting terribly.), CHILLS (Bad chills), HEADACHE (Bad headache) and MYALGIA (Sore muscles) in a 36-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 08-Apr-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 08-Apr-2021, the patient experienced PAIN OF SKIN (Sore skin), PAIN IN EXTREMITY (Arm is sore and hurting terribly.), CHILLS (Bad chills), HEADACHE (Bad headache), MYALGIA (Sore muscles) and PYREXIA (Fever running pretty hot). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN OF SKIN (Sore skin), PAIN IN EXTREMITY (Arm is sore and hurting terribly.), CHILLS (Bad chills), HEADACHE (Bad headache), MYALGIA (Sore muscles) and PYREXIA (Fever running pretty hot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Body temperature: 103.5 (High) 103.5 F and 102 (High) 102 F.         Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) 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 07-Apr-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 07-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: hot arm; red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot arm) and VACCINATION SITE ERYTHEMA (red arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot arm) and VACCINATION SITE ERYTHEMA (red arm). At the time of the report, VACCINATION SITE WARMTH (hot arm) and VACCINATION SITE ERYTHEMA (red arm) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Diarrhoea; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), FATIGUE (Fatigue) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-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 DIARRHOEA (Diarrhoea), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, DIARRHOEA (Diarrhoea) and PYREXIA (Fever) outcome was unknown and FATIGUE (Fatigue) had not resolved.            No concomitant medication reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received reporter mailing address added
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Incorrect route of product administration, Insomnia
Clinical narrative: Pain; sick; feel pain in the site of injection; Very tired; Headache; feeling pain on his body; injected the 1st dose on the wrong place where it was all the way up of his shoulder; not able to sleep due to pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), INSOMNIA (not able to sleep due to pain), ILLNESS (sick), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected the 1st dose on the wrong place where it was all the way up of his shoulder) and VACCINATION SITE PAIN (feel pain in the site of injection) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced INSOMNIA (not able to sleep due to pain), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected the 1st dose on the wrong place where it was all the way up of his shoulder) and MYALGIA (feeling pain on his body). On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (feel pain in the site of injection), FATIGUE (Very tired) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN (Pain) and ILLNESS (sick). On 08-Apr-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected the 1st dose on the wrong place where it was all the way up of his shoulder) had resolved. At the time of the report, PAIN (Pain), INSOMNIA (not able to sleep due to pain), ILLNESS (sick), VACCINATION SITE PAIN (feel pain in the site of injection), FATIGUE (Very tired), HEADACHE (Headache) and MYALGIA (feeling pain on his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Myalgia, Insomnia and Incorrect route of product administration events added.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Vaccination site pain
Clinical narrative: Pain; sick; feel pain in the site of injection; Very tired; Headache; feeling pain on his body; injected the 1st dose on the wrong place where it was all the way up of his shoulder; not able to sleep due to pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), INSOMNIA (not able to sleep due to pain), ILLNESS (sick), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected the 1st dose on the wrong place where it was all the way up of his shoulder) and VACCINATION SITE PAIN (feel pain in the site of injection) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced INSOMNIA (not able to sleep due to pain), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected the 1st dose on the wrong place where it was all the way up of his shoulder) and MYALGIA (feeling pain on his body). On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (feel pain in the site of injection), FATIGUE (Very tired) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN (Pain) and ILLNESS (sick). On 08-Apr-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected the 1st dose on the wrong place where it was all the way up of his shoulder) had resolved. At the time of the report, PAIN (Pain), INSOMNIA (not able to sleep due to pain), ILLNESS (sick), VACCINATION SITE PAIN (feel pain in the site of injection), FATIGUE (Very tired), HEADACHE (Headache) and MYALGIA (feeling pain on his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Myalgia, Insomnia and Incorrect route of product administration events added.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, SARS-CoV-2 antibody test positive, Vaccination site erythema
Clinical narrative: COVID Arm; delayed injection site swelling; delayed injection site redness; itching and erythema; itching and erythema; ongoing rash on chest; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE SWELLING (delayed injection site swelling), VACCINATION SITE ERYTHEMA (delayed injection site redness), RASH (ongoing rash on chest) and PRURITUS (itching and erythema) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Obesity. Concurrent medical conditions included Sulfonamide allergy, Drug allergy (Thimerosal Allergy (rash) and Tylenol (rash)) and Allergy to vaccine (Tetanus Vaccine (Anaphylaxis)). Concomitant products included MULTIVITAMINS;MINERALS for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced RASH (ongoing rash on chest). On 16-Mar-2021, the patient experienced PRURITUS (itching and erythema) and ERYTHEMA (itching and erythema). On 19-Mar-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE SWELLING (delayed injection site swelling) and VACCINATION SITE ERYTHEMA (delayed injection site redness). On 02-Apr-2021, VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE SWELLING (delayed injection site swelling) and VACCINATION SITE ERYTHEMA (delayed injection site redness) had resolved. At the time of the report, RASH (ongoing rash on chest), PRURITUS (itching and erythema) and ERYTHEMA (itching and erythema) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test positive: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment Medication included topical Ointment.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow-up information was received on date 13-APR-2021: Added Medical History, Concomitant medication, lab data. On 14-Apr-2021: Nonsignificant follow up appended
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling
Clinical narrative: COVID Arm; delayed injection site swelling; delayed injection site redness; itching and erythema; itching and erythema; ongoing rash on chest; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE SWELLING (delayed injection site swelling), VACCINATION SITE ERYTHEMA (delayed injection site redness), RASH (ongoing rash on chest) and PRURITUS (itching and erythema) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Obesity. Concurrent medical conditions included Sulfonamide allergy, Drug allergy (Thimerosal Allergy (rash) and Tylenol (rash)) and Allergy to vaccine (Tetanus Vaccine (Anaphylaxis)). Concomitant products included MULTIVITAMINS;MINERALS for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced RASH (ongoing rash on chest). On 16-Mar-2021, the patient experienced PRURITUS (itching and erythema) and ERYTHEMA (itching and erythema). On 19-Mar-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE SWELLING (delayed injection site swelling) and VACCINATION SITE ERYTHEMA (delayed injection site redness). On 02-Apr-2021, VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE SWELLING (delayed injection site swelling) and VACCINATION SITE ERYTHEMA (delayed injection site redness) had resolved. At the time of the report, RASH (ongoing rash on chest), PRURITUS (itching and erythema) and ERYTHEMA (itching and erythema) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test positive: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment Medication included topical Ointment.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow-up information was received on date 13-APR-2021: Added Medical History, Concomitant medication, lab data. On 14-Apr-2021: Nonsignificant follow up appended
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breast feeding mother took first dose of Moderna vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced EXPOSURE VIA BREAST MILK (Breast feeding mother took first dose of Moderna vaccine). On 09-Apr-2021, EXPOSURE VIA BREAST MILK (Breast feeding mother took first dose of Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Prenatal vitamins are used as concomitant medications but not specifically mentioned the vitamins.  No treatment medications included.  Additional information: She gave birth to her baby girl on 20Mar2021 following invitro fertilization (IVF) due to one year of infertility. She is currently breast feeding. This is her first pregnancy. Pregnancy was via spontaneous vagina delivery. She has no AE from the vaccine so far.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Fatigue; Sore throat; headache; Running nose; swelling lymph nodes on the neck on the same side where she received the injection; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (headache), RHINORRHOEA (Running nose) and LYMPHADENITIS (swelling lymph nodes on the neck on the same side where she received the injection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced FATIGUE (Fatigue), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (headache), RHINORRHOEA (Running nose) and LYMPHADENITIS (swelling lymph nodes on the neck on the same side where she received the injection). At the time of the report, FATIGUE (Fatigue), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (headache), RHINORRHOEA (Running nose) and LYMPHADENITIS (swelling lymph nodes on the neck on the same side where she received the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: diagnosed with covid-19; This spontaneous case was reported by a nurse and describes the occurrence of SARS-COV-2 TEST POSITIVE (diagnosed with covid-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (diagnosed with covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (diagnosed with covid-19) 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.   It was noted that the patient was not using any concomitant medications at the time of the event.   The patient did not receive any treatment for the event. The patient completed their quarantine period on 12Mar2021.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Deviation from recommended age group; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Deviation from recommended age group) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Deviation from recommended age group). On 03-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Deviation from recommended age group) 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.   17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine due to the change to the eligibility criteria announced by the authority   This case was linked to MOD21-069804, MOD-2021-068273, MOD21-069810 (E2B Linked Report).; Sender's Comments:  MOD21-069804:Crossed linked MOD-2021-068273:Crossed linked MOD21-069810:Crossed linked
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in Mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in Mouth) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste in Mouth). On 22-Mar-2021, DYSGEUSIA (Metallic taste in Mouth) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea, Pain, Pyrexia
Clinical narrative: fever; Joint pain; Headache; nausea; feeingl like throwing up; whole body aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (whole body aching), PYREXIA (fever), ARTHRALGIA (Joint pain), HEADACHE (Headache) and NAUSEA (nausea) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. H031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (whole body aching), ARTHRALGIA (Joint pain), HEADACHE (Headache), NAUSEA (nausea) and VOMITING (feeingl like throwing up). On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PAIN (whole body aching), PYREXIA (fever), ARTHRALGIA (Joint pain), HEADACHE (Headache), NAUSEA (nausea) and VOMITING (feeingl like throwing up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: fever; Joint pain; Headache; nausea; feeingl like throwing up; whole body aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (whole body aching), PYREXIA (fever), ARTHRALGIA (Joint pain), HEADACHE (Headache) and NAUSEA (nausea) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. H031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (whole body aching), ARTHRALGIA (Joint pain), HEADACHE (Headache), NAUSEA (nausea) and VOMITING (feeingl like throwing up). On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PAIN (whole body aching), PYREXIA (fever), ARTHRALGIA (Joint pain), HEADACHE (Headache), NAUSEA (nausea) and VOMITING (feeingl like throwing up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided