chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Dysuria, Fatigue
Clinical narrative: Fever; Chills; very slight headache that appears and then goes away; Sore joint and arm; Nausea; sore muscles; Fatigue; Feeling foggy / Brain fog; Urination problem : urination was not normal (hardly urinated , even drinking lots of water); Sore joint and arm; Dizzines / Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling foggy / Brain fog), DYSURIA (Urination problem : urination was not normal (hardly urinated , even drinking lots of water)), PAIN IN EXTREMITY (Sore joint and arm), DIZZINESS (Dizzines / Lightheadedness) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Sulfa) and Iodine allergy. Concomitant products included VITAMIN D3, UBIDECARENONE (COQ10 [UBIDECARENONE]), GINKGO BILOBA (GINGKO BILOBA) and NATTOKINASE for an unknown indication.    On 02-Mar-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling foggy / Brain fog), DYSURIA (Urination problem : urination was not normal (hardly urinated , even drinking lots of water)), FATIGUE (Fatigue) and NAUSEA (Nausea). 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore joint and arm), DIZZINESS (Dizzines / Lightheadedness) and MYALGIA (sore muscles). On 11-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), HEADACHE (very slight headache that appears and then goes away) and ARTHRALGIA (Sore joint and arm). On 25-Mar-2021, DYSURIA (Urination problem : urination was not normal (hardly urinated , even drinking lots of water)) had resolved. At the time of the report, FEELING ABNORMAL (Feeling foggy / Brain fog), PAIN IN EXTREMITY (Sore joint and arm), DIZZINESS (Dizzines / Lightheadedness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (very slight headache that appears and then goes away), FATIGUE (Fatigue), ARTHRALGIA (Sore joint and arm), NAUSEA (Nausea) and MYALGIA (sore muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-219973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Initial additional On 02-Jun-2021: Initial additional On 03-Jun-2021: Initial additional
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Fever; Chills; very slight headache that appears and then goes away; Sore joint and arm; Nausea; sore muscles; Fatigue; Feeling foggy / Brain fog; Urination problem : urination was not normal (hardly urinated , even drinking lots of water); Sore joint and arm; Dizzines / Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling foggy / Brain fog), DYSURIA (Urination problem : urination was not normal (hardly urinated , even drinking lots of water)), PAIN IN EXTREMITY (Sore joint and arm), DIZZINESS (Dizzines / Lightheadedness) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Sulfa) and Iodine allergy. Concomitant products included VITAMIN D3, UBIDECARENONE (COQ10 [UBIDECARENONE]), GINKGO BILOBA (GINGKO BILOBA) and NATTOKINASE for an unknown indication.    On 02-Mar-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling foggy / Brain fog), DYSURIA (Urination problem : urination was not normal (hardly urinated , even drinking lots of water)), FATIGUE (Fatigue) and NAUSEA (Nausea). 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore joint and arm), DIZZINESS (Dizzines / Lightheadedness) and MYALGIA (sore muscles). On 11-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), HEADACHE (very slight headache that appears and then goes away) and ARTHRALGIA (Sore joint and arm). On 25-Mar-2021, DYSURIA (Urination problem : urination was not normal (hardly urinated , even drinking lots of water)) had resolved. At the time of the report, FEELING ABNORMAL (Feeling foggy / Brain fog), PAIN IN EXTREMITY (Sore joint and arm), DIZZINESS (Dizzines / Lightheadedness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (very slight headache that appears and then goes away), FATIGUE (Fatigue), ARTHRALGIA (Sore joint and arm), NAUSEA (Nausea) and MYALGIA (sore muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-219973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Initial additional On 02-Jun-2021: Initial additional On 03-Jun-2021: Initial additional
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; very slight headache that appears and then goes away; Sore joint and arm; Nausea; sore muscles; Fatigue; Feeling foggy / Brain fog; Urination problem : urination was not normal (hardly urinated , even drinking lots of water); Sore joint and arm; Dizzines / Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling foggy / Brain fog), DYSURIA (Urination problem : urination was not normal (hardly urinated , even drinking lots of water)), PAIN IN EXTREMITY (Sore joint and arm), DIZZINESS (Dizzines / Lightheadedness) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Sulfa) and Iodine allergy. Concomitant products included VITAMIN D3, UBIDECARENONE (COQ10 [UBIDECARENONE]), GINKGO BILOBA (GINGKO BILOBA) and NATTOKINASE for an unknown indication.    On 02-Mar-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling foggy / Brain fog), DYSURIA (Urination problem : urination was not normal (hardly urinated , even drinking lots of water)), FATIGUE (Fatigue) and NAUSEA (Nausea). 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore joint and arm), DIZZINESS (Dizzines / Lightheadedness) and MYALGIA (sore muscles). On 11-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), HEADACHE (very slight headache that appears and then goes away) and ARTHRALGIA (Sore joint and arm). On 25-Mar-2021, DYSURIA (Urination problem : urination was not normal (hardly urinated , even drinking lots of water)) had resolved. At the time of the report, FEELING ABNORMAL (Feeling foggy / Brain fog), PAIN IN EXTREMITY (Sore joint and arm), DIZZINESS (Dizzines / Lightheadedness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (very slight headache that appears and then goes away), FATIGUE (Fatigue), ARTHRALGIA (Sore joint and arm), NAUSEA (Nausea) and MYALGIA (sore muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-219973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Initial additional On 02-Jun-2021: Initial additional On 03-Jun-2021: Initial additional
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (experiencing symptoms of sickness in stomach, no vomiting) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010a21a) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 26-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (experiencing symptoms of sickness in stomach, no vomiting). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Stomach discomfort, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (experiencing symptoms of sickness in stomach, no vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reportedly, the patient was taking 7-8 unspecified concomitant medications. The patient's additional treatment medications included unspecified acid reflux medicine. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Fax response requesting re-fax of ADR with patient's full name added to document.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Peripheral swelling, Pruritus, Rash
Clinical narrative: A hot red bump; Very tender; Rash again which was light pink and today it has gotten worse which is red; Its like pins and needles; Little bit itchy; I have a rash again; Arm was very hot; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Arm was very hot), PERIPHERAL SWELLING (A hot red bump), TENDERNESS (Very tender), ERYTHEMA (Rash again which was light pink and today it has gotten worse which is red) and HYPOAESTHESIA (Its like pins and needles) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant past medical history was provided.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and VITAMINS NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced SKIN WARM (Arm was very hot). On an unknown date, the patient experienced PERIPHERAL SWELLING (A hot red bump), TENDERNESS (Very tender), ERYTHEMA (Rash again which was light pink and today it has gotten worse which is red), HYPOAESTHESIA (Its like pins and needles), PRURITUS (Little bit itchy) and RASH (I have a rash again). At the time of the report, SKIN WARM (Arm was very hot), PERIPHERAL SWELLING (A hot red bump), TENDERNESS (Very tender), ERYTHEMA (Rash again which was light pink and today it has gotten worse which is red), HYPOAESTHESIA (Its like pins and needles), PRURITUS (Little bit itchy) and RASH (I have a rash again) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided by reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Tenderness
Clinical narrative: A hot red bump; Very tender; Rash again which was light pink and today it has gotten worse which is red; Its like pins and needles; Little bit itchy; I have a rash again; Arm was very hot; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Arm was very hot), PERIPHERAL SWELLING (A hot red bump), TENDERNESS (Very tender), ERYTHEMA (Rash again which was light pink and today it has gotten worse which is red) and HYPOAESTHESIA (Its like pins and needles) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant past medical history was provided.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and VITAMINS NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced SKIN WARM (Arm was very hot). On an unknown date, the patient experienced PERIPHERAL SWELLING (A hot red bump), TENDERNESS (Very tender), ERYTHEMA (Rash again which was light pink and today it has gotten worse which is red), HYPOAESTHESIA (Its like pins and needles), PRURITUS (Little bit itchy) and RASH (I have a rash again). At the time of the report, SKIN WARM (Arm was very hot), PERIPHERAL SWELLING (A hot red bump), TENDERNESS (Very tender), ERYTHEMA (Rash again which was light pink and today it has gotten worse which is red), HYPOAESTHESIA (Its like pins and needles), PRURITUS (Little bit itchy) and RASH (I have a rash again) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided by reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Nausea, Vomiting
Clinical narrative: Bad bellyache; Felt so weak; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Bad bellyache), ASTHENIA (Felt so weak), NAUSEA (Nausea) and VOMITING (Vomiting) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Flu vaccination and Drug allergy (allergic to a lot of medications including metformin).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). On 10-Mar-2021, the patient experienced ABDOMINAL PAIN (Bad bellyache) and ASTHENIA (Felt so weak). At the time of the report, ABDOMINAL PAIN (Bad bellyache) and ASTHENIA (Felt so weak) outcome was unknown and NAUSEA (Nausea) and VOMITING (Vomiting) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: administered unknown amount of doses from a vial; 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 INCORRECT DOSE ADMINISTERED (administered unknown amount of doses from a vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 10-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (administered unknown amount of doses from a vial). At the time of the report, INCORRECT DOSE ADMINISTERED (administered unknown amount of doses from a vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist called as a third party from a national medical company that has been involved with vaccinations. She received a call from a pharmacist today stating that they had administered unknown amount of doses from a vial that was punctured and left in the fridge for greater than 6 hours.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza, Pain
Clinical narrative: really bad body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (really bad body aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (really bad body aches). The patient was treated with IBUPROFEN ongoing since an unknown date for Ache, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date for Ache, at a dose of UNK dosage form. At the time of the report, PAIN (really bad body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, COVID-19: negative (Negative) negative. On 10-Mar-2021, Influenza: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.   This case was linked.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Bone pain, Headache, Oxygen saturation
Clinical narrative: Bone pain; sore; o2 stat - 92; waking up at night; loss of taste; severe headaches-headache pressure was persistent; low grade fever 100.5; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain), PAIN (sore), SLEEP DISORDER (waking up at night), AGEUSIA (loss of taste) and HEADACHE (severe headaches-headache pressure was persistent) in a 66-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 No adverse event (No reported medical history).    On 22-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021 at 7:00 PM, the patient experienced BONE PAIN (Bone pain), PAIN (sore), SLEEP DISORDER (waking up at night), AGEUSIA (loss of taste), HEADACHE (severe headaches-headache pressure was persistent), PYREXIA (low grade fever 100.5) and OXYGEN SATURATION DECREASED (o2 stat - 92). At the time of the report, BONE PAIN (Bone pain), PAIN (sore), SLEEP DISORDER (waking up at night), AGEUSIA (loss of taste), HEADACHE (severe headaches-headache pressure was persistent), PYREXIA (low grade fever 100.5) and OXYGEN SATURATION DECREASED (o2 stat - 92) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: 100.5 07:00 PM. On 22-Feb-2021, Oxygen saturation: 92 07:00 PM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included acetaminophen 1000mg for headaches.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pain, Pyrexia, Sleep disorder
Clinical narrative: Bone pain; sore; o2 stat - 92; waking up at night; loss of taste; severe headaches-headache pressure was persistent; low grade fever 100.5; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain), PAIN (sore), SLEEP DISORDER (waking up at night), AGEUSIA (loss of taste) and HEADACHE (severe headaches-headache pressure was persistent) in a 66-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 No adverse event (No reported medical history).    On 22-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021 at 7:00 PM, the patient experienced BONE PAIN (Bone pain), PAIN (sore), SLEEP DISORDER (waking up at night), AGEUSIA (loss of taste), HEADACHE (severe headaches-headache pressure was persistent), PYREXIA (low grade fever 100.5) and OXYGEN SATURATION DECREASED (o2 stat - 92). At the time of the report, BONE PAIN (Bone pain), PAIN (sore), SLEEP DISORDER (waking up at night), AGEUSIA (loss of taste), HEADACHE (severe headaches-headache pressure was persistent), PYREXIA (low grade fever 100.5) and OXYGEN SATURATION DECREASED (o2 stat - 92) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: 100.5 07:00 PM. On 22-Feb-2021, Oxygen saturation: 92 07:00 PM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included acetaminophen 1000mg for headaches.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Chills; Fever; Redness,itching and swelling of the injection site; Redness,itching and swelling of the injection site; Redness,itching and swelling of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness,itching and swelling of the injection site), VACCINATION SITE PRURITUS (Redness,itching and swelling of the injection site) and VACCINATION SITE SWELLING (Redness,itching and swelling of the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0Z7AZIA and 041L20A) for COVID-19 immunisation.     No relevant past medical history was provided.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness,itching and swelling of the injection site), VACCINATION SITE PRURITUS (Redness,itching and swelling of the injection site) and VACCINATION SITE SWELLING (Redness,itching and swelling of the injection site). On 10-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness,itching and swelling of the injection site), VACCINATION SITE PRURITUS (Redness,itching and swelling of the injection site) and VACCINATION SITE SWELLING (Redness,itching and swelling of the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 99.7 degree fahrenheit (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have any problems with first dose.  Additional concomitant drugs included diabetic medication, blood pressure  medication and thyroid medication (all unspecified).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Chills; Fever; Redness,itching and swelling of the injection site; Redness,itching and swelling of the injection site; Redness,itching and swelling of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness,itching and swelling of the injection site), VACCINATION SITE PRURITUS (Redness,itching and swelling of the injection site) and VACCINATION SITE SWELLING (Redness,itching and swelling of the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0Z7AZIA and 041L20A) for COVID-19 immunisation.     No relevant past medical history was provided.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness,itching and swelling of the injection site), VACCINATION SITE PRURITUS (Redness,itching and swelling of the injection site) and VACCINATION SITE SWELLING (Redness,itching and swelling of the injection site). On 10-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness,itching and swelling of the injection site), VACCINATION SITE PRURITUS (Redness,itching and swelling of the injection site) and VACCINATION SITE SWELLING (Redness,itching and swelling of the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 99.7 degree fahrenheit (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have any problems with first dose.  Additional concomitant drugs included diabetic medication, blood pressure  medication and thyroid medication (all unspecified).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gastric disorder, Night sweats, Paraesthesia, Rash
Clinical narrative: numbness and tingling in hands and feet; lungs felt heavy; night sweats; gastrointestinal issues; rash on face and neck; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (numbness and tingling in hands and feet), RESPIRATION ABNORMAL (lungs felt heavy), NIGHT SWEATS (night sweats), GASTRIC DISORDER (gastrointestinal issues) and RASH (rash on face and neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FISH OIL and VITAMIN D NOS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PARAESTHESIA (numbness and tingling in hands and feet), RESPIRATION ABNORMAL (lungs felt heavy), NIGHT SWEATS (night sweats), GASTRIC DISORDER (gastrointestinal issues), RASH (rash on face and neck) and FATIGUE (fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Mar-2021, GASTRIC DISORDER (gastrointestinal issues) had resolved. On 05-Mar-2021, RESPIRATION ABNORMAL (lungs felt heavy) had resolved. On 06-Mar-2021, PARAESTHESIA (numbness and tingling in hands and feet), RASH (rash on face and neck) and FATIGUE (fatigued) had resolved. On 08-Mar-2021, NIGHT SWEATS (night sweats) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon internal review on 21-May-2021, the age was corrected to unknown.
Sex: F
Vaccine: COVID19
Symptoms: Respiration abnormal
Clinical narrative: numbness and tingling in hands and feet; lungs felt heavy; night sweats; gastrointestinal issues; rash on face and neck; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (numbness and tingling in hands and feet), RESPIRATION ABNORMAL (lungs felt heavy), NIGHT SWEATS (night sweats), GASTRIC DISORDER (gastrointestinal issues) and RASH (rash on face and neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FISH OIL and VITAMIN D NOS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PARAESTHESIA (numbness and tingling in hands and feet), RESPIRATION ABNORMAL (lungs felt heavy), NIGHT SWEATS (night sweats), GASTRIC DISORDER (gastrointestinal issues), RASH (rash on face and neck) and FATIGUE (fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Mar-2021, GASTRIC DISORDER (gastrointestinal issues) had resolved. On 05-Mar-2021, RESPIRATION ABNORMAL (lungs felt heavy) had resolved. On 06-Mar-2021, PARAESTHESIA (numbness and tingling in hands and feet), RASH (rash on face and neck) and FATIGUE (fatigued) had resolved. On 08-Mar-2021, NIGHT SWEATS (night sweats) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon internal review on 21-May-2021, the age was corrected to unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: The skin at the injection site feels warmer than the skin around; swollen; Feeling tender; small red area there, larger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The skin at the injection site feels warmer than the skin around), VACCINATION SITE ERYTHEMA (small red area there, larger), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (Feeling tender) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN and VITAMINS NOS for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (small red area there, larger). On 09-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (Feeling tender). On an unknown date, the patient experienced VACCINATION SITE WARMTH (The skin at the injection site feels warmer than the skin around). At the time of the report, VACCINATION SITE WARMTH (The skin at the injection site feels warmer than the skin around), VACCINATION SITE ERYTHEMA (small red area there, larger), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (Feeling tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications includes unspecified body lotion on injection site . Reportedly the patient's body temperature was 97.8.    Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Initial additional : Included no new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Migraine, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Felt migraine coming on), HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 043L20A) for COVID-19 vaccination. No medical history was reported by the reporter. The patient's past medical history included No adverse event. Concomitant products included SIMVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). 04-Mar-2021, the patient experienced FATIGUE (Fatigue). On 05-Mar-2021, the patient experienced MIGRAINE (Felt migraine coming on). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) (oral) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency; ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRINIL) (oral) at an unspecified dose and frequency and MELATONIN (oral) at an unspecified dose and frequency. On 05-Mar-2021, MIGRAINE (Felt migraine coming on) had resolved. On 07-Mar-2021, HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved. Treatment for the events included Advil, Tylenol, Excedrin, and Melatonin.  This case was linked to MOD-2021-040959. Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: initial additional
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: heat and rash at the injection site; swelling, heat and rash at the injection site; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat and rash at the injection site), VACCINATION SITE SWELLING (swelling, heat and rash at the injection site) and VACCINATION SITE RASH (rash at the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-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 VACCINATION SITE WARMTH (heat and rash at the injection site), VACCINATION SITE SWELLING (swelling, heat and rash at the injection site) and VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE WARMTH (heat and rash at the injection site), VACCINATION SITE SWELLING (swelling, heat and rash at the injection site) and VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling, Urticaria, Vaccination site rash
Clinical narrative: hives; swelling; itchiness; redness; 18 x 14 cm rash on injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), SWELLING (swelling), PRURITUS (itchiness), ERYTHEMA (redness) and VACCINATION SITE RASH (18 x 14 cm rash on injection site arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced URTICARIA (hives), SWELLING (swelling), PRURITUS (itchiness), ERYTHEMA (redness) and VACCINATION SITE RASH (18 x 14 cm rash on injection site arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives), PRURITUS (itchiness), ERYTHEMA (redness) and VACCINATION SITE RASH (18 x 14 cm rash on injection site arm) outcome was unknown and SWELLING (swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was reported.    On 03-Mar-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (Body aches) outcome was unknown. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Rash, Swollen tongue
Clinical narrative: tongue swelling; neck to jaw rash; chills; being tired; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (tongue swelling), RASH (neck to jaw rash), CHILLS (chills) and FATIGUE (being tired) in an 86-year-old female patient who received mRNA-1273 (M oderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced SWOLLEN TONGUE (tongue swelling), RASH (neck to jaw rash), CHILLS (chills) and FATIGUE (being tired). At the time of the report, SWOLLEN TONGUE (tongue swelling), RASH (neck to jaw rash), CHILLS (chills) and FATIGUE (being tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Nausea, Pain in extremity, Underdose
Clinical narrative: slight nausea; Clear liquids leaked out during the vaccination; Clear liquids leaked out during the vaccination; sore arm; This spontaneous case was reported by a physician and describes the occurrence of DEVICE CONNECTION ISSUE (Clear liquids leaked out during the vaccination), UNDERDOSE (Clear liquids leaked out during the vaccination), PAIN IN EXTREMITY (sore arm) and NAUSEA (slight nausea) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Gastritis, Obsessive-compulsive disorder, Low back pain and High cholesterol. Concomitant products included OMEPRAZOLE for Gastritis, ATORVASTATIN for High cholesterol, CITALOPRAM for Obsessive-compulsive disorder.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (Clear liquids leaked out during the vaccination), UNDERDOSE (Clear liquids leaked out during the vaccination) and PAIN IN EXTREMITY (sore arm). On 11-Mar-2021, the patient experienced NAUSEA (slight nausea). On 10-Mar-2021, DEVICE CONNECTION ISSUE (Clear liquids leaked out during the vaccination) and UNDERDOSE (Clear liquids leaked out during the vaccination) had resolved. On 11-Mar-2021, NAUSEA (slight nausea) had resolved. On 13-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up information received on 04 May 2021 contained patient's medical history and concomitant medications, new events added and event outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Foreign body sensation in eyes, Nasal discomfort, Paraesthesia oral, Tongue discomfort
Clinical narrative: Feels like there are sand in her eyes; Eyes are burning, irritated every waking moment; Nose burning, irritated every waking moment; Tongue felt like it was burnt; Tongue started tingling; A spontaneous report was received from a consumer who was also a 75-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who felt like there are sand in her eyes/foreign body sensation in eyes, eyes are burning; irritated every waking moment/eye irritation, nose burning; irritated every waking moment/nasal discomfort, tongue started tingling/paraesthesia oral, and tongue felt like it was burnt/tongue discomfort.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Fexofenadine hydrochloride.  On 05 Mar 2021, approximately couple of hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: 027A21A) via unknown route for COVID-19 infection prophylaxis.  On 05 Mar 2021, couple of hours after receiving the vaccine patient's tongue started tingling all evening and the next day it felt like tongue was burnt. Patient's eyes and nose were burning every waking moment and were irritated. Patient also felt like there were sand in eyes.  Patient was eating the same thing and medications and detergent had not changed. The patient believed this was not an allergic reaction. Treatment for the event included benadryl for three nights but this was not working.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, felt like there are sand in her eyes, eyes are burning; irritated every waking moment, nose burning; irritated every waking moment, tongue started tingling and tongue felt like it was burnt was unknown at the time of this report.; 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Hypoaesthesia, Pain in extremity
Clinical narrative: started presenting pain on her hands/pain on feet; numbness on hands; headache; regular nose allergies; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (regular nose allergies), PAIN IN EXTREMITY (started presenting pain on her hands/pain on feet), HYPOAESTHESIA (numbness on hands) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (regular nose allergies). Concomitant products included OMEPRAZOLE for Gastritis, VITAMINS NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HYPERSENSITIVITY (regular nose allergies) and HEADACHE (headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (started presenting pain on her hands/pain on feet) and HYPOAESTHESIA (numbness on hands). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, HYPERSENSITIVITY (regular nose allergies), PAIN IN EXTREMITY (started presenting pain on her hands/pain on feet), HYPOAESTHESIA (numbness on hands) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additionally, patient received two other unspecified concomitant medications for gastritis.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Little bit tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little bit tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included NAPROXEN and ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.   On 08-Mar-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) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (Little bit tired). At the time of the report, FATIGUE (Little bit tired) outcome was unknown. Not Provided          No Treatments were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Bronchitis, Chest X-ray, Nausea, SARS-CoV-2 test
Clinical narrative: asthma, bronchitis; bronchitis; nausea; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (asthma, bronchitis), BRONCHITIS (bronchitis), VACCINATION SITE PAIN (pain at injection site) and NAUSEA (nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006MZ0A) for COVID-19 vaccination.     The patient's past medical history included Polycythemia (Polycythemia vera blood disorder). Concomitant products included HYDROXYUREA and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 04-Mar-2021, the patient experienced ASTHMA (asthma, bronchitis), BRONCHITIS (bronchitis) and NAUSEA (nausea). The patient was treated with AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency and LEVOFLOXACIN (LEVAQUIN) at an unspecified dose and frequency. At the time of the report, ASTHMA (asthma, bronchitis), BRONCHITIS (bronchitis), VACCINATION SITE PAIN (pain at injection site) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: clear (normal) clear. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events also included an unspecified rescue inhaler and steroid.