chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Hypertension, Oropharyngeal discomfort
Clinical narrative: sensation on forehead that turned between eyes; blood pressure went high; mental sensation on the throat/ minute 11 throat clamed down and lose air breath; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (sensation on forehead that turned between eyes), HYPERTENSION (blood pressure went high) and OROPHARYNGEAL DISCOMFORT (mental sensation on the throat/ minute 11 throat clamed down and lose air breath) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (IBPA) and Drug allergy (Victoza (victosa)). Concomitant products included METFORMIN, RAMIPRIL (ALTACE) and GLIPIZIDE for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DISCOMFORT (sensation on forehead that turned between eyes), HYPERTENSION (blood pressure went high) and OROPHARYNGEAL DISCOMFORT (mental sensation on the throat/ minute 11 throat clamed down and lose air breath). At the time of the report, DISCOMFORT (sensation on forehead that turned between eyes), HYPERTENSION (blood pressure went high) and OROPHARYNGEAL DISCOMFORT (mental sensation on the throat/ minute 11 throat clamed down and lose air breath) 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.   Treatment for the events included Benadryl and peptide.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Pain in extremity
Clinical narrative: GI problems; Arm may have been a little sore; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm may have been a little sore) and GASTROINTESTINAL DISORDER (GI problems) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No medical history reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm may have been a little sore). On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (GI problems). At the time of the report, PAIN IN EXTREMITY (Arm may have been a little sore) and GASTROINTESTINAL DISORDER (GI problems) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 23-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 07-May-2021. On 24-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 24-Feb-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment details were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site scar, Vaccination site warmth
Clinical narrative: injection site warm; area of injection had large spot; injection site itchness; injection site red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE SCAR (area of injection had large spot), VACCINATION SITE PRURITUS (injection site itchness) and VACCINATION SITE ERYTHEMA (injection site red) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included TAMSULOSIN, TRIAMCINOLONE ACETONIDE (NASACORT) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE SCAR (area of injection had large spot), VACCINATION SITE PRURITUS (injection site itchness) and VACCINATION SITE ERYTHEMA (injection site red). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE SCAR (area of injection had large spot), VACCINATION SITE PRURITUS (injection site itchness) and VACCINATION SITE ERYTHEMA (injection site red) 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.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: Pain at the site of injection; Fatigue and chills; Fatigue and chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the site of injection), FATIGUE (Fatigue and chills), CHILLS (Fatigue and chills) and MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Jan-2021 and the estimated date of delivery was 18-Oct-2021. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the site of injection), FATIGUE (Fatigue and chills), CHILLS (Fatigue and chills) and MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 04-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at the site of injection), FATIGUE (Fatigue and chills) and CHILLS (Fatigue and chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient stated, she does not want to take the second in her first trimester because of the fever aspect of the vaccine may have on her baby. Patient received the vaccine in the right arm. Patient is taking other medication.  Treatment medication not reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash on injection site that spread to be about palm size; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE RASH (Rash on injection site that spread to be about palm size) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20D) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching). On 07-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash on injection site that spread to be about palm size). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE RASH (Rash on injection site that spread to be about palm size) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received the vaccine on 20JAN2021 and on 6FEB2021 she experienced itching. On 7FEB2021 the patient reported rash on injection site that spread to be about palm size. Symptoms are ongoing
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Whole upper arm was red and rashy which then had extended to the elbow; Itching on arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Whole upper arm was red and rashy which then had extended to the elbow) and PRURITUS (Itching on arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 04-Feb-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 06-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Whole upper arm was red and rashy which then had extended to the elbow) and PRURITUS (Itching on arm). At the time of the report, RASH ERYTHEMATOUS (Whole upper arm was red and rashy which then had extended to the elbow) and PRURITUS (Itching on arm) outcome was unknown.  Action taken was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: rash and swelling in the injection site; rash and swelling in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash and swelling in the injection site) and VACCINATION SITE SWELLING (rash and swelling in the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash and swelling in the injection site) and VACCINATION SITE SWELLING (rash and swelling in the injection site). At the time of the report, VACCINATION SITE RASH (rash and swelling in the injection site) and VACCINATION SITE SWELLING (rash and swelling in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: red circle around the injection site; itching at the injection site; injection site swollen; injection site burning; having a rash, like a red circle around the injection site; pain on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain on her arm), VACCINATION SITE RASH (having a rash, like a red circle around the injection site), VACCINATION SITE ERYTHEMA (red circle around the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (injection site swollen) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) 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 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN (pain on her arm). On 06-Feb-2021, the patient experienced VACCINATION SITE RASH (having a rash, like a red circle around the injection site), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE PAIN (injection site burning). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red circle around the injection site). On 01-Feb-2021, PAIN (pain on her arm) had resolved. At the time of the report, VACCINATION SITE RASH (having a rash, like a red circle around the injection site), VACCINATION SITE ERYTHEMA (red circle around the injection site), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE PAIN (injection site burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: red circle around the injection site; itching at the injection site; injection site swollen; injection site burning; having a rash, like a red circle around the injection site; pain on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain on her arm), VACCINATION SITE RASH (having a rash, like a red circle around the injection site), VACCINATION SITE ERYTHEMA (red circle around the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (injection site swollen) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) 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 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN (pain on her arm). On 06-Feb-2021, the patient experienced VACCINATION SITE RASH (having a rash, like a red circle around the injection site), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE PAIN (injection site burning). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red circle around the injection site). On 01-Feb-2021, PAIN (pain on her arm) had resolved. At the time of the report, VACCINATION SITE RASH (having a rash, like a red circle around the injection site), VACCINATION SITE ERYTHEMA (red circle around the injection site), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE PAIN (injection site burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: His arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (His arm was sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (His arm was sore). At the time of the report, VACCINATION SITE PAIN (His arm was sore) 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. No treatment information was provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Urticaria
Clinical narrative: hives; itching; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (itching) and NAUSEA (Nausea) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced URTICARIA (hives), PRURITUS (itching) and NAUSEA (Nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Adverse event following immunisation, at a dose of UNK dosage form, qid. At the time of the report, URTICARIA (hives), PRURITUS (itching) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: temperature is 96.7 C; chills; soreness on the injection site; A spontaneous report was received from a consumer concerning a 80-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain (soreness on the injection site), chills and pyrexia (temperature is 96.7 °c).  The patient's medical history was not provided. Concomitant medications reported were Thyroid medication for drug use of unknown indication.  On 28 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Not provided) via unknown route for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced soreness on the injection site and chills few times for about 10 days. On an unknown date, the patient experienced drainage and On 25 Feb 2021, the patient stated she had temperature of 96.7 â°c.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives after injection on her legs, arms and traveling over full body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives after injection on her legs, arms and traveling over full body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced URTICARIA (Hives after injection on her legs, arms and traveling over full body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives after injection on her legs, arms and traveling over full body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain in extremity, Pyrexia
Clinical narrative: low grade fever of 99.5°F; body aches; slight headache; Diarrhea; A spontaneous report was received from a healthcare professional concerning a 73-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events diarrhea, low grade fever of 99.5â°f, body aches, slight headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced the event(s) diarrhea,On 9 Feb 2021, the patient experienced the event(s) low grade fever of 99.5â°f, body aches, slight headache.  Treatment details included For the symptoms: none., Other: Medication for her thyroid and Lisinopril., FMarasco 09Feb2021.  Action taken with mRNA-1273 in response to the events was not reported.  On 8 Feb 2021 the outcome of event(s), diarrhea was resolved. The outcome of event(s), low grade fever of 99, 5â°f, body aches, slight headache was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pruritus, Rash erythematous
Clinical narrative: Red rash; Itching; Warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), PRURITUS (Itching) and INJECTION SITE WARMTH (Warm to the touch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), PRURITUS (Itching) and INJECTION SITE WARMTH (Warm to the touch). The patient was treated with PRAMOCAINE HYDROCHLORIDE, ZINC ACETATE (CALADRYL CLEAR) for Itching, at an unspecified dose and frequency. On 26-Feb-2021, PRURITUS (Itching) and INJECTION SITE WARMTH (Warm to the touch) had resolved. At the time of the report, RASH ERYTHEMATOUS (Red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: rinjection site redness/ Redness has started to move down to her elbow area; warmth (hot to touch); severe itching around the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (rinjection site redness/ Redness has started to move down to her elbow area), INJECTION SITE WARMTH (warmth (hot to touch)) and INJECTION SITE PRURITUS (severe itching around the injection site.) 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 AFib, Congestive heart failure and Cancer. Concomitant products included TAMOXIFEN and APIXABAN (ELIQUIS) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (rinjection site redness/ Redness has started to move down to her elbow area), INJECTION SITE WARMTH (warmth (hot to touch)) and INJECTION SITE PRURITUS (severe itching around the injection site.). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (rinjection site redness/ Redness has started to move down to her elbow area), INJECTION SITE WARMTH (warmth (hot to touch)) and INJECTION SITE PRURITUS (severe itching around the injection site.) 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.   Reporter did not allow further contact
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Headache, Influenza like illness, Injection site induration, Night sweats
Clinical narrative: weakness; headache; sore arm with lump; 102 degree F fever; Flu-like symptoms; night sweats; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), NIGHT SWEATS (night sweats), ASTHENIA (weakness), HEADACHE (headache) and PYREXIA (102 degree F fever) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), NIGHT SWEATS (night sweats) and PYREXIA (102 degree F fever). On an unknown date, the patient experienced ASTHENIA (weakness), HEADACHE (headache) and INJECTION SITE INDURATION (sore arm with lump). On 28-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (weakness), HEADACHE (headache) and INJECTION SITE INDURATION (sore arm with lump) had resolved. At the time of the report, NIGHT SWEATS (night sweats) and PYREXIA (102 degree F fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: weakness; headache; sore arm with lump; 102 degree F fever; Flu-like symptoms; night sweats; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), NIGHT SWEATS (night sweats), ASTHENIA (weakness), HEADACHE (headache) and PYREXIA (102 degree F fever) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), NIGHT SWEATS (night sweats) and PYREXIA (102 degree F fever). On an unknown date, the patient experienced ASTHENIA (weakness), HEADACHE (headache) and INJECTION SITE INDURATION (sore arm with lump). On 28-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (weakness), HEADACHE (headache) and INJECTION SITE INDURATION (sore arm with lump) had resolved. At the time of the report, NIGHT SWEATS (night sweats) and PYREXIA (102 degree F fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: weakness; chills; fatigue; little bit headache; feverish; A spontaneous report (United States) was received from a healthcare professional concerning a 33-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fatigue, little bit headache, feverish, weakness,   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: LOT# 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Chills, Fatigue, little bit headache, feverish, weakness, Tylenol did not help.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, fatigue, little bit headache, feverish, weakness, tylenol did not help was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Flatulence, Headache, Myalgia, Vaccination site pain
Clinical narrative: Slight headache; Strong muscle; Strong joint pain; gassiness; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FLATULENCE (gassiness), VACCINATION SITE PAIN (Soreness at injection site), HEADACHE (Slight headache), MYALGIA (Strong muscle) and ARTHRALGIA (Strong joint pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced FLATULENCE (gassiness) and VACCINATION SITE PAIN (Soreness at injection site). On 06-Feb-2021, the patient experienced HEADACHE (Slight headache), MYALGIA (Strong muscle) and ARTHRALGIA (Strong joint pain). On 08-Feb-2021, FLATULENCE (gassiness), VACCINATION SITE PAIN (Soreness at injection site), HEADACHE (Slight headache), MYALGIA (Strong muscle) and ARTHRALGIA (Strong joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain, Pruritus, Rash
Clinical narrative: Sick to her stomach; pain; itchiing; rash 2 inches rectangular shape, hot; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of RASH (rash 2 inches rectangular shape, hot), ABDOMINAL DISCOMFORT (Sick to her stomach), PAIN (pain) and PRURITUS (itchiing) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Thyroid disorder and Hypertension. Concurrent medical conditions included Allergy to chemicals (allergic to codeine) and Hay fever.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Feb-2021, the patient experienced RASH (rash 2 inches rectangular shape, hot), ABDOMINAL DISCOMFORT (Sick to her stomach), PAIN (pain) and PRURITUS (itchiing). At the time of the report, RASH (rash 2 inches rectangular shape, hot), ABDOMINAL DISCOMFORT (Sick to her stomach), PAIN (pain) and PRURITUS (itchiing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included thyroid pills and blood pressure pills
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Tenderness
Clinical narrative: Arm started swelling; Getting very red; Tender; Really hot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm started swelling), ERYTHEMA (Getting very red), TENDERNESS (Tender) and FEELING HOT (Really hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-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 07-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm started swelling), ERYTHEMA (Getting very red), TENDERNESS (Tender) and FEELING HOT (Really hot). At the time of the report, PERIPHERAL SWELLING (Arm started swelling), ERYTHEMA (Getting very red) and TENDERNESS (Tender) outcome was unknown and FEELING HOT (Really hot) was resolving.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.; 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Hypertension
Clinical narrative: High Blood Pressure; High Blood Sugar; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High Blood Pressure) and BLOOD GLUCOSE INCREASED (High Blood Sugar) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus. Concomitant products included INSULIN for Diabetes.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HYPERTENSION (High Blood Pressure) and BLOOD GLUCOSE INCREASED (High Blood Sugar). On 04-Feb-2021, HYPERTENSION (High Blood Pressure) and BLOOD GLUCOSE INCREASED (High Blood Sugar) 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.   Concomitant product use was not provided by the reporter.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Tripled the size in my arm; very hot to touch/my arm is super super hot; a little bit red at the site/it was really red; feeling sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (feeling sore arm), SWELLING (Tripled the size in my arm), VACCINATION SITE WARMTH (very hot to touch/my arm is super super hot) and VACCINATION SITE ERYTHEMA (a little bit red at the site/it was really red) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (feeling sore arm), VACCINATION SITE WARMTH (very hot to touch/my arm is super super hot) and VACCINATION SITE ERYTHEMA (a little bit red at the site/it was really red). On 08-Feb-2021, the patient experienced SWELLING (Tripled the size in my arm). At the time of the report, PAIN IN EXTREMITY (feeling sore arm), SWELLING (Tripled the size in my arm), VACCINATION SITE WARMTH (very hot to touch/my arm is super super hot) and VACCINATION SITE ERYTHEMA (a little bit red at the site/it was really red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Influenza like illness, Pain in extremity
Clinical narrative: flu like symptoms; cough; no sense of taste; no sense of smell; arm pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm pain), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (cough), AGEUSIA (no sense of taste) and ANOSMIA (no sense of smell) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, ROSUVASTATIN, METFORMIN, LEVOTHYROXINE, PROBIOTICS NOS, TOCOPHERYL ACETATE (VITAMIN E [TOCOPHERYL ACETATE]), XANTOFYL, ZEAXANTHIN (LUTEIN ZEAXANTHIN), VITAMIN D3 and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 09-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (cough), AGEUSIA (no sense of taste) and ANOSMIA (no sense of smell). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. On 06-Feb-2021, PAIN IN EXTREMITY (arm pain) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (cough), AGEUSIA (no sense of taste) and ANOSMIA (no sense of smell) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: still itchy; red on my arm where I got the shot; chills; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (still itchy), CHILLS (chills), HEADACHE (bad headache) and VACCINATION SITE ERYTHEMA (red on my arm where I got the shot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 032L20A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), MONTELUKAST SODIUM (SINGULAIR) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced CHILLS (chills) and HEADACHE (bad headache). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (still itchy) and VACCINATION SITE ERYTHEMA (red on my arm where I got the shot). At the time of the report, VACCINATION SITE PRURITUS (still itchy), CHILLS (chills), HEADACHE (bad headache) and VACCINATION SITE ERYTHEMA (red on my arm where I got the shot) outcome was unknown. Not Provided    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 unspecified anti-itch cream..   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: No new information received, Argus ID number provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Pain in extremity, Rash erythematous, Rash pruritic
Clinical narrative: arm was sore; itchy rash near my chest; red itchy rash across my chest; allergic reaction; feel tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), RASH PRURITIC (itchy rash near my chest), FATIGUE (feel tired), RASH ERYTHEMATOUS (red itchy rash across my chest) and HYPERSENSITIVITY (allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Herbal products for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore), RASH PRURITIC (itchy rash near my chest), FATIGUE (feel tired), RASH ERYTHEMATOUS (red itchy rash across my chest) and HYPERSENSITIVITY (allergic reaction). At the time of the report, PAIN IN EXTREMITY (arm was sore), RASH PRURITIC (itchy rash near my chest), FATIGUE (feel tired), RASH ERYTHEMATOUS (red itchy rash across my chest) and HYPERSENSITIVITY (allergic reaction) outcome was unknown. Not Provided      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.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: not feel like her usual self; Fever 99.9 F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feel like her usual self) and PYREXIA (Fever 99.9 F) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-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 25-Feb-2021, the patient experienced FEELING ABNORMAL (not feel like her usual self) and PYREXIA (Fever 99.9 F). At the time of the report, FEELING ABNORMAL (not feel like her usual self) and PYREXIA (Fever 99.9 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Body temperature: fever 99.9 f (High) 99.9 F.         No relevant concomitant medication was reported.   Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fatigue; Fever - Temperature of 101.8F; Head Ache; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PAIN IN EXTREMITY (Arm Pain), PYREXIA (Fever - Temperature of 101.8F) and HEADACHE (Head Ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain). On 14-Feb-2021, the patient experienced FATIGUE (Fatigue), PYREXIA (Fever - Temperature of 101.8F) and HEADACHE (Head Ache). On 18-Jan-2021, PAIN IN EXTREMITY (Arm Pain) had resolved. On 18-Feb-2021, FATIGUE (Fatigue), PYREXIA (Fever - Temperature of 101.8F) and HEADACHE (Head Ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Headache
Clinical narrative: a couple red marks across; sharp headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (a couple red marks across) and HEADACHE (sharp headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031720A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Dermatitis allergic (surgical tape).    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced ERYTHEMA (a couple red marks across) and HEADACHE (sharp headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 500 milligram. At the time of the report, ERYTHEMA (a couple red marks across) and HEADACHE (sharp headache) had not 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.   Patient used cholesterol medicine as a Concomitant medication. Patient used aspirin Bayer back and body 500mg as a Treatment medication.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Papule, Pruritus, Rash, Skin exfoliation
Clinical narrative: skin breakouts on the V neck area their shoulder back, and around the foot inside of their elbow; itchy; scally; it's bumpy; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH (skin breakouts on the V neck area their shoulder back, and around the foot inside of their elbow), PRURITUS (itchy), SKIN EXFOLIATION (scally) and PAPULE (it's bumpy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included METOPROLOL, AMLODIPIN [AMLODIPINE], ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), ALPRAZOLAM, NAPROXEN SODIUM (ALEVE), VITAMIN D3, VITAMIN B12 [VITAMIN B12 NOS], ATORVASTATIN, ORLISTAT (LINESTAT) and FOLIC ACID for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced RASH (skin breakouts on the V neck area their shoulder back, and around the foot inside of their elbow), PRURITUS (itchy), SKIN EXFOLIATION (scally) and PAPULE (it's bumpy). At the time of the report, RASH (skin breakouts on the V neck area their shoulder back, and around the foot inside of their elbow), PRURITUS (itchy), SKIN EXFOLIATION (scally) and PAPULE (it's bumpy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were provided.