chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Vaccination site erythema; Vaccination site pruritus; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included CHOLESTEROL, ALLIUM SATIVUM, CAPSICUM ANNUUM, CRATAEGUS LAEVIGATA, FOENICULUM VULGARE, UBIDECARENONE (HEART) and LEVOFLOXACIN (LEVOPRIDE [LEVOFLOXACIN]) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: Fever; Fatigue; swelling of lymph node on the jaw; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (Fatigue) and LYMPHADENOPATHY (swelling of lymph node on the jaw) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dose. On 06-Jan-2021, the patient experienced PYREXIA (Fever), FATIGUE (Fatigue) and LYMPHADENOPATHY (swelling of lymph node on the jaw). At the time of the report, PYREXIA (Fever), FATIGUE (Fatigue) and LYMPHADENOPATHY (swelling of lymph node on the jaw) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-015280 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sorenessin the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sorenessin the injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sorenessin the injection site). At the time of the report, VACCINATION SITE PAIN (Sorenessin the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Injection site soreness; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts (Medical history reported as tree nut allergies.).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness) and VACCINATION SITE ERYTHEMA (Injection site redness). On 13-Feb-2021, VACCINATION SITE PAIN (Injection site soreness) and VACCINATION SITE ERYTHEMA (Injection site redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: pain at injection site; rash from injection site down to elbow; swelling at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (pain at injection site), INJECTION SITE RASH (rash from injection site down to elbow) and INJECTION SITE SWELLING (swelling at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, CLONIDINE and CARVEDILOL for Hypertension, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (pain at injection site), INJECTION SITE RASH (rash from injection site down to elbow) and INJECTION SITE SWELLING (swelling at injection site). At the time of the report, INJECTION SITE PAIN (pain at injection site) and INJECTION SITE SWELLING (swelling at injection site) outcome was unknown and INJECTION SITE RASH (rash from injection site down to elbow) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Full body rash; Everything itches but her legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Full body rash) and PRURITUS (Everything itches but her legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Feb-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 RASH (Full body rash) and PRURITUS (Everything itches but her legs). At the time of the report, RASH (Full body rash) and PRURITUS (Everything itches but her legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Bumps at injection; Injection site warm; Injection site redness; Injection site itch; Sore/arm was painful/tender to touch/skin near the injection site feels rough; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Bumps at injection), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE PRURITUS (Injection site itch) and VACCINATION SITE PAIN (Sore/arm was painful/tender to touch/skin near the injection site feels rough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Bumps at injection), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE PRURITUS (Injection site itch) and VACCINATION SITE PAIN (Sore/arm was painful/tender to touch/skin near the injection site feels rough). At the time of the report, VACCINATION SITE URTICARIA (Bumps at injection) had resolved and VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE PRURITUS (Injection site itch) and VACCINATION SITE PAIN (Sore/arm was painful/tender to touch/skin near the injection site feels rough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant product use was reported  No treatment details were provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: flue like symptoms; headache; chills; body ache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flue like symptoms), HEADACHE (headache), CHILLS (chills), PAIN (body ache) and NAUSEA (nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flue like symptoms), HEADACHE (headache), CHILLS (chills), PAIN (body ache) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (flue like symptoms), HEADACHE (headache), CHILLS (chills), PAIN (body ache) and NAUSEA (nausea) outcome was unknown.            This case was linked to MOD-2021-034624 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: RED FLUSHING OF THE FACE SIMILAR TO RED MANS SYNDROME; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (RED FLUSHING OF THE FACE SIMILAR TO RED MANS SYNDROME) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 224M20A) 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 16-Feb-2021, the patient experienced FLUSHING (RED FLUSHING OF THE FACE SIMILAR TO RED MANS SYNDROME). At the time of the report, FLUSHING (RED FLUSHING OF THE FACE SIMILAR TO RED MANS SYNDROME) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature decreased
Clinical narrative: balance is off; temperature; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BALANCE DISORDER (balance is off) and BODY TEMPERATURE DECREASED (temperature) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MZ0A) for COVID-19 vaccination.     Concomitant products included Blood pressure medication for an unknown indication.    On 09-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 BALANCE DISORDER (balance is off) and BODY TEMPERATURE DECREASED (temperature). At the time of the report, BALANCE DISORDER (balance is off) and BODY TEMPERATURE DECREASED (temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Vomiting
Clinical narrative: chills; throwing up; diarrhea; small headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), VOMITING (throwing up), DIARRHOEA (diarrhea) and HEADACHE (small headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced CHILLS (chills), VOMITING (throwing up), DIARRHOEA (diarrhea) and HEADACHE (small headache). At the time of the report, CHILLS (chills), VOMITING (throwing up), DIARRHOEA (diarrhea) and HEADACHE (small headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: Not feeling well; Area near the injection site is hot; Area near the injection site is extremely red; Rash near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), VACCINATION SITE WARMTH (Area near the injection site is hot), VACCINATION SITE ERYTHEMA (Area near the injection site is extremely red) and VACCINATION SITE RASH (Rash near the injection site) in a 73-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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MALAISE (Not feeling well), VACCINATION SITE WARMTH (Area near the injection site is hot), VACCINATION SITE ERYTHEMA (Area near the injection site is extremely red) and VACCINATION SITE RASH (Rash near the injection site). At the time of the report, MALAISE (Not feeling well), VACCINATION SITE WARMTH (Area near the injection site is hot), VACCINATION SITE ERYTHEMA (Area near the injection site is extremely red) and VACCINATION SITE RASH (Rash near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Injection site inflammation, Myalgia, Rash
Clinical narrative: tightness in her chest,sore in chest; skin rash; Welts at injection site; headache; muscle pain at injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (muscle pain at injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), CHEST DISCOMFORT (tightness in her chest,sore in chest) and RASH (skin rash) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced HEADACHE (headache), MYALGIA (muscle pain at injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 25-Jan-2021, the patient experienced CHEST DISCOMFORT (tightness in her chest,sore in chest), RASH (skin rash) and INJECTION SITE INFLAMMATION (Welts at injection site). At the time of the report, HEADACHE (headache), MYALGIA (muscle pain at injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), CHEST DISCOMFORT (tightness in her chest,sore in chest), RASH (skin rash) and INJECTION SITE INFLAMMATION (Welts at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: tightness in her chest,sore in chest; skin rash; Welts at injection site; headache; muscle pain at injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (muscle pain at injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), CHEST DISCOMFORT (tightness in her chest,sore in chest) and RASH (skin rash) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced HEADACHE (headache), MYALGIA (muscle pain at injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 25-Jan-2021, the patient experienced CHEST DISCOMFORT (tightness in her chest,sore in chest), RASH (skin rash) and INJECTION SITE INFLAMMATION (Welts at injection site). At the time of the report, HEADACHE (headache), MYALGIA (muscle pain at injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), CHEST DISCOMFORT (tightness in her chest,sore in chest), RASH (skin rash) and INJECTION SITE INFLAMMATION (Welts at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: pain in her disc in her back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in her disc in her back) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced BACK PAIN (pain in her disc in her back). At the time of the report, BACK PAIN (pain in her disc in her back) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation, Vaccination site mass
Clinical narrative: red irritation oval on injection site; red lump on injection site; red irritation oval on injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red irritation oval on injection site), INJECTION SITE IRRITATION (red irritation oval on injection site) and VACCINATION SITE MASS (red lump on injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medication history reported).    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (red irritation oval on injection site). On an unknown date, the patient experienced INJECTION SITE IRRITATION (red irritation oval on injection site) and VACCINATION SITE MASS (red lump on injection site). At the time of the report, INJECTION SITE ERYTHEMA (red irritation oval on injection site), INJECTION SITE IRRITATION (red irritation oval on injection site) and VACCINATION SITE MASS (red lump on injection site) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: No specific follow-up information recorded.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received 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 at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pustule
Clinical narrative: Sore knot with pus in it; headache; A spontaneous report was received from a consumer concerning an 88-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced sore knot with pus in it and headache.  The patient's medical history was not provided. No relevant concomitant medications were provided.  On 12 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 025L20A) on the left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced sore knot with pus in it and headache. Treatment for the events included Tylenol and cleansed the injection site with saline solution.  Action taken with mRNA-1273 in response to the events was not reported.    At the time of this report, the outcome of the events, sore knot with pus in it and headache resolved is unknown.  Based on Association comment Sore Knot with pus in it (Unlisted in System) and Headache (Listed in System).
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Swollen tongue
Clinical narrative: swollen tongue; Swollen lip and tongue; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (Swollen lip and tongue) and SWOLLEN TONGUE (swollen tongue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MOUTH SWELLING (Swollen lip and tongue). On an unknown date, the patient experienced SWOLLEN TONGUE (swollen tongue). At the time of the report, MOUTH SWELLING (Swollen lip and tongue) and SWOLLEN TONGUE (swollen tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: body aches; chills; fever; sore throat; A spontaneous report was received from a consumer concerning a 68-year-old, female patient who experienced  body aches/ pain, chills, fever/ pyrexia, sore throat/ Oropharyngeal pain.  The patient's medical history was not provided.   Concomitant product use was not provided  by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A] on 10-FEB-2021.  intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 10-FEB-2021, 68-year-old female patient received her first of two planned mRNA-1273 for prophylaxis of COVID-19. and approximately after 6 days on 16-FEB-2021 she experienced body ache, chills, fever, sore throat. Treatment information was  provided by reporter is she used Tylenol.    Action taken with mRNA-1273 in response to the event(s) was unknown.  The event(s), body aches/ pain, chills, fever/ pyrexia, sore throat/ Oropharyngeal pain. were considered unknown.  Based on MSA comment, Pain is Unlisted in all RSI.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Arm Red (Injection Site); Itchy arm at injection site; A spontaneous report was received from a consumer, concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced Itchy arm at injection site, arm Red.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 29-jan-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 042L20A) via intramuscular route for COVID-19 infection prophylaxis.   On 2-feb-2021  after first dose of vaccine, the patient experienced ongoing red on the injection site and itchy till 17-feb -2021. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, was considered to be unknown at the time of this report.  Based on MSA comment, Vaccination site erythema and Vaccination site pruritus is listed in CCDS also
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild injection site soreness; A spontaneous report was received from a consumer concerning a male patient of unknown age, who was administered with Moderna's COVID-19 vaccine and experienced injection site soreness.  Patient's current condition included kidney stone. Concomitant mediations were mentioned was hydrocodone.  On 12-FEB-2021,prior to the onset of events, patient received the first of two planned doses of mRNA-1273 vaccine(Lot number: unknown) for prophylaxis of covid-19 infection.  Following the vaccination on 12-FEB-2021,the patient experienced injection site soreness.The patient wanted to know if he could take Hydrocodone because ha believes he has kidney stone and injection site soreness.No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the event, injection site soreness was unknown.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded. The reported event is consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing; A  spontaneous  report was received from a consumer concerning a female patient of an 79 year old who received  Moderna's COVID -19 vaccine (mRNA-1273) and experience the occurrence of DYSPNOEA (Difficulty breathing ).     The patient's past medical history was not provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), SIMVASTATIN, AMLODIPINE, DICLOFENAC and OMEPRAZOLE for an unknown indication.    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) ( batch number -026L20A0)(unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, DYSPNOEA (Difficulty breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  in response to the event was not reported. The outcome of event was difficulty breathing was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: swelling throat; A Spontaneous report was received from consumer concerning a male patient of unknown age who received Moderna COVID-19 vaccine (m-RNA-1273) and experienced Pharyngeal swelling.  The patient has no medical history and no relevant concomitant medications.   On unknown date, prior to the onset of the events the patient received their first of dose of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route of administration for prophylaxis of COVID-19 infection.  Treatment information was not provided.   The events Decreased Pharyngeal swelling was unknown. The outcome of the events is unknown.   Action taken with mRNA-1273 in response to the events was not reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 29-Apr-2021. On 26-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). On 26-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: No specific follow-up information recorded.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash, two and a half inches around the vaccination area.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash, two and a half inches around the vaccination area.) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concomitant products included PANTOPRAZOLE, METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash, two and a half inches around the vaccination area.). At the time of the report, VACCINATION SITE RASH (Rash, two and a half inches around the vaccination area.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Patient did not treat the rash.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: No specific follow-up information recorded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hyperhidrosis, Influenza like illness, Musculoskeletal pain
Clinical narrative: flu like symptoms; Sweating; my joints are killing me, lower back, knees, and buttocks; fever of 100F; severe body aches; headaches just like when I had COVID but not as severe; my joints are killing me, lower back, knees, and buttocks; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever of 100F), MYALGIA (severe body aches), HEADACHE (headaches just like when I had COVID but not as severe) and ARTHRALGIA (my joints are killing me, lower back, knees, and buttocks) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Lupus syndrome (Lupus) and Rheumatoid arthritis.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 11-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever of 100F), MYALGIA (severe body aches), HEADACHE (headaches just like when I had COVID but not as severe), ARTHRALGIA (my joints are killing me, lower back, knees, and buttocks), HYPERHIDROSIS (Sweating) and MUSCULOSKELETAL PAIN (my joints are killing me, lower back, knees, and buttocks). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown, PYREXIA (fever of 100F) and HYPERHIDROSIS (Sweating) had resolved and MYALGIA (severe body aches), HEADACHE (headaches just like when I had COVID but not as severe), ARTHRALGIA (my joints are killing me, lower back, knees, and buttocks) and MUSCULOSKELETAL PAIN (my joints are killing me, lower back, knees, and buttocks) had not 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: flu like symptoms; Sweating; my joints are killing me, lower back, knees, and buttocks; fever of 100F; severe body aches; headaches just like when I had COVID but not as severe; my joints are killing me, lower back, knees, and buttocks; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever of 100F), MYALGIA (severe body aches), HEADACHE (headaches just like when I had COVID but not as severe) and ARTHRALGIA (my joints are killing me, lower back, knees, and buttocks) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Lupus syndrome (Lupus) and Rheumatoid arthritis.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 11-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever of 100F), MYALGIA (severe body aches), HEADACHE (headaches just like when I had COVID but not as severe), ARTHRALGIA (my joints are killing me, lower back, knees, and buttocks), HYPERHIDROSIS (Sweating) and MUSCULOSKELETAL PAIN (my joints are killing me, lower back, knees, and buttocks). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown, PYREXIA (fever of 100F) and HYPERHIDROSIS (Sweating) had resolved and MYALGIA (severe body aches), HEADACHE (headaches just like when I had COVID but not as severe), ARTHRALGIA (my joints are killing me, lower back, knees, and buttocks) and MUSCULOSKELETAL PAIN (my joints are killing me, lower back, knees, and buttocks) had not 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Skin discolouration, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Discoloration; Bruised circular area; Had a red welt about golf ball diameter sized; Redness; Swelling; Just sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SKIN DISCOLOURATION (Discoloration), CONTUSION (Bruised circular area), VACCINATION SITE PAIN (Just sore), VACCINATION SITE URTICARIA (Had a red welt about golf ball diameter sized) and VACCINATION SITE ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (Just sore). On 28-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Had a red welt about golf ball diameter sized), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). On 08-Feb-2021, the patient experienced SKIN DISCOLOURATION (Discoloration) and CONTUSION (Bruised circular area). 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, SKIN DISCOLOURATION (Discoloration), CONTUSION (Bruised circular area), VACCINATION SITE PAIN (Just sore), VACCINATION SITE URTICARIA (Had a red welt about golf ball diameter sized), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Discoloration; Bruised circular area; Had a red welt about golf ball diameter sized; Redness; Swelling; Just sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SKIN DISCOLOURATION (Discoloration), CONTUSION (Bruised circular area), VACCINATION SITE PAIN (Just sore), VACCINATION SITE URTICARIA (Had a red welt about golf ball diameter sized) and VACCINATION SITE ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (Just sore). On 28-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Had a red welt about golf ball diameter sized), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). On 08-Feb-2021, the patient experienced SKIN DISCOLOURATION (Discoloration) and CONTUSION (Bruised circular area). 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, SKIN DISCOLOURATION (Discoloration), CONTUSION (Bruised circular area), VACCINATION SITE PAIN (Just sore), VACCINATION SITE URTICARIA (Had a red welt about golf ball diameter sized), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives (Face and trunkal); Itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives (Face and trunkal)) and PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives (Face and trunkal)) and PRURITUS (Itching). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives (Face and trunkal)) and PRURITUS (Itching) outcome was unknown.            No concomitant medication was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Peripheral swelling, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: arm started to itch; large red patch; swelling and it is extending down the arm; Slight burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm started to itch), VACCINATION SITE ERYTHEMA (large red patch), PERIPHERAL SWELLING (swelling and it is extending down the arm) and BURNING SENSATION (Slight burning sensation) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for an unknown indication.     Concomitant products included DENOSUMAB (PROLIA) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (arm started to itch), VACCINATION SITE ERYTHEMA (large red patch), PERIPHERAL SWELLING (swelling and it is extending down the arm) and BURNING SENSATION (Slight burning sensation). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (arm started to itch), VACCINATION SITE ERYTHEMA (large red patch), PERIPHERAL SWELLING (swelling and it is extending down the arm) and BURNING SENSATION (Slight burning sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling, Rash
Clinical narrative: Swollen eye; Rash on neck; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swollen eye) and RASH (Rash on neck) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced RASH (Rash on neck). On an unknown date, the patient experienced EYE SWELLING (Swollen eye). At the time of the report, EYE SWELLING (Swollen eye) and RASH (Rash on neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19 after vaccination) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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. On 08-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19 after vaccination). At the time of the report, COVID-19 (tested positive for COVID-19 after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.    This case was linked to MOD21-030466 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever 100.6 F; Chills and she is Tired; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.6 F), CHILLS (Chills and she is Tired) and FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 16-Feb-2021, the patient experienced PYREXIA (Fever 100.6 F), CHILLS (Chills and she is Tired) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever 100.6 F), CHILLS (Chills and she is Tired) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Pyrexia: 100.6 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination complication
Clinical narrative: really sick; fever of 100.7 F; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (really sick), PYREXIA (fever of 100.7 F) and HEADACHE (Headaches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Foot surgery. Concurrent medical conditions included Drug allergy (Penicillin allergy). Concomitant products included GABAPENTIN for Nerve pain, OMEPRAZOLE for Stomach discomfort.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 16-Feb-2021, the patient experienced VACCINATION COMPLICATION (really sick), PYREXIA (fever of 100.7 F) and HEADACHE (Headaches). On 18-Feb-2021, VACCINATION COMPLICATION (really sick), PYREXIA (fever of 100.7 F) and HEADACHE (Headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Concomitant medication included gabapentin to treat foot nerve pain.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Headache
Clinical narrative: Headache; Fatigue; flushed face; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and FLUSHING (flushed face) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 18-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 HEADACHE (Headache), FATIGUE (Fatigue) and FLUSHING (flushed face). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue) and FLUSHING (flushed face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash, Rash papular
Clinical narrative: Massive rash down arm; Rash is hot and raised; Rash is hot and raised; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Massive rash down arm), FEELING HOT (Rash is hot and raised) and RASH PAPULAR (Rash is hot and raised) 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 07-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 RASH (Massive rash down arm), FEELING HOT (Rash is hot and raised) and RASH PAPULAR (Rash is hot and raised). At the time of the report, RASH (Massive rash down arm), FEELING HOT (Rash is hot and raised) and RASH PAPULAR (Rash is hot and raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.  No Treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.