chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Throat little itchy immediately after vaccine; Lip swollen; Hived lip; Elevated heart beat; Low grade fever; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Throat little itchy immediately after vaccine), LIP SWELLING (Lip swollen), URTICARIA (Hived lip), TACHYCARDIA (Elevated heart beat) and PYREXIA (Low grade fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (NSAIDS).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced THROAT IRRITATION (Throat little itchy immediately after vaccine), LIP SWELLING (Lip swollen), URTICARIA (Hived lip), TACHYCARDIA (Elevated heart beat), PYREXIA (Low grade fever) and VACCINATION SITE PAIN (Sore arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Apr-2021, THROAT IRRITATION (Throat little itchy immediately after vaccine), LIP SWELLING (Lip swollen), URTICARIA (Hived lip), TACHYCARDIA (Elevated heart beat) and PYREXIA (Low grade fever) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient visited emergency room. No concomitant medication reported. Treatment  also included steroid.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Induration, Injection site erythema, Somnolence
Clinical narrative: little hard in one spot; like her brain is not function 100%; red mark, 3 by 3 inches at the injection site; tired; pended all day sleeping more than awake; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE, INDURATION, FEELING ABNORMAL, INJECTION SITE ERYTHEMA, and FATIGUE in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Osteoporosis.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced SOMNOLENCE. On an unknown date, the patient experienced INDURATION, FEELING ABNORMAL, INJECTION SITE ERYTHEMA, and FATIGUE. At the time of the report, SOMNOLENCE, INDURATION, FEELING ABNORMAL, INJECTION SITE ERYTHEMA, and FATIGUE outcome was unknown.            No concomitants were reported. No treatment was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.   This case was linked to MOD-2021-060836.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, COVID-19, Cough, Fatigue, SARS-CoV-2 test
Clinical narrative: weird dreams; upper respiratory cough; extremely tired; covid-19; slight tenderness at injection site; slight redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19), ABNORMAL DREAMS (weird dreams), COUGH (upper respiratory cough), VACCINATION SITE PAIN (slight tenderness at injection site) and VACCINATION SITE ERYTHEMA (slight redness at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (slight tenderness at injection site) and VACCINATION SITE ERYTHEMA (slight redness at injection site). On 13-Mar-2021, the patient experienced COVID-19 (covid-19). On 14-Mar-2021, the patient experienced ABNORMAL DREAMS (weird dreams), COUGH (upper respiratory cough) and FATIGUE (extremely tired). On 18-Mar-2021, COVID-19 (covid-19), ABNORMAL DREAMS (weird dreams), COUGH (upper respiratory cough) and FATIGUE (extremely tired) had resolved. At the time of the report, VACCINATION SITE PAIN (slight tenderness at injection site) and VACCINATION SITE ERYTHEMA (slight redness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included antibodies. Concomitant medication not provided.   This case was linked to MOD-2021-067546 (E2B Linked Report).; Sender's Comments:  MOD-2021-067546:Husband case
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: weird dreams; upper respiratory cough; extremely tired; covid-19; slight tenderness at injection site; slight redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19), ABNORMAL DREAMS (weird dreams), COUGH (upper respiratory cough), VACCINATION SITE PAIN (slight tenderness at injection site) and VACCINATION SITE ERYTHEMA (slight redness at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (slight tenderness at injection site) and VACCINATION SITE ERYTHEMA (slight redness at injection site). On 13-Mar-2021, the patient experienced COVID-19 (covid-19). On 14-Mar-2021, the patient experienced ABNORMAL DREAMS (weird dreams), COUGH (upper respiratory cough) and FATIGUE (extremely tired). On 18-Mar-2021, COVID-19 (covid-19), ABNORMAL DREAMS (weird dreams), COUGH (upper respiratory cough) and FATIGUE (extremely tired) had resolved. At the time of the report, VACCINATION SITE PAIN (slight tenderness at injection site) and VACCINATION SITE ERYTHEMA (slight redness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included antibodies. Concomitant medication not provided.   This case was linked to MOD-2021-067546 (E2B Linked Report).; Sender's Comments:  MOD-2021-067546:Husband case
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site rash, Vaccination site warmth
Clinical narrative: was 4°F warmer at the site of rash; cherry red rash; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (was 4°F warmer at the site of rash), RASH ERYTHEMATOUS (cherry red rash) and VACCINATION SITE RASH (rash at the injection site) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE WARMTH (was 4°F warmer at the site of rash), RASH ERYTHEMATOUS (cherry red rash) and VACCINATION SITE RASH (rash at the injection site). On 05-Apr-2021, VACCINATION SITE WARMTH (was 4°F warmer at the site of rash), RASH ERYTHEMATOUS (cherry red rash) and VACCINATION SITE RASH (rash at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment drug information was not given.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site nodule, Vaccination site pruritus, Vaccination site rash
Clinical narrative: bumpy; moderna arm covid rash; itchy; turned a little bit red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (bumpy), VACCINATION SITE RASH (moderna arm covid rash), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (turned a little bit red) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE NODULE (bumpy), VACCINATION SITE RASH (moderna arm covid rash), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (turned a little bit red). At the time of the report, VACCINATION SITE NODULE (bumpy), VACCINATION SITE RASH (moderna arm covid rash), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (turned a little bit red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication not provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hunger, Hyperhidrosis
Clinical narrative: nausea; being dizzy; soaked in sweat; hunger; muscle pain; vominting; fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (being dizzy), HYPERHIDROSIS (soaked in sweat), HUNGER (hunger), MYALGIA (muscle pain) and VOMITING (vominting) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included ALPRAZOLAM (XANAX), QUETIAPINE FUMARATE (SEROQUEL) and VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for Product used for unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (being dizzy), HYPERHIDROSIS (soaked in sweat), HUNGER (hunger), MYALGIA (muscle pain), VOMITING (vominting), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced NAUSEA (nausea). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN COX [ACETYLSALICYLIC ACID]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (being dizzy), HYPERHIDROSIS (soaked in sweat), HUNGER (hunger), MYALGIA (muscle pain), VOMITING (vominting), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) had resolved.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: 2nd dose details and outcome of the events updated.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: nausea; being dizzy; soaked in sweat; hunger; muscle pain; vominting; fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (being dizzy), HYPERHIDROSIS (soaked in sweat), HUNGER (hunger), MYALGIA (muscle pain) and VOMITING (vominting) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included ALPRAZOLAM (XANAX), QUETIAPINE FUMARATE (SEROQUEL) and VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for Product used for unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (being dizzy), HYPERHIDROSIS (soaked in sweat), HUNGER (hunger), MYALGIA (muscle pain), VOMITING (vominting), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced NAUSEA (nausea). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN COX [ACETYLSALICYLIC ACID]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (being dizzy), HYPERHIDROSIS (soaked in sweat), HUNGER (hunger), MYALGIA (muscle pain), VOMITING (vominting), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) had resolved.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: 2nd dose details and outcome of the events updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine headache.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MIGRAINE (migraine headache). The patient was treated with SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine headache, at an unspecified dose and frequency. On 09-Mar-2021, MIGRAINE (migraine headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash papular, Vaccination site rash
Clinical narrative: itchy; raised rash; rash on the injection arm on the under arm, above the elbow; "arm sore for two days",; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("arm sore for two days",), PRURITUS (itchy), RASH PAPULAR (raised rash) and VACCINATION SITE RASH (rash on the injection arm on the under arm, above the elbow) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY ("arm sore for two days",). On 01-Apr-2021, the patient experienced PRURITUS (itchy), RASH PAPULAR (raised rash) and VACCINATION SITE RASH (rash on the injection arm on the under arm, above the elbow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency; HYDROCORTISONE (topical) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at an unspecified dose and frequency. On 24-Mar-2021, PAIN IN EXTREMITY ("arm sore for two days",) had resolved. At the time of the report, PRURITUS (itchy), RASH PAPULAR (raised rash) and VACCINATION SITE RASH (rash on the injection arm on the under arm, above the elbow) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: The follow up received on 01-JUN-2021. AE  contact information is (email) updated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Bedridden, Diarrhoea, Headache, Myalgia
Clinical narrative: muscle aches; fever; headache; "I was throwing up"; "I had Diarrhea"; "We just laid around for two days doing nothing"; "My reaction was worse than my husbands"; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA ("I had Diarrhea"), BEDRIDDEN ("We just laid around for two days doing nothing"), ADVERSE REACTION ("My reaction was worse than my husbands"), MYALGIA (muscle aches) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced DIARRHOEA ("I had Diarrhea"), BEDRIDDEN ("We just laid around for two days doing nothing"), ADVERSE REACTION ("My reaction was worse than my husbands") and VOMITING ("I was throwing up"). On an unknown date, the patient experienced MYALGIA (muscle aches), PYREXIA (fever) and HEADACHE (headache). On 17-May-2021, DIARRHOEA ("I had Diarrhea"), BEDRIDDEN ("We just laid around for two days doing nothing"), ADVERSE REACTION ("My reaction was worse than my husbands") and VOMITING ("I was throwing up") had resolved. At the time of the report, MYALGIA (muscle aches), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided.Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Non-significant follow-up appended; Sender's Comments:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: muscle aches; fever; headache; "I was throwing up"; "I had Diarrhea"; "We just laid around for two days doing nothing"; "My reaction was worse than my husbands"; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA ("I had Diarrhea"), BEDRIDDEN ("We just laid around for two days doing nothing"), ADVERSE REACTION ("My reaction was worse than my husbands"), MYALGIA (muscle aches) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced DIARRHOEA ("I had Diarrhea"), BEDRIDDEN ("We just laid around for two days doing nothing"), ADVERSE REACTION ("My reaction was worse than my husbands") and VOMITING ("I was throwing up"). On an unknown date, the patient experienced MYALGIA (muscle aches), PYREXIA (fever) and HEADACHE (headache). On 17-May-2021, DIARRHOEA ("I had Diarrhea"), BEDRIDDEN ("We just laid around for two days doing nothing"), ADVERSE REACTION ("My reaction was worse than my husbands") and VOMITING ("I was throwing up") had resolved. At the time of the report, MYALGIA (muscle aches), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided.Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Non-significant follow-up appended; Sender's Comments:
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Back pain (Occasional Back Pain).   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced BACK PAIN (back pain). At the time of the report, BACK PAIN (back pain) had resolved.            No concomitant medications were provided. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-147408 (Linked Report). This case was linked to MOD-2021-147408 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Live follow up received on 16-May-2021; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-147408:Dose 2
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: rash on his ankles, feet, upper back, back and sides of neck, around the injection site 2x3 inches, rash was getting darker around his ankles; rash around the injection site 2X3 inches and very dark red, down his arms to his wrists; This spontaneous case was reported by a nurse and describes the occurrence of RASH (rash on his ankles, feet, upper back, back and sides of neck, around the injection site 2x3 inches, rash was getting darker around his ankles) and VACCINATION SITE RASH (rash around the injection site 2X3 inches and very dark red, down his arms to his wrists) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced RASH (rash on his ankles, feet, upper back, back and sides of neck, around the injection site 2x3 inches, rash was getting darker around his ankles) and VACCINATION SITE RASH (rash around the injection site 2X3 inches and very dark red, down his arms to his wrists). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 mg every 6 hours; FAMOTIDINE (PEPCID AC) at a dose of 20 mg 1 tab at bedtime as needed and METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) at a dose of 24 mg titrating down for 6 days. At the time of the report, RASH (rash on his ankles, feet, upper back, back and sides of neck, around the injection site 2x3 inches, rash was getting darker around his ankles) and VACCINATION SITE RASH (rash around the injection site 2X3 inches and very dark red, down his arms to his wrists) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  Action taken with mRNA-1273 in response to events was not applicable.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain, Vaccination site vesicles
Clinical narrative: But after second dose there is a pocket full of fluid under the injection site.; At a certain light it looks like a may be blueish bruise.; arm was tender/arm was painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (But after second dose there is a pocket full of fluid under the injection site.), VACCINATION SITE BRUISING (At a certain light it looks like a may be blueish bruise.) and VACCINATION SITE PAIN (arm was tender/arm was painful) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MELATONIN for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE VESICLES (But after second dose there is a pocket full of fluid under the injection site.), VACCINATION SITE BRUISING (At a certain light it looks like a may be blueish bruise.) and VACCINATION SITE PAIN (arm was tender/arm was painful). At the time of the report, VACCINATION SITE VESICLES (But after second dose there is a pocket full of fluid under the injection site.), VACCINATION SITE BRUISING (At a certain light it looks like a may be blueish bruise.) and VACCINATION SITE PAIN (arm was tender/arm was painful) had resolved.            No treatment information was provided.   This case was linked to MOD21-069291 (E2B Linked Report).  Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Added reporter information. Updated the outcome of events.; Sender's Comments:  MOD21-069291:MOD-2021-067565 1st dose case
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Electrocardiogram, Fall, Vital signs measurement
Clinical narrative: severe stomach cramps; Upon standing up, fell over; diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (severe stomach cramps), FALL (Upon standing up, fell over) and DIARRHOEA (diarrhea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (severe stomach cramps), FALL (Upon standing up, fell over) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (severe stomach cramps), FALL (Upon standing up, fell over) and DIARRHOEA (diarrhea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Electrocardiogram: normal (normal) normal. On 04-Apr-2021, Vital signs measurement: normal (normal) bloodwork normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment medications provided by the reporter.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea after the second dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Nausea (suffering with nausea for two years), Vomiting (suffering with vomiting for two years) and Itching. Concomitant products included ATORVASTATIN for Cholesterol blood excessive, HYDROXYZINE for Itching, ONDANSETRON for Nausea and Vomiting, AZITHROMYCIN (AZO) for Supplementation therapy, COGNIUM for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (nausea after the second dose). The patient was treated with ONDANSETRON for Nausea, at a dose of 4 mg. At the time of the report, NAUSEA (nausea after the second dose) outcome was unknown. Not Provided          Concomitant products included Azo as a urinary health supplement.  Action taken with mRNA-1273 in response to event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up received on 26 June 2021 contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Rash macular
Clinical narrative: red blotches; Inflamed 2 inch wide and 3 inch high; This spontaneous case was reported by a patient and describes the occurrence of RASH MACULAR (red blotches) and DERMATITIS (Inflamed 2 inch wide and 3 inch high) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis and Depression.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (red blotches) and DERMATITIS (Inflamed 2 inch wide and 3 inch high). At the time of the report, RASH MACULAR (red blotches) and DERMATITIS (Inflamed 2 inch wide and 3 inch high) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient reported for concomitant medications taking antidepressants, supplements for osteoporosis and medication for cholesterol.   No treatment information for the first dose events were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-067635 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067635:2nd dose
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pain, Pruritus, Rash pruritic, Urticaria
Clinical narrative: Itchy rash on thigh; Hives on chest, breast, on both arms, ears, and face; Fire ants crawling all over/ itchy and painful; Itchy and painful; Face is flush; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on thigh), URTICARIA (Hives on chest, breast, on both arms, ears, and face), PAIN (Fire ants crawling all over/ itchy and painful), PRURITUS (Itchy and painful) and FLUSHING (Face is flush) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy and Drug allergy (cleocin). Concomitant products included TRIAMTERENE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash on thigh), URTICARIA (Hives on chest, breast, on both arms, ears, and face), PAIN (Fire ants crawling all over/ itchy and painful), PRURITUS (Itchy and painful) and FLUSHING (Face is flush). The patient was treated with PREDNISONE at a dose of 10 mg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and LEVOCETIRIZINE at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash on thigh), URTICARIA (Hives on chest, breast, on both arms, ears, and face), PAIN (Fire ants crawling all over/ itchy and painful), PRURITUS (Itchy and painful) and FLUSHING (Face is flush) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: has gotten covid; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Apr-2021 and was forwarded to the company on 05-Apr-2021.    This spontaneous case was reported by an other and describes the occurrence of COVID-19 (has gotten covid) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced COVID-19 (has gotten covid). At the time of the report, COVID-19 (has gotten covid) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. Treatment information were not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: a rash appeared at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 03-Apr-2021, the patient experienced VACCINATION SITE RASH. At the time of the report, VACCINATION SITE RASH outcome was unknown. Not Related.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Doses were given one week apart; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses were given one week apart) 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 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses were given one week apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses were given one week apart) 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 Concomitant drugs are provided, and no medicines apart from suspect drug was not provided   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: "Covid arm"; swollen injection site; vaccination site rash; itchy at the injection sit; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION ("Covid arm"), VACCINATION SITE SWELLING (swollen injection site), VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE PRURITUS (itchy at the injection sit) in a 70-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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ADVERSE REACTION ("Covid arm"), VACCINATION SITE SWELLING (swollen injection site), VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE PRURITUS (itchy at the injection sit). On 20-Mar-2021, ADVERSE REACTION ("Covid arm"), VACCINATION SITE SWELLING (swollen injection site), VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE PRURITUS (itchy at the injection sit) outcome was unknown. Not Provided          Concomitant information was not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-067598 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067598:
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under the age of 18 years old has received the first dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the age of 18 years old has received the first dose) in an adolescent male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the age of 18 years old has received the first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the age of 18 years old has received the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The reporter called for guidance on how long the patient should wait to receive his second dose of the Moderna vaccine.  Concomitant medications were not reported.; Sender's Comments: This report refers to a case of Product administered to patient of Inappropriate age for mRNA-1273, lot # unknown with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) 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. In March 2021, the patient experienced COVID-19 (COVID-19). On 07-Apr-2021, COVID-19 (COVID-19) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product is not provided. No treatment information is provided.  Reporter stated the patients quarantine period would end on 07APR2021 and second dose was scheduled 08APR2021.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Myalgia
Clinical narrative: Lethargy; Chills; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 19-Feb-2021 to 28-Feb-2021.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced LETHARGY (Lethargy), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle pain). On 25-Mar-2021, LETHARGY (Lethargy), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified eye drops and supplements. No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Malaise
Clinical narrative: redness all over the injection area, the upper torso and the back which looks like a sunburn; didn't feel like herself; very stuffy nose; dry heaving; runny nose; nauseous; headache; extremely tired; chills; fever; started feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (didn't feel like herself), RETCHING (dry heaving), RHINORRHOEA (runny nose), NASAL CONGESTION (very stuffy nose) and MALAISE (started feeling unwell) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced MALAISE (started feeling unwell), CHILLS (chills) and PYREXIA (fever). On 03-Apr-2021, the patient experienced RETCHING (dry heaving), RHINORRHOEA (runny nose), NAUSEA (nauseous), HEADACHE (headache) and FATIGUE (extremely tired). On 04-Apr-2021, the patient experienced FEELING ABNORMAL (didn't feel like herself) and NASAL CONGESTION (very stuffy nose). On 05-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness all over the injection area, the upper torso and the back which looks like a sunburn). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (didn't feel like herself), RETCHING (dry heaving), RHINORRHOEA (runny nose), NASAL CONGESTION (very stuffy nose), MALAISE (started feeling unwell), VACCINATION SITE ERYTHEMA (redness all over the injection area, the upper torso and the back which looks like a sunburn), CHILLS (chills), PYREXIA (fever), NAUSEA (nauseous), HEADACHE (headache) and FATIGUE (extremely tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea, Pyrexia, Retching, Rhinorrhoea
Clinical narrative: redness all over the injection area, the upper torso and the back which looks like a sunburn; didn't feel like herself; very stuffy nose; dry heaving; runny nose; nauseous; headache; extremely tired; chills; fever; started feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (didn't feel like herself), RETCHING (dry heaving), RHINORRHOEA (runny nose), NASAL CONGESTION (very stuffy nose) and MALAISE (started feeling unwell) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced MALAISE (started feeling unwell), CHILLS (chills) and PYREXIA (fever). On 03-Apr-2021, the patient experienced RETCHING (dry heaving), RHINORRHOEA (runny nose), NAUSEA (nauseous), HEADACHE (headache) and FATIGUE (extremely tired). On 04-Apr-2021, the patient experienced FEELING ABNORMAL (didn't feel like herself) and NASAL CONGESTION (very stuffy nose). On 05-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness all over the injection area, the upper torso and the back which looks like a sunburn). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (didn't feel like herself), RETCHING (dry heaving), RHINORRHOEA (runny nose), NASAL CONGESTION (very stuffy nose), MALAISE (started feeling unwell), VACCINATION SITE ERYTHEMA (redness all over the injection area, the upper torso and the back which looks like a sunburn), CHILLS (chills), PYREXIA (fever), NAUSEA (nauseous), HEADACHE (headache) and FATIGUE (extremely tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: redness all over the injection area, the upper torso and the back which looks like a sunburn; didn't feel like herself; very stuffy nose; dry heaving; runny nose; nauseous; headache; extremely tired; chills; fever; started feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (didn't feel like herself), RETCHING (dry heaving), RHINORRHOEA (runny nose), NASAL CONGESTION (very stuffy nose) and MALAISE (started feeling unwell) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced MALAISE (started feeling unwell), CHILLS (chills) and PYREXIA (fever). On 03-Apr-2021, the patient experienced RETCHING (dry heaving), RHINORRHOEA (runny nose), NAUSEA (nauseous), HEADACHE (headache) and FATIGUE (extremely tired). On 04-Apr-2021, the patient experienced FEELING ABNORMAL (didn't feel like herself) and NASAL CONGESTION (very stuffy nose). On 05-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness all over the injection area, the upper torso and the back which looks like a sunburn). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (didn't feel like herself), RETCHING (dry heaving), RHINORRHOEA (runny nose), NASAL CONGESTION (very stuffy nose), MALAISE (started feeling unwell), VACCINATION SITE ERYTHEMA (redness all over the injection area, the upper torso and the back which looks like a sunburn), CHILLS (chills), PYREXIA (fever), NAUSEA (nauseous), HEADACHE (headache) and FATIGUE (extremely tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported. Action taken with mRNA-1273 in response to the event was not applicable.