chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Muscle tightness, Muscular weakness, Musculoskeletal chest pain, Myalgia
Clinical narrative: big lump on the left side by her rib cage; muscles in her legs hurt every time she walks; It feels like a hurt rib cage; is sore to the touch; They feel weak; the muscles are tight; This spontaneous case was reported by a consumer and describes the occurrence of MASS (big lump on the left side by her rib cage), MYALGIA (muscles in her legs hurt every time she walks), MUSCULOSKELETAL CHEST PAIN (It feels like a hurt rib cage), PAIN IN EXTREMITY (is sore to the touch) and MUSCULAR WEAKNESS (They feel weak) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (product used for unknown indication).    On 22-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 MASS (big lump on the left side by her rib cage), MYALGIA (muscles in her legs hurt every time she walks), MUSCULOSKELETAL CHEST PAIN (It feels like a hurt rib cage), PAIN IN EXTREMITY (is sore to the touch), MUSCULAR WEAKNESS (They feel weak) and MUSCLE TIGHTNESS (the muscles are tight). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia and Muscle tightness, at an unspecified dose and frequency and TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) for Myalgia and Pain, at an unspecified dose and frequency. At the time of the report, MASS (big lump on the left side by her rib cage), MYALGIA (muscles in her legs hurt every time she walks), MUSCULOSKELETAL CHEST PAIN (It feels like a hurt rib cage), PAIN IN EXTREMITY (is sore to the touch), MUSCULAR WEAKNESS (They feel weak) and MUSCLE TIGHTNESS (the muscles are tight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: big lump on the left side by her rib cage; muscles in her legs hurt every time she walks; It feels like a hurt rib cage; is sore to the touch; They feel weak; the muscles are tight; This spontaneous case was reported by a consumer and describes the occurrence of MASS (big lump on the left side by her rib cage), MYALGIA (muscles in her legs hurt every time she walks), MUSCULOSKELETAL CHEST PAIN (It feels like a hurt rib cage), PAIN IN EXTREMITY (is sore to the touch) and MUSCULAR WEAKNESS (They feel weak) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (product used for unknown indication).    On 22-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 MASS (big lump on the left side by her rib cage), MYALGIA (muscles in her legs hurt every time she walks), MUSCULOSKELETAL CHEST PAIN (It feels like a hurt rib cage), PAIN IN EXTREMITY (is sore to the touch), MUSCULAR WEAKNESS (They feel weak) and MUSCLE TIGHTNESS (the muscles are tight). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia and Muscle tightness, at an unspecified dose and frequency and TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) for Myalgia and Pain, at an unspecified dose and frequency. At the time of the report, MASS (big lump on the left side by her rib cage), MYALGIA (muscles in her legs hurt every time she walks), MUSCULOSKELETAL CHEST PAIN (It feels like a hurt rib cage), PAIN IN EXTREMITY (is sore to the touch), MUSCULAR WEAKNESS (They feel weak) and MUSCLE TIGHTNESS (the muscles are tight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Limb discomfort, Rash
Clinical narrative: Rash on back of the neck after the vaccine about 3-4 hours afterwards and spread to should and ches; Slight headache; arm discomfort; Getting dizzy off and on not sure if its from Zyrtec or vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back of the neck after the vaccine about 3-4 hours afterwards and spread to should and ches), HEADACHE (Slight headache), LIMB DISCOMFORT (arm discomfort) and DIZZINESS (Getting dizzy off and on not sure if its from Zyrtec or vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced RASH (Rash on back of the neck after the vaccine about 3-4 hours afterwards and spread to should and ches), HEADACHE (Slight headache), LIMB DISCOMFORT (arm discomfort) and DIZZINESS (Getting dizzy off and on not sure if its from Zyrtec or vaccine). At the time of the report, RASH (Rash on back of the neck after the vaccine about 3-4 hours afterwards and spread to should and ches), HEADACHE (Slight headache), LIMB DISCOMFORT (arm discomfort) and DIZZINESS (Getting dizzy off and on not sure if its from Zyrtec or vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug was taken. No treatment drug was taken.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Heart rate, Heart rate increased, Oropharyngeal discomfort, Vomiting
Clinical narrative: Increased heartbeat; quirky feeling in throat; Vomiting; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Increased heartbeat), OROPHARYNGEAL DISCOMFORT (quirky feeling in throat), VOMITING (Vomiting) and DIARRHOEA (diarrhea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Mar-2021, the patient experienced HEART RATE INCREASED (Increased heartbeat), OROPHARYNGEAL DISCOMFORT (quirky feeling in throat), VOMITING (Vomiting) and DIARRHOEA (diarrhea). At the time of the report, HEART RATE INCREASED (Increased heartbeat), OROPHARYNGEAL DISCOMFORT (quirky feeling in throat), VOMITING (Vomiting) and DIARRHOEA (diarrhea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Heart rate: 120 beats/min (High) developed an increase in heart rate upto 120 beats/ mnt.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE for an unknown indication. Patient gave consent for safety team to follow up with them   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Illness, Vomiting
Clinical narrative: headache; threw up; really sick; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), ILLNESS (really sick), HEADACHE (headache) and VOMITING (threw up) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 101A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach). On 04-Mar-2021, the patient experienced ILLNESS (really sick) and VOMITING (threw up). On an unknown date, the patient experienced HEADACHE (headache). On 05-Mar-2021, ILLNESS (really sick) and VOMITING (threw up) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) had not resolved and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication nor treatment provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Started like a little red bump; Red Bump itched; Left arm has a rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Started like a little red bump), PRURITUS (Red Bump itched) and RASH (Left arm has a rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 98162) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Allergy.    On 11-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 ERYTHEMA (Started like a little red bump), PRURITUS (Red Bump itched) and RASH (Left arm has a rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Started like a little red bump), PRURITUS (Red Bump itched) and RASH (Left arm has a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included medications for blood pressure and allergy.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided    Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-059975.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at the site). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (pain at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not included.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Headache, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of ear pain (sore arm, chills, earache), pain in extremity (sore arm, chills, earache), headache and chills (Sore arm, chills, earache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 01314209) for COVID-19 immunization. No medical history reported. On Mar 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 9, 2021, patient experienced ear pain (sore arm, chills, earache), pain in extremity (sore arm, chills, earache), headache and chills (sore arm, chills, earache). At the time of the report, ear pain (sore arm, chills, earache), pain in extremity (sore arm, chills, earache), headache and chills (sore arm, chills, earache) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Tenderness
Clinical narrative: Sore and tender arm; Sore and tender arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore and tender arm) and TENDERNESS (Sore and tender arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030L20A) for COVID-19 vaccination.     Concomitant products included RAMIPRIL for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (Sore and tender arm) and TENDERNESS (Sore and tender arm). On 27-Feb-2021, MYALGIA (Sore and tender arm) and TENDERNESS (Sore and tender arm) had resolved.            No treatment medication were provided. Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up information received on 30-JUN-2021  contains no new  information.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chest discomfort, Dizziness, Head discomfort
Clinical narrative: Warm in the chest; Warm in the shoulder; warm in the abdomen; warm in the head; Sensation inside the head felt like was was going to faint; Knuckle started to hurt; This case was received via an unknown source (no reference has been entered for a health authority) on 09-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT, MUSCULOSKELETAL DISCOMFORT, ABDOMINAL DISCOMFORT, HEAD DISCOMFORT, and DIZZINESS in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse events (No reported medical history.).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced CHEST DISCOMFORT, MUSCULOSKELETAL DISCOMFORT, ABDOMINAL DISCOMFORT, HEAD DISCOMFORT, DIZZINESS, and ARTHRALGIA. At the time of the report, CHEST DISCOMFORT, MUSCULOSKELETAL DISCOMFORT, ABDOMINAL DISCOMFORT, DIZZINESS, and ARTHRALGIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   Reporter did not allow further contact. Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Warm in the chest; Warm in the shoulder; warm in the abdomen; warm in the head; Sensation inside the head felt like was was going to faint; Knuckle started to hurt; This case was received via an unknown source (no reference has been entered for a health authority) on 09-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT, MUSCULOSKELETAL DISCOMFORT, ABDOMINAL DISCOMFORT, HEAD DISCOMFORT, and DIZZINESS in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse events (No reported medical history.).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced CHEST DISCOMFORT, MUSCULOSKELETAL DISCOMFORT, ABDOMINAL DISCOMFORT, HEAD DISCOMFORT, DIZZINESS, and ARTHRALGIA. At the time of the report, CHEST DISCOMFORT, MUSCULOSKELETAL DISCOMFORT, ABDOMINAL DISCOMFORT, DIZZINESS, and ARTHRALGIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   Reporter did not allow further contact. Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Heart rate increased
Clinical narrative: Rapid heart beat; Sensation of fluid moving around her body; Brain spin; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart beat), FEELING ABNORMAL (Sensation of fluid moving around her body) and DIZZINESS (Brain spin) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid heart beat), FEELING ABNORMAL (Sensation of fluid moving around her body) and DIZZINESS (Brain spin). At the time of the report, HEART RATE INCREASED (Rapid heart beat), FEELING ABNORMAL (Sensation of fluid moving around her body) and DIZZINESS (Brain spin) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was reported.   Concomitant product use was not provided by the reporter.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Confusional state, Disorientation, Disturbance in attention
Clinical narrative: Severe chills; disoriented; confused; haze over words; couldn't remember what people told him; mental lag; confusion; temperature; This spontaneous case was reported by a patient and describes the occurrence of BODY TEMPERATURE INCREASED (temperature), CHILLS (Severe chills), DISORIENTATION (disoriented), CONFUSIONAL STATE (confused) and SPEECH DISORDER (haze over words) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (temperature). On 06-Mar-2021, the patient experienced CHILLS (Severe chills), DISORIENTATION (disoriented), CONFUSIONAL STATE (confused), SPEECH DISORDER (haze over words), MEMORY IMPAIRMENT (couldn't remember what people told him), DISTURBANCE IN ATTENTION (mental lag) and CONFUSIONAL STATE (confusion). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 06-Mar-2021, BODY TEMPERATURE INCREASED (temperature) had resolved. At the time of the report, CHILLS (Severe chills), DISORIENTATION (disoriented), CONFUSIONAL STATE (confused), SPEECH DISORDER (haze over words), MEMORY IMPAIRMENT (couldn't remember what people told him), DISTURBANCE IN ATTENTION (mental lag) and CONFUSIONAL STATE (confusion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Lab data: Temperature 101.6  Concomitant product use was not reported.   Reporter did not allow further contact
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Speech disorder
Clinical narrative: Severe chills; disoriented; confused; haze over words; couldn't remember what people told him; mental lag; confusion; temperature; This spontaneous case was reported by a patient and describes the occurrence of BODY TEMPERATURE INCREASED (temperature), CHILLS (Severe chills), DISORIENTATION (disoriented), CONFUSIONAL STATE (confused) and SPEECH DISORDER (haze over words) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (temperature). On 06-Mar-2021, the patient experienced CHILLS (Severe chills), DISORIENTATION (disoriented), CONFUSIONAL STATE (confused), SPEECH DISORDER (haze over words), MEMORY IMPAIRMENT (couldn't remember what people told him), DISTURBANCE IN ATTENTION (mental lag) and CONFUSIONAL STATE (confusion). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 06-Mar-2021, BODY TEMPERATURE INCREASED (temperature) had resolved. At the time of the report, CHILLS (Severe chills), DISORIENTATION (disoriented), CONFUSIONAL STATE (confused), SPEECH DISORDER (haze over words), MEMORY IMPAIRMENT (couldn't remember what people told him), DISTURBANCE IN ATTENTION (mental lag) and CONFUSIONAL STATE (confusion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Lab data: Temperature 101.6  Concomitant product use was not reported.   Reporter did not allow further contact
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccinated 17 year old; A spontaneous report was received from a healthcare professional concerning a 17-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Mar 2021, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number: 013A21A) for prophylaxis of COVID-19 infection.    The patient was vaccinated at 17 years old. No Treatment information was provided.    Action taken with mRNA-1273 in response to the events was not provided.  The event vaccinated at 17 years old was considered resolved on 04 mar 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 01321A) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye swelling, Heart rate increased
Clinical narrative: eyes were burning, eyelids swollen; eyes were burning, eyelids swollen; heart rate went from resting to 116.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE SWELLING (eyes were burning, eyelids swollen), EYE IRRITATION (eyes were burning, eyelids swollen) and HEART RATE INCREASED (heart rate went from resting to 116.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced EYE SWELLING (eyes were burning, eyelids swollen), EYE IRRITATION (eyes were burning, eyelids swollen) and HEART RATE INCREASED (heart rate went from resting to 116.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE SWELLING (eyes were burning, eyelids swollen), EYE IRRITATION (eyes were burning, eyelids swollen) and HEART RATE INCREASED (heart rate went from resting to 116.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Breast discharge, Breast inflammation, Chills
Clinical narrative: Noticed pocket of fluid out of left breast; Swelling on left breast; Slight redness of left breast; A lot of swelling on left armpit; Redness on injection site of left arm; Period of chills; Slight elevation of temperature measured 99.4 F; Hot flashes; Had a diarrhea; Pain on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BREAST INFLAMMATION (Swelling on left breast), ERYTHEMA (Slight redness of left breast), BREAST DISCHARGE (Noticed pocket of fluid out of left breast), BODY TEMPERATURE INCREASED (Slight elevation of temperature measured 99.4 F) and HOT FLUSH (Hot flashes) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer in 2012.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain on the injection site). On 04-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (Slight elevation of temperature measured 99.4 F), HOT FLUSH (Hot flashes), DIARRHOEA (Had a diarrhea) and CHILLS (Period of chills). On 05-Mar-2021, the patient experienced BREAST INFLAMMATION (Swelling on left breast), ERYTHEMA (Slight redness of left breast), PERIPHERAL SWELLING (A lot of swelling on left armpit) and INJECTION SITE ERYTHEMA (Redness on injection site of left arm). On 06-Mar-2021, the patient experienced BREAST DISCHARGE (Noticed pocket of fluid out of left breast). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 04-Mar-2021, BODY TEMPERATURE INCREASED (Slight elevation of temperature measured 99.4 F), HOT FLUSH (Hot flashes), DIARRHOEA (Had a diarrhea) and CHILLS (Period of chills) had resolved. On 05-Mar-2021, VACCINATION SITE PAIN (Pain on the injection site) had resolved. At the time of the report, BREAST INFLAMMATION (Swelling on left breast), ERYTHEMA (Slight redness of left breast), BREAST DISCHARGE (Noticed pocket of fluid out of left breast) and INJECTION SITE ERYTHEMA (Redness on injection site of left arm) outcome was unknown and PERIPHERAL SWELLING (A lot of swelling on left armpit) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2020, SARS-CoV-2 test: positive (Positive) positive. On 04-Mar-2021, Body temperature: 99.4 (Inconclusive) 99.4 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: No specific follow-up information recorded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Hot flush, Injection site erythema, Peripheral swelling
Clinical narrative: Noticed pocket of fluid out of left breast; Swelling on left breast; Slight redness of left breast; A lot of swelling on left armpit; Redness on injection site of left arm; Period of chills; Slight elevation of temperature measured 99.4 F; Hot flashes; Had a diarrhea; Pain on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BREAST INFLAMMATION (Swelling on left breast), ERYTHEMA (Slight redness of left breast), BREAST DISCHARGE (Noticed pocket of fluid out of left breast), BODY TEMPERATURE INCREASED (Slight elevation of temperature measured 99.4 F) and HOT FLUSH (Hot flashes) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer in 2012.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain on the injection site). On 04-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (Slight elevation of temperature measured 99.4 F), HOT FLUSH (Hot flashes), DIARRHOEA (Had a diarrhea) and CHILLS (Period of chills). On 05-Mar-2021, the patient experienced BREAST INFLAMMATION (Swelling on left breast), ERYTHEMA (Slight redness of left breast), PERIPHERAL SWELLING (A lot of swelling on left armpit) and INJECTION SITE ERYTHEMA (Redness on injection site of left arm). On 06-Mar-2021, the patient experienced BREAST DISCHARGE (Noticed pocket of fluid out of left breast). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 04-Mar-2021, BODY TEMPERATURE INCREASED (Slight elevation of temperature measured 99.4 F), HOT FLUSH (Hot flashes), DIARRHOEA (Had a diarrhea) and CHILLS (Period of chills) had resolved. On 05-Mar-2021, VACCINATION SITE PAIN (Pain on the injection site) had resolved. At the time of the report, BREAST INFLAMMATION (Swelling on left breast), ERYTHEMA (Slight redness of left breast), BREAST DISCHARGE (Noticed pocket of fluid out of left breast) and INJECTION SITE ERYTHEMA (Redness on injection site of left arm) outcome was unknown and PERIPHERAL SWELLING (A lot of swelling on left armpit) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2020, SARS-CoV-2 test: positive (Positive) positive. On 04-Mar-2021, Body temperature: 99.4 (Inconclusive) 99.4 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: No specific follow-up information recorded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Noticed pocket of fluid out of left breast; Swelling on left breast; Slight redness of left breast; A lot of swelling on left armpit; Redness on injection site of left arm; Period of chills; Slight elevation of temperature measured 99.4 F; Hot flashes; Had a diarrhea; Pain on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BREAST INFLAMMATION (Swelling on left breast), ERYTHEMA (Slight redness of left breast), BREAST DISCHARGE (Noticed pocket of fluid out of left breast), BODY TEMPERATURE INCREASED (Slight elevation of temperature measured 99.4 F) and HOT FLUSH (Hot flashes) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer in 2012.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain on the injection site). On 04-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (Slight elevation of temperature measured 99.4 F), HOT FLUSH (Hot flashes), DIARRHOEA (Had a diarrhea) and CHILLS (Period of chills). On 05-Mar-2021, the patient experienced BREAST INFLAMMATION (Swelling on left breast), ERYTHEMA (Slight redness of left breast), PERIPHERAL SWELLING (A lot of swelling on left armpit) and INJECTION SITE ERYTHEMA (Redness on injection site of left arm). On 06-Mar-2021, the patient experienced BREAST DISCHARGE (Noticed pocket of fluid out of left breast). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 04-Mar-2021, BODY TEMPERATURE INCREASED (Slight elevation of temperature measured 99.4 F), HOT FLUSH (Hot flashes), DIARRHOEA (Had a diarrhea) and CHILLS (Period of chills) had resolved. On 05-Mar-2021, VACCINATION SITE PAIN (Pain on the injection site) had resolved. At the time of the report, BREAST INFLAMMATION (Swelling on left breast), ERYTHEMA (Slight redness of left breast), BREAST DISCHARGE (Noticed pocket of fluid out of left breast) and INJECTION SITE ERYTHEMA (Redness on injection site of left arm) outcome was unknown and PERIPHERAL SWELLING (A lot of swelling on left armpit) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2020, SARS-CoV-2 test: positive (Positive) positive. On 04-Mar-2021, Body temperature: 99.4 (Inconclusive) 99.4 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Burning sensation, Erythema, Fatigue, Oropharyngeal discomfort
Clinical narrative: Redness/Elbows were red; Throat issues; Skin was burning; All around her neck and in the front of where her clavicle bone is - red and burning, back was burning; Anxiety attack; Rash; Felt a little tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Redness/Elbows were red), OROPHARYNGEAL DISCOMFORT (Throat issues), SKIN BURNING SENSATION (Skin was burning), BURNING SENSATION (All around her neck and in the front of where her clavicle bone is - red and burning, back was burning) and ANXIETY (Anxiety attack) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety. Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ERYTHEMA (Redness/Elbows were red), OROPHARYNGEAL DISCOMFORT (Throat issues), SKIN BURNING SENSATION (Skin was burning), BURNING SENSATION (All around her neck and in the front of where her clavicle bone is - red and burning, back was burning), ANXIETY (Anxiety attack), RASH (Rash) and FATIGUE (Felt a little tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 25 mg three times a day. On 07-Mar-2021, ERYTHEMA (Redness/Elbows were red), OROPHARYNGEAL DISCOMFORT (Throat issues), SKIN BURNING SENSATION (Skin was burning), BURNING SENSATION (All around her neck and in the front of where her clavicle bone is - red and burning, back was burning), ANXIETY (Anxiety attack), RASH (Rash) and FATIGUE (Felt a little tired) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that it was allergy season all day long where she lives. The patient had been using Aloe vera on her skin to help with the skin rash and back burning
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin burning sensation
Clinical narrative: Redness/Elbows were red; Throat issues; Skin was burning; All around her neck and in the front of where her clavicle bone is - red and burning, back was burning; Anxiety attack; Rash; Felt a little tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Redness/Elbows were red), OROPHARYNGEAL DISCOMFORT (Throat issues), SKIN BURNING SENSATION (Skin was burning), BURNING SENSATION (All around her neck and in the front of where her clavicle bone is - red and burning, back was burning) and ANXIETY (Anxiety attack) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety. Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ERYTHEMA (Redness/Elbows were red), OROPHARYNGEAL DISCOMFORT (Throat issues), SKIN BURNING SENSATION (Skin was burning), BURNING SENSATION (All around her neck and in the front of where her clavicle bone is - red and burning, back was burning), ANXIETY (Anxiety attack), RASH (Rash) and FATIGUE (Felt a little tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 25 mg three times a day. On 07-Mar-2021, ERYTHEMA (Redness/Elbows were red), OROPHARYNGEAL DISCOMFORT (Throat issues), SKIN BURNING SENSATION (Skin was burning), BURNING SENSATION (All around her neck and in the front of where her clavicle bone is - red and burning, back was burning), ANXIETY (Anxiety attack), RASH (Rash) and FATIGUE (Felt a little tired) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that it was allergy season all day long where she lives. The patient had been using Aloe vera on her skin to help with the skin rash and back burning
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Nausea, Pain in extremity
Clinical narrative: Feels terrible; Sinus congestion; Dizziness; Sore arm; Fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels terrible), SINUS CONGESTION (Sinus congestion), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feels terrible), SINUS CONGESTION (Sinus congestion), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, FEELING ABNORMAL (Feels terrible), SINUS CONGESTION (Sinus congestion), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sinus congestion
Clinical narrative: Feels terrible; Sinus congestion; Dizziness; Sore arm; Fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels terrible), SINUS CONGESTION (Sinus congestion), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feels terrible), SINUS CONGESTION (Sinus congestion), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, FEELING ABNORMAL (Feels terrible), SINUS CONGESTION (Sinus congestion), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nervous system disorder, Pain, Pyrexia
Clinical narrative: nerves are shot; fever of 99.1 F.; her arm was "more sore"; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (nerves are shot), PAIN (her arm was "more sore") and PYREXIA (fever of 99.1 F.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN (her arm was "more sore"). On 09-Mar-2021, the patient experienced NERVOUS SYSTEM DISORDER (nerves are shot) and PYREXIA (fever of 99.1 F.). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, NERVOUS SYSTEM DISORDER (nerves are shot) and PAIN (her arm was "more sore") outcome was unknown and PYREXIA (fever of 99.1 F.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 99.1 (Inconclusive) 99.1.         Concomitant medications on use were not provided.  Action taken with mRNA-1273 was not applicable.   This case was linked to MOD-2021-038084, MOD-2021-038078 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: nausea; site was red and very large, round and hard; stomach cramp and felt like throwing up; itchiness around the site; red around the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red around the site), NAUSEA (nausea), VACCINATION SITE INDURATION (site was red and very large, round and hard), ABDOMINAL PAIN UPPER (stomach cramp and felt like throwing up) and VACCINATION SITE PRURITUS (itchiness around the site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), AZELASTINE, MONTELUKAST SODIUM and BUDESONIDE (PULMICORT) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red around the site), VACCINATION SITE INDURATION (site was red and very large, round and hard), ABDOMINAL PAIN UPPER (stomach cramp and felt like throwing up) and VACCINATION SITE PRURITUS (itchiness around the site). On 03-Mar-2021, the patient experienced NAUSEA (nausea). The patient was treated with TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) for Adverse event, at a dose of 0.025 %. At the time of the report, VACCINATION SITE ERYTHEMA (red around the site), NAUSEA (nausea), VACCINATION SITE INDURATION (site was red and very large, round and hard), ABDOMINAL PAIN UPPER (stomach cramp and felt like throwing up) and VACCINATION SITE PRURITUS (itchiness around the site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Vaccination site pain
Clinical narrative: Small rash at Injection site; Rash is burning and stinging; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Small rash at Injection site) and VACCINATION SITE PAIN (Rash is burning and stinging) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 immunisation.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INJECTION SITE RASH (Small rash at Injection site) and VACCINATION SITE PAIN (Rash is burning and stinging). At the time of the report, INJECTION SITE RASH (Small rash at Injection site) and VACCINATION SITE PAIN (Rash is burning and stinging) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No concomitant medications or treatment details reported.