chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: Experiencing a fever; Headaches; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Experiencing a fever), HEADACHE (Headaches) and ARTHRALGIA (Joint pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (Experiencing a fever), HEADACHE (Headaches) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 3 doses. At the time of the report, PYREXIA (Experiencing a fever), HEADACHE (Headaches) and ARTHRALGIA (Joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported Treatment medication included 3 doses of Tylenol
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Amniocentesis, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (three per week, Prior use) and Ex-smoker (pack a week,Prior use) on 10-Dec-2020. Concurrent medical conditions included Pain. Concomitant products included PARACETAMOL (TYLENOL) for Pain.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Oct-2020 and the estimated date of delivery was 18-Aug-2021. On 17-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 17-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Dec-2020, Amniocentesis: normal (normal) normal. On 10-Dec-2020, Pregnancy test: positive (Positive) positive. On 10-Dec-2020, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient previous pregnancy history included live pre-term birth on 30-Jul-2012. On an unspecified date, the patient had ultrasound scan and amniocentesis which were normal. The date of positive pregnancy test was 10-Dec-2020 and estimated date of conception was 18-Aug-2021. The patient has an established prenatal care. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Internal review on 21-Jul-2021 resulted in updates to the pregnancy details.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Vaccination site pain
Clinical narrative: rapid heart beat; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat) and VACCINATION SITE PAIN (pain at injection site) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEART RATE INCREASED (rapid heart beat) and VACCINATION SITE PAIN (pain at injection site). On 18-Feb-2021, HEART RATE INCREASED (rapid heart beat) had resolved. On 19-Feb-2021, VACCINATION SITE PAIN (pain at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Heart rate: inconclusive (Inconclusive) rapid heart beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided. for mRNA-1273 (Moderna COVID-19 Vaccine) (intramuscular), the reporter did not provide any causality assessment.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Patient mentioned that event pain at vaccination site lasted for 10 days.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: patient received 2 doses of Moderna Covid Vaccine consecutively today; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (patient received 2 doses of Moderna Covid Vaccine consecutively today) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-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 17-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (patient received 2 doses of Moderna Covid Vaccine consecutively today). On 17-Mar-2021, EXTRA DOSE ADMINISTERED (patient received 2 doses of Moderna Covid Vaccine consecutively today) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with the drug in response to the event is not applicable.  No concomitant and treatment medications were reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Pain on the Right wrist; little Sore Shoulder/Sore Right Shoulder; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (little Sore Shoulder/Sore Right Shoulder) and ARTHRALGIA (Pain on the Right wrist) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (little Sore Shoulder/Sore Right Shoulder). On 17-Mar-2021, the patient experienced ARTHRALGIA (Pain on the Right wrist). On 16-Mar-2021, VACCINATION SITE PAIN (little Sore Shoulder/Sore Right Shoulder) had resolved. At the time of the report, ARTHRALGIA (Pain on the Right wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: felt pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (felt pain at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (felt pain at the injection site). At the time of the report, VACCINATION SITE PAIN (felt pain at the injection site) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  Treatment information was not provided. No lab data has been provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up information received on 15 Jul 2021 contains non-significant information.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Nausea, Pain in extremity
Clinical narrative: soreness on arm; weakness; nausea; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (soreness on arm), ASTHENIA (weakness) and NAUSEA (nausea) 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 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness on arm), ASTHENIA (weakness) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (soreness on arm), ASTHENIA (weakness) and NAUSEA (nausea) outcome was unknown. Not Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  No treatment medication provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: Lump in the right arm but patient received vaccination in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Lump in the right arm but patient received vaccination in the left arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced SKIN MASS (Lump in the right arm but patient received vaccination in the left arm). At the time of the report, SKIN MASS (Lump in the right arm but patient received vaccination in the left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Had chills for 3 or 4 hours after receiving the vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of CHILLS (Had chills for 3 or 4 hours after receiving the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Had chills for 3 or 4 hours after receiving the vaccine). At the time of the report, CHILLS (Had chills for 3 or 4 hours after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: sick all day; fatigue; headache; joint pain; muscle pain; temperature; nausea; under an electric blanket with chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (sick all day), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) 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.     Concomitant products included WARFARIN SODIUM (JANTOVEN) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced MALAISE (sick all day), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), PYREXIA (temperature), NAUSEA (nausea) and CHILLS (under an electric blanket with chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (sick all day), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), PYREXIA (temperature), NAUSEA (nausea) and CHILLS (under an electric blanket with chills) outcome was unknown.            The action taken with the drug was Not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: sick all day; fatigue; headache; joint pain; muscle pain; temperature; nausea; under an electric blanket with chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (sick all day), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) 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.     Concomitant products included WARFARIN SODIUM (JANTOVEN) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced MALAISE (sick all day), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), PYREXIA (temperature), NAUSEA (nausea) and CHILLS (under an electric blanket with chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (sick all day), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), PYREXIA (temperature), NAUSEA (nausea) and CHILLS (under an electric blanket with chills) outcome was unknown.            The action taken with the drug was Not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site pain, Vaccination site warmth
Clinical narrative: Red in the inside lower part of the deltoid area (not where the shot is but below it); The area is tender and warm to the touch; Itches near the bicep area; The area is tender and warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red in the inside lower part of the deltoid area (not where the shot is but below it)), VACCINATION SITE WARMTH (The area is tender and warm to the touch), PRURITUS (Itches near the bicep area) and VACCINATION SITE PAIN (The area is tender and warm to the touch) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis (Takes paracetamol on a chronic basis for arthritis). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced ERYTHEMA (Red in the inside lower part of the deltoid area (not where the shot is but below it)), VACCINATION SITE WARMTH (The area is tender and warm to the touch), PRURITUS (Itches near the bicep area) and VACCINATION SITE PAIN (The area is tender and warm to the touch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Red in the inside lower part of the deltoid area (not where the shot is but below it)), VACCINATION SITE WARMTH (The area is tender and warm to the touch), PRURITUS (Itches near the bicep area) and VACCINATION SITE PAIN (The area is tender and warm to the touch) outcome was unknown. Not Provided          The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-048145 .
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound foetal
Clinical narrative: 13 Weeks Pregnant received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (13 Weeks Pregnant received the vaccine) in a 38-year-old female patient (gravida 7, para 4) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage in April 2018 and Miscarriage in March 2019. Concurrent medical conditions included Migraine since 1992 and Penicillin allergy (also allergic to cephalosporin.). Concomitant products included PARACETAMOL (TYLENOL) for Headache, PRENATAL + DHA for Pregnancy.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 23-Nov-2020 and the estimated date of delivery was 19-Sep-2021. On 10-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (13 Weeks Pregnant received the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 10-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (13 Weeks Pregnant received the vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Pregnancy test: positive (Positive) Positive. In 2021, Ultrasound foetal: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. Patient had 4 Live pregnancies previously and 2 miscarriages in Apr 2018 and Mar 2019. Estimated conception-2020 NICT was performed in Feb 2021 and results were normal.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to bee sting, Food allergy (Allergic to beef) and Shellfish allergy.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 17-Mar-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: little bit bigger/bumps on left side of my face on chin and above that; itchy; red bumps on left side of my face/ on chin and above that/red; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE (little bit bigger/bumps on left side of my face on chin and above that), PRURITUS (itchy) and ERYTHEMA (red bumps on left side of my face/ on chin and above that/red) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (little bit bigger/bumps on left side of my face on chin and above that), PRURITUS (itchy) and ERYTHEMA (red bumps on left side of my face/ on chin and above that/red). At the time of the report, SWELLING FACE (little bit bigger/bumps on left side of my face on chin and above that), PRURITUS (itchy) and ERYTHEMA (red bumps on left side of my face/ on chin and above that/red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details not provided.   This case was linked to MOD21-056518 (E2B Linked Report).; Sender's Comments:  MOD21-056518:Crosslinked with patient case
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: experiencing chills; fever of 100.7; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (experiencing chills) and PYREXIA (fever of 100.7) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event reported).    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (experiencing chills) and PYREXIA (fever of 100.7). At the time of the report, CHILLS (experiencing chills) and PYREXIA (fever of 100.7) outcome was unknown. Not Provided          no treatment is provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Myalgia, Pyrexia, Vaccination site rash
Clinical narrative: She had fever; chills; aches; small rash around the injection site; vertigo; Doesn't feel good; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (She had fever), CHILLS (chills), MYALGIA (aches), VACCINATION SITE RASH (small rash around the injection site) and VERTIGO (vertigo) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PYREXIA (She had fever), CHILLS (chills), MYALGIA (aches), VACCINATION SITE RASH (small rash around the injection site), VERTIGO (vertigo) and MALAISE (Doesn't feel good). At the time of the report, PYREXIA (She had fever), CHILLS (chills) and MYALGIA (aches) had resolved and VACCINATION SITE RASH (small rash around the injection site), VERTIGO (vertigo) and MALAISE (Doesn't feel good) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: She had fever; chills; aches; small rash around the injection site; vertigo; Doesn't feel good; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (She had fever), CHILLS (chills), MYALGIA (aches), VACCINATION SITE RASH (small rash around the injection site) and VERTIGO (vertigo) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PYREXIA (She had fever), CHILLS (chills), MYALGIA (aches), VACCINATION SITE RASH (small rash around the injection site), VERTIGO (vertigo) and MALAISE (Doesn't feel good). At the time of the report, PYREXIA (She had fever), CHILLS (chills) and MYALGIA (aches) had resolved and VACCINATION SITE RASH (small rash around the injection site), VERTIGO (vertigo) and MALAISE (Doesn't feel good) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Real red on the right arm; Itchy from shoulder to elbow; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Real red on the right arm) and PRURITUS (Itchy from shoulder to elbow) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Liver cirrhosis, Diabetes, Cardiac disorder and Hypertension.   On 12-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 an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Real red on the right arm) and PRURITUS (Itchy from shoulder to elbow). At the time of the report, INJECTION SITE ERYTHEMA (Real red on the right arm) and PRURITUS (Itchy from shoulder to elbow) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Benadryl was used as treatment medication on 16th and 17th march 2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and MYALGIA (body aches) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031a21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (Headache) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, HEADACHE (Headache) and MYALGIA (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash erythematous
Clinical narrative: big red spots with swelling on right arm 3 inches in diameter; two inch disc around the injection site on the left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (big red spots with swelling on right arm 3 inches in diameter) and PERIPHERAL SWELLING (two inch disc around the injection site on the left arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for an unknown indication.     Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PERIPHERAL SWELLING (two inch disc around the injection site on the left arm). On an unknown date, the patient experienced RASH ERYTHEMATOUS (big red spots with swelling on right arm 3 inches in diameter). At the time of the report, RASH ERYTHEMATOUS (big red spots with swelling on right arm 3 inches in diameter) had resolved and PERIPHERAL SWELLING (two inch disc around the injection site on the left arm) outcome was unknown. Not Provided          No Treatment information provided
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Therapeutic response unexpected, Wheezing
Clinical narrative: healing of eye disease; wheezing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (healing of eye disease) and WHEEZING (wheezing) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 42L20A) for COVID-19 vaccination.     The patient's past medical history included Coats' disease. Concomitant products included BEVACIZUMAB (AVASTIN [BEVACIZUMAB]), LEVOTHYROXINE SODIUM (LEVOXINE [LEVOTHYROXINE SODIUM]), LISINOPRIL, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), CLOPIDOGREL BISULFATE (PLAVIX), ROSUVASTATIN CALCIUM (CRESTOR), AZELASTINE HYDROCHLORIDE (ASTELIN [AZELASTINE HYDROCHLORIDE]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (healing of eye disease) and WHEEZING (wheezing). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (healing of eye disease) and WHEEZING (wheezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) She had negative covid test..         No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient went to ENT.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Severe shoulder pain; Couldn't even move arm; Did expect soreness, but this is more than that; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Severe shoulder pain), MOBILITY DECREASED (Couldn't even move arm) and PAIN IN EXTREMITY (Did expect soreness, but this is more than that) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced ARTHRALGIA (Severe shoulder pain) and MOBILITY DECREASED (Couldn't even move arm). 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Did expect soreness, but this is more than that). On 07-Mar-2021, ARTHRALGIA (Severe shoulder pain) had resolved. At the time of the report, MOBILITY DECREASED (Couldn't even move arm) had resolved and PAIN IN EXTREMITY (Did expect soreness, but this is more than that) outcome was unknown. Not Provided          Treatment information was not provided. No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-MAY-2021 contains non-significant information.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, SARS-CoV-2 test, Urticaria, Wound
Clinical narrative: Itchy rash on abdomen: on arm, spreading on legs; Started to welt on legs; Open sores; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on abdomen: on arm, spreading on legs), URTICARIA (Started to welt on legs) and WOUND (Open sores) in an 83-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 in 2021. Concurrent medical conditions included Pain and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Pain.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Itchy rash on abdomen: on arm, spreading on legs), URTICARIA (Started to welt on legs) and WOUND (Open sores). The patient was treated with NYSTATIN at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Itchy rash on abdomen: on arm, spreading on legs), URTICARIA (Started to welt on legs) and WOUND (Open sores) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         Other concomitant products included blood pressure medication.  Treatment medication included anti itching cream (unspecified).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Additional information included patient initials, treatment and additional events.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dysgeusia, Throat tightness
Clinical narrative: throat thickening; weird taste; elevated blood pressure(185/90); This spontaneous case was reported by a pharmacist and describes the occurrence of THROAT TIGHTNESS (throat thickening), DYSGEUSIA (weird taste) and BLOOD PRESSURE INCREASED (elevated blood pressure(185/90)) in a 66-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 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 THROAT TIGHTNESS (throat thickening), DYSGEUSIA (weird taste) and BLOOD PRESSURE INCREASED (elevated blood pressure(185/90)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 03-Mar-2021 at a dose of 12.5 mg. On 03-Mar-2021, THROAT TIGHTNESS (throat thickening), DYSGEUSIA (weird taste) and BLOOD PRESSURE INCREASED (elevated blood pressure(185/90)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Blood pressure measurement: 185/90 hg/mm (High) 185/90 hg/mm and 130/90 hg/mm (High) 130/90 hg/mm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: Itchy; got a rash on top of his shoulders, across his shoulder blades, a little down his arm, and across the top of his back that is very spotty, spots on belly; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and RASH MACULAR (got a rash on top of his shoulders, across his shoulder blades, a little down his arm, and across the top of his back that is very spotty, spots on belly) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Shingles. Concomitant products included AMLODIPINE, BENAZEPRIL, HYDROCHLOROTHIAZIDE, GLIMEPIRIDE and DIPHENHYDRAMINE HYDROCHLORIDE (WAL DRYL) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PRURITUS (Itchy) and RASH MACULAR (got a rash on top of his shoulders, across his shoulder blades, a little down his arm, and across the top of his back that is very spotty, spots on belly). The patient was treated with CORTISONE at a dose of 1 dosage form. At the time of the report, PRURITUS (Itchy) and RASH MACULAR (got a rash on top of his shoulders, across his shoulder blades, a little down his arm, and across the top of his back that is very spotty, spots on belly) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: red, itchy swelling on her arm at the injection site; red, itchy swelling on her arm at the injection site; red, itchy swelling on her arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (red, itchy swelling on her arm at the injection site), VACCINATION SITE ERYTHEMA (red, itchy swelling on her arm at the injection site) and VACCINATION SITE SWELLING (red, itchy swelling on her arm at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     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 17-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (red, itchy swelling on her arm at the injection site), VACCINATION SITE ERYTHEMA (red, itchy swelling on her arm at the injection site) and VACCINATION SITE SWELLING (red, itchy swelling on her arm at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PRURITUS (red, itchy swelling on her arm at the injection site), VACCINATION SITE ERYTHEMA (red, itchy swelling on her arm at the injection site) and VACCINATION SITE SWELLING (red, itchy swelling on her arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination complication
Clinical narrative: Second dose scheduled more than 36 days away from the first dose; Mild symptoms after administration; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled more than 36 days away from the first dose) and VACCINATION COMPLICATION (Mild symptoms after administration) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to many antibiotics).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION COMPLICATION (Mild symptoms after administration). On 18-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled more than 36 days away from the first dose). On 18-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled more than 36 days away from the first dose) had resolved. At the time of the report, VACCINATION COMPLICATION (Mild symptoms after administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications include Blood thinner.  The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: The follow-up document received; As telephone contact report and has significant data reported. Event start date was updated as 8-Feb-2021.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Somnolence, Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of discomfort (felt uncomfortable), somnolence (slept a lot) and vaccination complication (mild symptoms only) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included gastrointestinal disorder (intestinal problems), bladder disorder and peripheral neuropathy. On Feb 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, the patient experienced discomfort (felt uncomfortable), somnolence (slept a lot) and vaccination complication (mild symptoms only). At the time of the report, discomfort (felt uncomfortable), somnolence (slept a lot) and vaccination complication (mild symptoms only) outcome: unknown. mRNA-1273 (Moderna COVID-19 vaccine), intramuscular dosing remained unchanged. No concomitant medications or treatment information reported. This case linked to MOD-2021-048182 (patient link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Two inch disc around the injection site on the left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Two inch disc around the injection site on the left arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #002B21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sensitive skin and Rosacea. Concomitant products included DOXYCYCLINE (DOXYCLINE [DOXYCYCLINE]) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (Two inch disc around the injection site on the left arm). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Two inch disc around the injection site on the left arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Eye swelling, Rash
Clinical narrative: swollen left eye; redness on right hand and wrist; itching of both eyes; rash underneath eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (swollen left eye), ERYTHEMA (redness on right hand and wrist), EYE PRURITUS (itching of both eyes) and RASH (rash underneath eye) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (tetracycline), Drug allergy (meloxicam (Mobic)) and Drug allergy (amitriptyline). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ALPRAZOLAM for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced EYE SWELLING (swollen left eye), ERYTHEMA (redness on right hand and wrist), EYE PRURITUS (itching of both eyes) and RASH (rash underneath eye). The patient was treated with POLYVINYL ALCOHOL, POVIDONE (REFRESH CLASSIC LUBRICANT EYE DROPS) for Eye irritation, at an unspecified dose and frequency. At the time of the report, EYE SWELLING (swollen left eye), EYE PRURITUS (itching of both eyes) and RASH (rash underneath eye) had not resolved and ERYTHEMA (redness on right hand and wrist) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction to an allergy shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction to an allergy shot) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction to an allergy shot). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) ongoing from 16-Mar-2021 for Adverse event, at a dose of 125 mg. At the time of the report, HYPERSENSITIVITY (allergic reaction to an allergy shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Telephone Contact Report (TCR) Called and consumer said she don't need a follow-up, she is doing fine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Vaccination site reaction
Clinical narrative: redness that is increasing in size; warm; feel pain; covid arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (covid arm), ERYTHEMA (redness that is increasing in size), FEELING HOT (warm) and PAIN (feel pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE REACTION (covid arm), ERYTHEMA (redness that is increasing in size), FEELING HOT (warm) and PAIN (feel pain). At the time of the report, VACCINATION SITE REACTION (covid arm), ERYTHEMA (redness that is increasing in size), FEELING HOT (warm) and PAIN (feel pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.