chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: Sore Injection Site; Swollen Lymph Node (Left Armpit); Chills; Fever 99F; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore Injection Site), LYMPHADENOPATHY (Swollen Lymph Node (Left Armpit)), CHILLS (Chills), PYREXIA (Fever 99F) and FATIGUE (Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced INJECTION SITE PAIN (Sore Injection Site), LYMPHADENOPATHY (Swollen Lymph Node (Left Armpit)), CHILLS (Chills), PYREXIA (Fever 99F), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Sore Injection Site), LYMPHADENOPATHY (Swollen Lymph Node (Left Armpit)), CHILLS (Chills), PYREXIA (Fever 99F), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore Injection Site; Swollen Lymph Node (Left Armpit); Chills; Fever 99F; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore Injection Site), LYMPHADENOPATHY (Swollen Lymph Node (Left Armpit)), CHILLS (Chills), PYREXIA (Fever 99F) and FATIGUE (Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced INJECTION SITE PAIN (Sore Injection Site), LYMPHADENOPATHY (Swollen Lymph Node (Left Armpit)), CHILLS (Chills), PYREXIA (Fever 99F), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Sore Injection Site), LYMPHADENOPATHY (Swollen Lymph Node (Left Armpit)), CHILLS (Chills), PYREXIA (Fever 99F), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching to arms, legs and back of head; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching to arms, legs and back of head) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PRURITUS (Itching to arms, legs and back of head). The patient was treated with PARACETAMOL (TYLENOL) for Itching, at an unspecified dose and frequency. On 07-Mar-2021, PRURITUS (Itching to arms, legs and back of head) had resolved. 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Hyperhidrosis
Clinical narrative: feels like dog crap; arm felt real heavy and hurt real bad; sweats; very tired; nauseous; body aches; felt horrible; chills; fever, still running fever of 100; one episode of puking, vomiting; This spontaneous case was reported by an other health care professional and describes the occurrence of LIMB DISCOMFORT (arm felt real heavy and hurt real bad), HYPERHIDROSIS (sweats), FEELING ABNORMAL (feels like dog crap), PAIN (body aches) and MALAISE (felt horrible) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (survivor of long-haul COVID). Concurrent medical conditions included Asthma and Bronchiectasis NOS.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (body aches), MALAISE (felt horrible), CHILLS (chills), PYREXIA (fever, still running fever of 100) and VOMITING (one episode of puking, vomiting). On 08-Mar-2021, the patient experienced HYPERHIDROSIS (sweats), FATIGUE (very tired) and NAUSEA (nauseous). On an unknown date, the patient experienced LIMB DISCOMFORT (arm felt real heavy and hurt real bad) and FEELING ABNORMAL (feels like dog crap). At the time of the report, LIMB DISCOMFORT (arm felt real heavy and hurt real bad), HYPERHIDROSIS (sweats), FEELING ABNORMAL (feels like dog crap), PAIN (body aches), MALAISE (felt horrible), CHILLS (chills), PYREXIA (fever, still running fever of 100), VOMITING (one episode of puking, vomiting), FATIGUE (very tired) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 100 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.   No treatment information reported   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information received on 24-MAY-2021 contains non-significant information. Email id of the reporter added
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: feels like dog crap; arm felt real heavy and hurt real bad; sweats; very tired; nauseous; body aches; felt horrible; chills; fever, still running fever of 100; one episode of puking, vomiting; This spontaneous case was reported by an other health care professional and describes the occurrence of LIMB DISCOMFORT (arm felt real heavy and hurt real bad), HYPERHIDROSIS (sweats), FEELING ABNORMAL (feels like dog crap), PAIN (body aches) and MALAISE (felt horrible) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (survivor of long-haul COVID). Concurrent medical conditions included Asthma and Bronchiectasis NOS.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (body aches), MALAISE (felt horrible), CHILLS (chills), PYREXIA (fever, still running fever of 100) and VOMITING (one episode of puking, vomiting). On 08-Mar-2021, the patient experienced HYPERHIDROSIS (sweats), FATIGUE (very tired) and NAUSEA (nauseous). On an unknown date, the patient experienced LIMB DISCOMFORT (arm felt real heavy and hurt real bad) and FEELING ABNORMAL (feels like dog crap). At the time of the report, LIMB DISCOMFORT (arm felt real heavy and hurt real bad), HYPERHIDROSIS (sweats), FEELING ABNORMAL (feels like dog crap), PAIN (body aches), MALAISE (felt horrible), CHILLS (chills), PYREXIA (fever, still running fever of 100), VOMITING (one episode of puking, vomiting), FATIGUE (very tired) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 100 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.   No treatment information reported   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information received on 24-MAY-2021 contains non-significant information. Email id of the reporter added
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: feels like dog crap; arm felt real heavy and hurt real bad; sweats; very tired; nauseous; body aches; felt horrible; chills; fever, still running fever of 100; one episode of puking, vomiting; This spontaneous case was reported by an other health care professional and describes the occurrence of LIMB DISCOMFORT (arm felt real heavy and hurt real bad), HYPERHIDROSIS (sweats), FEELING ABNORMAL (feels like dog crap), PAIN (body aches) and MALAISE (felt horrible) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (survivor of long-haul COVID). Concurrent medical conditions included Asthma and Bronchiectasis NOS.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (body aches), MALAISE (felt horrible), CHILLS (chills), PYREXIA (fever, still running fever of 100) and VOMITING (one episode of puking, vomiting). On 08-Mar-2021, the patient experienced HYPERHIDROSIS (sweats), FATIGUE (very tired) and NAUSEA (nauseous). On an unknown date, the patient experienced LIMB DISCOMFORT (arm felt real heavy and hurt real bad) and FEELING ABNORMAL (feels like dog crap). At the time of the report, LIMB DISCOMFORT (arm felt real heavy and hurt real bad), HYPERHIDROSIS (sweats), FEELING ABNORMAL (feels like dog crap), PAIN (body aches), MALAISE (felt horrible), CHILLS (chills), PYREXIA (fever, still running fever of 100), VOMITING (one episode of puking, vomiting), FATIGUE (very tired) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 100 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.   No treatment information reported   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information received on 24-MAY-2021 contains non-significant information. Email id of the reporter added
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Sedation
Clinical narrative: Sweating; Dopey; Bogged down; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), SEDATION (Dopey), FEELING ABNORMAL (Bogged down) and CHILLS (Chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029LZOA) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma. Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced HYPERHIDROSIS (Sweating), SEDATION (Dopey) and FEELING ABNORMAL (Bogged down). At the time of the report, HYPERHIDROSIS (Sweating), SEDATION (Dopey), FEELING ABNORMAL (Bogged down) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication includes Cellselfazine 500 mg and 2 Drops for Glaucoma.  No treatment information was reported.   This case was linked to MOD-2021-254161 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: The significant follow up received in which Medical History is added. Concomitant drugs were added. Events were added.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: fatigue; injection site pain/ Soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and INJECTION SITE PAIN (injection site pain/ Soreness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue) and INJECTION SITE PAIN (injection site pain/ Soreness). At the time of the report, FATIGUE (fatigue) and INJECTION SITE PAIN (injection site pain/ Soreness) outcome was unknown. Not Provided          No concomitant medication reported  No treatment information was provided  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: itch at injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itch at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE from 15-Jun-2013 to an unknown date for Blood pressure management.   On 01-Mar-2021 at 11:22 AM, 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 12-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at injection site). On 20-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itch at injection site). At the time of the report, INJECTION SITE PRURITUS (itch at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) outcome was unknown.            Treatment information include cold compress.  Action taken with mRNA-1273 in response to the event was not applicable.     This case was linked to MOD-2021-037442 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Batch number is updated
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: stomach upset; no appetite; pain; Felt blah; extremely tired; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset), DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (pain), FEELING ABNORMAL (Felt blah) and FATIGUE (extremely tired) in a 90-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.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach upset), DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (pain), FEELING ABNORMAL (Felt blah), FATIGUE (extremely tired) and CHILLS (chills). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset), DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (pain), FEELING ABNORMAL (Felt blah), FATIGUE (extremely tired) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitent medication provided. no treatment information provided.   Reporter did not allow further contact
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: stomach upset; no appetite; pain; Felt blah; extremely tired; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset), DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (pain), FEELING ABNORMAL (Felt blah) and FATIGUE (extremely tired) in a 90-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.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach upset), DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (pain), FEELING ABNORMAL (Felt blah), FATIGUE (extremely tired) and CHILLS (chills). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset), DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (pain), FEELING ABNORMAL (Felt blah), FATIGUE (extremely tired) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitent medication provided. no treatment information provided.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: We're now at 49 days after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (We're now at 49 days after receiving 1st dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement. Concomitant products included IBUPROFEN for Knee replacement.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (We're now at 49 days after receiving 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (We're now at 49 days after receiving 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (We're now at 49 days after receiving 1st dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement. Concomitant products included IBUPROFEN for Knee replacement.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (We're now at 49 days after receiving 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (We're now at 49 days after receiving 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information for the event was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: missed 03March2021 schedule second dose; Tested Positive for COVID-19 post First Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested Positive for COVID-19 post First Vaccine) and PRODUCT DOSE OMISSION ISSUE (missed 03March2021 schedule second dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     NO Medical History Information was reported.     On 13-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 COVID-19 (Tested Positive for COVID-19 post First Vaccine). On 03-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 03March2021 schedule second dose). At the time of the report, COVID-19 (Tested Positive for COVID-19 post First Vaccine) and PRODUCT DOSE OMISSION ISSUE (missed 03March2021 schedule second dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient received covid-19 antibody infusion on 26-Feb-2021. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested Positive for COVID-19 post First Vaccine) and PRODUCT DOSE OMISSION ISSUE (missed 03March2021 schedule second dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     NO Medical History Information was reported.     On 13-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 COVID-19 (Tested Positive for COVID-19 post First Vaccine). On 03-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 03March2021 schedule second dose). At the time of the report, COVID-19 (Tested Positive for COVID-19 post First Vaccine) and PRODUCT DOSE OMISSION ISSUE (missed 03March2021 schedule second dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient received covid-19 antibody infusion on 26-Feb-2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Tinnitus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (pulsating tinnitus, stating she can hear her pulse in her head), CHILLS (having chills) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 16-Feb-2021, the patient experienced TINNITUS (pulsating tinnitus, stating she can hear her pulse in her head) and CHILLS (having chills). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with Tylenol at an unspecified dose and frequency. At the time of the report, TINNITUS (pulsating tinnitus, stating she can hear her pulse in her head), CHILLS (having chills) and HEADACHE (headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include colonoscopy prep.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Pain, Pyrexia, Sleep disorder, Swelling
Clinical narrative: SWELLING IN LEFT PECTORIAL AREA; huge bulge from pectoral area to the axillary area; REDNESS AT INJECTION SITE; FEVER; ACHES; SWELLING; COULDENT SLEEP WELL; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (COULDENT SLEEP WELL), SWELLING (SWELLING IN LEFT PECTORIAL AREA), PAIN (ACHES), SWELLING (SWELLING) and SWELLING (huge bulge from pectoral area to the axillary area) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02S(or5)A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced SLEEP DISORDER (COULDENT SLEEP WELL), PAIN (ACHES), SWELLING (SWELLING), INJECTION SITE ERYTHEMA (REDNESS AT INJECTION SITE) and PYREXIA (FEVER). On 05-Mar-2021, the patient experienced SWELLING (SWELLING IN LEFT PECTORIAL AREA) and SWELLING (huge bulge from pectoral area to the axillary area). At the time of the report, SLEEP DISORDER (COULDENT SLEEP WELL), SWELLING (SWELLING IN LEFT PECTORIAL AREA), PAIN (ACHES), SWELLING (SWELLING), SWELLING (huge bulge from pectoral area to the axillary area), INJECTION SITE ERYTHEMA (REDNESS AT INJECTION SITE) and PYREXIA (FEVER) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: No specific follow-up information recorded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Vaccination complication
Clinical narrative: felt side effects; fatigue; Headache; cold chills; fever 101 F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt side effects), FATIGUE (fatigue), HEADACHE (Headache), CHILLS (cold chills) and PYREXIA (fever 101 F) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 06-Mar-2021, the patient experienced VACCINATION COMPLICATION (felt side effects), FATIGUE (fatigue), HEADACHE (Headache), CHILLS (cold chills) and PYREXIA (fever 101 F). At the time of the report, VACCINATION COMPLICATION (felt side effects), FATIGUE (fatigue), HEADACHE (Headache), CHILLS (cold chills) and PYREXIA (fever 101 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Feeling abnormal, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms; Aches/ Pain; Unable to eat/Anorexia; Feeling terrible; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Aches/ Pain), FEEDING DISORDER (Unable to eat/Anorexia) and FEELING ABNORMAL (Feeling terrible) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Aches/ Pain), FEEDING DISORDER (Unable to eat/Anorexia) and FEELING ABNORMAL (Feeling terrible). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Aches/ Pain), FEEDING DISORDER (Unable to eat/Anorexia) and FEELING ABNORMAL (Feeling terrible) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included blood pressure medication, hypercholesterolemia medication and hyperlipidemia medication.  Treatment for the event included none.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Additional information received included reporter details.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: woke up throwing up at 10 minutes to 1:00 AM; nauseous all day; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (woke up throwing up at 10 minutes to 1:00 AM) and NAUSEA (nauseous all day) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. L025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia. Concomitant products included INSULIN for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VOMITING (woke up throwing up at 10 minutes to 1:00 AM) and NAUSEA (nauseous all day). On 06-Mar-2021, VOMITING (woke up throwing up at 10 minutes to 1:00 AM) had resolved. On 07-Mar-2021, NAUSEA (nauseous all day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. Concomitant medications include: hypercholesterolemia medicine   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Reporter's details were updated
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: hot spot; (rash) came back/rash in left arm; red spot; itchiness extended pretty much to my upper arm, almost until the elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot spot), VACCINATION SITE PRURITUS (itchiness extended pretty much to my upper arm, almost until the elbow), VACCINATION SITE RASH ((rash) came back/rash in left arm) and VACCINATION SITE ERYTHEMA (red spot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 045A21A) for COVID-19 vaccination.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), LEVOTHYROXINE, LORATADINE (CLARITIN [LORATADINE]) and COLECALCIFEROL (VITAMIN D3 1000) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness extended pretty much to my upper arm, almost until the elbow). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot spot), VACCINATION SITE RASH ((rash) came back/rash in left arm) and VACCINATION SITE ERYTHEMA (red spot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at a dose of once or twice. At the time of the report, VACCINATION SITE WARMTH (hot spot) outcome was unknown and VACCINATION SITE PRURITUS (itchiness extended pretty much to my upper arm, almost until the elbow), VACCINATION SITE RASH ((rash) came back/rash in left arm) and VACCINATION SITE ERYTHEMA (red spot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient said that the rash lasted for 3-4 days,but then it came back. It lasted around 12 days at the most. Patient said that cold compresses worked the best. Patient takes Omega 3 1280 mg twice a day.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received contains significant information: updated event - hot spot, Event onset day, Concomitant medication, treatment medication, expiration date of 1st dose, second dose information, email, address information updated.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: He Missed the Second which was scheduled for March2021; tested positive for COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (He Missed the Second which was scheduled for March2021) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (He Missed the Second which was scheduled for March2021). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He Missed the Second which was scheduled for March2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information included, COVID-19 Antibody Infusion was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: site of injection has red big lump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (site of injection has red big lump) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 VACCINATION SITE MASS (site of injection has red big lump). At the time of the report, VACCINATION SITE MASS (site of injection has red big lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Swelling face
Clinical narrative: left side of the face  swelling up , lump under the jawline and in front of the ear lobe; heaviness in the body; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (heaviness in the body) and SWELLING FACE (left side of the face  swelling up , lump under the jawline and in front of the ear lobe) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced ASTHENIA (heaviness in the body). On 06-Mar-2021, the patient experienced SWELLING FACE (left side of the face  swelling up , lump under the jawline and in front of the ear lobe). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of UNK dosage form. At the time of the report, ASTHENIA (heaviness in the body) and SWELLING FACE (left side of the face  swelling up , lump under the jawline and in front of the ear lobe) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: It's been 49 days since receiving the 1st dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It's been 49 days since receiving the 1st dose of the vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROCHLOROTHIAZIDE, TELMISARTAN (MICARDIS HCT) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (It's been 49 days since receiving the 1st dose of the vaccine). On 18-Jan-2021, PRODUCT DOSE OMISSION ISSUE (It's been 49 days since receiving the 1st dose of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination site discomfort, Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash on same arm of injection; Arm swollen; Arm tight, arm hard; Covid arm; Arm red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Arm red), VACCINATION SITE RASH (Rash on same arm of injection), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE DISCOMFORT (Arm tight, arm hard) and COVID-19 (Covid arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, GLIPIZIDE, CETIRIZINE, LATANOPROST, FLUTICASONE, DILTIAZEM, LEVOTHYROXINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm red), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE DISCOMFORT (Arm tight, arm hard) and COVID-19 (Covid arm). On 06-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash on same arm of injection). At the time of the report, VACCINATION SITE ERYTHEMA (Arm red), VACCINATION SITE RASH (Rash on same arm of injection), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE DISCOMFORT (Arm tight, arm hard) and COVID-19 (Covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Fatigue, Gait disturbance, Headache
Clinical narrative: general discomfort; trouble walking; vertigo; Sore throat; redness; very sore arm; headache; phenomenal fatigue; slight swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (general discomfort), GAIT DISTURBANCE (trouble walking), VERTIGO (vertigo), OROPHARYNGEAL PAIN (Sore throat) and ERYTHEMA (redness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUOXETINE, AMLODIPINE and ATORVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ERYTHEMA (redness), PAIN IN EXTREMITY (very sore arm), HEADACHE (headache), FATIGUE (phenomenal fatigue) and VACCINATION SITE SWELLING (slight swelling at the injection site). On an unknown date, the patient experienced DISCOMFORT (general discomfort), GAIT DISTURBANCE (trouble walking), VERTIGO (vertigo) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, DISCOMFORT (general discomfort), GAIT DISTURBANCE (trouble walking), VERTIGO (vertigo), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (headache) and FATIGUE (phenomenal fatigue) outcome was unknown and ERYTHEMA (redness), PAIN IN EXTREMITY (very sore arm) and VACCINATION SITE SWELLING (slight swelling at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: No specific follow-up information recorded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Vaccination site swelling, Vertigo
Clinical narrative: general discomfort; trouble walking; vertigo; Sore throat; redness; very sore arm; headache; phenomenal fatigue; slight swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (general discomfort), GAIT DISTURBANCE (trouble walking), VERTIGO (vertigo), OROPHARYNGEAL PAIN (Sore throat) and ERYTHEMA (redness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUOXETINE, AMLODIPINE and ATORVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ERYTHEMA (redness), PAIN IN EXTREMITY (very sore arm), HEADACHE (headache), FATIGUE (phenomenal fatigue) and VACCINATION SITE SWELLING (slight swelling at the injection site). On an unknown date, the patient experienced DISCOMFORT (general discomfort), GAIT DISTURBANCE (trouble walking), VERTIGO (vertigo) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, DISCOMFORT (general discomfort), GAIT DISTURBANCE (trouble walking), VERTIGO (vertigo), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (headache) and FATIGUE (phenomenal fatigue) outcome was unknown and ERYTHEMA (redness), PAIN IN EXTREMITY (very sore arm) and VACCINATION SITE SWELLING (slight swelling at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: No specific follow-up information recorded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site cellulitis, Injection site discolouration, Injection site erythema, Injection site induration
Clinical narrative: Diagnosed with cellulitis in arm of injection; Raised area 5 in X 4 in at site of injection; Redness at site of injection; nduration at site of injection; Redness spread to upper arm and antecubital site of injected arm; Site of injection is cherry red; Itchiness at site of injection; Tenderness at site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at site of injection), INJECTION SITE INDURATION (nduration at site of injection), INJECTION SITE MASS (Raised area 5 in X 4 in at site of injection), ERYTHEMA (Redness spread to upper arm and antecubital site of injected arm) and INJECTION SITE DISCOLOURATION (Site of injection is cherry red) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 23-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at site of injection), INJECTION SITE INDURATION (nduration at site of injection), INJECTION SITE MASS (Raised area 5 in X 4 in at site of injection), ERYTHEMA (Redness spread to upper arm and antecubital site of injected arm), INJECTION SITE DISCOLOURATION (Site of injection is cherry red), INJECTION SITE PRURITUS (Itchiness at site of injection) and INJECTION SITE PAIN (Tenderness at site of injection). On 24-Feb-2021, the patient experienced INJECTION SITE CELLULITIS (Diagnosed with cellulitis in arm of injection). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) on 23-Feb-2021 at a dose of UNK dosage form and DOXYCYCLINE on 24-Feb-2021 at a dose of UNK dosage form. At the time of the report, INJECTION SITE ERYTHEMA (Redness at site of injection), INJECTION SITE INDURATION (nduration at site of injection), INJECTION SITE MASS (Raised area 5 in X 4 in at site of injection), ERYTHEMA (Redness spread to upper arm and antecubital site of injected arm), INJECTION SITE DISCOLOURATION (Site of injection is cherry red), INJECTION SITE PRURITUS (Itchiness at site of injection), INJECTION SITE PAIN (Tenderness at site of injection) and INJECTION SITE CELLULITIS (Diagnosed with cellulitis in arm of injection) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.