chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Oropharyngeal pain, Pain
Clinical narrative: feeling sick and ache; runny nose; feeling sick and ache; little headache; Fever; tired; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feeling sick and ache), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), PAIN (feeling sick and ache) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-1900, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 12-Mar-2021, the patient experienced FATIGUE (tired). On 13-Mar-2021, the patient experienced HEADACHE (little headache) and PYREXIA (Fever). On 14-Mar-2021, the patient experienced ILLNESS (feeling sick and ache). On 15-Mar-2021, the patient experienced RHINORRHOEA (runny nose). On an unknown date, the patient experienced PAIN (feeling sick and ache). At the time of the report, ILLNESS (feeling sick and ache), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), PAIN (feeling sick and ache), FATIGUE (tired), HEADACHE (little headache) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Outcome of events updated to Recovered/Resolved.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: feeling sick and ache; runny nose; feeling sick and ache; little headache; Fever; tired; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feeling sick and ache), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), PAIN (feeling sick and ache) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-1900, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 12-Mar-2021, the patient experienced FATIGUE (tired). On 13-Mar-2021, the patient experienced HEADACHE (little headache) and PYREXIA (Fever). On 14-Mar-2021, the patient experienced ILLNESS (feeling sick and ache). On 15-Mar-2021, the patient experienced RHINORRHOEA (runny nose). On an unknown date, the patient experienced PAIN (feeling sick and ache). At the time of the report, ILLNESS (feeling sick and ache), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), PAIN (feeling sick and ache), FATIGUE (tired), HEADACHE (little headache) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Outcome of events updated to Recovered/Resolved.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Musculoskeletal stiffness, Pruritus, Swelling
Clinical narrative: Stiffness; Swelling; Big hard lump; Itching; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), MASS (Big hard lump), PRURITUS (Itching) and MUSCULOSKELETAL STIFFNESS (Stiffness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included METOPROLOL SUCCINATE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), VITAMINS NOS, PREGABALIN and BIOTIN for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced SWELLING (Swelling), MASS (Big hard lump) and PRURITUS (Itching). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness). At the time of the report, SWELLING (Swelling), MASS (Big hard lump), PRURITUS (Itching) and MUSCULOSKELETAL STIFFNESS (Stiffness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-044320 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: Chest and ribs painful; Diarrhea; Fever; Pain in muscles; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest and ribs painful), DIARRHOEA (Diarrhea), PYREXIA (Fever) and MYALGIA (Pain in muscles) in an 81-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest and ribs painful), DIARRHOEA (Diarrhea), PYREXIA (Fever) and MYALGIA (Pain in muscles). The patient was treated with ASA at a dose of UNK dosage form. At the time of the report, CHEST PAIN (Chest and ribs painful), DIARRHOEA (Diarrhea), PYREXIA (Fever) and MYALGIA (Pain in muscles) was resolving.            Action taken with mRNA-1273 in response to the event was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Document contains no new information (NNI).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Side heat at injection site; Swelling at injection site; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Side heat at injection site), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE RASH (Rash at injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00813) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced INJECTION SITE WARMTH (Side heat at injection site), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE RASH (Rash at injection site). At the time of the report, INJECTION SITE WARMTH (Side heat at injection site), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE RASH (Rash at injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Patient denied to contact PC.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Ageusia, Anosmia, Back pain, Dysgeusia
Clinical narrative: metal taste in mouth - very prominent; loss of taste and smell; loss of taste and smell; back pain on the right and in the front of stomach; in the front of stomach; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSGEUSIA (metal taste in mouth - very prominent), AGEUSIA (loss of taste and smell), ANOSMIA (loss of taste and smell), BACK PAIN (back pain on the right and in the front of stomach) and ABDOMINAL PAIN UPPER (in the front of stomach) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 immunisation.     The patient's past medical history included Injection (she received the wrong type of steroid; cortisone instead of Euflexxa) on 10-Feb-2021. Concomitant products included CORTISONE and HYALURONATE SODIUM (EUFLEXXA) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced DYSGEUSIA (metal taste in mouth - very prominent), AGEUSIA (loss of taste and smell), ANOSMIA (loss of taste and smell), BACK PAIN (back pain on the right and in the front of stomach) and ABDOMINAL PAIN UPPER (in the front of stomach). At the time of the report, DYSGEUSIA (metal taste in mouth - very prominent), AGEUSIA (loss of taste and smell), ANOSMIA (loss of taste and smell), BACK PAIN (back pain on the right and in the front of stomach) and ABDOMINAL PAIN UPPER (in the front of stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Hypoaesthesia, Vaccination site injury, Vaccination site pain
Clinical narrative: Arm at the injection site has a dent (swallow hole); dent feels numb; Voice is raspy; Arm has muscle but this area feels like it has no muscle; Arm was severely sore for 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INJURY (Arm at the injection site has a dent (swallow hole)), HYPOAESTHESIA (dent feels numb), DYSPHONIA (Voice is raspy), HYPOAESTHESIA (Arm has muscle but this area feels like it has no muscle) and VACCINATION SITE PAIN (Arm was severely sore for 2-3 days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm was severely sore for 2-3 days). On 12-Mar-2021, the patient experienced VACCINATION SITE INJURY (Arm at the injection site has a dent (swallow hole)), HYPOAESTHESIA (dent feels numb), DYSPHONIA (Voice is raspy) and HYPOAESTHESIA (Arm has muscle but this area feels like it has no muscle). On 19-Feb-2021, VACCINATION SITE PAIN (Arm was severely sore for 2-3 days) had resolved. At the time of the report, VACCINATION SITE INJURY (Arm at the injection site has a dent (swallow hole)), HYPOAESTHESIA (dent feels numb), DYSPHONIA (Voice is raspy) and HYPOAESTHESIA (Arm has muscle but this area feels like it has no muscle) 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.  Treatment information was not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in an 80-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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced CHILLS (Chills). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Chills, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taking concomitant medication but did not provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Injection side swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection side swelling) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  .  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), HYDROCODONE and IBUPROFEN for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Injection side swelling). At the time of the report, VACCINATION SITE SWELLING (Injection side swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided by the reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased
Clinical narrative: Elevated heart rate; General fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Elevated heart rate) and FATIGUE (General fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced HEART RATE INCREASED (Elevated heart rate) and FATIGUE (General fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, HEART RATE INCREASED (Elevated heart rate) and FATIGUE (General fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medicines (names were not specified).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On an unknown date, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Skin bacterial infection
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SKIN BACTERIAL INFECTION (A bacterial skin infection), ERYTHEMA (Arm turned red), PERIPHERAL SWELLING (Arm turned swollen), PRURITUS (Arm turned itchy) and RASH (Rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, SIMVASTATIN, CENTRUM SILVER WOMEN 50+ and CALCIUM CITRATE TETRAHYDRATE, COLECALCIFEROL (CITROCALCIO) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021 at 2:28 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced SKIN BACTERIAL INFECTION (A bacterial skin infection), ERYTHEMA (Arm turned red), PERIPHERAL SWELLING (Arm turned swollen), PRURITUS (Arm turned itchy) and RASH (Rash). The patient was treated with SULFAMETHOXAZOLE;TRIMETHOPRIM for Bacterial infection, at an unspecified dose and frequency. At the time of the report, SKIN BACTERIAL INFECTION (A bacterial skin infection), ERYTHEMA (Arm turned red), PERIPHERAL SWELLING (Arm turned swollen), PRURITUS (Arm turned itchy) and RASH (Rash) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient was pot on a safe barrier bandage, circular bandage, thick around outside and bandage part in the middle, where the vaccine was injected.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Patient demographics, concomitant medications, treatment medication and additional event updated.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Discomfort, Nervousness, Psychomotor hyperactivity, Restlessness
Clinical narrative: It was so restless I was afraid for my heart/got restless/ restlessness increased; Was so restless that he was afraid to go to sleep; Became hyper; Felt nervous; Felt insecure; Very fast in my thinking; Shivering and couldn't stop it; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (It was so restless I was afraid for my heart/got restless/ restlessness increased), SLEEP DISORDER (Was so restless that he was afraid to go to sleep), PSYCHOMOTOR HYPERACTIVITY (Became hyper), NERVOUSNESS (Felt nervous) and DISCOMFORT (Felt insecure) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESTLESSNESS (It was so restless I was afraid for my heart/got restless/ restlessness increased), SLEEP DISORDER (Was so restless that he was afraid to go to sleep), PSYCHOMOTOR HYPERACTIVITY (Became hyper), NERVOUSNESS (Felt nervous), DISCOMFORT (Felt insecure), THINKING ABNORMAL (Very fast in my thinking) and CHILLS (Shivering and couldn't stop it). At the time of the report, RESTLESSNESS (It was so restless I was afraid for my heart/got restless/ restlessness increased), SLEEP DISORDER (Was so restless that he was afraid to go to sleep), PSYCHOMOTOR HYPERACTIVITY (Became hyper), NERVOUSNESS (Felt nervous), DISCOMFORT (Felt insecure), THINKING ABNORMAL (Very fast in my thinking) and CHILLS (Shivering and couldn't stop it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient experienced shivering, he meditated, and it slowed down and fell asleep. During the episode, he felt nervous; was walking from one room to another and couldn't stop talking. He also stated that the things that were unusual were extensive walking and couldn't stand still.  No relevant concomitant medications were reported. No treatment information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Thinking abnormal
Clinical narrative: It was so restless I was afraid for my heart/got restless/ restlessness increased; Was so restless that he was afraid to go to sleep; Became hyper; Felt nervous; Felt insecure; Very fast in my thinking; Shivering and couldn't stop it; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (It was so restless I was afraid for my heart/got restless/ restlessness increased), SLEEP DISORDER (Was so restless that he was afraid to go to sleep), PSYCHOMOTOR HYPERACTIVITY (Became hyper), NERVOUSNESS (Felt nervous) and DISCOMFORT (Felt insecure) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESTLESSNESS (It was so restless I was afraid for my heart/got restless/ restlessness increased), SLEEP DISORDER (Was so restless that he was afraid to go to sleep), PSYCHOMOTOR HYPERACTIVITY (Became hyper), NERVOUSNESS (Felt nervous), DISCOMFORT (Felt insecure), THINKING ABNORMAL (Very fast in my thinking) and CHILLS (Shivering and couldn't stop it). At the time of the report, RESTLESSNESS (It was so restless I was afraid for my heart/got restless/ restlessness increased), SLEEP DISORDER (Was so restless that he was afraid to go to sleep), PSYCHOMOTOR HYPERACTIVITY (Became hyper), NERVOUSNESS (Felt nervous), DISCOMFORT (Felt insecure), THINKING ABNORMAL (Very fast in my thinking) and CHILLS (Shivering and couldn't stop it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient experienced shivering, he meditated, and it slowed down and fell asleep. During the episode, he felt nervous; was walking from one room to another and couldn't stop talking. He also stated that the things that were unusual were extensive walking and couldn't stand still.  No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Lower than recommended dose at 0.4 ml for 2nd vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Lower than recommended dose at 0.4 ml for 2nd vaccine) 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) (Intramuscular) .4 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Lower than recommended dose at 0.4 ml for 2nd vaccine). At the time of the report, ACCIDENTAL UNDERDOSE (Lower than recommended dose at 0.4 ml for 2nd vaccine) had 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.  Action taken with mRNA-1273 in response to the events was  not applicable.; Reporter's Comments: This report refers to a case of accidental under dose for mRNA-1273 with no associated AEs.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19, Fatigue, Headache, Hunger
Clinical narrative: felt tingling in her stomach; Her hands have started to sweat again; her legs when she goes up stairs are still very weak; very tired; her stomach was making noises; she was very hungry; symptoms similar to those she had when she had COVID-19; fell asleep; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (symptoms similar to those she had when she had COVID-19), SOMNOLENCE (fell asleep), ABDOMINAL DISCOMFORT (her stomach was making noises), HUNGER (she was very hungry) and PARAESTHESIA (felt tingling in her stomach) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 12-Dec-2020.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced COVID-19 (symptoms similar to those she had when she had COVID-19), SOMNOLENCE (fell asleep) and HEADACHE (headache). On 13-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (her stomach was making noises), HUNGER (she was very hungry) and FATIGUE (very tired). On an unknown date, the patient experienced PARAESTHESIA (felt tingling in her stomach), HYPERHIDROSIS (Her hands have started to sweat again) and MUSCULAR WEAKNESS (her legs when she goes up stairs are still very weak). At the time of the report, COVID-19 (symptoms similar to those she had when she had COVID-19), SOMNOLENCE (fell asleep), ABDOMINAL DISCOMFORT (her stomach was making noises), HUNGER (she was very hungry), PARAESTHESIA (felt tingling in her stomach), HYPERHIDROSIS (Her hands have started to sweat again), MUSCULAR WEAKNESS (her legs when she goes up stairs are still very weak), FATIGUE (very tired) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Muscular weakness, Paraesthesia, Somnolence
Clinical narrative: felt tingling in her stomach; Her hands have started to sweat again; her legs when she goes up stairs are still very weak; very tired; her stomach was making noises; she was very hungry; symptoms similar to those she had when she had COVID-19; fell asleep; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (symptoms similar to those she had when she had COVID-19), SOMNOLENCE (fell asleep), ABDOMINAL DISCOMFORT (her stomach was making noises), HUNGER (she was very hungry) and PARAESTHESIA (felt tingling in her stomach) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 12-Dec-2020.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced COVID-19 (symptoms similar to those she had when she had COVID-19), SOMNOLENCE (fell asleep) and HEADACHE (headache). On 13-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (her stomach was making noises), HUNGER (she was very hungry) and FATIGUE (very tired). On an unknown date, the patient experienced PARAESTHESIA (felt tingling in her stomach), HYPERHIDROSIS (Her hands have started to sweat again) and MUSCULAR WEAKNESS (her legs when she goes up stairs are still very weak). At the time of the report, COVID-19 (symptoms similar to those she had when she had COVID-19), SOMNOLENCE (fell asleep), ABDOMINAL DISCOMFORT (her stomach was making noises), HUNGER (she was very hungry), PARAESTHESIA (felt tingling in her stomach), HYPERHIDROSIS (Her hands have started to sweat again), MUSCULAR WEAKNESS (her legs when she goes up stairs are still very weak), FATIGUE (very tired) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Nausea, Vomiting
Clinical narrative: Nauseas; Vomited; Felt crumby; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt crumby), CHILLS (Chills), NAUSEA (Nauseas) and VOMITING (Vomited) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced CHILLS (Chills). On 13-Mar-2021, the patient experienced FEELING ABNORMAL (Felt crumby). On 14-Mar-2021, the patient experienced NAUSEA (Nauseas) and VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Felt crumby), CHILLS (Chills), NAUSEA (Nauseas) and VOMITING (Vomited) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Erythema, Pain, Rash
Clinical narrative: Real sore/ painful; Patch under her breast/pea shaped; Red in that area/red around the area; A cluster of three of them; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Real sore/ painful), RASH (Patch under her breast/pea shaped), ERYTHEMA (Red in that area/red around the area) and ADVERSE REACTION (A cluster of three of them) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A0LA) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Real sore/ painful), RASH (Patch under her breast/pea shaped), ERYTHEMA (Red in that area/red around the area) and ADVERSE REACTION (A cluster of three of them). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, PAIN (Real sore/ painful), RASH (Patch under her breast/pea shaped), ERYTHEMA (Red in that area/red around the area) and ADVERSE REACTION (A cluster of three of them) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Low grade fever 99.3; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade fever 99.3) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001V21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade fever 99.3). On 15-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, PYREXIA (Low grade fever 99.3) outcome was unknown.            No relevant concomitant medications were provided.  Reportedly, the arm was sore for 1.5 days. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received on 5-MAY-2021. no new information
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is hurt but not much; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is hurt but not much) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 (arm is hurt but not much). At the time of the report, PAIN IN EXTREMITY (arm is hurt but not much) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not provided. patient planning to take his 2nd dose on 14-apr-2021.o right arm.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage
Clinical narrative: when the HCP took off the needle, she bleed; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HAEMORRHAGE (when the HCP took off the needle, she bleed) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced INJECTION SITE HAEMORRHAGE (when the HCP took off the needle, she bleed). At the time of the report, INJECTION SITE HAEMORRHAGE (when the HCP took off the needle, she bleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Mass excision, Pruritus, Rash macular
Clinical narrative: COVID-arm; redness grew bigger; looks blotchy; bump on her arm; itchy; This spontaneous case was reported by a consumer and describes the occurrence of MASS EXCISION (bump on her arm), PRURITUS (itchy), HYPERSENSITIVITY (COVID-arm), ERYTHEMA (redness grew bigger) and RASH MACULAR (looks blotchy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) 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 13-Mar-2021, the patient experienced MASS EXCISION (bump on her arm) and PRURITUS (itchy). On 14-Mar-2021, the patient experienced HYPERSENSITIVITY (COVID-arm), ERYTHEMA (redness grew bigger) and RASH MACULAR (looks blotchy). At the time of the report, MASS EXCISION (bump on her arm), PRURITUS (itchy), HYPERSENSITIVITY (COVID-arm), ERYTHEMA (redness grew bigger) and RASH MACULAR (looks blotchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Birth control pills were included as concomitant medications
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: a little vaccine dripped on the patient's arm while it was being administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (a little vaccine dripped on the patient's arm while it was being administered) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (a little vaccine dripped on the patient's arm while it was being administered). At the time of the report, UNDERDOSE (a little vaccine dripped on the patient's arm while it was being administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Toothache, Vaccination site mass
Clinical narrative: lump in arm; tooth ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump in arm), TOOTHACHE (tooth ache) and HEADACHE (headache) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE MASS (lump in arm), TOOTHACHE (tooth ache) and HEADACHE (headache). On 17-Feb-2021, VACCINATION SITE MASS (lump in arm), TOOTHACHE (tooth ache) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Reporter stated that Patient was planning to see a dentist.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chills, Decreased appetite, Dizziness
Clinical narrative: Diagnosed with Covid-19; Dizziness; Weakness; No appetite; Fever; Chills; Tiredness/Fatigue; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid-19), DIZZINESS (Dizziness), ASTHENIA (Weakness), DECREASED APPETITE (No appetite) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), DECREASED APPETITE (No appetite), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness/Fatigue) and HEADACHE (Headaches). On 22-Feb-2021, the patient experienced COVID-19 (Diagnosed with Covid-19). The patient was treated with AZITHROMYCIN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Diagnosed with Covid-19), DIZZINESS (Dizziness), ASTHENIA (Weakness), DECREASED APPETITE (No appetite), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness/Fatigue) and HEADACHE (Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  The patient reported that she diagnosed with Covid-19 on 22-feb-2021 with positive test. She went to an urgent care on 27-feb-2021 where she was received azithromycin, and symptoms resolved in 3-4 days. She stated that she got covid-19 from her son who was visiting to them, and not from the vaccine. She is scheduled to get second dose on 19-mar-2021. She was asking if she should get the second dose of the vaccination or wait.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: Diagnosed with Covid-19; Dizziness; Weakness; No appetite; Fever; Chills; Tiredness/Fatigue; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid-19), DIZZINESS (Dizziness), ASTHENIA (Weakness), DECREASED APPETITE (No appetite) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), DECREASED APPETITE (No appetite), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness/Fatigue) and HEADACHE (Headaches). On 22-Feb-2021, the patient experienced COVID-19 (Diagnosed with Covid-19). The patient was treated with AZITHROMYCIN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Diagnosed with Covid-19), DIZZINESS (Dizziness), ASTHENIA (Weakness), DECREASED APPETITE (No appetite), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness/Fatigue) and HEADACHE (Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  The patient reported that she diagnosed with Covid-19 on 22-feb-2021 with positive test. She went to an urgent care on 27-feb-2021 where she was received azithromycin, and symptoms resolved in 3-4 days. She stated that she got covid-19 from her son who was visiting to them, and not from the vaccine. She is scheduled to get second dose on 19-mar-2021. She was asking if she should get the second dose of the vaccination or wait.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pruritus
Clinical narrative: redness at the injection site; rash at the injection site; site was swollen like a big ball; itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE RASH (rash at the injection site), INJECTION SITE SWELLING (site was swollen like a big ball) and PRURITUS (itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE RASH (rash at the injection site), INJECTION SITE SWELLING (site was swollen like a big ball) and PRURITUS (itchy). At the time of the report, INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE RASH (rash at the injection site), INJECTION SITE SWELLING (site was swollen like a big ball) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment was provided.    Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Vaccination site rash
Clinical narrative: Arm started tingling; Arm became numb; Soreness in arm; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Arm started tingling), HYPOAESTHESIA (Arm became numb), PAIN IN EXTREMITY (Soreness in arm) and VACCINATION SITE RASH (Rash at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Cardiac disorder NOS. Concomitant products included IBUPROFEN for Arthritis.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PARAESTHESIA (Arm started tingling), HYPOAESTHESIA (Arm became numb), PAIN IN EXTREMITY (Soreness in arm) and VACCINATION SITE RASH (Rash at injection site). At the time of the report, PARAESTHESIA (Arm started tingling), HYPOAESTHESIA (Arm became numb), PAIN IN EXTREMITY (Soreness in arm) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she took ibuprofen which she was already taking for arthritis.   This case was linked to MOD-2021-044537 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: Hurt alot; Sore arm; Red lump with a 2 inch diameter; it was tender, sore and itchy; it was tender, sore and itchy; Red lump with a 2 inch diameter; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurt alot), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (Red lump with a 2 inch diameter), VACCINATION SITE PRURITUS (it was tender, sore and itchy) and VACCINATION SITE PAIN (it was tender, sore and itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE, ATENOLOL and METFORMIN for an unknown indication.    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN (Hurt alot), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (Red lump with a 2 inch diameter), VACCINATION SITE PRURITUS (it was tender, sore and itchy), VACCINATION SITE PAIN (it was tender, sore and itchy) and VACCINATION SITE ERYTHEMA (Red lump with a 2 inch diameter). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 23-Feb-2021, PAIN (Hurt alot), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (it was tender, sore and itchy) and VACCINATION SITE PAIN (it was tender, sore and itchy) had resolved. At the time of the report, VACCINATION SITE MASS (Red lump with a 2 inch diameter) and VACCINATION SITE ERYTHEMA (Red lump with a 2 inch diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.