chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin, Ultrasound breast
Clinical narrative: large bruise on right breast; swollen lymph nodes under right arm; tenderness in her lymph nodes; Feels like she has been put through the ringer; sensitivity under right arm; Almost passed out; Dry-heaves; Became sweaty; Headaches; Nausea; 102 Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost passed out), RETCHING (Dry-heaves), HYPERHIDROSIS (Became sweaty), FEELING ABNORMAL (Feels like she has been put through the ringer) and SENSITIVE SKIN (sensitivity under right arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism, High cholesterol and Contrast media allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN CALCIUM (CRESTOR), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and ZINC for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PRESYNCOPE (Almost passed out) and HYPERHIDROSIS (Became sweaty). 20-Apr-2021, the patient experienced RETCHING (Dry-heaves), SENSITIVE SKIN (sensitivity under right arm), HEADACHE (Headaches), NAUSEA (Nausea) and PYREXIA (102 Fever). On 21-Apr-2021, the patient experienced FEELING ABNORMAL (Feels like she has been put through the ringer). On 22-Apr-2021, the patient experienced CONTUSION (large bruise on right breast) and LYMPHADENOPATHY (swollen lymph nodes under right arm). 22-Apr-2021, the patient experienced LYMPH NODE PAIN (tenderness in her lymph nodes). On 22-Apr-2021, PRESYNCOPE (Almost passed out), RETCHING (Dry-heaves), HYPERHIDROSIS (Became sweaty), SENSITIVE SKIN (sensitivity under right arm), NAUSEA (Nausea) and PYREXIA (102 Fever) had resolved. At the time of the report, FEELING ABNORMAL (Feels like she has been put through the ringer), CONTUSION (large bruise on right breast), LYMPHADENOPATHY (swollen lymph nodes under right arm), LYMPH NODE PAIN (tenderness in her lymph nodes) and HEADACHE (Headaches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Ultrasound breast: Negative.         .   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Significant Follow-up appended.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Off label use, Pain
Clinical narrative: scheduled for their third dose; Body aches; Chills; Low grade fever; Headache; Second dose received on day 96; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Second dose received on day 96), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for their third dose), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Low grade fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 08-Jan-2021. Concomitant products included METOPROLOL SUCCINATE (TOPROL XL), AMLODIPINE BESILATE (NORVASC), PROGESTERONE, CLONAZEPAM, FAMOTIDINE, ACETYLSALICYLIC ACID (ASPIRIN 81) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced OFF LABEL USE (Second dose received on day 96). 13-Apr-2021, the patient experienced PAIN (Body aches), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headache). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for their third dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OFF LABEL USE (Second dose received on day 96), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for their third dose), PAIN (Body aches), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.         This case was linked to MOD-2021-083078, MOD-2021-083092 (E2B Linked Report). This case was linked to MOD-2021-083104 (Patient Link).; Sender's Comments:  MOD-2021-083078:husband 1st dose case MOD-2021-083092:husband 2nd dose case
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: scheduled for their third dose; Body aches; Chills; Low grade fever; Headache; Second dose received on day 96; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Second dose received on day 96), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for their third dose), PAIN (Body aches), CHILLS (Chills) and PYREXIA (Low grade fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 08-Jan-2021. Concomitant products included METOPROLOL SUCCINATE (TOPROL XL), AMLODIPINE BESILATE (NORVASC), PROGESTERONE, CLONAZEPAM, FAMOTIDINE, ACETYLSALICYLIC ACID (ASPIRIN 81) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced OFF LABEL USE (Second dose received on day 96). 13-Apr-2021, the patient experienced PAIN (Body aches), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headache). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for their third dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OFF LABEL USE (Second dose received on day 96), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled for their third dose), PAIN (Body aches), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.         This case was linked to MOD-2021-083078, MOD-2021-083092 (E2B Linked Report). This case was linked to MOD-2021-083104 (Patient Link).; Sender's Comments:  MOD-2021-083078:husband 1st dose case MOD-2021-083092:husband 2nd dose case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Lot of pain in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Lot of pain in her left arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B2X) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, VERAPAMIL, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), TRAMADOL, ATORVASTATIN, DULOXETINE HYDROCHLORIDE (CYMBALTA) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (PROAIR BRONQUIAL) for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Lot of pain in her left arm). At the time of the report, VACCINATION SITE PAIN (Lot of pain in her left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory details was given. No treatment information was given.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Outcome of event, Date of Dose 2 vaccination updated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose not administered with in 36 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose not administered with in 36 days after the first dose) in a 63-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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose not administered with in 36 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose not administered with in 36 days after the first dose) had resolved. Unknown      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were given. No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20-May-2021 added patient received second dose.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Oropharyngeal pain, Pyrexia, Sinusitis
Clinical narrative: Running a Fever; Cough; sore throat; Little Congested; Sinus issues; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Running a Fever), COUGH (Cough), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (Little Congested) and SINUSITIS (Sinus issues) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TETANUS ADS IMPFSTOFF (Routine Tetanus shot due to stepping on a nail 10 years ago. Scheduled on 15-APR-2021. Advised to Wait for additional 14 days to take vaccination) since an unknown date.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Running a Fever), COUGH (Cough), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (Little Congested) and SINUSITIS (Sinus issues). At the time of the report, PYREXIA (Running a Fever), COUGH (Cough), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (Little Congested) and SINUSITIS (Sinus issues) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gait inability, Headache, Oropharyngeal pain, Pain
Clinical narrative: experienced everything on the FAQ sheet side effect except for vomiting; her arm was hurting and it went up into her neck; Sore Throat; diarrhea; was hurting so bad; she also could barely get off the sofa; Headache; temperature of 105; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced everything on the FAQ sheet side effect except for vomiting), PAIN (her arm was hurting and it went up into her neck), OROPHARYNGEAL PAIN (Sore Throat), DIARRHOEA (diarrhea) and PAIN (was hurting so bad) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION COMPLICATION (experienced everything on the FAQ sheet side effect except for vomiting), PAIN (her arm was hurting and it went up into her neck), OROPHARYNGEAL PAIN (Sore Throat), DIARRHOEA (diarrhea), PAIN (was hurting so bad), GAIT INABILITY (she also could barely get off the sofa), HEADACHE (Headache) and PYREXIA (temperature of 105). At the time of the report, VACCINATION COMPLICATION (experienced everything on the FAQ sheet side effect except for vomiting), PAIN (her arm was hurting and it went up into her neck), OROPHARYNGEAL PAIN (Sore Throat), DIARRHOEA (diarrhea), PAIN (was hurting so bad), GAIT INABILITY (she also could barely get off the sofa), HEADACHE (Headache) and PYREXIA (temperature of 105) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: experienced everything on the FAQ sheet side effect except for vomiting; her arm was hurting and it went up into her neck; Sore Throat; diarrhea; was hurting so bad; she also could barely get off the sofa; Headache; temperature of 105; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced everything on the FAQ sheet side effect except for vomiting), PAIN (her arm was hurting and it went up into her neck), OROPHARYNGEAL PAIN (Sore Throat), DIARRHOEA (diarrhea) and PAIN (was hurting so bad) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION COMPLICATION (experienced everything on the FAQ sheet side effect except for vomiting), PAIN (her arm was hurting and it went up into her neck), OROPHARYNGEAL PAIN (Sore Throat), DIARRHOEA (diarrhea), PAIN (was hurting so bad), GAIT INABILITY (she also could barely get off the sofa), HEADACHE (Headache) and PYREXIA (temperature of 105). At the time of the report, VACCINATION COMPLICATION (experienced everything on the FAQ sheet side effect except for vomiting), PAIN (her arm was hurting and it went up into her neck), OROPHARYNGEAL PAIN (Sore Throat), DIARRHOEA (diarrhea), PAIN (was hurting so bad), GAIT INABILITY (she also could barely get off the sofa), HEADACHE (Headache) and PYREXIA (temperature of 105) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Heart rate increased
Clinical narrative: Some numbness in arm; Tingly in arm; Pain on side; Sweat a lot for about 40 hours; Heart rate was 135; Oxygen was down to 91; Joint pain; Chills so bad; Fatigue; Strong headache; Muscle pain; Fever 101.6; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Some numbness in arm), PARAESTHESIA (Tingly in arm), PAIN (Pain on side), HYPERHIDROSIS (Sweat a lot for about 40 hours) and HEART RATE INCREASED (Heart rate was 135) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included METFORMIN for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced HYPOAESTHESIA (Some numbness in arm), PARAESTHESIA (Tingly in arm), PAIN (Pain on side), HYPERHIDROSIS (Sweat a lot for about 40 hours), HEART RATE INCREASED (Heart rate was 135), OXYGEN SATURATION (Oxygen was down to 91), ARTHRALGIA (Joint pain), CHILLS (Chills so bad), FATIGUE (Fatigue), HEADACHE (Strong headache), MYALGIA (Muscle pain) and PYREXIA (Fever 101.6). At the time of the report, HYPOAESTHESIA (Some numbness in arm), PARAESTHESIA (Tingly in arm), PAIN (Pain on side), HYPERHIDROSIS (Sweat a lot for about 40 hours), HEART RATE INCREASED (Heart rate was 135), OXYGEN SATURATION (Oxygen was down to 91), ARTHRALGIA (Joint pain), CHILLS (Chills so bad), FATIGUE (Fatigue), HEADACHE (Strong headache), MYALGIA (Muscle pain) and PYREXIA (Fever 101.6) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include metformin, blood pressure medications, cholesterol medications.  Treatment for the event included ibuprofen (Advil)
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Myalgia, Oxygen saturation, Pain
Clinical narrative: Some numbness in arm; Tingly in arm; Pain on side; Sweat a lot for about 40 hours; Heart rate was 135; Oxygen was down to 91; Joint pain; Chills so bad; Fatigue; Strong headache; Muscle pain; Fever 101.6; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Some numbness in arm), PARAESTHESIA (Tingly in arm), PAIN (Pain on side), HYPERHIDROSIS (Sweat a lot for about 40 hours) and HEART RATE INCREASED (Heart rate was 135) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included METFORMIN for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced HYPOAESTHESIA (Some numbness in arm), PARAESTHESIA (Tingly in arm), PAIN (Pain on side), HYPERHIDROSIS (Sweat a lot for about 40 hours), HEART RATE INCREASED (Heart rate was 135), OXYGEN SATURATION (Oxygen was down to 91), ARTHRALGIA (Joint pain), CHILLS (Chills so bad), FATIGUE (Fatigue), HEADACHE (Strong headache), MYALGIA (Muscle pain) and PYREXIA (Fever 101.6). At the time of the report, HYPOAESTHESIA (Some numbness in arm), PARAESTHESIA (Tingly in arm), PAIN (Pain on side), HYPERHIDROSIS (Sweat a lot for about 40 hours), HEART RATE INCREASED (Heart rate was 135), OXYGEN SATURATION (Oxygen was down to 91), ARTHRALGIA (Joint pain), CHILLS (Chills so bad), FATIGUE (Fatigue), HEADACHE (Strong headache), MYALGIA (Muscle pain) and PYREXIA (Fever 101.6) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include metformin, blood pressure medications, cholesterol medications.  Treatment for the event included ibuprofen (Advil)
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Some numbness in arm; Tingly in arm; Pain on side; Sweat a lot for about 40 hours; Heart rate was 135; Oxygen was down to 91; Joint pain; Chills so bad; Fatigue; Strong headache; Muscle pain; Fever 101.6; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Some numbness in arm), PARAESTHESIA (Tingly in arm), PAIN (Pain on side), HYPERHIDROSIS (Sweat a lot for about 40 hours) and HEART RATE INCREASED (Heart rate was 135) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included METFORMIN for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced HYPOAESTHESIA (Some numbness in arm), PARAESTHESIA (Tingly in arm), PAIN (Pain on side), HYPERHIDROSIS (Sweat a lot for about 40 hours), HEART RATE INCREASED (Heart rate was 135), OXYGEN SATURATION (Oxygen was down to 91), ARTHRALGIA (Joint pain), CHILLS (Chills so bad), FATIGUE (Fatigue), HEADACHE (Strong headache), MYALGIA (Muscle pain) and PYREXIA (Fever 101.6). At the time of the report, HYPOAESTHESIA (Some numbness in arm), PARAESTHESIA (Tingly in arm), PAIN (Pain on side), HYPERHIDROSIS (Sweat a lot for about 40 hours), HEART RATE INCREASED (Heart rate was 135), OXYGEN SATURATION (Oxygen was down to 91), ARTHRALGIA (Joint pain), CHILLS (Chills so bad), FATIGUE (Fatigue), HEADACHE (Strong headache), MYALGIA (Muscle pain) and PYREXIA (Fever 101.6) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include metformin, blood pressure medications, cholesterol medications.  Treatment for the event included ibuprofen (Advil)
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), NAUSEA (nausea) and HEADACHE (severe headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced HEADACHE (severe headache). On an unknown date, the patient experienced MALAISE (feeling sick) and NAUSEA (nausea). At the time of the report, MALAISE (feeling sick), NAUSEA (nausea) and HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided.  Treatment Medication provided was common pill that accelerates digestion.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Non-Significant follow up appended to AER
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: soreness in arm; redness at the site of injection; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of the second episode of PAIN IN EXTREMITY (soreness in arm), the first episode of PAIN IN EXTREMITY (soreness in arm) and VACCINATION SITE ERYTHEMA (redness at the site of injection) 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 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced the first episode of PAIN IN EXTREMITY (soreness in arm). On 21-Apr-2021, the patient experienced the second episode of PAIN IN EXTREMITY (soreness in arm) and VACCINATION SITE ERYTHEMA (redness at the site of injection). At the time of the report, last episode of PAIN IN EXTREMITY (soreness in arm) and VACCINATION SITE ERYTHEMA (redness at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose given 44 days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose given 44 days ago) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose given 44 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose given 44 days ago) outcome was unknown. Not Provided      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.   The pharmacist wanted information if patient can get second dose. concomitiant medication use was not provided by the reporter  Treatment information was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Upper-airway cough syndrome, Urinary tract infection
Clinical narrative: Cough; post nasal drip; UTI; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), UPPER-AIRWAY COUGH SYNDROME (post nasal drip) and URINARY TRACT INFECTION (UTI) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough), UPPER-AIRWAY COUGH SYNDROME (post nasal drip) and URINARY TRACT INFECTION (UTI). At the time of the report, COUGH (Cough), UPPER-AIRWAY COUGH SYNDROME (post nasal drip) and URINARY TRACT INFECTION (UTI) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Antibiotics for UTI. No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: temperature with 102; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature with 102) 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 COVID-19 in November 2020.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PYREXIA (temperature with 102). At the time of the report, PYREXIA (temperature with 102) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: Chills; Arm swollen; Not felt well; Headache; Tired; Achy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen), FEELING ABNORMAL (Not felt well), HEADACHE (Headache), FATIGUE (Tired) and MYALGIA (Achy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen), HEADACHE (Headache), FATIGUE (Tired) and MYALGIA (Achy). 12-Apr-2021, the patient experienced FEELING ABNORMAL (Not felt well). On 17-Apr-2021, the patient experienced CHILLS (Chills). At the time of the report, PERIPHERAL SWELLING (Arm swollen) and HEADACHE (Headache) was resolving and FEELING ABNORMAL (Not felt well), FATIGUE (Tired), MYALGIA (Achy) and CHILLS (Chills) outcome was unknown.            Concomitant medication were not reported. Treatment included unspecified pain killers.   This case was linked to US-MODERNATX, INC.-MOD-2021-083120 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: TCR received Contains No new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083120: CROSSLINKED WITH DOSE 1
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Chills; Arm swollen; Not felt well; Headache; Tired; Achy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen), FEELING ABNORMAL (Not felt well), HEADACHE (Headache), FATIGUE (Tired) and MYALGIA (Achy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen), HEADACHE (Headache), FATIGUE (Tired) and MYALGIA (Achy). 12-Apr-2021, the patient experienced FEELING ABNORMAL (Not felt well). On 17-Apr-2021, the patient experienced CHILLS (Chills). At the time of the report, PERIPHERAL SWELLING (Arm swollen) and HEADACHE (Headache) was resolving and FEELING ABNORMAL (Not felt well), FATIGUE (Tired), MYALGIA (Achy) and CHILLS (Chills) outcome was unknown.            Concomitant medication were not reported. Treatment included unspecified pain killers.   This case was linked to US-MODERNATX, INC.-MOD-2021-083120 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: TCR received Contains No new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083120: CROSSLINKED WITH DOSE 1
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Oedema peripheral
Clinical narrative: edema of ankle; ankle swells; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (edema of ankle) and JOINT SWELLING (ankle swells) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 08-Mar-2021, the patient experienced OEDEMA PERIPHERAL (edema of ankle) and JOINT SWELLING (ankle swells). At the time of the report, OEDEMA PERIPHERAL (edema of ankle) and JOINT SWELLING (ankle swells) outcome was unknown. Not Provided          treatment include salt free diet.   This case was linked to MOD-2021-083129 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oropharyngeal pain, Pyrexia, Viral infection
Clinical narrative: Bad Headache; Fever; Very very Bad Sore throat; body ache; Side effects like COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad Headache), PYREXIA (Fever), OROPHARYNGEAL PAIN (Very very Bad Sore throat), MYALGIA (body ache) and VIRAL INFECTION (Side effects like COVID-19) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hip bursitis (Hip bursitis surgery) on 09-Apr-2021. Concurrent medical conditions included Arthritis.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (Bad Headache), PYREXIA (Fever), OROPHARYNGEAL PAIN (Very very Bad Sore throat), MYALGIA (body ache) and VIRAL INFECTION (Side effects like COVID-19). On 30-Mar-2021, HEADACHE (Bad Headache), PYREXIA (Fever), OROPHARYNGEAL PAIN (Very very Bad Sore throat), MYALGIA (body ache) and VIRAL INFECTION (Side effects like COVID-19) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided. No concomitant medication was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Tinnitus
Clinical narrative: ringing in ears/Ear ringing; face numbness/1/2 face numbness; This case was initially received via an unknown source, no reference has been entered for a health authority on 21-Apr-2021. The most recent information was received on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (face numbness) and TINNITUS (Ear ringing) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No historical condition was reported by reporter.  Concomitant products included BUPROPION for Antidepressant therapy, LEVOTHYROXIN for Thyroid therapy.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced HYPOAESTHESIA (face numbness). On 24-Mar-2021, the patient experienced TINNITUS (Ear ringing). On 24-Mar-2021, HYPOAESTHESIA (face numbness) and TINNITUS (Ear ringing) had resolved with sequelae. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.   This case was linked to US-MODERNATX, INC-MOD-2021-083167.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant follow-up receive on 06-AUG-2021 included concomitant drug information and update both events outcome. Causality was updated to related. Sender's Comments:  US-MODERNATX, INC-MOD-2021-083167: CROSS LINKED WITH DOSE 2.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 80-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 an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment drugs were reported.   This case was linked to MOD-2021-083175 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: chills; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and MYALGIA (arm soreness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced CHILLS (chills) and MYALGIA (arm soreness). On 07-Feb-2021, CHILLS (chills) and MYALGIA (arm soreness) had resolved.      No treatment information was provided. No relevant concomitant medications reported.  This case was linked to US-MODERNATX, INC.-MOD-2021-008962 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-008962:dose 1
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: sinus congestion; tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) and SINUS CONGESTION (sinus congestion) 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 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). On an unknown date, the patient experienced SINUS CONGESTION (sinus congestion). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) and SINUS CONGESTION (sinus congestion) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-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. Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up received  and  patient denied consent to Follow-up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: bleeding from the vaccine site; pain in arm; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bleeding from the vaccine site), VACCINATION SITE PAIN (pain in arm) and PYREXIA (slight fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding from the vaccine site), VACCINATION SITE PAIN (pain in arm) and PYREXIA (slight fever). At the time of the report, VACCINATION SITE HAEMORRHAGE (bleeding from the vaccine site), VACCINATION SITE PAIN (pain in arm) and PYREXIA (slight fever) outcome was unknown. Not Provided          The patient is on inhaler for COPD. Action taken with mRNA-1273 in response to the event was not applicable. No treatment reported.   This case was linked to MOD-2021-083128 (E2B Linked Report).; Sender's Comments:  MOD-2021-083128:First Dose Case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Hyperhidrosis, Illness
Clinical narrative: very sick; coughing/cough is uncomfortable/minor cough; sweating; fever; chills; body ache; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (very sick), COUGH (coughing/cough is uncomfortable/minor cough), HYPERHIDROSIS (sweating), PYREXIA (fever) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced ILLNESS (very sick), COUGH (coughing/cough is uncomfortable/minor cough), HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache). The patient was treated with AZITHROMYCIN DIHYDRATE (ZIPACK) at a dose of 1 dosage form and PREDNISOLONE at a dose of 5 mg. At the time of the report, ILLNESS (very sick), COUGH (coughing/cough is uncomfortable/minor cough), HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided Patient stated that she doing gargle of salt water. lung breathing test and everything is fine
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: very sick; coughing/cough is uncomfortable/minor cough; sweating; fever; chills; body ache; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (very sick), COUGH (coughing/cough is uncomfortable/minor cough), HYPERHIDROSIS (sweating), PYREXIA (fever) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced ILLNESS (very sick), COUGH (coughing/cough is uncomfortable/minor cough), HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache). The patient was treated with AZITHROMYCIN DIHYDRATE (ZIPACK) at a dose of 1 dosage form and PREDNISOLONE at a dose of 5 mg. At the time of the report, ILLNESS (very sick), COUGH (coughing/cough is uncomfortable/minor cough), HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided Patient stated that she doing gargle of salt water. lung breathing test and everything is fine
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: Pain in lower back; Pain in left leg; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain in lower back) and PAIN IN EXTREMITY (Pain in left leg) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced BACK PAIN (Pain in lower back) and PAIN IN EXTREMITY (Pain in left leg). At the time of the report, BACK PAIN (Pain in lower back) and PAIN IN EXTREMITY (Pain in left leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Palpitations
Clinical narrative: I have heart palpitations.; It feels like its a lump where I got the shot. It's a big circle of red and it's swollen.; site is red, warm to the touch, and swollen; swollen with a lump; site is red, warm to the touch, and swollen; Vaccination site pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 21-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (I have heart palpitations.), INJECTION SITE MASS (It feels like its a lump where I got the shot. It's a big circle of red and it's swollen.), INJECTION SITE ERYTHEMA (site is red, warm to the touch, and swollen), INJECTION SITE SWELLING (swollen with a lump) and INJECTION SITE WARMTH (site is red, warm to the touch, and swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (NO RELEVANT HISTORY PROVIDED.).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PALPITATIONS (I have heart palpitations.), INJECTION SITE MASS (It feels like its a lump where I got the shot. It's a big circle of red and it's swollen.), INJECTION SITE ERYTHEMA (site is red, warm to the touch, and swollen), INJECTION SITE SWELLING (swollen with a lump), INJECTION SITE WARMTH (site is red, warm to the touch, and swollen) and VACCINATION SITE PAIN (Vaccination site pain). On 14-Apr-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. At the time of the report, PALPITATIONS (I have heart palpitations.), INJECTION SITE MASS (It feels like its a lump where I got the shot. It's a big circle of red and it's swollen.), INJECTION SITE ERYTHEMA (site is red, warm to the touch, and swollen), INJECTION SITE SWELLING (swollen with a lump) and INJECTION SITE WARMTH (site is red, warm to the touch, and swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There were no concomitant and treatment medications provided in source document.