chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Gastrooesophageal reflux disease, Headache, Myalgia, Pyrexia
Clinical narrative: Shivering; high fever of almost 103 degrees Fahrenheit; acid reflux; arm sore at injection site; Fever; chills; minor body aches; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), VACCINATION SITE PAIN (arm sore at injection site), PYREXIA (Fever), CHILLS (chills) and MYALGIA (minor body aches) in a 39-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) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), VACCINATION SITE PAIN (arm sore at injection site), PYREXIA (Fever), CHILLS (chills), MYALGIA (minor body aches) and HEADACHE (slight headache). On 05-May-2021, the patient experienced CHILLS (Shivering) and PYREXIA (high fever of almost 103 degrees Fahrenheit). On 05-May-2021, PYREXIA (Fever) and HEADACHE (slight headache) had resolved. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), VACCINATION SITE PAIN (arm sore at injection site), CHILLS (chills), MYALGIA (minor body aches), CHILLS (Shivering) and PYREXIA (high fever of almost 103 degrees Fahrenheit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment medication include Ibuprofen .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events were not applicable.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Shivering; high fever of almost 103 degrees Fahrenheit; acid reflux; arm sore at injection site; Fever; chills; minor body aches; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), VACCINATION SITE PAIN (arm sore at injection site), PYREXIA (Fever), CHILLS (chills) and MYALGIA (minor body aches) in a 39-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) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), VACCINATION SITE PAIN (arm sore at injection site), PYREXIA (Fever), CHILLS (chills), MYALGIA (minor body aches) and HEADACHE (slight headache). On 05-May-2021, the patient experienced CHILLS (Shivering) and PYREXIA (high fever of almost 103 degrees Fahrenheit). On 05-May-2021, PYREXIA (Fever) and HEADACHE (slight headache) had resolved. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), VACCINATION SITE PAIN (arm sore at injection site), CHILLS (chills), MYALGIA (minor body aches), CHILLS (Shivering) and PYREXIA (high fever of almost 103 degrees Fahrenheit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment medication include Ibuprofen .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events were not applicable.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Back pain, Chills, Musculoskeletal stiffness
Clinical narrative: stiffness on back and neck; pain on back; arthritis-like; riddle with muscle pain; joint aches; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness on back and neck), BACK PAIN (pain on back), ARTHRITIS (arthritis-like), MYALGIA (riddle with muscle pain) and ARTHRALGIA (joint aches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Q48A421A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Polymyalgia rheumatica. Concomitant products included AMLODIPINE BESYLATE, CARVEDILOL PHOSPHATE, ALLOPURINOL, EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA) and LOSARTAN for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness on back and neck), BACK PAIN (pain on back), ARTHRITIS (arthritis-like), MYALGIA (riddle with muscle pain) and ARTHRALGIA (joint aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness on back and neck), BACK PAIN (pain on back), ARTHRITIS (arthritis-like), MYALGIA (riddle with muscle pain) and ARTHRALGIA (joint aches) outcome was unknown and PYREXIA (fever) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received. Updated vaccine facility ,medical history. Updated  treatment drug .Dose 1  date and batch lot .Updated dose 2 date .
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: stiffness on back and neck; pain on back; arthritis-like; riddle with muscle pain; joint aches; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness on back and neck), BACK PAIN (pain on back), ARTHRITIS (arthritis-like), MYALGIA (riddle with muscle pain) and ARTHRALGIA (joint aches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Q48A421A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Polymyalgia rheumatica. Concomitant products included AMLODIPINE BESYLATE, CARVEDILOL PHOSPHATE, ALLOPURINOL, EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA) and LOSARTAN for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness on back and neck), BACK PAIN (pain on back), ARTHRITIS (arthritis-like), MYALGIA (riddle with muscle pain) and ARTHRALGIA (joint aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness on back and neck), BACK PAIN (pain on back), ARTHRITIS (arthritis-like), MYALGIA (riddle with muscle pain) and ARTHRALGIA (joint aches) outcome was unknown and PYREXIA (fever) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received. Updated vaccine facility ,medical history. Updated  treatment drug .Dose 1  date and batch lot .Updated dose 2 date .
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Eye pruritus, Feeling cold, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Eyes started to burn"; "Eyes all red"; "Itching so bad I want to poke my eye out"; Watering also a lot, my eyes"; "Very light cold-like something"; This spontaneous case was reported by a consumer and describes the occurrence of THERMAL BURNS OF EYE (Eyes started to burn"), OCULAR HYPERAEMIA ("Eyes all red"), EYE PRURITUS ("Itching so bad I want to poke my eye out"), LACRIMATION INCREASED (Watering also a lot, my eyes") and FEELING COLD ("Very light cold-like something") in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Eye infection.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced FEELING COLD ("Very light cold-like something"). On 05-May-2021, the patient experienced THERMAL BURNS OF EYE (Eyes started to burn"), OCULAR HYPERAEMIA ("Eyes all red"), EYE PRURITUS ("Itching so bad I want to poke my eye out") and LACRIMATION INCREASED (Watering also a lot, my eyes"). On 07-Apr-2021, FEELING COLD ("Very light cold-like something") had resolved. At the time of the report, THERMAL BURNS OF EYE (Eyes started to burn"), OCULAR HYPERAEMIA ("Eyes all red"), EYE PRURITUS ("Itching so bad I want to poke my eye out") and LACRIMATION INCREASED (Watering also a lot, my eyes") outcome was unknown. 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.   This case was linked to MOD-2021-106388 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Peripheral swelling, Urticaria, Vaccination complication
Clinical narrative: with the 1st dose she got "Moderna Arm; Arm red after 1st dose; Arm swollen after 1st dose; Red welt after 1st dose; Arm very sore after 1st dose,couldn't lift her arm very far; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (with the 1st dose she got "Moderna Arm), ERYTHEMA (Arm red after 1st dose), PERIPHERAL SWELLING (Arm swollen after 1st dose), URTICARIA (Red welt after 1st dose) and MYALGIA (Arm very sore after 1st dose,couldn't lift her arm very far) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 VACCINATION COMPLICATION (with the 1st dose she got "Moderna Arm), ERYTHEMA (Arm red after 1st dose), PERIPHERAL SWELLING (Arm swollen after 1st dose), URTICARIA (Red welt after 1st dose) and MYALGIA (Arm very sore after 1st dose,couldn't lift her arm very far). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (with the 1st dose she got "Moderna Arm), ERYTHEMA (Arm red after 1st dose), PERIPHERAL SWELLING (Arm swollen after 1st dose), URTICARIA (Red welt after 1st dose) and MYALGIA (Arm very sore after 1st dose,couldn't lift her arm very far) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   This case was linked to MOD-2021-106434 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Possible deviation from the recommended interval between the first and second moderna covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possible deviation from the recommended interval between the first and second moderna covid-19 vaccine) 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 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possible deviation from the recommended interval between the first and second moderna covid-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possible deviation from the recommended interval between the first and second moderna covid-19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-106080 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: pain (in legs) more so than she normally experiences; legs were super super sensitive; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain (in legs) more so than she normally experiences) and PARAESTHESIA (legs were super super sensitive) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included GABAPENTIN and INSULIN for an unknown indication.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain (in legs) more so than she normally experiences) and PARAESTHESIA (legs were super super sensitive). At the time of the report, PAIN IN EXTREMITY (pain (in legs) more so than she normally experiences) and PARAESTHESIA (legs were super super sensitive) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included gabapentin for neuropathy.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: I found out that I was actually pregnant when I got the 2nd shot.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (I found out that I was actually pregnant when I got the 2nd shot.) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 28-Jan-2021 and the estimated date of delivery was 04-Nov-2021. On 26-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (I found out that I was actually pregnant when I got the 2nd shot.). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 26-Feb-2021, EXPOSURE DURING PREGNANCY (I found out that I was actually pregnant when I got the 2nd shot.) had resolved. Not Provided          No concomitant products were provided.  No treatment information was reported.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: growing rash all over his body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (growing rash all over his body) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) 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) .5. On an unknown date, the patient experienced RASH (growing rash all over his body). The patient was treated with CLOBETASOL ongoing since an unknown date at a dose of 1 dosage form and PREDNISONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, RASH (growing rash all over his body) had not resolved. 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.   No concomitant medication information was mentioned   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Route of administration Added On 29-Jun-2021: live follow up recived on 29-JUN-2021
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: not able to receive second dose of Moderna vaccine until 48 days after first dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not able to receive second dose of Moderna vaccine until 48 days after first dose) in a 74-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not able to receive second dose of Moderna vaccine until 48 days after first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not able to receive second dose of Moderna vaccine until 48 days after first dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The action taken with mRNA-1273 was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal
Clinical narrative: Feel like crap; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel like crap) and DIARRHOEA (diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced FEELING ABNORMAL (Feel like crap) and DIARRHOEA (diarrhea). At the time of the report, FEELING ABNORMAL (Feel like crap) outcome was unknown and DIARRHOEA (diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary mass, Axillary pain, Back pain, Feeling abnormal
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness), FEELING ABNORMAL (Felt horrible), AXILLARY MASS (painful lump in the armpit), NECK MASS (lump on the collar bone) and BACK PAIN (back pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm Soreness), FEELING ABNORMAL (Felt horrible), AXILLARY MASS (painful lump in the armpit), NECK MASS (lump on the collar bone), BACK PAIN (back pain), ASTHENIA (no energy for two weeks) and VACCINATION SITE LYMPHADENOPATHY (swelling under the arm). On an unknown date, the patient experienced MOBILITY DECREASED (Her arm still doesn't have full mobility due to soreness) and AXILLARY PAIN (painful lump in the armpit). At the time of the report, PAIN IN EXTREMITY (Arm Soreness), FEELING ABNORMAL (Felt horrible), AXILLARY MASS (painful lump in the armpit), NECK MASS (lump on the collar bone), BACK PAIN (back pain), ASTHENIA (no energy for two weeks), MOBILITY DECREASED (Her arm still doesn't have full mobility due to soreness), VACCINATION SITE LYMPHADENOPATHY (swelling under the arm) and AXILLARY PAIN (painful lump in the armpit) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Neck mass, Pain in extremity, Vaccination site lymphadenopathy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness), FEELING ABNORMAL (Felt horrible), AXILLARY MASS (painful lump in the armpit), NECK MASS (lump on the collar bone) and BACK PAIN (back pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm Soreness), FEELING ABNORMAL (Felt horrible), AXILLARY MASS (painful lump in the armpit), NECK MASS (lump on the collar bone), BACK PAIN (back pain), ASTHENIA (no energy for two weeks) and VACCINATION SITE LYMPHADENOPATHY (swelling under the arm). On an unknown date, the patient experienced MOBILITY DECREASED (Her arm still doesn't have full mobility due to soreness) and AXILLARY PAIN (painful lump in the armpit). At the time of the report, PAIN IN EXTREMITY (Arm Soreness), FEELING ABNORMAL (Felt horrible), AXILLARY MASS (painful lump in the armpit), NECK MASS (lump on the collar bone), BACK PAIN (back pain), ASTHENIA (no energy for two weeks), MOBILITY DECREASED (Her arm still doesn't have full mobility due to soreness), VACCINATION SITE LYMPHADENOPATHY (swelling under the arm) and AXILLARY PAIN (painful lump in the armpit) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness since 2nd dose; Vertigo since 2nd dose/Head is spinning after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness since 2nd dose) and VERTIGO (Vertigo since 2nd dose/Head is spinning after 2nd dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016b21a) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 27-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 DIZZINESS (Dizziness since 2nd dose) and VERTIGO (Vertigo since 2nd dose/Head is spinning after 2nd dose). At the time of the report, DIZZINESS (Dizziness since 2nd dose) and VERTIGO (Vertigo since 2nd dose/Head is spinning after 2nd dose) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported for Dose 2 Events.   This case was linked to MOD-2021-106416 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: severe headache; soreness of injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of injection arm) and HEADACHE (severe headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced PAIN IN EXTREMITY (soreness of injection arm). On 05-May-2021, the patient experienced HEADACHE (severe headache). At the time of the report, PAIN IN EXTREMITY (soreness of injection arm) and HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache since she got her second shot of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache since she got her second shot of the vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 036B21A;) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VENLAFAXINE, CHLORTHALIDONE, METOPROLOL, olmasartan, COLESTIPOL, CLOPIDOGREL BISULFATE (PLAVIX), PANTOPRAZOLE, ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO), praluent inj pen, CYCLOBENZAPRINE, CILOSTAZOL (PLETAL), ZOLPIDEM, HYDROCHLOROTHIAZIDE, mometasone cream, SALBUTAMOL (ALBUTEROL HFA), GUAIFENESIN (MUCINEX), METHYLCELLULOSE (CITRUCEL), cultural and VITAMIN B COMPLEX for an unknown indication, CURCUMA LONGA RHIZOME, PIPER NIGRUM FRUIT (TURMERIC +), VITAMIN D3 and LORATADINE.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 14-Apr-2021, the patient experienced HEADACHE (headache since she got her second shot of the vaccine). At the time of the report, HEADACHE (headache since she got her second shot of the vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment includes Extra strength Tylenol every 6 hours Cardiologist appointment 3May2021 Primary care doctor appointment 7May2021   This case was linked to US-MODERNATX, INC.-MOD-2021-106233 (E2B Linked Report). This case was linked to MOD-2021-106167 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106233:sister case
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot in the right arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003c21A and 012a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clot in the right arm). At the time of the report, THROMBOSIS (blood clot in the right arm) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. This is a non-serious event, however, medical history, con meds, details regarding the type of clot, tests/diagnostics and treatment are required for further assessment.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal discomfort, Nasopharyngitis
Clinical narrative: has a cold; disconfort in the nose; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (has a cold) and NASAL DISCOMFORT (disconfort in the nose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history were reported.     On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced NASOPHARYNGITIS (has a cold) and NASAL DISCOMFORT (disconfort in the nose). At the time of the report, NASOPHARYNGITIS (has a cold) and NASAL DISCOMFORT (disconfort in the nose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  Treatment included Hot water with ginger.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm was a little weird and hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was a little weird and hurting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was a little weird and hurting). At the time of the report, VACCINATION SITE PAIN (Arm was a little weird and hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product details were provided by the reporter. No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up  received- Email address of the reporter and Patient gender and Patient initials has been added.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Headache
Clinical narrative: feeling weak; sleeping a lot; no appetite; chills; headache; joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling weak), SOMNOLENCE (sleeping a lot), DECREASED APPETITE (no appetite), CHILLS (chills) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced ASTHENIA (feeling weak), SOMNOLENCE (sleeping a lot), DECREASED APPETITE (no appetite), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joints hurt). At the time of the report, ASTHENIA (feeling weak), SOMNOLENCE (sleeping a lot), DECREASED APPETITE (no appetite), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joints hurt) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant and treatment medication were not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: feeling weak; sleeping a lot; no appetite; chills; headache; joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling weak), SOMNOLENCE (sleeping a lot), DECREASED APPETITE (no appetite), CHILLS (chills) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced ASTHENIA (feeling weak), SOMNOLENCE (sleeping a lot), DECREASED APPETITE (no appetite), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joints hurt). At the time of the report, ASTHENIA (feeling weak), SOMNOLENCE (sleeping a lot), DECREASED APPETITE (no appetite), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joints hurt) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant and treatment medication were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Rash
Clinical narrative: sick; rash; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), RASH (rash) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), RASH (rash) and HEADACHE (headache). At the time of the report, ILLNESS (sick), RASH (rash) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant details were provided No treatment details were provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test positive
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19) and NAUSEA (Queasy In Stomach) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19) and NAUSEA (Queasy In Stomach). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19) and NAUSEA (Queasy In Stomach) 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.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN and CELECOXIB (CELEBREX) for an unknown indication.    On 26-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 VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received dose from a vial that was opened at 2pm yesterday; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from a vial that was opened at 2pm yesterday) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-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 EXPIRED PRODUCT ADMINISTERED (patient received dose from a vial that was opened at 2pm yesterday). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received dose from a vial that was opened at 2pm yesterday) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. No Relevant concomitant medications was reported. Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: body feels like I have flu; arm was sore; Fatigue; muscle aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (body feels like I have flu), PAIN IN EXTREMITY (arm was sore), FATIGUE (Fatigue), MYALGIA (muscle aches) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (body feels like I have flu), PAIN IN EXTREMITY (arm was sore), FATIGUE (Fatigue), MYALGIA (muscle aches) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency; CYCLOBENZAPRINE at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (body feels like I have flu), PAIN IN EXTREMITY (arm was sore), FATIGUE (Fatigue), MYALGIA (muscle aches) and HEADACHE (headache) outcome was unknown.        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.   Concomitant medications details were not reported by the reporter.   This case was linked to MOD-2021-106468 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine Administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine Administered) 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 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 13-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine Administered). On 13-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine Administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Follow-up received via TCR , updated previous event from missed dose to Inappropriate schedule of vaccine administered. Patient denied consent for further follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired Moderna vaccine to female patient on 05May2021/Moderna vial was punctured and it was suppose to discard after 6 hours but she used that vaccine near about 18 hours; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Moderna vaccine to female patient on 05May2021/Moderna vial was punctured and it was suppose to discard after 6 hours but she used that vaccine near about 18 hours) 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) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Moderna vaccine to female patient on 05May2021/Moderna vial was punctured and it was suppose to discard after 6 hours but she used that vaccine near about 18 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Moderna vaccine to female patient on 05May2021/Moderna vial was punctured and it was suppose to discard after 6 hours but she used that vaccine near about 18 hours) 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.   No treatment and concomitant medication reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had Covid-19) 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. Concurrent medical conditions included Allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced COVID-19 (had Covid-19). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, COVID-19 (had Covid-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported.   This case was linked to MOD-2021-106465 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: multiple, unknown patients developed "COVID arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (multiple, unknown patients developed "COVID arm) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (multiple, unknown patients developed "COVID arm). At the time of the report, VACCINATION COMPLICATION (multiple, unknown patients developed "COVID arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs were not provided Concomitant drugs were not provided
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling hot, Pain in extremity, Pyrexia
Clinical narrative: Hot in her muscles; Sore and painful arm; Fever; Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot in her muscles), PAIN IN EXTREMITY (Sore and painful arm), PYREXIA (Fever) and ANXIETY (Anxiety) in a 60-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Hot in her muscles), PAIN IN EXTREMITY (Sore and painful arm), PYREXIA (Fever) and ANXIETY (Anxiety). At the time of the report, FEELING HOT (Hot in her muscles), PAIN IN EXTREMITY (Sore and painful arm), PYREXIA (Fever) and ANXIETY (Anxiety) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 030B21A) for COVID-19 vaccination.     The patient's past medical history included Bone marrow transplant (The bone marrow transplantation was done at SEP 2018.) in September 2018. Concurrent medical conditions included Acute myeloid leukemia. Concomitant products included TACROLIMUS, ALLOPURINOL and ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) 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 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown. Not Provided          No treatment information was provided.  Action taken with the drug in response to events was not applicable.   This case was linked to MOD-2021-106467 (Patient Link).