chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mobility decreased, Musculoskeletal stiffness, Skin disorder, Swelling
Clinical narrative: Stiffness; Swelling; Crippled; skin disorder; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), SWELLING (Swelling), MOBILITY DECREASED (Crippled), SKIN DISORDER (skin disorder) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), SWELLING (Swelling), MOBILITY DECREASED (Crippled), SKIN DISORDER (skin disorder) and FATIGUE (Fatigue). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness), SWELLING (Swelling) and MOBILITY DECREASED (Crippled) was resolving and SKIN DISORDER (skin disorder) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that in 2021, the patient experienced crippled.  No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: No specific follow-up information recorded.
Sex: M
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 a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) 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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Pain, Pyrexia
Clinical narrative: Aches; Cough; Rash; shakes/ "almost rigors"; Fever (102F); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Aches), COUGH (Cough), RASH (Rash), CHILLS (shakes/ "almost rigors") and PYREXIA (Fever (102F)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 23-Dec-2020, 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 (Aches), COUGH (Cough), RASH (Rash), CHILLS (shakes/ "almost rigors") and PYREXIA (Fever (102F)). At the time of the report, PAIN (Aches), COUGH (Cough), RASH (Rash), CHILLS (shakes/ "almost rigors") and PYREXIA (Fever (102F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 °F (High) 102.     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 product information was not provided. Treatment information was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Aches; Cough; Rash; shakes/ "almost rigors"; Fever (102F); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Aches), COUGH (Cough), RASH (Rash), CHILLS (shakes/ "almost rigors") and PYREXIA (Fever (102F)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 23-Dec-2020, 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 (Aches), COUGH (Cough), RASH (Rash), CHILLS (shakes/ "almost rigors") and PYREXIA (Fever (102F)). At the time of the report, PAIN (Aches), COUGH (Cough), RASH (Rash), CHILLS (shakes/ "almost rigors") and PYREXIA (Fever (102F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 °F (High) 102.     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 product information was not provided. Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site erythema
Clinical narrative: vaccination site erythema; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (vaccination site erythema) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Concurrent medical conditions included Crohn's disease (moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) injection. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (vaccination site erythema). At the time of the report, VACCINATION SITE ERYTHEMA (vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Rash
Clinical narrative: 45hrs later Moderna Arm  is developing; acute pain at the injection site; 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 RASH (45hrs later Moderna Arm  is developing) and INJECTION SITE PAIN (acute pain at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (45hrs later Moderna Arm  is developing) and INJECTION SITE PAIN (acute pain at the injection site). At the time of the report, RASH (45hrs later Moderna Arm  is developing) and INJECTION SITE PAIN (acute pain at the injection site) outcome was unknown.            The patient reported after the 2nd dose of vaccine he experienced acute pain at the injection site, unlike any other vaccine. The patient reported that he has taken a lot of vaccines in the past.  The patient reported that it was his 2nd arm  now as recommended.   This case was linked to MOD-2021-067078, MOD-2021-067078 (Patient Link).   Reporter did not allow further contact
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: itchiness; rash couple of inches below injection site; redness; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchiness), RASH (rash couple of inches below injection site) and ERYTHEMA (redness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PRURITUS (itchiness), RASH (rash couple of inches below injection site) and ERYTHEMA (redness). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Adverse event, at a dose of cream. At the time of the report, PRURITUS (itchiness), RASH (rash couple of inches below injection site) and ERYTHEMA (redness) had resolved.            No concomitant medications were provided.   This case was linked to MOD-2021-038241 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: AE resolved
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Pyrexia, Urticaria
Clinical narrative: Hives; Migraine; Body aches; Fever; This spontaneous case was reported by a non-health professional and describes the occurrence of URTICARIA (Hives), MIGRAINE (Migraine), MYALGIA (Body aches) and PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced URTICARIA (Hives), MIGRAINE (Migraine), MYALGIA (Body aches) and PYREXIA (Fever). On 31-Mar-2021, URTICARIA (Hives), MIGRAINE (Migraine), MYALGIA (Body aches) and PYREXIA (Fever) had resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Sore arm; Morning stiffness; Lower back pain; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Morning stiffness) and BACK PAIN (Lower back pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    The patient's past medical history included Early morning stiffness in 2020, Low back pain in 2020, Injection site bruising in 2020 and Bruising in 2020. Concurrent medical conditions included Ankylosing spondylitis.   On 22-Jul-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Morning stiffness) and BACK PAIN (Lower back pain). At the time of the report, PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Morning stiffness) and BACK PAIN (Lower back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported included immunosuppressant and non steroidal anti-inflammatory drugs.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     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 05-Apr-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Caller received the 1st dose on 05Mar2021 and tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller received the 1st dose on 05Mar2021 and tested positive for Covid-19) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced COVID-19 (Caller received the 1st dose on 05Mar2021 and tested positive for Covid-19). At the time of the report, COVID-19 (Caller received the 1st dose on 05Mar2021 and tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment medications provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness; When she is lying in bed it feels everything is spinning/when she is sitting upright she feels fine; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and VERTIGO (When she is lying in bed it feels everything is spinning/when she is sitting upright she feels fine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced DIZZINESS (Dizziness) and VERTIGO (When she is lying in bed it feels everything is spinning/when she is sitting upright she feels fine). At the time of the report, DIZZINESS (Dizziness) and VERTIGO (When she is lying in bed it feels everything is spinning/when she is sitting upright she feels fine) had not resolved.            No concomitant medications provided. No treatment information reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Musculoskeletal pain, Product dose omission issue, Pruritus
Clinical narrative: 2nd dose pass 35 days; Red bumps; red bumps and was covered in hives; Left buttock extremely sore; Left hip extremely sore; itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL PAIN (Left buttock extremely sore), PRURITUS (itching), ERYTHEMA (Red bumps), URTICARIA (red bumps and was covered in hives) and PRODUCT DOSE OMISSION ISSUE (2nd dose pass 35 days) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2020, the patient experienced PRURITUS (itching). On 19-Feb-2021, the patient experienced MUSCULOSKELETAL PAIN (Left buttock extremely sore) and ARTHRALGIA (Left hip extremely sore). On 24-Feb-2021, the patient experienced ERYTHEMA (Red bumps) and URTICARIA (red bumps and was covered in hives). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose pass 35 days). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL PAIN (Left buttock extremely sore), PRURITUS (itching), ERYTHEMA (Red bumps), URTICARIA (red bumps and was covered in hives) and ARTHRALGIA (Left hip extremely sore) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (2nd dose pass 35 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.    Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Additional information received on 06-APR-2021and does not contain any information.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 2nd dose pass 35 days; Red bumps; red bumps and was covered in hives; Left buttock extremely sore; Left hip extremely sore; itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL PAIN (Left buttock extremely sore), PRURITUS (itching), ERYTHEMA (Red bumps), URTICARIA (red bumps and was covered in hives) and PRODUCT DOSE OMISSION ISSUE (2nd dose pass 35 days) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2020, the patient experienced PRURITUS (itching). On 19-Feb-2021, the patient experienced MUSCULOSKELETAL PAIN (Left buttock extremely sore) and ARTHRALGIA (Left hip extremely sore). On 24-Feb-2021, the patient experienced ERYTHEMA (Red bumps) and URTICARIA (red bumps and was covered in hives). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose pass 35 days). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL PAIN (Left buttock extremely sore), PRURITUS (itching), ERYTHEMA (Red bumps), URTICARIA (red bumps and was covered in hives) and ARTHRALGIA (Left hip extremely sore) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (2nd dose pass 35 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.    Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Additional information received on 06-APR-2021and does not contain any information.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: lump on collar bone; This spontaneous case was reported by a consumer and describes the occurrence of lump on collar bone in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced lump on collar bone. At the time of the report, lump on collar bone outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient received the vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received the vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received the vaccine). On 26-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medication included inhaler for asthma. No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Additional information received and contains medical history and concomitant medication.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Under 18 years of age was given first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years of age was given first dose) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years of age was given first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years of age was given first dose) 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.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 018B21A) with no associated AEs.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: Sore arm; Red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and INJECTION SITE ERYTHEMA (Red at the injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.    On 24-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 SITE PAIN (Sore arm) and INJECTION SITE ERYTHEMA (Red at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm) and INJECTION SITE ERYTHEMA (Red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications also included high blood pressure medication and cholesterol medication. The patient did not take any treatment medication.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination site pain
Clinical narrative: pain in arm; fatigue; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in arm), FATIGUE (fatigue) and NAUSEA (nauseas) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in arm), FATIGUE (fatigue) and NAUSEA (nauseas). At the time of the report, VACCINATION SITE PAIN (pain in arm), FATIGUE (fatigue) and NAUSEA (nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue
Clinical narrative: diarrhea; little tiredness; mild fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FATIGUE (little tiredness), FATIGUE (mild fatigue) and CHILLS (chills) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040P21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (little tiredness) and FATIGUE (mild fatigue). 02-Apr-2021, the patient experienced CHILLS (chills). On 04-Apr-2021, DIARRHOEA (diarrhea), FATIGUE (mild fatigue) and CHILLS (chills) had resolved. At the time of the report, FATIGUE (little tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.   This case was linked to MOD-2021-067364 (E2B Linked Report).; Sender's Comments:  MOD-2021-067364:family member case
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache
Clinical narrative: Pain on lower back; Joint pain on her left hip; Joint pain on left knee; Joint pain on both shoulders; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain on lower back), ARTHRALGIA (Joint pain on her left hip), ARTHRALGIA (Joint pain on left knee), ARTHRALGIA (Joint pain on both shoulders) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for Antacid therapy.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced BACK PAIN (Pain on lower back), ARTHRALGIA (Joint pain on her left hip), ARTHRALGIA (Joint pain on left knee), ARTHRALGIA (Joint pain on both shoulders) and HEADACHE (Headache). At the time of the report, BACK PAIN (Pain on lower back), ARTHRALGIA (Joint pain on her left hip), ARTHRALGIA (Joint pain on left knee), ARTHRALGIA (Joint pain on both shoulders) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: lingering headache that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (lingering headache that comes and goes) 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) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HEADACHE (lingering headache that comes and goes). At the time of the report, HEADACHE (lingering headache that comes and goes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported. No treatment information was provided.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced COVID-19 (tested positive). At the time of the report, COVID-19 (tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) 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 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). At the time of the report, AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) COVID-19 test was negative.         No concomitant medications were provided. No treatment details pertained to the events were provided.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced COVID-19 (Tested positive). At the time of the report, COVID-19 (Tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment details pertained to the events were provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Tiredness; Fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Nasal congestion (Nasal congestion and chest congestion). Concomitant products included DEXTROMETHORPHAN for Nasal congestion and Congestion pulmonary, FLUTICASONE, ATORVASTATIN CALCIUM (LIPITOR) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced FATIGUE (Tiredness), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). On 23-Mar-2021, FATIGUE (Tiredness), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Second dose of mRNA-1273 vaccine scheduled for 18-Apr-2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lethargy, Nausea, Pain
Clinical narrative: Severe chills; Fatigue; Lethargic; Nausea; soreness; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), TENDERNESS (Tenderness), PAIN (Soreness), FATIGUE (Fatigue) and CHILLS (Severe chills) in a 57-year-old female 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 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced LETHARGY (Lethargic), TENDERNESS (Tenderness), PAIN (Soreness), FATIGUE (Fatigue), CHILLS (Severe chills) and NAUSEA (Nausea). On 04-Apr-2021, TENDERNESS (Tenderness), PAIN (Soreness), FATIGUE (Fatigue), CHILLS (Severe chills) and NAUSEA (Nausea) had resolved. At the time of the report, LETHARGY (Lethargic) outcome was unknown.            No concomitant medications were provided No treatment medications were provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Severe chills; Fatigue; Lethargic; Nausea; soreness; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), TENDERNESS (Tenderness), PAIN (Soreness), FATIGUE (Fatigue) and CHILLS (Severe chills) in a 57-year-old female 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 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced LETHARGY (Lethargic), TENDERNESS (Tenderness), PAIN (Soreness), FATIGUE (Fatigue), CHILLS (Severe chills) and NAUSEA (Nausea). On 04-Apr-2021, TENDERNESS (Tenderness), PAIN (Soreness), FATIGUE (Fatigue), CHILLS (Severe chills) and NAUSEA (Nausea) had resolved. At the time of the report, LETHARGY (Lethargic) outcome was unknown.            No concomitant medications were provided No treatment medications were provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: lifts her arm it is very achy; warm to the touch; injection arm sore/hurt; swollen; achy; sore arm for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for a day or two), VACCINATION SITE MOVEMENT IMPAIRMENT (lifts her arm it is very achy), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (injection arm sore/hurt) and VACCINATION SITE SWELLING (swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a day or two). On 02-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (lifts her arm it is very achy), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (injection arm sore/hurt), VACCINATION SITE SWELLING (swollen) and MYALGIA (achy). At the time of the report, PAIN IN EXTREMITY (sore arm for a day or two), VACCINATION SITE MOVEMENT IMPAIRMENT (lifts her arm it is very achy), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (injection arm sore/hurt), VACCINATION SITE SWELLING (swollen) and MYALGIA (achy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: lifts her arm it is very achy; warm to the touch; injection arm sore/hurt; swollen; achy; sore arm for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for a day or two), VACCINATION SITE MOVEMENT IMPAIRMENT (lifts her arm it is very achy), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (injection arm sore/hurt) and VACCINATION SITE SWELLING (swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a day or two). On 02-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (lifts her arm it is very achy), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (injection arm sore/hurt), VACCINATION SITE SWELLING (swollen) and MYALGIA (achy). At the time of the report, PAIN IN EXTREMITY (sore arm for a day or two), VACCINATION SITE MOVEMENT IMPAIRMENT (lifts her arm it is very achy), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (injection arm sore/hurt), VACCINATION SITE SWELLING (swollen) and MYALGIA (achy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Fatigue, Headache, Myalgia
Clinical narrative: Elevated sugar level since getting the second dose; Sore arm; Body aches; headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Elevated sugar level since getting the second dose), VACCINATION SITE PAIN (Sore arm), MYALGIA (Body aches), HEADACHE (headache) and FATIGUE (Fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Elevated sugar level since getting the second dose), VACCINATION SITE PAIN (Sore arm), MYALGIA (Body aches), HEADACHE (headache) and FATIGUE (Fatigue). At the time of the report, BLOOD GLUCOSE INCREASED (Elevated sugar level since getting the second dose), VACCINATION SITE PAIN (Sore arm), MYALGIA (Body aches), HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: elevated (High) Elevated blood glucose level.         No concomitant medications were provided No treatment medications were provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Elevated sugar level since getting the second dose; Sore arm; Body aches; headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Elevated sugar level since getting the second dose), VACCINATION SITE PAIN (Sore arm), MYALGIA (Body aches), HEADACHE (headache) and FATIGUE (Fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Elevated sugar level since getting the second dose), VACCINATION SITE PAIN (Sore arm), MYALGIA (Body aches), HEADACHE (headache) and FATIGUE (Fatigue). At the time of the report, BLOOD GLUCOSE INCREASED (Elevated sugar level since getting the second dose), VACCINATION SITE PAIN (Sore arm), MYALGIA (Body aches), HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: elevated (High) Elevated blood glucose level.         No concomitant medications were provided No treatment medications were provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: Dizziness; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Sore Arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008821-2A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020.    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 DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Sore Arm). At the time of the report, DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Sore Arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-067157 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067157:crosslinked with wife case
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Vaccination site pain
Clinical narrative: sore arm; Arm has a huge lump; Arm is red; Arm is warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Arm is warm to the touch), VACCINATION SITE PAIN (sore arm), INJECTION SITE SWELLING (Arm has a huge lump) and INJECTION SITE ERYTHEMA (Arm is red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced INJECTION SITE WARMTH (Arm is warm to the touch), INJECTION SITE SWELLING (Arm has a huge lump) and INJECTION SITE ERYTHEMA (Arm is red). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, INJECTION SITE WARMTH (Arm is warm to the touch), INJECTION SITE SWELLING (Arm has a huge lump) and INJECTION SITE ERYTHEMA (Arm is red) had not resolved and VACCINATION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: worst hives on feet only; itching at the vaccination site; swelled up a bit but no big deal; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (worst hives on feet only), VACCINATION SITE PRURITUS (itching at the vaccination site) and VACCINATION SITE SWELLING (swelled up a bit but no big deal) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced URTICARIA (worst hives on feet only), VACCINATION SITE PRURITUS (itching at the vaccination site) and VACCINATION SITE SWELLING (swelled up a bit but no big deal). At the time of the report, URTICARIA (worst hives on feet only) had not resolved and VACCINATION SITE PRURITUS (itching at the vaccination site) and VACCINATION SITE SWELLING (swelled up a bit but no big deal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Muscular weakness, Vaccination site erythema
Clinical narrative: cannot lay down on this arm; felt something under her sleeve; red, hot, and was scratchy from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (cannot lay down on this arm), FEELING ABNORMAL (felt something under her sleeve) and VACCINATION SITE ERYTHEMA (red, hot, and was scratchy from the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history information provided.  Concomitant products included LAMOTRIGINE and CLONAZEPAM (KLONOPIN) for an unknown indication.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced MUSCULAR WEAKNESS (cannot lay down on this arm), FEELING ABNORMAL (felt something under her sleeve) and VACCINATION SITE ERYTHEMA (red, hot, and was scratchy from the injection site). At the time of the report, MUSCULAR WEAKNESS (cannot lay down on this arm), FEELING ABNORMAL (felt something under her sleeve) and VACCINATION SITE ERYTHEMA (red, hot, and was scratchy from the injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. No treatment information provided.