chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Injection was given to low down (apparently not in the muscle); Itching around area where the injection; Redness around area where the injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injection was given to low down (apparently not in the muscle)), VACCINATION SITE PRURITUS (Itching around area where the injection) and VACCINATION SITE ERYTHEMA (Redness around area where the injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injection was given to low down (apparently not in the muscle)), VACCINATION SITE PRURITUS (Itching around area where the injection) and VACCINATION SITE ERYTHEMA (Redness around area where the injection). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injection was given to low down (apparently not in the muscle)) had resolved and VACCINATION SITE PRURITUS (Itching around area where the injection) and VACCINATION SITE ERYTHEMA (Redness around area where the injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product use was reported.  No treatment details were provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysgeusia, Fatigue, Feeling hot
Clinical narrative: Spotting, bleeding; Cramping; Pain in arm; Hot; Strange feeling in my inner ear; Metal taste; Light-headed; Chills; Tired; Head pain, intermittent; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VAGINAL HAEMORRHAGE (Spotting, bleeding), MUSCLE SPASMS (Cramping), PAIN IN EXTREMITY (Pain in arm), FEELING HOT (Hot) and INNER EAR DISORDER (Strange feeling in my inner ear) in a 59-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 Hormone replacement therapy.    On 16-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 VAGINAL HAEMORRHAGE (Spotting, bleeding), MUSCLE SPASMS (Cramping), PAIN IN EXTREMITY (Pain in arm), FEELING HOT (Hot), INNER EAR DISORDER (Strange feeling in my inner ear), DYSGEUSIA (Metal taste), DIZZINESS (Light-headed), CHILLS (Chills), FATIGUE (Tired) and HEADACHE (Head pain, intermittent). At the time of the report, VAGINAL HAEMORRHAGE (Spotting, bleeding), MUSCLE SPASMS (Cramping), PAIN IN EXTREMITY (Pain in arm), FEELING HOT (Hot), INNER EAR DISORDER (Strange feeling in my inner ear), DYSGEUSIA (Metal taste), DIZZINESS (Light-headed), CHILLS (Chills), FATIGUE (Tired) and HEADACHE (Head pain, intermittent) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound pelvis: (normal) normal.         No Concomitant medications were provided No treatment information provided.    This case was linked to MOD-2021-086998, MOD-2021-086998 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inner ear disorder, Muscle spasms, Pain in extremity, Ultrasound pelvis
Clinical narrative: Spotting, bleeding; Cramping; Pain in arm; Hot; Strange feeling in my inner ear; Metal taste; Light-headed; Chills; Tired; Head pain, intermittent; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VAGINAL HAEMORRHAGE (Spotting, bleeding), MUSCLE SPASMS (Cramping), PAIN IN EXTREMITY (Pain in arm), FEELING HOT (Hot) and INNER EAR DISORDER (Strange feeling in my inner ear) in a 59-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 Hormone replacement therapy.    On 16-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 VAGINAL HAEMORRHAGE (Spotting, bleeding), MUSCLE SPASMS (Cramping), PAIN IN EXTREMITY (Pain in arm), FEELING HOT (Hot), INNER EAR DISORDER (Strange feeling in my inner ear), DYSGEUSIA (Metal taste), DIZZINESS (Light-headed), CHILLS (Chills), FATIGUE (Tired) and HEADACHE (Head pain, intermittent). At the time of the report, VAGINAL HAEMORRHAGE (Spotting, bleeding), MUSCLE SPASMS (Cramping), PAIN IN EXTREMITY (Pain in arm), FEELING HOT (Hot), INNER EAR DISORDER (Strange feeling in my inner ear), DYSGEUSIA (Metal taste), DIZZINESS (Light-headed), CHILLS (Chills), FATIGUE (Tired) and HEADACHE (Head pain, intermittent) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound pelvis: (normal) normal.         No Concomitant medications were provided No treatment information provided.    This case was linked to MOD-2021-086998, MOD-2021-086998 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Spotting, bleeding; Cramping; Pain in arm; Hot; Strange feeling in my inner ear; Metal taste; Light-headed; Chills; Tired; Head pain, intermittent; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VAGINAL HAEMORRHAGE (Spotting, bleeding), MUSCLE SPASMS (Cramping), PAIN IN EXTREMITY (Pain in arm), FEELING HOT (Hot) and INNER EAR DISORDER (Strange feeling in my inner ear) in a 59-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 Hormone replacement therapy.    On 16-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 VAGINAL HAEMORRHAGE (Spotting, bleeding), MUSCLE SPASMS (Cramping), PAIN IN EXTREMITY (Pain in arm), FEELING HOT (Hot), INNER EAR DISORDER (Strange feeling in my inner ear), DYSGEUSIA (Metal taste), DIZZINESS (Light-headed), CHILLS (Chills), FATIGUE (Tired) and HEADACHE (Head pain, intermittent). At the time of the report, VAGINAL HAEMORRHAGE (Spotting, bleeding), MUSCLE SPASMS (Cramping), PAIN IN EXTREMITY (Pain in arm), FEELING HOT (Hot), INNER EAR DISORDER (Strange feeling in my inner ear), DYSGEUSIA (Metal taste), DIZZINESS (Light-headed), CHILLS (Chills), FATIGUE (Tired) and HEADACHE (Head pain, intermittent) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound pelvis: (normal) normal.         No Concomitant medications were provided No treatment information provided.    This case was linked to MOD-2021-086998, MOD-2021-086998 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Contrast media allergy, Dermatitis allergic, Diarrhoea, Dry mouth, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CONTRAST MEDIA ALLERGY (Contrast media allergy), DERMATITIS ALLERGIC (Allergic rash), DIARRHEA (Diarrhea), PERIPHERAL SWELLING (Swelling arm) and DRY MOUTH (dry mouth) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for an unknown indication. The patient's past medical history included Lymphocytosis and Estrogen receptor positive status ER. Concurrent medical conditions included sulfa antibiotic and Iodine allergy. Concomitant products included ANASTROZOLE (ARIMIDEX), COLECALCIFEROL (COLECALCIFEROL D3), CYANOCOBALAMIN, FLUTICASONE PROPIONATE, PROBIOTICS NOS and LORATADINE (CLARITINE) for an unknown indication. On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 mg. On an unknown date, the patient experienced CONTRAST MEDIA ALLERGY (Contrast media allergy), DERMATITIS ALLERGIC (Allergic rash), DIARRHOEA (Diarrhea), PERIPHERAL SWELLING (Swelling arm), DRY MOUTH (dry mouth) and PERIPHERAL SWELLING (swelling in legs and feet worse). At the time of the report, CONTRAST MEDIA ALLERGY (Contrast media allergy), DIARRHOEA (Diarrhea) and DRY MOUTH (dry mouth) outcome was unknown, DERMATITIS ALLERGIC (Allergic rash) and PERIPHERAL SWELLING (Swelling arm) had resolved and PERIPHERAL SWELLING (swelling in legs and feet worse) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-086818, MOD-2021-086711, MOD-2021-086996, MOD-2021-085006 (E2B Linked Report). This case was linked to MOD-2021-087217, MOD-2021-087217. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: new events updated; Sender's Comments: MOD-2021-086818:Case received in same source doc email; MOD-2021-086711:Case received in same source doc email MOD-2021-086996:Case received in same source doc email; MOD-2021-085006:Case received in same source doc email.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CONTRAST MEDIA ALLERGY (Contrast media allergy), DERMATITIS ALLERGIC (Allergic rash), DIARRHEA (Diarrhea), PERIPHERAL SWELLING (Swelling arm) and DRY MOUTH (dry mouth) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for an unknown indication. The patient's past medical history included Lymphocytosis and Estrogen receptor positive status ER. Concurrent medical conditions included sulfa antibiotic and Iodine allergy. Concomitant products included ANASTROZOLE (ARIMIDEX), COLECALCIFEROL (COLECALCIFEROL D3), CYANOCOBALAMIN, FLUTICASONE PROPIONATE, PROBIOTICS NOS and LORATADINE (CLARITINE) for an unknown indication. On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 mg. On an unknown date, the patient experienced CONTRAST MEDIA ALLERGY (Contrast media allergy), DERMATITIS ALLERGIC (Allergic rash), DIARRHOEA (Diarrhea), PERIPHERAL SWELLING (Swelling arm), DRY MOUTH (dry mouth) and PERIPHERAL SWELLING (swelling in legs and feet worse). At the time of the report, CONTRAST MEDIA ALLERGY (Contrast media allergy), DIARRHOEA (Diarrhea) and DRY MOUTH (dry mouth) outcome was unknown, DERMATITIS ALLERGIC (Allergic rash) and PERIPHERAL SWELLING (Swelling arm) had resolved and PERIPHERAL SWELLING (swelling in legs and feet worse) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-086818, MOD-2021-086711, MOD-2021-086996, MOD-2021-085006 (E2B Linked Report). This case was linked to MOD-2021-087217, MOD-2021-087217. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: new events updated; Sender's Comments: MOD-2021-086818:Case received in same source doc email; MOD-2021-086711:Case received in same source doc email MOD-2021-086996:Case received in same source doc email; MOD-2021-085006:Case received in same source doc email.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: Generalised rash; Vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of RASH (Generalised rash) and VACCINATION SITE PAIN (Vaccination site pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    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) (unknown route) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced RASH (Generalised rash). At the time of the report, RASH (Generalised rash) was resolving and VACCINATION SITE PAIN (Vaccination site pain) had not resolved. Not applicable      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter's causality for the events of RASH ALL OVER BODY with RINVOQ (UPADACITINIB) was a reasonable possibility. The reporter's causality for the events of PAINFUL INJECTION/COVID-19 VACCINE HURT ARM with RINVOQ (UPADACITINIB) was no reasonable possibility. No Concomitant medication were reported. Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Additional information  received on 25 May 2021 and does not contain any  new information.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Swelling face
Clinical narrative: some swelling around his face and jaw/ "Squishy golf ball sized lump"/does feel something but not hard/swelling has endured a little over 10 days; some swelling around his face and jaw; lump is numb; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (some swelling around his face and jaw/ "Squishy golf ball sized lump"/does feel something but not hard/swelling has endured a little over 10 days), SWELLING FACE (some swelling around his face and jaw) and HYPOAESTHESIA (lump is numb) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SWELLING FACE (some swelling around his face and jaw/ "Squishy golf ball sized lump"/does feel something but not hard/swelling has endured a little over 10 days), SWELLING FACE (some swelling around his face and jaw) and HYPOAESTHESIA (lump is numb). At the time of the report, SWELLING FACE (some swelling around his face and jaw/ "Squishy golf ball sized lump"/does feel something but not hard/swelling has endured a little over 10 days), SWELLING FACE (some swelling around his face and jaw) and HYPOAESTHESIA (lump is numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       healthcare professional  has ordered to perform  an ultrasound on 23-APR-2021  no relevant concomitant product was reported  no treatment product was reported
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; No adverse events; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and NO ADVERSE EVENT (No adverse events) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021 at 1:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and NO ADVERSE EVENT (No adverse events). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved and NO ADVERSE EVENT (No adverse events) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. Treatment medication was not provided.   This case was linked to MOD-2021-011291 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up information received and contains No new information
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feel weird; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel weird) in a 66-year-old male 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 ABNORMAL (Feel weird). At the time of the report, FEELING ABNORMAL (Feel weird) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment was reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Myalgia, Nausea
Clinical narrative: Sick for 2 days; Tiredness; headache; nausea; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for 2 days), FATIGUE (Tiredness), HEADACHE (headache), NAUSEA (nausea) and MYALGIA (Muscle aches) in a 40-year-old male 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 ILLNESS (Sick for 2 days), FATIGUE (Tiredness), HEADACHE (headache), NAUSEA (nausea) and MYALGIA (Muscle aches). At the time of the report, ILLNESS (Sick for 2 days), FATIGUE (Tiredness), HEADACHE (headache), NAUSEA (nausea) and MYALGIA (Muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  Treatment medication were not provided.   This case was linked to MOD-2021-087237 (Linked Report).; Sender's Comments:  MOD-2021-087237:same reporter US-MODERNATX, INC.-MOD-2021-087237:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: really bad headache; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (really bad headache) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced HEADACHE (really bad headache) and VOMITING (vomiting). At the time of the report, HEADACHE (really bad headache) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Paranasal sinus discomfort
Clinical narrative: headache; sinus pressure; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukaemia.    The patient's past medical history included Lymphocytosis. Concurrent medical conditions included Iodine allergy, Estrogen receptor assay and Drug allergy (SULFA ANTIBIOTICS). Concomitant products included ANASTROZOLE (ARIMIDEX), COLECALCIFEROL (D3), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), PROBIOTICS NOS and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient experienced PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache). At the time of the report, PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache) to have an unknown relationship.    This case was linked to MOD-2021-087097 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-086818:Case received in same source doc email MOD-2021-086711:Case received in same source doc email  MOD-2021-086996:Case received in same source doc email  MOD-2021-085006:Case received in same source doc email
Age: 66.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Rash
Clinical narrative: rash; This spontaneous case was reported by a physician and describes the occurrence of RASH (rash) in a 66-year-old patient of an unknown gender 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.    no medical history provided by reporter.    On 09-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 started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant and treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Myalgia, Nausea
Clinical narrative: In bed sick for two day; Tirdness; nausea; Muscle ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (In bed sick for two day), FATIGUE (Tirdness), NAUSEA (nausea), MYALGIA (Muscle ache) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (In bed sick for two day), FATIGUE (Tirdness), NAUSEA (nausea), MYALGIA (Muscle ache) and HEADACHE (headache). At the time of the report, ILLNESS (In bed sick for two day), FATIGUE (Tirdness), NAUSEA (nausea), MYALGIA (Muscle ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-087196 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-087196:Same reporter
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: body ache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills). At the time of the report, MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No concomitant medication was provided.  No Treatment Medication was provided.   This case was linked to MOD-2021-013573 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Biopsy lymph gland, Lymphadenopathy, Positron emission tomogram, Vaccination complication
Clinical narrative: Activity in three places; One possible malignant lymph node felt under the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Activity in three places) and LYMPHADENOPATHY (One possible malignant lymph node felt under the arm) 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 Mammogram.   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 VACCINATION COMPLICATION (Activity in three places) and LYMPHADENOPATHY (One possible malignant lymph node felt under the arm). At the time of the report, VACCINATION COMPLICATION (Activity in three places) and LYMPHADENOPATHY (One possible malignant lymph node felt under the arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy lymph gland: inconclusive (Inconclusive) The surgeon that performed a biopsy on one possible malignant lymph node felt that the one under the arm was most likely a result of shots as the surgeon could feel nothing in the area to cause cancer concern.. In 2021, Positron emission tomogram: inconclusive (Inconclusive) PET scan noted activity in three places. Two of which had nothing to do with vaccine injections. However the third was under the arm pit of both shots..         No relevant concomitant medications were reported. The patient had declined a mammogram as there have been some possible ties to a mammogram in the time span of the shots. The surgeon that performed biopsy of lymph node reported of feeling nothing in the area under arm to cause cancer concern.  No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-033076 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis. Concurrent medical conditions included Ankylosing spondylitis. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). At the time of the report, PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) Fever. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication and treatment information were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Somnolence
Clinical narrative: Arm swollen; Sore arm; Very Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Sore arm) and SOMNOLENCE (Very Sleepy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Sore arm) and SOMNOLENCE (Very Sleepy). At the time of the report, PERIPHERAL SWELLING (Arm swollen) and PAIN IN EXTREMITY (Sore arm) had resolved and SOMNOLENCE (Very Sleepy) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-073940 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (Swelling of Legs) and PRURITUS (Itching) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included DICLOFENAC EPOLAMINE, HYDROXYZINE HYDROCHLORIDE, MELATONIN and CYANOCOBALAMIN (VIT B12) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. and IBRUTINIB (IMBRUVICA) (unknown route) 420 milligram once a day. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of Legs) and PRURITUS (Itching). At the time of the report, PERIPHERAL SWELLING (Swelling of Legs) and PRURITUS (Itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment reported for these events.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Night sweats
Clinical narrative: Night Sweats; Body aches; Chills; Fever of 102; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night Sweats), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever of 102) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced NIGHT SWEATS (Night Sweats), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever of 102) and HEADACHE (Headache). At the time of the report, NIGHT SWEATS (Night Sweats), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever of 102) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided/unknown by the reporter. Treatment for the event included Paracetamol.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Night Sweats; Body aches; Chills; Fever of 102; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night Sweats), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever of 102) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced NIGHT SWEATS (Night Sweats), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever of 102) and HEADACHE (Headache). At the time of the report, NIGHT SWEATS (Night Sweats), MYALGIA (Body aches), CHILLS (Chills), PYREXIA (Fever of 102) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided/unknown by the reporter. Treatment for the event included Paracetamol.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Hives on the throat; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on the throat) and PAIN IN EXTREMITY (Sore 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 URTICARIA (Hives on the throat) and PAIN IN EXTREMITY (Sore arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives on the throat) and PAIN IN EXTREMITY (Sore arm) had resolved.            No concomitants were reported.   This case was linked to MOD-2021-033096 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lethargy, Myalgia, Pyrexia
Clinical narrative: Lethargic; Vaccination site pain; Vaccination site warmth; Vaccination site erythema; Tired; Fever; Chills; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), PAIN IN EXTREMITY (Very sore/Aches Arm), FEELING HOT (Very Sore/Aches Arm, red, hot to touch), ERYTHEMA (Very Sore/Aches Arm, red, hot to touch) and FATIGUE (Tired) in a 66-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease).   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) 40 milligram. On an unknown date, the patient experienced LETHARGY (Lethargic), PAIN IN EXTREMITY (Very sore/Aches Arm), FEELING HOT (Very Sore/Aches Arm, red, hot to touch), ERYTHEMA (Very Sore/Aches Arm, red, hot to touch), FATIGUE (Tired), PYREXIA (Fever), CHILLS (Chills) and PAIN (Aches All over). At the time of the report, LETHARGY (Lethargic), PAIN IN EXTREMITY (Very sore/Aches Arm), FEELING HOT (Very Sore/Aches Arm, red, hot to touch), ERYTHEMA (Very Sore/Aches Arm, red, hot to touch) and PYREXIA (Fever) had resolved and FATIGUE (Tired), CHILLS (Chills) and PAIN (Aches All over) had not resolved.            Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-MAY-2021 and does not contains new information
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Lethargic; Vaccination site pain; Vaccination site warmth; Vaccination site erythema; Tired; Fever; Chills; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), PAIN IN EXTREMITY (Very sore/Aches Arm), FEELING HOT (Very Sore/Aches Arm, red, hot to touch), ERYTHEMA (Very Sore/Aches Arm, red, hot to touch) and FATIGUE (Tired) in a 66-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease).   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) 40 milligram. On an unknown date, the patient experienced LETHARGY (Lethargic), PAIN IN EXTREMITY (Very sore/Aches Arm), FEELING HOT (Very Sore/Aches Arm, red, hot to touch), ERYTHEMA (Very Sore/Aches Arm, red, hot to touch), FATIGUE (Tired), PYREXIA (Fever), CHILLS (Chills) and PAIN (Aches All over). At the time of the report, LETHARGY (Lethargic), PAIN IN EXTREMITY (Very sore/Aches Arm), FEELING HOT (Very Sore/Aches Arm, red, hot to touch), ERYTHEMA (Very Sore/Aches Arm, red, hot to touch) and PYREXIA (Fever) had resolved and FATIGUE (Tired), CHILLS (Chills) and PAIN (Aches All over) had not resolved.            Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-MAY-2021 and does not contains new information
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE BRUISING (injection site bruising) and INJECTION SITE BRUISING (Injection site bruising) in a 73-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) for Crohn's disease. Concurrent medical conditions included Crohn's disease. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) dosage form. In February 2021, the patient experienced INJECTION SITE BRUISING (injection site bruising). On 05-Mar-2021, the patient experienced INJECTION SITE BRUISING (Injection site bruising). At the time of the report, INJECTION SITE BRUISING (injection site bruising) had resolved and INJECTION SITE BRUISING (Injection site bruising) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The co-suspect drug was Humira (solution for injection in pre-filled pen) (Adalimumab), sub-cutaneous route of administration. The reporter assessed the event, injection site bruising, as reasonably possible to Humira. On an unspecified day in February 2021,the patient reported that she experienced silver dollar sized bruise at the injection site, after the first dose of covid-19 vaccine, which faded to yellow and resolved. On 05-Mar-2021,after the administration of second dose of covid-19 vaccine,  the patient experienced a similar, large, dime-sized bruise at the injection site,  which  is resolving. No concomitant medications were reported. No treatment information was reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis, Plaque psoriasis (moderate to severe chronic plaque) and Penicillin allergy. Concomitant products included ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriatic arthritis, CLOBETASOL for Psoriasis.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced FATIGUE (Tired). On 08-Feb-2021, FATIGUE (Tired) had resolved.            Treatment medications were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable    This case was linked to MOD-2021-087480.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: NNI-Added VAER
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 70-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) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 18-Jun-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had resolved. after second dose          Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up information received on 21-May-2021 contain no new information
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Fatigue, Headache, Insomnia
Clinical narrative: exhausted; headache; Joint pain; Not feeling good; Unable to sleep; Pain in hands; she can't lift herself up; Body ache; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (exhausted), HEADACHE (headache), ARTHRALGIA (Joint pain), PAIN (Body ache) and MALAISE (Not feeling good) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Recurrent UTI, Sjogren's syndrome, Pneumonia and Anaemia. Concomitant products included TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis, DAILY VITE [COLECALCIFEROL;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RETINOL ACETATE;THIAMINE HYDROCHLORIDE;THIAMINE MONONITRATE;TOCOPHEROL] and PREDNISONE for an unknown indication.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN (Body ache). On an unknown date, the patient experienced FATIGUE (exhausted), HEADACHE (headache), ARTHRALGIA (Joint pain), MALAISE (Not feeling good), INSOMNIA (Unable to sleep), PAIN IN EXTREMITY (Pain in hands) and BEDRIDDEN (she can't lift herself up). At the time of the report, FATIGUE (exhausted), HEADACHE (headache), ARTHRALGIA (Joint pain), PAIN (Body ache), MALAISE (Not feeling good), INSOMNIA (Unable to sleep), PAIN IN EXTREMITY (Pain in hands) and BEDRIDDEN (she can't lift herself up) 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.   No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pain in extremity
Clinical narrative: exhausted; headache; Joint pain; Not feeling good; Unable to sleep; Pain in hands; she can't lift herself up; Body ache; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (exhausted), HEADACHE (headache), ARTHRALGIA (Joint pain), PAIN (Body ache) and MALAISE (Not feeling good) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Recurrent UTI, Sjogren's syndrome, Pneumonia and Anaemia. Concomitant products included TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis, DAILY VITE [COLECALCIFEROL;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RETINOL ACETATE;THIAMINE HYDROCHLORIDE;THIAMINE MONONITRATE;TOCOPHEROL] and PREDNISONE for an unknown indication.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN (Body ache). On an unknown date, the patient experienced FATIGUE (exhausted), HEADACHE (headache), ARTHRALGIA (Joint pain), MALAISE (Not feeling good), INSOMNIA (Unable to sleep), PAIN IN EXTREMITY (Pain in hands) and BEDRIDDEN (she can't lift herself up). At the time of the report, FATIGUE (exhausted), HEADACHE (headache), ARTHRALGIA (Joint pain), PAIN (Body ache), MALAISE (Not feeling good), INSOMNIA (Unable to sleep), PAIN IN EXTREMITY (Pain in hands) and BEDRIDDEN (she can't lift herself up) 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.   No treatment medication details was reported.