chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Insomnia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: sleep more during the day; scarring from the rash; skin feels like sandpaper now where the rash appeared; rash hurt/ rash that covered my arm, stomach and legs; rash was red; could not sleep at night; Still itches; rash burned when tried to put anti itch cream; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (rash was red), INSOMNIA (could not sleep at night), RASH PRURITIC (Still itches), BURNING SENSATION (rash burned when tried to put anti itch cream) and SOMNOLENCE (sleep more during the day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced RASH ERYTHEMATOUS (rash was red), INSOMNIA (could not sleep at night), RASH PRURITIC (Still itches), BURNING SENSATION (rash burned when tried to put anti itch cream) and RASH (rash hurt/ rash that covered my arm, stomach and legs). On an unknown date, the patient experienced SOMNOLENCE (sleep more during the day), SCAR (scarring from the rash) and SKIN TEXTURE ABNORMAL (skin feels like sandpaper now where the rash appeared). The patient was treated with HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE) ongoing since an unknown date for Adverse event, at a dose of 25 milligram and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at a dose of 20 milligram twice a day. At the time of the report, RASH ERYTHEMATOUS (rash was red), RASH PRURITIC (Still itches), SCAR (scarring from the rash), SKIN TEXTURE ABNORMAL (skin feels like sandpaper now where the rash appeared) and RASH (rash hurt/ rash that covered my arm, stomach and legs) had not resolved and INSOMNIA (could not sleep at night), BURNING SENSATION (rash burned when tried to put anti itch cream) and SOMNOLENCE (sleep more during the day) outcome was unknown.            No concomitant drugs were provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up received on 06-May-2021 and event verbatim updated. On 14-Jun-2021: Follow-up received on 14-Jun-2021, included additional events of scar and skin texture abnormal. On 20-Jul-2021: Follow up received on 21-Jul-2021 and contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Scar, Skin texture abnormal, Somnolence
Clinical narrative: sleep more during the day; scarring from the rash; skin feels like sandpaper now where the rash appeared; rash hurt/ rash that covered my arm, stomach and legs; rash was red; could not sleep at night; Still itches; rash burned when tried to put anti itch cream; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (rash was red), INSOMNIA (could not sleep at night), RASH PRURITIC (Still itches), BURNING SENSATION (rash burned when tried to put anti itch cream) and SOMNOLENCE (sleep more during the day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced RASH ERYTHEMATOUS (rash was red), INSOMNIA (could not sleep at night), RASH PRURITIC (Still itches), BURNING SENSATION (rash burned when tried to put anti itch cream) and RASH (rash hurt/ rash that covered my arm, stomach and legs). On an unknown date, the patient experienced SOMNOLENCE (sleep more during the day), SCAR (scarring from the rash) and SKIN TEXTURE ABNORMAL (skin feels like sandpaper now where the rash appeared). The patient was treated with HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE) ongoing since an unknown date for Adverse event, at a dose of 25 milligram and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at a dose of 20 milligram twice a day. At the time of the report, RASH ERYTHEMATOUS (rash was red), RASH PRURITIC (Still itches), SCAR (scarring from the rash), SKIN TEXTURE ABNORMAL (skin feels like sandpaper now where the rash appeared) and RASH (rash hurt/ rash that covered my arm, stomach and legs) had not resolved and INSOMNIA (could not sleep at night), BURNING SENSATION (rash burned when tried to put anti itch cream) and SOMNOLENCE (sleep more during the day) outcome was unknown.            No concomitant drugs were provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up received on 06-May-2021 and event verbatim updated. On 14-Jun-2021: Follow-up received on 14-Jun-2021, included additional events of scar and skin texture abnormal. On 20-Jul-2021: Follow up received on 21-Jul-2021 and contains no new information
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Myalgia, Nausea
Clinical narrative: dizzy; weak; body aches; nausea; temperature was 99.2; right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (weak), MYALGIA (body aches), NAUSEA (nausea) and PYREXIA (temperature was 99.2) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included HERBAL NOS, INOSITOL, LYCOPENE, MINERALS NOS, RESVERATROL, VITAMINS NOS, XANTOFYL, ZEAXANTHIN (PHYTOMULTI), COLECALCIFEROL (D3), LUTEIN [XANTOFYL], ALOE VERA and CALCIUM, MAGNESIUM (CALCIUM MAGNESIUM [CALCIUM;MAGNESIUM]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (right arm was sore). On 11-Mar-2021, the patient experienced DIZZINESS (dizzy), ASTHENIA (weak), MYALGIA (body aches), NAUSEA (nausea) and PYREXIA (temperature was 99.2). On 12-Mar-2021, DIZZINESS (dizzy), ASTHENIA (weak), MYALGIA (body aches), NAUSEA (nausea), PYREXIA (temperature was 99.2) and VACCINATION SITE PAIN (right arm was sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 99.2 (High) at 2:30 a.m. temperature was 99.2 and 100.8 (High) at 7:50 a.m. temperature was 100.8.         The action taken with mRNA-1273 (Moderna COVID-19 vaccine) was not applicable  No treatment medications were reported   This case was linked to MOD-2021-107720, MOD-2021-107720 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: No new information was provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: dizzy; weak; body aches; nausea; temperature was 99.2; right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (weak), MYALGIA (body aches), NAUSEA (nausea) and PYREXIA (temperature was 99.2) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included HERBAL NOS, INOSITOL, LYCOPENE, MINERALS NOS, RESVERATROL, VITAMINS NOS, XANTOFYL, ZEAXANTHIN (PHYTOMULTI), COLECALCIFEROL (D3), LUTEIN [XANTOFYL], ALOE VERA and CALCIUM, MAGNESIUM (CALCIUM MAGNESIUM [CALCIUM;MAGNESIUM]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (right arm was sore). On 11-Mar-2021, the patient experienced DIZZINESS (dizzy), ASTHENIA (weak), MYALGIA (body aches), NAUSEA (nausea) and PYREXIA (temperature was 99.2). On 12-Mar-2021, DIZZINESS (dizzy), ASTHENIA (weak), MYALGIA (body aches), NAUSEA (nausea), PYREXIA (temperature was 99.2) and VACCINATION SITE PAIN (right arm was sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 99.2 (High) at 2:30 a.m. temperature was 99.2 and 100.8 (High) at 7:50 a.m. temperature was 100.8.         The action taken with mRNA-1273 (Moderna COVID-19 vaccine) was not applicable  No treatment medications were reported   This case was linked to MOD-2021-107720, MOD-2021-107720 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: No new information was provided
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pyrexia
Clinical narrative: 101+fever; Very tired; very weak; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (101+fever), FATIGUE (Very tired) and ASTHENIA (very weak) 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. On an unknown date, the patient experienced PYREXIA (101+fever), FATIGUE (Very tired) and ASTHENIA (very weak). At the time of the report, PYREXIA (101+fever), FATIGUE (Very tired) and ASTHENIA (very weak) was resolving.            Concomitant information was not reported.  Treatment information provided included lots of rest and water.   This case was linked to MOD-2021-025653 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Accidental exposure to product
Clinical narrative: some liquid (Moderna vaccine) was fell on his bare skin; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (some liquid (Moderna vaccine) was fell on his bare skin) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (some liquid (Moderna vaccine) was fell on his bare skin). At the time of the report, ACCIDENTAL EXPOSURE TO PRODUCT (some liquid (Moderna vaccine) was fell on his bare skin) 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-2021-107772 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-107772:For sister
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Lymphadenopathy, Rash erythematous, Swelling face
Clinical narrative: she had a reaction to something; swelling on her face; swollen glands near her ear and on her neck; rash that was red at top of her face near the ear; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (she had a reaction to something), SWELLING FACE (swelling on her face), RASH ERYTHEMATOUS (rash that was red at top of her face near the ear) and LYMPHADENOPATHY (swollen glands near her ear and on her neck) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, OLMESARTAN MEDOXOMIL, ROSUVASTATIN, DILTIAZEM, SITAGLIPTIN and VITAMIN D3 for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (rash that was red at top of her face near the ear). On 14-Feb-2021, the patient experienced LYMPHADENOPATHY (swollen glands near her ear and on her neck). On an unknown date, the patient experienced ADVERSE EVENT (she had a reaction to something) and SWELLING FACE (swelling on her face). At the time of the report, ADVERSE EVENT (she had a reaction to something), RASH ERYTHEMATOUS (rash that was red at top of her face near the ear) and LYMPHADENOPATHY (swollen glands near her ear and on her neck) had not resolved and SWELLING FACE (swelling on her face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included an unknown dosage of steroids.    This case was linked to MOD21-081896 (E2B Linked Report). This case was linked to MOD21-030460 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No specific follow-up information recorded.   This case was linked to MOD21-081896 (E2B Linked Report). This case was linked to MOD21-030460 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: concomitant medications , new event information were adedd; Sender's Comments:  MOD21-081896:2nd Dose
Sex: M
Vaccine: COVID19
Symptoms: Milia
Clinical narrative: little specks on face and chest; 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 MILIA (little specks on face and chest) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced MILIA (little specks on face and chest). At the time of the report, MILIA (little specks on face and chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-100529 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Stool analysis
Clinical narrative: Severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhea) in an 80-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 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 DIARRHOEA (Severe diarrhea). At the time of the report, DIARRHOEA (Severe diarrhea) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Stool analysis: normal (normal) normal.         no treatment and concomitant medication was provided by the reporter   This case was linked to MOD-2021-076873, MOD-2021-042580, MOD-2021-040930, MOD-2021-107944 (E2B Linked Report).; Sender's Comments:  MOD-2021-076873:Same reporter/different patient (wife 1st dose) MOD-2021-042580:Same reporter/different patient (wife 2nd dose) MOD-2021-040930:Same reporter/different patient (husband case) MOD-2021-107944:Same reporter/different patient (50s male)
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Severe diarrhea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Severe diarrhea). At the time of the report, DIARRHOEA (Severe diarrhea) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.    This case was linked to MOD-2021-076873, MOD-2021-042580, MOD-2021-040930, MOD-2021-107944 (E2B Linked Report).; Sender's Comments:  MOD-2021-076873:Same reporter/different patient (wife 1st dose) MOD-2021-042580:Same reporter/different patient (wife 2nd dose) MOD-2021-040930:Same reporter/different patient (husband) MOD-2021-107944:Same reporter/different patient (80s male)
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash developed on the whole body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash developed on the whole body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced RASH (Rash developed on the whole body). At the time of the report, RASH (Rash developed on the whole body) outcome was unknown. Not Provided          Concomitant product usage were not provided. Treatment details were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 6 service members receiving 2nd dose after 60 days of 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (6 service members receiving 2nd dose after 60 days of 1st dose) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (6 service members receiving 2nd dose after 60 days of 1st dose). On 06-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (6 service members receiving 2nd dose after 60 days of 1st dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medication was reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood glucose, Dizziness
Clinical narrative: Anxiety; Lightheadedness; This spontaneous case was reported by a physician and describes the occurrence of ANXIETY (Anxiety) and DIZZINESS (Lightheadedness) in a 57-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 Hidradenitis suppurativa.    No medical history was provided by the reporter.    On 19-Jul-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced ANXIETY (Anxiety) and DIZZINESS (Lightheadedness). At the time of the report, ANXIETY (Anxiety) and DIZZINESS (Lightheadedness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Blood glucose: increased (abnormal) increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment were not reported
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, Myalgia, Pain
Clinical narrative: Swelling in armpit; pain in back and leg; fatigue; muscle pain; Left supraclavicular lymphadenopathy; Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in armpit), PAIN (pain in back and leg), FATIGUE (fatigue), MYALGIA (muscle pain) and LYMPHADENOPATHY (Left supraclavicular lymphadenopathy) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Endometriosis.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling in armpit), PAIN (pain in back and leg), FATIGUE (fatigue), MYALGIA (muscle pain), LYMPHADENOPATHY (Left supraclavicular lymphadenopathy) and ARTHRALGIA (Knee pain). At the time of the report, SWELLING (Swelling in armpit), MYALGIA (muscle pain) and ARTHRALGIA (Knee pain) outcome was unknown and FATIGUE (fatigue) and LYMPHADENOPATHY (Left supraclavicular lymphadenopathy) had not resolved.            Concomitant product use was not provided.Treatment information was not provided   This case was linked to MOD-2021-002591 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling in armpit; pain in back and leg; fatigue; muscle pain; Left supraclavicular lymphadenopathy; Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in armpit), PAIN (pain in back and leg), FATIGUE (fatigue), MYALGIA (muscle pain) and LYMPHADENOPATHY (Left supraclavicular lymphadenopathy) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Endometriosis.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling in armpit), PAIN (pain in back and leg), FATIGUE (fatigue), MYALGIA (muscle pain), LYMPHADENOPATHY (Left supraclavicular lymphadenopathy) and ARTHRALGIA (Knee pain). At the time of the report, SWELLING (Swelling in armpit), MYALGIA (muscle pain) and ARTHRALGIA (Knee pain) outcome was unknown and FATIGUE (fatigue) and LYMPHADENOPATHY (Left supraclavicular lymphadenopathy) had not resolved.            Concomitant product use was not provided.Treatment information was not provided   This case was linked to MOD-2021-002591 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. Not Provided          Concomitant medications were not reported. Treatment medications were not reported.    Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough, Dysphonia, Fatigue
Clinical narrative: Dysphonia; Cough returned; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Dysphonia), COUGH (Cough returned) and FATIGUE (Fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for Endometrial cancer.    Concurrent medical conditions included Endometrial cancer. Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for Endometrial cancer.   On 20-Apr-2021, the patient started LENVATINIB MESILATE (LENVIMA) (Oral) 20 mg once a day. On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced COUGH (Cough returned) and FATIGUE (Fatigue). On an unknown date, the patient experienced DYSPHONIA (Dysphonia). At the time of the report, DYSPHONIA (Dysphonia), COUGH (Cough returned) and FATIGUE (Fatigue) had not resolved.            No treatment information was provided.  Patient reports cough returned approximately 3 days ago after second Moderna injection Apr/24/2021. Patient has more fatigue and lethargy after injection. Patient did not feel any different with increase dose of Lenvima until taking the second COVID vaccine. Patient reports dysphonia since start of therapy possibly increased with increase dose of Lenvima. Labs completed this morning, will have Keytruda infusion today and MD appointment.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Vaccination site erythema
Clinical narrative: Allergic skin reaction; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Allergic skin reaction) and 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.     The patient's past medical history included No adverse event.    On 24-Apr-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 DERMATITIS ALLERGIC (Allergic skin reaction) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, DERMATITIS ALLERGIC (Allergic skin reaction) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that patient had never been allergic to anything.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: Fatigue Extreme; Rash; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue Extreme) and RASH (Rash) in a 66-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.    Concurrent medical conditions included Rheumatoid 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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue Extreme) and RASH (Rash). At the time of the report, FATIGUE (Fatigue Extreme) and RASH (Rash) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There was no reported medical history. The patient stopped Rinvoq for seven weeks to take the Covid Moderna Vaccine. She was noticing extreme fatigue and got a rash after the first injection that lasted until two weeks after the second vaccine dose. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant and treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: itching; hive rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (hive rash at injection site) and VACCINATION SITE PRURITUS (itching) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044321A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Codeine, Sulfa drug allergy) and Adhesive tape allergy (Mastisol adhesive allergy). Concomitant products included LOSARTAN, ATORVASTATIN, TRAMADOL, TRAZODONE and SERTRALINE for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE URTICARIA (hive rash at injection site). On 19-Apr-2021 at 4:00 PM, the patient experienced VACCINATION SITE PRURITUS (itching). At the time of the report, VACCINATION SITE URTICARIA (hive rash at injection site) and VACCINATION SITE PRURITUS (itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Dehydration, Headache
Clinical narrative: Dehydration; Headache; Cataract aggravated; This spontaneous case was reported by an other health care professional and describes the occurrence of CATARACT (Cataract aggravated), DEHYDRATION (Dehydration) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe Rheumatoid Arthritis), Hypertension, High cholesterol, Pre-diabetes (Pre diabetes type 2), Acid reflux (esophageal), Alcohol use (Wine user, 1 to 2 glasses at night, started in 1966), Tobacco user (10 cigarette per day started in 1968) and Dehydration since September 2019. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), BUPROPION and DULOXETINE HYDROCHLORIDE (CYMBALTA) for Antidepressant therapy, PRAVASTATIN for High cholesterol, HYDROCHLOROTHIAZIDE and LOSARTAN for Hypertension, METFORMIN for Prediabetes, HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) and PREDNISONE for Rheumatoid arthritis.   On 10-Oct-2019, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 milligram once a week. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced CATARACT (Cataract aggravated). On 27-Feb-2021, the patient experienced HEADACHE (Headache). On 01-Mar-2021, the patient experienced DEHYDRATION (Dehydration). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Mar-2021, HEADACHE (Headache) had resolved. On 04-Mar-2021, DEHYDRATION (Dehydration) had resolved. In March 2021, CATARACT (Cataract aggravated) had resolved. Patient had cataract surgery on right eye on 10-Feb-2021 and 24-Feb-2021 for the left eye.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CATARACT (Cataract aggravated), DEHYDRATION (Dehydration) and HEADACHE (Headache) to be not related.    The patient was treated with Tylenol.  Company comment Based on current available information and the temporal association between product use and the start date of the events cannot be excluded.   This case was linked to MOD-2021-108204 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20 May 2021: Updated e mail of reporter.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Pain in extremity
Clinical narrative: Pain in arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache) in an adult 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter. No laboratory provided by reporter
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Large lymph node on collar bone; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Large lymph node on collar bone) in an 18-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 LYMPHADENOPATHY (Large lymph node on collar bone). At the time of the report, LYMPHADENOPATHY (Large lymph node on collar bone) 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: U
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: lower lip swelled; 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 LIP SWELLING (lower lip swelled) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIP SWELLING (lower lip swelled). At the time of the report, LIP SWELLING (lower lip swelled) outcome was unknown.            No concomitant medication were reported No treatment medications were reported Action taken with mRNA-1273 Moderna COVID-19 Vaccine was not applicable
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Body aches; Headache; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-May-2021 and was forwarded to Moderna on 06-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PAIN (Body aches), PYREXIA (Fever) and HEADACHE (Headache) had resolved.            The patient doesn't want another follow-up.   This case was linked to MOD-2021-044882 (Patient Link).   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Mild headache) and PYREXIA (Slight fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension since April 2019, Cholesterol since April 2019, Allergy to antibiotic (cipro), Food allergy (some food allergy), Drug allergy (statins) and Allergy (fiber glass). Concomitant products included EVOLOCUMAB (REPATHA) for Cholesterol, CARVEDILOL from April 2019 to an unknown date, LISINOPRIL, CLOPIDOGREL and ASPIRIN [ACETYLSALICYLIC ACID] for Hypertension, MINERALS NOS, VITAMINS NOS (ONE A DAY [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Mild headache) and PYREXIA (Slight fever). At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (Mild headache) and PYREXIA (Slight fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. This case was linked to MOD-2021-076430. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up received does not contain any new information with respect to dose 1.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: fever; chills; exhaustion; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and NAUSEA (nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031220A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy, Hypertension, Acid reflux (oesophageal), Hyperplasia adrenal and Drug allergy. Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), SPIRONOLACTONE and SIMVASTATIN (ZOCOR) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-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 PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and NAUSEA (nausea). At the time of the report, PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and NAUSEA (nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-020695 (Patient Link).
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) and FATIGUE (Tiredness) 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (unknown route) 75 mg. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PYREXIA (Fever) and FATIGUE (Tiredness). At the time of the report, PYREXIA (Fever) and FATIGUE (Tiredness) outcome was unknown. 1st dose AE      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 43.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever; tiredness; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (fever) and FATIGUE (tiredness) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    The patient's past medical history included COVID-19 in July 2020.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 75 mg once. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PYREXIA (fever) and FATIGUE (tiredness). At the time of the report, PYREXIA (fever) and FATIGUE (tiredness) outcome was unknown. 2nd dose AE      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications reported.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Vaccination site erythema, Vaccination site rash
Clinical narrative: vaccination site rash; ache; vaccination site erythema; ache; This spontaneous case was reported by a physician and describes the occurrence of the second episode of PAIN (ache), the first episode of PAIN (ache), VACCINATION SITE ERYTHEMA (vaccination site erythema) and VACCINATION SITE RASH (vaccination site rash) in a 60-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.    No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 UNK. In April 2021, the patient experienced the first episode of PAIN (ache). On an unknown date, the patient experienced the second episode of PAIN (ache), VACCINATION SITE ERYTHEMA (vaccination site erythema) and VACCINATION SITE RASH (vaccination site rash). At the time of the report, last episode of PAIN (ache), VACCINATION SITE ERYTHEMA (vaccination site erythema) and VACCINATION SITE RASH (vaccination site rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment: The patient was treated with Prednisone.  On 21-APR-2021 received update to patient demographics, event information, reporter opinion of causality, suspected drug information, concomitant drug information and narrative description. The event of "ACHY" and "VACCINE RASH, RED RASH AT THE INJECTION SITE AFTER SECOND DOSE" were added.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Joint swelling, Knee arthroplasty, Pain
Clinical narrative: knee swelling; pain in knee; total knee replacement; postoperative complication; Circulatory disorder peripheral; numbness; tingling; pain; This spontaneous case was reported by a physician and describes the occurrence of JOINT SWELLING (knee swelling), KNEE ARTHROPLASTY (total knee replacement), ARTHRALGIA (pain in knee), POST PROCEDURAL COMPLICATION (postoperative complication) and PERIPHERAL VASCULAR DISORDER (Circulatory disorder peripheral) in a 77-year-old patient of an unknown gender 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) injection for an unknown indication.    The patient's past medical history included Cigarette smoker (Smoker/ Half of pack of cigarette per day) from 1957 to 1981, Alcohol use (Occasional Alcohol use, might be three times a years) and Knee replacement (Left knee replaced). Concomitant products included GABAPENTIN and IBUPROFEN for an unknown indication.   On 06-Jan-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. In 2020, the patient experienced PAIN (pain). On 09-Sep-2020, the patient experienced KNEE ARTHROPLASTY (total knee replacement). In September 2020, the patient experienced POST PROCEDURAL COMPLICATION (postoperative complication), PERIPHERAL VASCULAR DISORDER (Circulatory disorder peripheral), HYPOAESTHESIA (numbness) and PARAESTHESIA (tingling). On an unknown date, the patient experienced JOINT SWELLING (knee swelling) and ARTHRALGIA (pain in knee). At the time of the report, JOINT SWELLING (knee swelling), KNEE ARTHROPLASTY (total knee replacement), ARTHRALGIA (pain in knee), POST PROCEDURAL COMPLICATION (postoperative complication), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling) and PAIN (pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test:.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The treatment information was unknown.  The action taken with mRNA-1273 in response to the events were not applicable.