chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site urticaria
Clinical narrative: Flu-like symptoms; Welting at injection site; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) and VACCINATION SITE URTICARIA (Welting at injection site) in a 37-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) injection for Ankylosing spondylitis and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and VACCINATION SITE URTICARIA (Welting at injection site). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved and VACCINATION SITE URTICARIA (Welting at injection site) had resolved with sequelae.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash lasted 2 days; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash lasted 2 days) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash lasted 2 days). At the time of the report, RASH (rash lasted 2 days) had resolved.            Concomitant product use was not provided by the reporter.   Treatment: Patients wife put some alcohol and salve on the rash.   This case was linked to MOD-2021-037506 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Patient details updated and first dose information updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chest X-ray, Confusional state
Clinical narrative: dizziness; pressure around ears and eyes; pain in back of neck; hyperventilating; stress; raised bp 187/105; confusion; thinking has been off; walking difficulty; eras are buzzing; sleep talking; aches/ pain all over; fever 104; heahache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (raised bp 187/105), CONFUSIONAL STATE (confusion), THINKING ABNORMAL (thinking has been off), GAIT DISTURBANCE (walking difficulty) and TINNITUS (eras are buzzing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Multiple sclerosis and Pacemaker insertion (cardiac) (follow up).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced SLEEP TALKING (sleep talking), PAIN (aches/ pain all over), PYREXIA (fever 104) and HEADACHE (heahache). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (raised bp 187/105), CONFUSIONAL STATE (confusion), THINKING ABNORMAL (thinking has been off), GAIT DISTURBANCE (walking difficulty), TINNITUS (eras are buzzing), DIZZINESS (dizziness), HEAD DISCOMFORT (pressure around ears and eyes), NECK PAIN (pain in back of neck), HYPERVENTILATION (hyperventilating) and STRESS (stress).  At the time of the report, BLOOD PRESSURE INCREASED (raised bp 187/105), CONFUSIONAL STATE (confusion), THINKING ABNORMAL (thinking has been off), GAIT DISTURBANCE (walking difficulty), TINNITUS (eras are buzzing), SLEEP TALKING (sleep talking), DIZZINESS (dizziness), HEAD DISCOMFORT (pressure around ears and eyes), NECK PAIN (pain in back of neck), HYPERVENTILATION (hyperventilating), STRESS (stress), PAIN (aches/ pain all over), PYREXIA (fever 104) and HEADACHE (heahache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement (140-90 mmHg): 94/62 mmHg (Low) Losartan 50mg  titrated to 20mg  still BP low, Losartan completely stopped by HCP. On 11-Mar-2021, Body temperature:. On 05-Apr-2021, Blood pressure measurement (140-90 mmHg): 187/105 mmHg High. On 05-Apr-2021, Body temperature: 104 High. On 28-Apr-2021, Chest X-ray: normal. On 28-Apr-2021, Electrocardiogram: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-0100891 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Gait disturbance, Head discomfort, Headache
Clinical narrative: dizziness; pressure around ears and eyes; pain in back of neck; hyperventilating; stress; raised bp 187/105; confusion; thinking has been off; walking difficulty; eras are buzzing; sleep talking; aches/ pain all over; fever 104; heahache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (raised bp 187/105), CONFUSIONAL STATE (confusion), THINKING ABNORMAL (thinking has been off), GAIT DISTURBANCE (walking difficulty) and TINNITUS (eras are buzzing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Multiple sclerosis and Pacemaker insertion (cardiac) (follow up).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced SLEEP TALKING (sleep talking), PAIN (aches/ pain all over), PYREXIA (fever 104) and HEADACHE (heahache). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (raised bp 187/105), CONFUSIONAL STATE (confusion), THINKING ABNORMAL (thinking has been off), GAIT DISTURBANCE (walking difficulty), TINNITUS (eras are buzzing), DIZZINESS (dizziness), HEAD DISCOMFORT (pressure around ears and eyes), NECK PAIN (pain in back of neck), HYPERVENTILATION (hyperventilating) and STRESS (stress).  At the time of the report, BLOOD PRESSURE INCREASED (raised bp 187/105), CONFUSIONAL STATE (confusion), THINKING ABNORMAL (thinking has been off), GAIT DISTURBANCE (walking difficulty), TINNITUS (eras are buzzing), SLEEP TALKING (sleep talking), DIZZINESS (dizziness), HEAD DISCOMFORT (pressure around ears and eyes), NECK PAIN (pain in back of neck), HYPERVENTILATION (hyperventilating), STRESS (stress), PAIN (aches/ pain all over), PYREXIA (fever 104) and HEADACHE (heahache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement (140-90 mmHg): 94/62 mmHg (Low) Losartan 50mg  titrated to 20mg  still BP low, Losartan completely stopped by HCP. On 11-Mar-2021, Body temperature:. On 05-Apr-2021, Blood pressure measurement (140-90 mmHg): 187/105 mmHg High. On 05-Apr-2021, Body temperature: 104 High. On 28-Apr-2021, Chest X-ray: normal. On 28-Apr-2021, Electrocardiogram: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-0100891 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperventilation, Neck pain, Pain, Pyrexia, Sleep talking
Clinical narrative: dizziness; pressure around ears and eyes; pain in back of neck; hyperventilating; stress; raised bp 187/105; confusion; thinking has been off; walking difficulty; eras are buzzing; sleep talking; aches/ pain all over; fever 104; heahache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (raised bp 187/105), CONFUSIONAL STATE (confusion), THINKING ABNORMAL (thinking has been off), GAIT DISTURBANCE (walking difficulty) and TINNITUS (eras are buzzing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Multiple sclerosis and Pacemaker insertion (cardiac) (follow up).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced SLEEP TALKING (sleep talking), PAIN (aches/ pain all over), PYREXIA (fever 104) and HEADACHE (heahache). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (raised bp 187/105), CONFUSIONAL STATE (confusion), THINKING ABNORMAL (thinking has been off), GAIT DISTURBANCE (walking difficulty), TINNITUS (eras are buzzing), DIZZINESS (dizziness), HEAD DISCOMFORT (pressure around ears and eyes), NECK PAIN (pain in back of neck), HYPERVENTILATION (hyperventilating) and STRESS (stress).  At the time of the report, BLOOD PRESSURE INCREASED (raised bp 187/105), CONFUSIONAL STATE (confusion), THINKING ABNORMAL (thinking has been off), GAIT DISTURBANCE (walking difficulty), TINNITUS (eras are buzzing), SLEEP TALKING (sleep talking), DIZZINESS (dizziness), HEAD DISCOMFORT (pressure around ears and eyes), NECK PAIN (pain in back of neck), HYPERVENTILATION (hyperventilating), STRESS (stress), PAIN (aches/ pain all over), PYREXIA (fever 104) and HEADACHE (heahache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement (140-90 mmHg): 94/62 mmHg (Low) Losartan 50mg  titrated to 20mg  still BP low, Losartan completely stopped by HCP. On 11-Mar-2021, Body temperature:. On 05-Apr-2021, Blood pressure measurement (140-90 mmHg): 187/105 mmHg High. On 05-Apr-2021, Body temperature: 104 High. On 28-Apr-2021, Chest X-ray: normal. On 28-Apr-2021, Electrocardiogram: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-0100891 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Stress, Thinking abnormal, Tinnitus
Clinical narrative: dizziness; pressure around ears and eyes; pain in back of neck; hyperventilating; stress; raised bp 187/105; confusion; thinking has been off; walking difficulty; eras are buzzing; sleep talking; aches/ pain all over; fever 104; heahache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (raised bp 187/105), CONFUSIONAL STATE (confusion), THINKING ABNORMAL (thinking has been off), GAIT DISTURBANCE (walking difficulty) and TINNITUS (eras are buzzing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Multiple sclerosis and Pacemaker insertion (cardiac) (follow up).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced SLEEP TALKING (sleep talking), PAIN (aches/ pain all over), PYREXIA (fever 104) and HEADACHE (heahache). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (raised bp 187/105), CONFUSIONAL STATE (confusion), THINKING ABNORMAL (thinking has been off), GAIT DISTURBANCE (walking difficulty), TINNITUS (eras are buzzing), DIZZINESS (dizziness), HEAD DISCOMFORT (pressure around ears and eyes), NECK PAIN (pain in back of neck), HYPERVENTILATION (hyperventilating) and STRESS (stress).  At the time of the report, BLOOD PRESSURE INCREASED (raised bp 187/105), CONFUSIONAL STATE (confusion), THINKING ABNORMAL (thinking has been off), GAIT DISTURBANCE (walking difficulty), TINNITUS (eras are buzzing), SLEEP TALKING (sleep talking), DIZZINESS (dizziness), HEAD DISCOMFORT (pressure around ears and eyes), NECK PAIN (pain in back of neck), HYPERVENTILATION (hyperventilating), STRESS (stress), PAIN (aches/ pain all over), PYREXIA (fever 104) and HEADACHE (heahache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement (140-90 mmHg): 94/62 mmHg (Low) Losartan 50mg  titrated to 20mg  still BP low, Losartan completely stopped by HCP. On 11-Mar-2021, Body temperature:. On 05-Apr-2021, Blood pressure measurement (140-90 mmHg): 187/105 mmHg High. On 05-Apr-2021, Body temperature: 104 High. On 28-Apr-2021, Chest X-ray: normal. On 28-Apr-2021, Electrocardiogram: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-0100891 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Malaise, Pyrexia
Clinical narrative: didn't feel great at all; very weak; chills; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel great at all), ASTHENIA (very weak), CHILLS (chills) and PYREXIA (slight fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (didn't feel great at all), ASTHENIA (very weak), CHILLS (chills) and PYREXIA (slight fever). At the time of the report, MALAISE (didn't feel great at all), ASTHENIA (very weak), CHILLS (chills) and PYREXIA (slight fever) outcome was unknown.            No concomitant medications reported by reporter. No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-101483 , MOD-2021-101494 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paresis, Hypoacusis, Hypoaesthesia oral, Lacrimation increased, Otitis media
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOACUSIS, OTITIS MEDIA (serous otitis media), FACIAL PARESIS, LACRIMATION INCREASED and HYPOAESTHESIA ORAL in a 50-year-old female patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Apr-2021, the patient received first dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced HYPOACUSIS. On 23-Apr-2021, the patient experienced OTITIS MEDIA (serous otitis media). On 29-Apr-2021, the patient experienced FACIAL PARESIS, LACRIMATION INCREASED and HYPOAESTHESIA ORAL. On 29-Apr-2021, OTITIS MEDIA had resolved. At the time of the report, HYPOACUSIS, FACIAL PARESIS. LACRIMATION INCREASED and HYPOAESTHESIA ORAL had resolved. No concomitant medications were provided. No treatment medications were provided. This case was linked to MOD21-084619 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Event Outcome Updated: "No Symptoms at present."; Sender's Comments: MOD21-084619.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Rash, Swelling, Swelling face, Vaccination complication
Clinical narrative: Swelling in the face; swelling in neck; swelling in eyes; rash on neck; Rash on face; Issues with Espphagus and lungs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swelling in the face), SWELLING (swelling in neck), EYE SWELLING (swelling in eyes), RASH (rash on neck) and RASH (Rash on face) 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 medical history has not been reported.     In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Swelling in the face), SWELLING (swelling in neck), EYE SWELLING (swelling in eyes), RASH (rash on neck), RASH (Rash on face) and VACCINATION COMPLICATION (Issues with Espphagus and lungs). At the time of the report, SWELLING FACE (Swelling in the face), SWELLING (swelling in neck), EYE SWELLING (swelling in eyes), RASH (rash on neck), RASH (Rash on face) and VACCINATION COMPLICATION (Issues with Espphagus and lungs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported. The patient had been put on several rounds of steroids which helped temporarily but the rash and swelling retuned as soon as she tapered off.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Illness, Myalgia
Clinical narrative: the patient was quite sick for 48 hours; chills; fatigue; muscle pain; nausea; vomiting/numerous episodes of vomiting; bad headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (the patient was quite sick for 48 hours), CHILLS (chills), FATIGUE (fatigue), MYALGIA (muscle pain) and NAUSEA (nausea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUOXETINE and LORAZEPAM for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue), MYALGIA (muscle pain), NAUSEA (nausea), VOMITING (vomiting/numerous episodes of vomiting), HEADACHE (bad headache) and PYREXIA (fever). On an unknown date, the patient experienced ILLNESS (the patient was quite sick for 48 hours). At the time of the report, ILLNESS (the patient was quite sick for 48 hours) was resolving and CHILLS (chills), FATIGUE (fatigue), MYALGIA (muscle pain), NAUSEA (nausea), VOMITING (vomiting/numerous episodes of vomiting), HEADACHE (bad headache) and PYREXIA (fever) outcome was unknown.            No treatment medications were provided
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: the patient was quite sick for 48 hours; chills; fatigue; muscle pain; nausea; vomiting/numerous episodes of vomiting; bad headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (the patient was quite sick for 48 hours), CHILLS (chills), FATIGUE (fatigue), MYALGIA (muscle pain) and NAUSEA (nausea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUOXETINE and LORAZEPAM for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue), MYALGIA (muscle pain), NAUSEA (nausea), VOMITING (vomiting/numerous episodes of vomiting), HEADACHE (bad headache) and PYREXIA (fever). On an unknown date, the patient experienced ILLNESS (the patient was quite sick for 48 hours). At the time of the report, ILLNESS (the patient was quite sick for 48 hours) was resolving and CHILLS (chills), FATIGUE (fatigue), MYALGIA (muscle pain), NAUSEA (nausea), VOMITING (vomiting/numerous episodes of vomiting), HEADACHE (bad headache) and PYREXIA (fever) outcome was unknown.            No treatment medications were provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count, Malaise
Clinical narrative: Ill; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Ill) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No past medical history information was provided.  Concurrent medical conditions included B-cell aplasia (B Cells no longer have any) and Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for Multiple sclerosis.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced MALAISE (Ill). At the time of the report, MALAISE (Ill) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Lymphocyte count: decreased (Low) t cells decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event was not provided
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling abnormal, Pyrexia
Clinical narrative: Didn't feel great at all; Very weak; Had chills; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Didn't feel great at all), ASTHENIA (Very weak), CHILLS (Had chills) and PYREXIA (Slight fever) 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 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 FEELING ABNORMAL (Didn't feel great at all), ASTHENIA (Very weak), CHILLS (Had chills) and PYREXIA (Slight fever). At the time of the report, FEELING ABNORMAL (Didn't feel great at all), ASTHENIA (Very weak), CHILLS (Had chills) and PYREXIA (Slight fever) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided.  Action taken with mRNA-1273 in response to events were not applicable.   This case was linked to MOD-2021-101483 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: paused humira for 3 weeks due to getting Moderna vaccine; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (paused humira for 3 weeks due to getting Moderna vaccine) in a 66-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 Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (paused humira for 3 weeks due to getting Moderna vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (paused humira for 3 weeks due to getting Moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment or concomitant medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: Extreme achiness; Dizziness; Nausea; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extreme achiness), DIZZINESS (Dizziness), NAUSEA (Nausea) and PYREXIA (Low grade fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Drug allergy (Allergy to Streptomycin) and Mycobacterium avium intracellulare infection since 2018. Concomitant products included METOCLOPRAMIDE HYDROCHLORIDE (REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]), ROSUVASTATIN CALCIUM (CRESTOR), OLMESARTAN MEDOXOMIL (BENICAR), ESTRADIOL and DEXLANSOPRAZOLE (DEXILANT) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (Extreme achiness), DIZZINESS (Dizziness), NAUSEA (Nausea) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Mar-2021, PAIN (Extreme achiness), DIZZINESS (Dizziness), NAUSEA (Nausea) and PYREXIA (Low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: positive (Positive) positive. On 17-Feb-2021, Body temperature: increased (High) low-grade fever..
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Extreme achiness; Dizziness; Nausea; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extreme achiness), DIZZINESS (Dizziness), NAUSEA (Nausea) and PYREXIA (Low grade fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Drug allergy (Allergy to Streptomycin) and Mycobacterium avium intracellulare infection since 2018. Concomitant products included METOCLOPRAMIDE HYDROCHLORIDE (REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]), ROSUVASTATIN CALCIUM (CRESTOR), OLMESARTAN MEDOXOMIL (BENICAR), ESTRADIOL and DEXLANSOPRAZOLE (DEXILANT) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (Extreme achiness), DIZZINESS (Dizziness), NAUSEA (Nausea) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Mar-2021, PAIN (Extreme achiness), DIZZINESS (Dizziness), NAUSEA (Nausea) and PYREXIA (Low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: positive (Positive) positive. On 17-Feb-2021, Body temperature: increased (High) low-grade fever..
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Hypersomnia, Nausea
Clinical narrative: She slept all day; pain in all joints,all of the joints hurt; knees hurt like I'm 90; threw up; nausea; debilitating headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (She slept all day), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (pain in all joints,all of the joints hurt; knees hurt like I'm 90) and NAUSEA (nausea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030BZ1A and 022HPVP;) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (debilitating headache). On an unknown date, the patient experienced HYPERSOMNIA (She slept all day), ARTHRALGIA (pain in all joints,all of the joints hurt; knees hurt like I'm 90) and VOMITING (threw up). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Apr-2021, PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) had resolved. At the time of the report, HYPERSOMNIA (She slept all day), ARTHRALGIA (pain in all joints,all of the joints hurt; knees hurt like I'm 90), HEADACHE (debilitating headache) and VOMITING (threw up) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-101514 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101514:First dose case
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: She slept all day; pain in all joints,all of the joints hurt; knees hurt like I'm 90; threw up; nausea; debilitating headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (She slept all day), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (pain in all joints,all of the joints hurt; knees hurt like I'm 90) and NAUSEA (nausea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030BZ1A and 022HPVP;) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (debilitating headache). On an unknown date, the patient experienced HYPERSOMNIA (She slept all day), ARTHRALGIA (pain in all joints,all of the joints hurt; knees hurt like I'm 90) and VOMITING (threw up). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Apr-2021, PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) had resolved. At the time of the report, HYPERSOMNIA (She slept all day), ARTHRALGIA (pain in all joints,all of the joints hurt; knees hurt like I'm 90), HEADACHE (debilitating headache) and VOMITING (threw up) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-101514 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101514:First dose case
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M204 and 001BZ1A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Smoker (Ex tobacco smoker three cigarettes a day) from 1969 to 1996. Concurrent medical conditions included Diabetes, Torn muscle since November 2020, Shoulder pain since November 2020, Fall since November 2020, Thyroid disorder NOS, Kidney stones since 1967, Depression, Arthritis and Allergy. Concomitant products included FLUTICASONE and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, SULFASALAZINE for Arthritis, VENLAFAXINE for Depression, METFORMIN for Diabetes, HYDROCHLOROTHIAZIDE for Kidney stones, POTASSIUM for Potassium deficiency, LEVOTHYROXINE for Thyroid disorder NOS, CLOPIDOGREL, CICLOSPORIN (RESTASIS), PRAVASTATIN, VITAMIN D3, COBAMAMIDE (VITAMIN B12 [COBAMAMIDE]), PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) and PLANTAGO OVATA SEED HUSK (PSYLLIUM HUSKS) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-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) (Subcutaneous) 40 mg. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Vaccination site pain). In March 2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Vaccination site pain) to be probably related.    Concomitant medication clopidogrel was as blood thinner, restasis as eye medicine, metamucil and psyllium husks helps to go to bathroom.  Patient abstains from alcohol.  On Nov 2020, patient fell down and experienced torn muscle and shoulder pain. Patient had concomitant therapy of C Pap Oxygen Level three. Patient underwent x-ray and magnetic resonance imaging on unknown date and was advised to undergo a surgery.  On 08 Feb 2021, patient underwent surgery and was treated with oxycodone and ibuprofen for the shoulder pain. Patient discontinued humira two to three weeks before the surgery and restart it two to three weeks after the surgery. On 09 Feb 2021, patient was discharged from hospital. Patient was on therapy and was recovering.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: unexpected menstruation cycle; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (unexpected menstruation cycle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (unexpected menstruation cycle). At the time of the report, MENSTRUATION IRREGULAR (unexpected menstruation cycle) outcome was unknown.       Action taken with Moderna covid-19 vaccine( mRNA-1273 )was not applicable
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pruritus, Pyrexia
Clinical narrative: chills; nausea; fever; headache; itchiness; rash; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea), PYREXIA (fever), HEADACHE (headache) and RASH (rash) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     ethnicity: Not Hispanic or Latino.  The patient's past medical history included Type 2 diabetes mellitus in August 2006. Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]) for Blood pressure high, SIMVASTATIN, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and ASCORBIC ACID, BIOFLAVONOIDS NOS (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]) for an unknown indication.   On 03-Feb-2021, 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) (unknown route) dosage was changed to 2. On 02-Nov-2011, the patient experienced RASH (rash). On 02-Nov-2020, the patient experienced PRURITUS (itchiness). On 03-Mar-2021, the patient experienced CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and HEADACHE (headache). On 18-Feb-2021, RASH (rash) and PRURITUS (itchiness) had resolved. On 05-Mar-2021, CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant list is provided. No treatment is given.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No information is provided in the attached document of the additional information. On 29-Apr-2021: Additional info-2 On 03-May-2021: No specific follow-up information recorded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: chills; nausea; fever; headache; itchiness; rash; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea), PYREXIA (fever), HEADACHE (headache) and RASH (rash) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     ethnicity: Not Hispanic or Latino.  The patient's past medical history included Type 2 diabetes mellitus in August 2006. Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]) for Blood pressure high, SIMVASTATIN, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and ASCORBIC ACID, BIOFLAVONOIDS NOS (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]) for an unknown indication.   On 03-Feb-2021, 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) (unknown route) dosage was changed to 2. On 02-Nov-2011, the patient experienced RASH (rash). On 02-Nov-2020, the patient experienced PRURITUS (itchiness). On 03-Mar-2021, the patient experienced CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and HEADACHE (headache). On 18-Feb-2021, RASH (rash) and PRURITUS (itchiness) had resolved. On 05-Mar-2021, CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant list is provided. No treatment is given.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No information is provided in the attached document of the additional information. On 29-Apr-2021: Additional info-2 On 03-May-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in an adult 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 information was reported.   On an unknown date, the patient received first 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 VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date patient experienced little twinge in arm after vaccination  No treatment medications reported
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: sore arm; little tired; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (little tired) and HEADACHE (bad headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022HPVP and 030BZIA) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for Allergy.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (little tired) and HEADACHE (bad headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 30-Mar-2021, HEADACHE (bad headache) had resolved. At the time of the report, FATIGUE (little tired) outcome was unknown.            Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-101504 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101504:Second dose case
Sex: U
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: soreness; 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 PAIN (soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (soreness). At the time of the report, PAIN (soreness) outcome was unknown.            No relevant concomitant medication information provided.  No relevant treatment medication information provided.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain, Vaccination site pain
Clinical narrative: feeling unwell; generalized aching; Vaccination site pain; fatigue; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (feeling unwell), PAIN (generalized aching), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue) in a 27-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) injection for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MALAISE (feeling unwell), PAIN (generalized aching), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue). At the time of the report, MALAISE (feeling unwell), PAIN (generalized aching), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not Applicable.  No Concomitant medication information reported. No treatment medication information reported.