chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Bone pain; Strong body aches; Headache; Fever; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BONE PAIN (Bone pain), MYALGIA (Strong body aches), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19, Panic attack, Breathing difficult, Fever, Chills, Nausea, Vomiting and Diarrhea.   On 03-Mar-2021, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced BONE PAIN (Bone pain), MYALGIA (Strong body aches), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 500 mg. At the time of the report, BONE PAIN (Bone pain), MYALGIA (Strong body aches), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Thyroid disorder: inconclusive (Inconclusive) Inconclusive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       The concomitant medications were provided as unknown medication for thyroid.  Action taken with mRNA-1273 in response to the drug was no change   This case was linked to US-MODERNATX, INC.-MOD-2021-070034 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070034:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: Bone pain; Strong body aches; Headache; Fever; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BONE PAIN (Bone pain), MYALGIA (Strong body aches), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19, Panic attack, Breathing difficult, Fever, Chills, Nausea, Vomiting and Diarrhea.   On 03-Mar-2021, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced BONE PAIN (Bone pain), MYALGIA (Strong body aches), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 500 mg. At the time of the report, BONE PAIN (Bone pain), MYALGIA (Strong body aches), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Thyroid disorder: inconclusive (Inconclusive) Inconclusive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       The concomitant medications were provided as unknown medication for thyroid.  Action taken with mRNA-1273 in response to the drug was no change   This case was linked to US-MODERNATX, INC.-MOD-2021-070034 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070034:
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: contracted COVID-19; 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 SARS-COV-2 TEST POSITIVE (contracted COVID-19) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (contracted COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (contracted COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-069798, US-MODERNATX, INC.-MOD-2021-069807 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069798:Crosslinked (First dose) US-MODERNATX, INC.-MOD-2021-069807:Crosslinked (second dose)
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Platelet count
Clinical narrative: Cramps in head/cramps in all over her body; fatigue in all over her body; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps in head/cramps in all over her body) and FATIGUE (fatigue in all over her body) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension and Thyroid disorder. Concomitant products included METFORMIN for Diabetes, TELMISARTAN for Hypertension.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced MUSCLE SPASMS (Cramps in head/cramps in all over her body) and FATIGUE (fatigue in all over her body). At the time of the report, MUSCLE SPASMS (Cramps in head/cramps in all over her body) and FATIGUE (fatigue in all over her body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Platelet count: low Low. On 05-Apr-2021, Platelet count: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Leboxetoril for thyroids. Treatment medication included Ibuprofen. Platelets were low before the vaccine, and 5 days after the vaccine platelets were normal
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: headache; arm pain at the injection; body ache; joint ache; nausea; fatigue; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), VACCINATION SITE PAIN (arm pain at the injection), MYALGIA (body ache), ARTHRALGIA (joint ache) and NAUSEA (nausea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported.).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced HEADACHE (headache), VACCINATION SITE PAIN (arm pain at the injection), MYALGIA (body ache), ARTHRALGIA (joint ache), NAUSEA (nausea), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever). On 03-Apr-2021, HEADACHE (headache), VACCINATION SITE PAIN (arm pain at the injection), MYALGIA (body ache), ARTHRALGIA (joint ache), NAUSEA (nausea), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment details included Tylenol.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: headache; arm pain at the injection; body ache; joint ache; nausea; fatigue; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), VACCINATION SITE PAIN (arm pain at the injection), MYALGIA (body ache), ARTHRALGIA (joint ache) and NAUSEA (nausea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported.).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced HEADACHE (headache), VACCINATION SITE PAIN (arm pain at the injection), MYALGIA (body ache), ARTHRALGIA (joint ache), NAUSEA (nausea), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever). On 03-Apr-2021, HEADACHE (headache), VACCINATION SITE PAIN (arm pain at the injection), MYALGIA (body ache), ARTHRALGIA (joint ache), NAUSEA (nausea), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment details included Tylenol.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Tenderness
Clinical narrative: Tender to the touch; Headache; Swollen gland on the right side of the neck; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender to the touch), HEADACHE (Headache) and LYMPHADENOPATHY (Swollen gland on the right side of the neck) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced HEADACHE (Headache) and LYMPHADENOPATHY (Swollen gland on the right side of the neck). On 07-Apr-2021, the patient experienced TENDERNESS (Tender to the touch). At the time of the report, TENDERNESS (Tender to the touch), HEADACHE (Headache) and LYMPHADENOPATHY (Swollen gland on the right side of the neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Rash, Vaccination site pruritus
Clinical narrative: Shoulder pain; Itchy at injection site; Rash -across chest to face and eyes; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain), VACCINATION SITE PRURITUS (Itchy at injection site) and RASH (Rash -across chest to face and eyes) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis and Surgery (Surgery to right arm).    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced RASH (Rash -across chest to face and eyes). On an unknown date, the patient experienced ARTHRALGIA (Shoulder pain) and VACCINATION SITE PRURITUS (Itchy at injection site). At the time of the report, ARTHRALGIA (Shoulder pain), VACCINATION SITE PRURITUS (Itchy at injection site) and RASH (Rash -across chest to face and eyes) outcome was unknown. Not Provided          Concomitant product use included singular.  Treatment details included benadryl.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: weakness; sleepiness; tiredness; fever of 101°F/elevated temperature of 102 for a few days; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA, SOMNOLENCE, FATIGUE, PYREXIA, and HEADACHE in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026b21a and 003A21A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy and Bone marrow disorder. Concurrent medical conditions included Blood pressure. Concomitant products included MULTIVITAMIN and VITAMIN D for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced ASTHENIA, SOMNOLENCE, FATIGUE, PYREXIA, and HEADACHE. The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA, SOMNOLENCE, FATIGUE, and HEADACHE outcome was unknown, and PYREXIA had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 101 (High). On an unknown date, Body temperature: 102 (High).         Concomitant Included Blood pressure medication.   This case was linked to MOD-2021-047276.   Most recent FOLLOW-UP information incorporated above on 06-Jul-2021, Follow-up information received on 06-jul-2021 contains significant information patient lab data updated result, event pyrexia outcome updated to recovered resolved.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: weakness; sleepiness; tiredness; fever of 101°F/elevated temperature of 102 for a few days; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA, SOMNOLENCE, FATIGUE, PYREXIA, and HEADACHE in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026b21a and 003A21A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy and Bone marrow disorder. Concurrent medical conditions included Blood pressure. Concomitant products included MULTIVITAMIN and VITAMIN D for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced ASTHENIA, SOMNOLENCE, FATIGUE, PYREXIA, and HEADACHE. The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA, SOMNOLENCE, FATIGUE, and HEADACHE outcome was unknown, and PYREXIA had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 101 (High). On an unknown date, Body temperature: 102 (High).         Concomitant Included Blood pressure medication.   This case was linked to MOD-2021-047276.   Most recent FOLLOW-UP information incorporated above on 06-Jul-2021, Follow-up information received on 06-jul-2021 contains significant information patient lab data updated result, event pyrexia outcome updated to recovered resolved.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Head discomfort, Influenza like illness, Pain in extremity, Rhinorrhoea
Clinical narrative: Soreness in her left arm; Runny nose; Tenderness in her left arm; General weakness; Flu-like Symptoms; Her head is bloated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her left arm), RHINORRHOEA (Runny nose), TENDERNESS (Tenderness in her left arm), ASTHENIA (General weakness) and INFLUENZA LIKE ILLNESS (Flu-like Symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced RHINORRHOEA (Runny nose), TENDERNESS (Tenderness in her left arm), ASTHENIA (General weakness), INFLUENZA LIKE ILLNESS (Flu-like Symptoms) and HEAD DISCOMFORT (Her head is bloated). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in her left arm). At the time of the report, PAIN IN EXTREMITY (Soreness in her left arm), RHINORRHOEA (Runny nose), TENDERNESS (Tenderness in her left arm), ASTHENIA (General weakness), INFLUENZA LIKE ILLNESS (Flu-like Symptoms) and HEAD DISCOMFORT (Her head is bloated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Soreness in her left arm; Runny nose; Tenderness in her left arm; General weakness; Flu-like Symptoms; Her head is bloated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her left arm), RHINORRHOEA (Runny nose), TENDERNESS (Tenderness in her left arm), ASTHENIA (General weakness) and INFLUENZA LIKE ILLNESS (Flu-like Symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced RHINORRHOEA (Runny nose), TENDERNESS (Tenderness in her left arm), ASTHENIA (General weakness), INFLUENZA LIKE ILLNESS (Flu-like Symptoms) and HEAD DISCOMFORT (Her head is bloated). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in her left arm). At the time of the report, PAIN IN EXTREMITY (Soreness in her left arm), RHINORRHOEA (Runny nose), TENDERNESS (Tenderness in her left arm), ASTHENIA (General weakness), INFLUENZA LIKE ILLNESS (Flu-like Symptoms) and HEAD DISCOMFORT (Her head is bloated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Illness, Pyrexia
Clinical narrative: fever of 101°F-102°F for 3-4hours; feeling really sick; high temperature; chills; felt really tired; shivering; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (feeling really sick), PYREXIA (high temperature), CHILLS (chills), FATIGUE (felt really tired) and CHILLS (shivering) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) 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 10-Mar-2021, the patient experienced ILLNESS (feeling really sick). 10-Mar-2021, the patient experienced PYREXIA (high temperature), CHILLS (chills), FATIGUE (felt really tired) and CHILLS (shivering). On an unknown date, the patient experienced PYREXIA (fever of 101°F-102°F for 3-4hours). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Mar-2021, CHILLS (chills), FATIGUE (felt really tired) and CHILLS (shivering) outcome was unknown. At the time of the report, ILLNESS (feeling really sick), PYREXIA (high temperature) and PYREXIA (fever of 101°F-102°F for 3-4hours) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case pertains to patient 2. Cases will be crosslinked. This patient (Patient 2) called a doctor and done blood work. The patient took Tylenol for treatment and the patient will see a doctor. concomitant medication include High blood pressure medication.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Needle issue, Underdose
Clinical narrative: Needle broke off and a portion of the vaccine dribbled down her arm; Needle broke off and a portion of the vaccine dribbled down her arm; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Needle broke off and a portion of the vaccine dribbled down her arm) and NEEDLE ISSUE (Needle broke off and a portion of the vaccine dribbled down her arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced UNDERDOSE (Needle broke off and a portion of the vaccine dribbled down her arm) and NEEDLE ISSUE (Needle broke off and a portion of the vaccine dribbled down her arm). On 17-Mar-2021, UNDERDOSE (Needle broke off and a portion of the vaccine dribbled down her arm) and NEEDLE ISSUE (Needle broke off and a portion of the vaccine dribbled down her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: Bad chills; Fever; Bad headache; Every joint aches; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Bad chills), PYREXIA (Fever), HEADACHE (Bad headache) and ARTHRALGIA (Every joint aches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced CHILLS (Bad chills), PYREXIA (Fever), HEADACHE (Bad headache) and ARTHRALGIA (Every joint aches). At the time of the report, CHILLS (Bad chills), PYREXIA (Fever), HEADACHE (Bad headache) and ARTHRALGIA (Every joint aches) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Headache, Malaise, Nausea
Clinical narrative: Shaking; Chills; headache; nausea; metallic tase; malaise; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (Shaking), CHILLS (Chills), HEADACHE (headache), NAUSEA (nausea) and DYSGEUSIA (metallic tase) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ringing in ears on 03-Mar-2021, Paracentesis ears on 03-Mar-2021, Malaise from 04-Feb-2021 to 06-Feb-2021, Taste metallic from 04-Feb-2021 to 06-Feb-2021, Nausea from 04-Feb-2021 to 06-Feb-2021, Headache from 04-Feb-2021 to 06-Feb-2021, Chills from 04-Feb-2021 to 06-Feb-2021 and Shaking from 04-Feb-2021 to 06-Feb-2021. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Migraine, BISOPROLOL FUMARATE (ZEBETA), HCTZ, KCL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), AMLODIPINE BESILATE (NORVASC), LISINOPRIL DIHYDRATE (PRINIVIL), TRAVOPROST (TRAVATAN BAK FREE), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), COLECALCIFEROL (VITAMIN D 3), ASCORBIC ACID, ZINC SULFATE (VITAMIN C & ZINK), PROBIOTIC 10, CALCIUM and MULTIVITAMIN & MINERAL for an unknown indication.   On 04-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 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (headache), NAUSEA (nausea), DYSGEUSIA (metallic tase) and MALAISE (malaise). On 05-Feb-2021, the patient experienced TREMOR (Shaking) and CHILLS (Chills). On 06-Feb-2021, TREMOR (Shaking), CHILLS (Chills), HEADACHE (headache), NAUSEA (nausea), DYSGEUSIA (metallic tase) and MALAISE (malaise) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Shaking; Chills; headache; nausea; metallic tase; malaise; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (Shaking), CHILLS (Chills), HEADACHE (headache), NAUSEA (nausea) and DYSGEUSIA (metallic tase) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ringing in ears on 03-Mar-2021, Paracentesis ears on 03-Mar-2021, Malaise from 04-Feb-2021 to 06-Feb-2021, Taste metallic from 04-Feb-2021 to 06-Feb-2021, Nausea from 04-Feb-2021 to 06-Feb-2021, Headache from 04-Feb-2021 to 06-Feb-2021, Chills from 04-Feb-2021 to 06-Feb-2021 and Shaking from 04-Feb-2021 to 06-Feb-2021. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Migraine, BISOPROLOL FUMARATE (ZEBETA), HCTZ, KCL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), AMLODIPINE BESILATE (NORVASC), LISINOPRIL DIHYDRATE (PRINIVIL), TRAVOPROST (TRAVATAN BAK FREE), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), COLECALCIFEROL (VITAMIN D 3), ASCORBIC ACID, ZINC SULFATE (VITAMIN C & ZINK), PROBIOTIC 10, CALCIUM and MULTIVITAMIN & MINERAL for an unknown indication.   On 04-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 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (headache), NAUSEA (nausea), DYSGEUSIA (metallic tase) and MALAISE (malaise). On 05-Feb-2021, the patient experienced TREMOR (Shaking) and CHILLS (Chills). On 06-Feb-2021, TREMOR (Shaking), CHILLS (Chills), HEADACHE (headache), NAUSEA (nausea), DYSGEUSIA (metallic tase) and MALAISE (malaise) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Muscle tightness
Clinical narrative: Fever; Chills; Fatigue; Headaches; Muscle pain; Joint pain; Soreness on his arm/Tenderness on his arm; Tightness on his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, MUSCLE TIGHTNESS, PYREXIA, CHILLS, and FATIGUE in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic. Concomitant products included ESCITALOPRAM, ROSUVASTATIN, INSULIN, VITAMINS, and AMLODIPINE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY and MUSCLE TIGHTNESS. On 10-Mar-2021, the patient experienced PYREXIA, CHILLS, FATIGUE, HEADACHE, MYALGIA, and ARTHRALGIA. On 11-Mar-2021, PYREXIA had resolved. On 13-Mar-2021, CHILLS, FATIGUE, HEADACHE, MYALGIA, and ARTHRALGIA had resolved. On 14-Mar-2021, PAIN IN EXTREMITY and MUSCLE TIGHTNESS had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included Blood thinner. Treatment information were not provided.   This case was linked to MOD-2021-070009.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up information received on 19-may-2021 contains non-significant information. Sender's Comments: MOD-2021-070009: 2nd dose.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; Fatigue; Headaches; Muscle pain; Joint pain; Soreness on his arm/Tenderness on his arm; Tightness on his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, MUSCLE TIGHTNESS, PYREXIA, CHILLS, and FATIGUE in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic. Concomitant products included ESCITALOPRAM, ROSUVASTATIN, INSULIN, VITAMINS, and AMLODIPINE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY and MUSCLE TIGHTNESS. On 10-Mar-2021, the patient experienced PYREXIA, CHILLS, FATIGUE, HEADACHE, MYALGIA, and ARTHRALGIA. On 11-Mar-2021, PYREXIA had resolved. On 13-Mar-2021, CHILLS, FATIGUE, HEADACHE, MYALGIA, and ARTHRALGIA had resolved. On 14-Mar-2021, PAIN IN EXTREMITY and MUSCLE TIGHTNESS had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included Blood thinner. Treatment information were not provided.   This case was linked to MOD-2021-070009.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up information received on 19-may-2021 contains non-significant information. Sender's Comments: MOD-2021-070009: 2nd dose.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: bone aches; chills; headache; is also tired; pain in the arm that started that afternoon.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm that started that afternoon.), BONE PAIN (bone aches), CHILLS (chills), HEADACHE (headache) and FATIGUE (is also tired) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm that started that afternoon.). On 07-Apr-2021, the patient experienced BONE PAIN (bone aches), CHILLS (chills), HEADACHE (headache) and FATIGUE (is also tired). At the time of the report, PAIN IN EXTREMITY (pain in the arm that started that afternoon.), BONE PAIN (bone aches), CHILLS (chills), HEADACHE (headache) and FATIGUE (is also tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    concomitant medications included pill for sugar, fish capsule and pill for cholesterol.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Stress
Clinical narrative: headache; Stress; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and STRESS (Stress) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 04-Apr-2021, the patient experienced HEADACHE (headache) and STRESS (Stress). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) and STRESS (Stress) outcome was unknown. Not Provided
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.   Most recent FOLLOW-UP information incorporated above included on 25-Jun-2021: Follow-up contains, Non-significant information.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nasal congestion, Pain in extremity, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid; Arm pain; Flu like symptoms; nose congestion; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid), PAIN IN EXTREMITY (Arm pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NASAL CONGESTION (nose congestion) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NASAL CONGESTION (nose congestion). On 23-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid), PAIN IN EXTREMITY (Arm pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NASAL CONGESTION (nose congestion) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Ringing in ears; Stuffed up feeling in ears; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (Ringing in ears) and EAR DISCOMFORT (Stuffed up feeling in ears) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination.     Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Migraine, BISOPROLOL FUMARATE (ZEBETA), HCTZ, KCL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), AMLODIPINE BESILATE (NORVASC), LISINOPRIL DIHYDRATE (PRINIVIL), TRAVOPROST (TRAVATAN), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID], PROBIOTICS NOS, CALCIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 04-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) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced TINNITUS (Ringing in ears) and EAR DISCOMFORT (Stuffed up feeling in ears). At the time of the report, TINNITUS (Ringing in ears) and EAR DISCOMFORT (Stuffed up feeling in ears) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history was reported by the reporter. No treatment information was provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) on 07-Apr-2021 for Headache, at a dose of 500 mg. At the time of the report, HEADACHE (Headaches) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Influenza, Pharyngitis streptococcal
Clinical narrative: Bronchitis; Strep throat; Influenza B; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), PHARYNGITIS STREPTOCOCCAL (Strep throat) and INFLUENZA (Influenza B) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced BRONCHITIS (Bronchitis), PHARYNGITIS STREPTOCOCCAL (Strep throat) and INFLUENZA (Influenza B). At the time of the report, BRONCHITIS (Bronchitis), PHARYNGITIS STREPTOCOCCAL (Strep throat) and INFLUENZA (Influenza B) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient was prescribed with Amoxicillin, Mucinex and Prednisone.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache in the forehead area and it is dull and constant; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache in the forehead area and it is dull and constant) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HEADACHE (Headache in the forehead area and it is dull and constant). At the time of the report, HEADACHE (Headache in the forehead area and it is dull and constant) had not resolved.            Concomitant product use was not provided by the reporter.  Treatment medications included Ibuprofen for headache and cetirizine for allergies.  Action taken with mRNA-1273 in response to the events was not Applicable  Company comment:Based on he current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on he current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and FATIGUE (fatigue) 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 PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.7 (High) The patient had fever.         No concomitant medications were reported.No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Ocular discomfort
Clinical narrative: Bleeding nose; Eye discomfort; This spontaneous case was reported by a nurse and describes the occurrence of EPISTAXIS (Bleeding nose) and OCULAR DISCOMFORT (Eye discomfort) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced EPISTAXIS (Bleeding nose) and OCULAR DISCOMFORT (Eye discomfort). On 13-Mar-2021, EPISTAXIS (Bleeding nose) and OCULAR DISCOMFORT (Eye discomfort) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were provided.   This case was linked to -MODERNATX, INC.-MOD-2021-069928 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-069928:Case for second dose
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Hypokinesia, Muscular weakness, Oedema peripheral
Clinical narrative: sleeping up to 14 hours a day; pain in both arms but especially the left one; extreme fatigue; muscle weakness; difficulty getting out of chair; puffiness in her feet; hand tremors; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (hand tremors), MUSCULAR WEAKNESS (muscle weakness), HYPOKINESIA (difficulty getting out of chair), OEDEMA PERIPHERAL (puffiness in her feet) and HYPERSOMNIA (sleeping up to 14 hours a day) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dementia (The patient suffers from dementia, Site is worsening) since 2013, Hyperlipidemia (no recent changes) and Arthritis (increased pain, stiffness, difficulty getting up from chair, hand tremors since covid vaccines given). Concomitant products included DONEPEZIL for Dementia, VITAMIN B12 [VITAMIN B12 NOS] for Memory disturbance and Nerve damage.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced MUSCULAR WEAKNESS (muscle weakness), HYPOKINESIA (difficulty getting out of chair) and FATIGUE (extreme fatigue). In 2021, the patient experienced TREMOR (hand tremors) and OEDEMA PERIPHERAL (puffiness in her feet). On an unknown date, the patient experienced HYPERSOMNIA (sleeping up to 14 hours a day) and PAIN IN EXTREMITY (pain in both arms but especially the left one). At the time of the report, TREMOR (hand tremors), HYPOKINESIA (difficulty getting out of chair), OEDEMA PERIPHERAL (puffiness in her feet), HYPERSOMNIA (sleeping up to 14 hours a day), PAIN IN EXTREMITY (pain in both arms but especially the left one) and FATIGUE (extreme fatigue) had not resolved and MUSCULAR WEAKNESS (muscle weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Vitamin B12 gummies of 500 mcg were also taken as concomitant medication for memory and nerve function from  March 2021 and still ongoing  The symptoms mentioned previously (extreme tiredness, weakness, hand tremors, difficulty getting out of a chair, sleeping up to 14 hours a day, pain in extremities-epecially the left arm all started after the patient received the moderna vaccine.  It started with the first vaccine and is ongoing and has not resolved.  She saw her primary care doctor on 4/27/2021 who only said that he had not heard of the covid vaccine causing such symptoms for an extended period of time.  He also did not know whether the vaccine triggered worsening of her dementia.  The puffiness in her feet started around the last week of April.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Significant:Additional AE, medical history, con med updated