chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Swelling, Tonsillar hypertrophy
Clinical narrative: went to ER since I could not bring fever down; sore throat; swollen; swollen tonsils; she was in bed for few days; it was red; it was hurting; chills; fever ranging from 100 to 104.1; soreness from her left elbow to her left ear; chest tightness; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (soreness from her left elbow to her left ear), CHEST DISCOMFORT (chest tightness), EMERGENCY CARE (went to ER since I could not bring fever down), OROPHARYNGEAL PAIN (sore throat) and SWELLING (swollen) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020 and Coronary artery disease.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (soreness from her left elbow to her left ear), CHEST DISCOMFORT (chest tightness), OROPHARYNGEAL PAIN (sore throat), SWELLING (swollen), TONSILLAR HYPERTROPHY (swollen tonsils), MALAISE (she was in bed for few days), ERYTHEMA (it was red), PAIN (it was hurting), CHILLS (chills) and PYREXIA (fever ranging from 100 to 104.1). On 25-Mar-2021, the patient experienced EMERGENCY CARE (went to ER since I could not bring fever down). At the time of the report, PAIN (soreness from her left elbow to her left ear), CHEST DISCOMFORT (chest tightness), EMERGENCY CARE (went to ER since I could not bring fever down), OROPHARYNGEAL PAIN (sore throat), SWELLING (swollen), TONSILLAR HYPERTROPHY (swollen tonsils), MALAISE (she was in bed for few days), ERYTHEMA (it was red), PAIN (it was hurting), CHILLS (chills) and PYREXIA (fever ranging from 100 to 104.1) outcome was unknown. 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 concomitant medications were provided.   No treatment was reported for the events.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus, Vaccination site mass
Clinical narrative: Itchy; Then it was raised; her injection site started to become red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), VACCINATION SITE MASS (Then it was raised) and INJECTION SITE ERYTHEMA (her injection site started to become red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Apr-2021, the patient experienced PRURITUS (Itchy), VACCINATION SITE MASS (Then it was raised) and INJECTION SITE ERYTHEMA (her injection site started to become red). At the time of the report, PRURITUS (Itchy), VACCINATION SITE MASS (Then it was raised) and INJECTION SITE ERYTHEMA (her injection site started to become red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information provided about any treatment and concomitant medications.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced INJECTION SITE PAIN (Sore arm). At the time of the report, INJECTION SITE PAIN (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-081447 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081447:Case for dose 2
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Patient scheduled to receive the second dose of the vaccine is being administered 90 days after first dose; This spontaneous case was reported by a physician and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Patient scheduled to receive the second dose of the vaccine is being administered 90 days after first dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient scheduled to receive the second dose of the vaccine is being administered 90 days after first dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Patient scheduled to receive the second dose of the vaccine is being administered 90 days after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm soreness) and FATIGUE (General fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041A21A and 046A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included INSULIN LISPRO (HUMALOG), LISINOPRIL, LAMOTRIGINE, METFORMIN and ATORVASTATIN for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection arm soreness) and FATIGUE (General fatigue). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Injection arm soreness) and FATIGUE (General fatigue) outcome was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: pain in Lymph nodes; Swelling in Lymph nodes; headache; fever; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (pain in Lymph nodes), LYMPHADENOPATHY (Swelling in Lymph nodes), HEADACHE (headache), PYREXIA (fever) and MYALGIA (muscle pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced LYMPH NODE PAIN (pain in Lymph nodes), LYMPHADENOPATHY (Swelling in Lymph nodes), HEADACHE (headache), PYREXIA (fever) and MYALGIA (muscle pain). At the time of the report, LYMPH NODE PAIN (pain in Lymph nodes), LYMPHADENOPATHY (Swelling in Lymph nodes), HEADACHE (headache), PYREXIA (fever) and MYALGIA (muscle pain) outcome was unknown.            Concomitant medication was not provided  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-081444 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081444:Case for dose 1
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SIMVASTATIN, TRANEXAMIC ACID (LYSTEDA), OMEPRAZOLE, VITAMIN D2, LISINOPRIL, METOPROLOL, METFORMIN, PROGESTERONE, SPIRONOLACTONE and PHENTERMINE HYDROCHLORIDE, TOPIRAMATE (QSYMIA) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced ALOPECIA (hair loss). At the time of the report, ALOPECIA (hair loss) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug include Qsymia-15/92 mg dose.  Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Refraction disorder, Vision blurred
Clinical narrative: Cant focus her eyes; Blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of REFRACTION DISORDER (Cant focus her eyes) and VISION BLURRED (Blurry vision) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 044B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-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 experienced REFRACTION DISORDER (Cant focus her eyes) and VISION BLURRED (Blurry vision). At the time of the report, REFRACTION DISORDER (Cant focus her eyes) and VISION BLURRED (Blurry vision) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable Other concomitant medications reported were Vitamins No treatment reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling face
Clinical narrative: Hurting of left arm for 48 hours/Achy left arm; Swelling of left side of face; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hurting of left arm for 48 hours/Achy left arm) and SWELLING FACE (Swelling of left side of face) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Hurting of left arm for 48 hours/Achy left arm) and SWELLING FACE (Swelling of left side of face). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Hurting of left arm for 48 hours/Achy left arm) outcome was unknown and SWELLING FACE (Swelling of left side of face) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Nausea, Vomiting
Clinical narrative: Loss of appetite; Diarrhea; nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), NAUSEA (nausea) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included IBD and Autoimmune disorder.   On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), NAUSEA (nausea) and VOMITING (Vomiting). At the time of the report, DECREASED APPETITE (Loss of appetite), DIARRHOEA (Diarrhea), NAUSEA (nausea) and VOMITING (Vomiting) outcome was unknown.            Concomitant medication information not provided. Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Headache, Myalgia
Clinical narrative: headache; tiredness; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (tiredness) and MYALGIA (body aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced HEADACHE (headache), FATIGUE (tiredness) and MYALGIA (body aches). At the time of the report, HEADACHE (headache), FATIGUE (tiredness) and MYALGIA (body aches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Blood pressure measurement: 170/90 (High) high 170/90.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported.. Treatment: Blood pressure medication
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hyperhidrosis, Nasopharyngitis
Clinical narrative: she feels under the weather; Sweating through the night and this morning; Patient feels like she is having a beginnings of a cold; Feel really tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she feels under the weather), HYPERHIDROSIS (Sweating through the night and this morning), NASOPHARYNGITIS (Patient feels like she is having a beginnings of a cold) and FATIGUE (Feel really tired) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (she feels under the weather), HYPERHIDROSIS (Sweating through the night and this morning), NASOPHARYNGITIS (Patient feels like she is having a beginnings of a cold) and FATIGUE (Feel really tired). At the time of the report, FEELING ABNORMAL (she feels under the weather), HYPERHIDROSIS (Sweating through the night and this morning), NASOPHARYNGITIS (Patient feels like she is having a beginnings of a cold) and FATIGUE (Feel really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not reported.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare
Clinical narrative: horrible horrible dreams; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (horrible horrible dreams) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Dreams abnormal in 2017. Previously administered products included for Product used for unknown indication: Amlodipine in 2017. Past adverse reactions to the above products included Dreams abnormal with Amlodipine.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced NIGHTMARE (horrible horrible dreams). At the time of the report, NIGHTMARE (horrible horrible dreams) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The  patient was taking 24 hr. Tylenol to help her sleep.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Pyrexia, Sensory loss
Clinical narrative: couldn't smell or taste anything; coughing; headaches; fatigued; fever; This spontaneous case was reported by a consumer and describes the occurrence of SENSORY LOSS (couldn't smell or taste anything), COUGH (coughing), HEADACHE (headaches), FATIGUE (fatigued) and PYREXIA (fever) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SENSORY LOSS (couldn't smell or taste anything), COUGH (coughing), HEADACHE (headaches), FATIGUE (fatigued) and PYREXIA (fever). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SENSORY LOSS (couldn't smell or taste anything), COUGH (coughing), HEADACHE (headaches), FATIGUE (fatigued) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Need to redo the 1st dose because of temp excursion; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Need to redo the 1st dose because of temp excursion) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-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 PRODUCT TEMPERATURE EXCURSION ISSUE (Need to redo the 1st dose because of temp excursion). On 07-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Need to redo the 1st dose because of temp excursion) had resolved.            Treatment medication not provided. Concomitant medication not provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dysstasia, Feeling abnormal, Gait inability, Head discomfort
Clinical narrative: very high temperature; needed help going to the bathroom; feels a little fussy headed; slept till the next evening; felt very miserably; couldn't get out of bed; COVID-19 Test positive; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BODY TEMPERATURE INCREASED (very high temperature), GAIT INABILITY (needed help going to the bathroom), HEAD DISCOMFORT (feels a little fussy headed), SOMNOLENCE (slept till the next evening) and FEELING ABNORMAL (felt very miserably) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had COVID19 last December.) in December 2020. Concurrent medical conditions included COPD. Concomitant products included CITALOPRAM, FAMOTIDINE, IRON, LOSARTAN, METOPROLOL, ALENDRONATE SODIUM (FOSAMAX), SIMVASTATIN, PREDNISONE and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced BODY TEMPERATURE INCREASED (very high temperature), GAIT INABILITY (needed help going to the bathroom), HEAD DISCOMFORT (feels a little fussy headed), SOMNOLENCE (slept till the next evening), FEELING ABNORMAL (felt very miserably), DYSSTASIA (couldn't get out of bed) and SARS-COV-2 TEST POSITIVE (COVID-19 Test positive). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 18-Apr-2021, BODY TEMPERATURE INCREASED (very high temperature), GAIT INABILITY (needed help going to the bathroom), SOMNOLENCE (slept till the next evening), FEELING ABNORMAL (felt very miserably), DYSSTASIA (couldn't get out of bed) and SARS-COV-2 TEST POSITIVE (COVID-19 Test positive) had resolved. At the time of the report, HEAD DISCOMFORT (feels a little fussy headed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR received on 26-May-2021 contains significant information. Reporter informed that the patient is improving. Also stated that the patient may not receive the second dose of vaccine due to adverse event.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Somnolence
Clinical narrative: very high temperature; needed help going to the bathroom; feels a little fussy headed; slept till the next evening; felt very miserably; couldn't get out of bed; COVID-19 Test positive; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BODY TEMPERATURE INCREASED (very high temperature), GAIT INABILITY (needed help going to the bathroom), HEAD DISCOMFORT (feels a little fussy headed), SOMNOLENCE (slept till the next evening) and FEELING ABNORMAL (felt very miserably) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had COVID19 last December.) in December 2020. Concurrent medical conditions included COPD. Concomitant products included CITALOPRAM, FAMOTIDINE, IRON, LOSARTAN, METOPROLOL, ALENDRONATE SODIUM (FOSAMAX), SIMVASTATIN, PREDNISONE and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced BODY TEMPERATURE INCREASED (very high temperature), GAIT INABILITY (needed help going to the bathroom), HEAD DISCOMFORT (feels a little fussy headed), SOMNOLENCE (slept till the next evening), FEELING ABNORMAL (felt very miserably), DYSSTASIA (couldn't get out of bed) and SARS-COV-2 TEST POSITIVE (COVID-19 Test positive). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 18-Apr-2021, BODY TEMPERATURE INCREASED (very high temperature), GAIT INABILITY (needed help going to the bathroom), SOMNOLENCE (slept till the next evening), FEELING ABNORMAL (felt very miserably), DYSSTASIA (couldn't get out of bed) and SARS-COV-2 TEST POSITIVE (COVID-19 Test positive) had resolved. At the time of the report, HEAD DISCOMFORT (feels a little fussy headed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR received on 26-May-2021 contains significant information. Reporter informed that the patient is improving. Also stated that the patient may not receive the second dose of vaccine due to adverse event.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Feeling abnormal, Hypoaesthesia, Paraesthesia oral
Clinical narrative: numbness immediately on the right side of face (nose and mouth); tongue feeling not right; Nose felt strange; felt uncomfortable still within the 15 minutes; mild lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness immediately on the right side of face (nose and mouth)), PARAESTHESIA ORAL (tongue feeling not right), FEELING ABNORMAL (Nose felt strange), DISCOMFORT (felt uncomfortable still within the 15 minutes) and DIZZINESS (mild lightheadedness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.). Concomitant products included MULTI VIT, CYANOCOBALAMIN (B 12), BIOTIN and ASCORBIC ACID (VIT C) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HYPOAESTHESIA (numbness immediately on the right side of face (nose and mouth)), PARAESTHESIA ORAL (tongue feeling not right), FEELING ABNORMAL (Nose felt strange), DISCOMFORT (felt uncomfortable still within the 15 minutes) and DIZZINESS (mild lightheadedness). On 18-Mar-2021, HYPOAESTHESIA (numbness immediately on the right side of face (nose and mouth)), PARAESTHESIA ORAL (tongue feeling not right), FEELING ABNORMAL (Nose felt strange), DISCOMFORT (felt uncomfortable still within the 15 minutes) and DIZZINESS (mild lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no  treatment  details reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site erythema, Malaise, Nausea, Pain
Clinical narrative: feeling sick; aching; fever of 102.1; nauseous; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), PAIN (aching), PYREXIA (fever of 102.1), NAUSEA (nauseous) and INJECTION SITE ERYTHEMA (redness at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced MALAISE (feeling sick), PAIN (aching), PYREXIA (fever of 102.1), NAUSEA (nauseous) and INJECTION SITE ERYTHEMA (redness at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 20-Apr-2021, NAUSEA (nauseous) had resolved. At the time of the report, MALAISE (feeling sick), PAIN (aching), PYREXIA (fever of 102.1) and INJECTION SITE ERYTHEMA (redness at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Body temperature: 102.1 (High) High.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Concomitant drug information was high blood pressure medication.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feeling sick; aching; fever of 102.1; nauseous; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), PAIN (aching), PYREXIA (fever of 102.1), NAUSEA (nauseous) and INJECTION SITE ERYTHEMA (redness at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced MALAISE (feeling sick), PAIN (aching), PYREXIA (fever of 102.1), NAUSEA (nauseous) and INJECTION SITE ERYTHEMA (redness at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 20-Apr-2021, NAUSEA (nauseous) had resolved. At the time of the report, MALAISE (feeling sick), PAIN (aching), PYREXIA (fever of 102.1) and INJECTION SITE ERYTHEMA (redness at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Body temperature: 102.1 (High) High.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Concomitant drug information was high blood pressure medication.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: injection arm was considerably swollen; red spot at injection site was intensely red; the same symptoms came back more worse that before after 8 to 9 days; injection arm was more itchy.; injection arm soreness; injection arm was itchy; injection arm was swollen; developed red spot at the injection site; fatigue; malaise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection arm soreness), PRURITUS (injection arm was itchy), VACCINATION SITE SWELLING (injection arm was swollen), VACCINATION SITE ERYTHEMA (developed red spot at the injection site) and FATIGUE (fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection arm soreness), PRURITUS (injection arm was itchy), VACCINATION SITE SWELLING (injection arm was swollen), VACCINATION SITE ERYTHEMA (developed red spot at the injection site), FATIGUE (fatigue) and MALAISE (malaise). On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection arm was considerably swollen), VACCINATION SITE ERYTHEMA (red spot at injection site was intensely red), VACCINATION SITE REACTION (the same symptoms came back more worse that before after 8 to 9 days) and PRURITUS (injection arm was more itchy.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (injection arm soreness), PRURITUS (injection arm was itchy), VACCINATION SITE SWELLING (injection arm was swollen), VACCINATION SITE ERYTHEMA (developed red spot at the injection site), FATIGUE (fatigue), MALAISE (malaise), VACCINATION SITE SWELLING (injection arm was considerably swollen), VACCINATION SITE ERYTHEMA (red spot at injection site was intensely red), VACCINATION SITE REACTION (the same symptoms came back more worse that before after 8 to 9 days) and PRURITUS (injection arm was more itchy.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling
Clinical narrative: injection arm was considerably swollen; red spot at injection site was intensely red; the same symptoms came back more worse that before after 8 to 9 days; injection arm was more itchy.; injection arm soreness; injection arm was itchy; injection arm was swollen; developed red spot at the injection site; fatigue; malaise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection arm soreness), PRURITUS (injection arm was itchy), VACCINATION SITE SWELLING (injection arm was swollen), VACCINATION SITE ERYTHEMA (developed red spot at the injection site) and FATIGUE (fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection arm soreness), PRURITUS (injection arm was itchy), VACCINATION SITE SWELLING (injection arm was swollen), VACCINATION SITE ERYTHEMA (developed red spot at the injection site), FATIGUE (fatigue) and MALAISE (malaise). On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection arm was considerably swollen), VACCINATION SITE ERYTHEMA (red spot at injection site was intensely red), VACCINATION SITE REACTION (the same symptoms came back more worse that before after 8 to 9 days) and PRURITUS (injection arm was more itchy.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (injection arm soreness), PRURITUS (injection arm was itchy), VACCINATION SITE SWELLING (injection arm was swollen), VACCINATION SITE ERYTHEMA (developed red spot at the injection site), FATIGUE (fatigue), MALAISE (malaise), VACCINATION SITE SWELLING (injection arm was considerably swollen), VACCINATION SITE ERYTHEMA (red spot at injection site was intensely red), VACCINATION SITE REACTION (the same symptoms came back more worse that before after 8 to 9 days) and PRURITUS (injection arm was more itchy.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: nauseous; headache on and off; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) and HEADACHE (headache on and off) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced NAUSEA (nauseous) and HEADACHE (headache on and off). At the time of the report, NAUSEA (nauseous) and HEADACHE (headache on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant medication provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Myalgia, Paraesthesia oral
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of dyspnea (shortness of breath), oral paresthesia (tingling in tongue), pyrexia (fever), chills and extreme fatigue in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. The patient's past medical history included anaphylactic reaction to vaccine. Patient stated she had an anaphylactic shock with another vaccine, not Moderna. On Apr 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient had dyspnea (shortness of breath), oral paresthesia (tingling in tongue), pyrexia (fever), chills, extreme fatigue and myalgia (soreness). At the time of the report, dyspnea (shortness of breath), oral paresthesia (tingling in tongue), pyrexia (fever), chills, extreme fatigue and myalgia  (soreness) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.  No concomitant medications provided. Patient reported she had a "problem with epinephrine." No treatment reported for these events.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of dyspnea (shortness of breath), oral paresthesia (tingling in tongue), pyrexia (fever), chills and extreme fatigue in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. The patient's past medical history included anaphylactic reaction to vaccine. Patient stated she had an anaphylactic shock with another vaccine, not Moderna. On Apr 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient had dyspnea (shortness of breath), oral paresthesia (tingling in tongue), pyrexia (fever), chills, extreme fatigue and myalgia (soreness). At the time of the report, dyspnea (shortness of breath), oral paresthesia (tingling in tongue), pyrexia (fever), chills, extreme fatigue and myalgia  (soreness) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.  No concomitant medications provided. Patient reported she had a "problem with epinephrine." No treatment reported for these events.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: invalid dose interval beyond 36; pain at injection site right arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (invalid dose interval beyond 36) and VACCINATION SITE PAIN (pain at injection site right arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site right arm). On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (invalid dose interval beyond 36). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (invalid dose interval beyond 36) and VACCINATION SITE PAIN (pain at injection site right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided. No lab data was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up information received and outcome was updated and reported declined to FU.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis, Allergy (bactrim allergy) and Allergy (Feldene allergy). Concomitant products included METHOTREXATE for Arthritis. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.   Treatment information was not provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm).   On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on  regular blood pressure medications (unspecified).   This case was linked to US-MODERNATX, INC.-MOD-2021-081481 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081481:
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Swelling, Vaccination site rash
Clinical narrative: there was some swelling; right arm started itching; developed a slight rash on her right arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (there was some swelling), INJECTION SITE PRURITUS (right arm started itching) and VACCINATION SITE RASH (developed a slight rash on her right arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol and Clot blood (blood clots in her legs and lungs) since 23-Jan-2021. Concomitant products included RIVAROXABAN (XARELTO), LOVASTATIN, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), VITAMIN D [VITAMIN D NOS] and IRON for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced INJECTION SITE PRURITUS (right arm started itching) and VACCINATION SITE RASH (developed a slight rash on her right arm). On an unknown date, the patient experienced SWELLING (there was some swelling). At the time of the report, SWELLING (there was some swelling), INJECTION SITE PRURITUS (right arm started itching) and VACCINATION SITE RASH (developed a slight rash on her right arm) had resolved.            Treatment medication included  over the counter benadryl cream.  The symptoms started 3 days after the vaccine and lasted about 1-2 weeks.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant Follow- up received-the event swelling  added, duration of event  and outcome was updated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue
Clinical narrative: needle had broken when drawing the dose, resulting in the skin exposure to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (needle had broken when drawing the dose, resulting in the skin exposure to vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (needle had broken when drawing the dose, resulting in the skin exposure to vaccine). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 28-Mar-2021, DEVICE CONNECTION ISSUE (needle had broken when drawing the dose, resulting in the skin exposure to vaccine) outcome was unknown. Not Provided          Concomitant medication was not provided Treatment medication include ibuprofen     This case was linked to US-MODERNATX, INC.-MOD-2021-081345 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081345:1st dose
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: stiffness; sore arm; sore shoulder; fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), PAIN IN EXTREMITY (sore arm), ARTHRALGIA (sore shoulder) and PYREXIA (fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), PAIN IN EXTREMITY (sore arm), ARTHRALGIA (sore shoulder) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness), PAIN IN EXTREMITY (sore arm), ARTHRALGIA (sore shoulder) and PYREXIA (fever) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-275254.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up document received. .Second dose case created. Action taken updated.