chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dizziness, Feeling abnormal, Headache
Clinical narrative: Body ache; Feeling very disorented; Dizzyness; Cough; Diarrhea; Itching on face and neck; Feeling very sick to my stomach; Feeling nausuated; Low grade fever; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body ache), FEELING ABNORMAL (Feeling very disorented), DIZZINESS (Dizzyness), COUGH (Cough) and DIARRHOEA (Diarrhea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus, Sjogren's, Rheumatoid arthritis and Osteoporosis. Concomitant products included PREDNISONE, CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and VITAMIN D3 for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (Body ache), FEELING ABNORMAL (Feeling very disorented), DIZZINESS (Dizzyness), COUGH (Cough), DIARRHOEA (Diarrhea), PRURITUS (Itching on face and neck), MALAISE (Feeling very sick to my stomach), NAUSEA (Feeling nausuated) and PYREXIA (Low grade fever). 13-Mar-2021, the patient experienced HEADACHE (Headache). On 27-Mar-2021, PAIN (Body ache), FEELING ABNORMAL (Feeling very disorented), DIZZINESS (Dizzyness), COUGH (Cough), DIARRHOEA (Diarrhea), PRURITUS (Itching on face and neck), MALAISE (Feeling very sick to my stomach), NAUSEA (Feeling nausuated), PYREXIA (Low grade fever) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Pruritus, Pyrexia
Clinical narrative: Body ache; Feeling very disorented; Dizzyness; Cough; Diarrhea; Itching on face and neck; Feeling very sick to my stomach; Feeling nausuated; Low grade fever; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body ache), FEELING ABNORMAL (Feeling very disorented), DIZZINESS (Dizzyness), COUGH (Cough) and DIARRHOEA (Diarrhea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus, Sjogren's, Rheumatoid arthritis and Osteoporosis. Concomitant products included PREDNISONE, CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN, ZINC, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and VITAMIN D3 for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (Body ache), FEELING ABNORMAL (Feeling very disorented), DIZZINESS (Dizzyness), COUGH (Cough), DIARRHOEA (Diarrhea), PRURITUS (Itching on face and neck), MALAISE (Feeling very sick to my stomach), NAUSEA (Feeling nausuated) and PYREXIA (Low grade fever). 13-Mar-2021, the patient experienced HEADACHE (Headache). On 27-Mar-2021, PAIN (Body ache), FEELING ABNORMAL (Feeling very disorented), DIZZINESS (Dizzyness), COUGH (Cough), DIARRHOEA (Diarrhea), PRURITUS (Itching on face and neck), MALAISE (Feeling very sick to my stomach), NAUSEA (Feeling nausuated), PYREXIA (Low grade fever) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Injection site pain, Lymphadenopathy
Clinical narrative: very large swollen lymph node; developed a very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (developed a very sore arm) and LYMPHADENOPATHY (very large swollen lymph node) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No medication history provided by the reporter.  Concomitant products included ATENOLOL for Blood pressure.   On 08-Apr-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 an unknown date, the patient experienced INJECTION SITE PAIN (developed a very sore arm) and LYMPHADENOPATHY (very large swollen lymph node). At the time of the report, INJECTION SITE PAIN (developed a very sore arm) outcome was unknown and LYMPHADENOPATHY (very large swollen lymph node) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: 150/84 (High) normally 122/70. On 08-Apr-2021, Heart rate: high High.         Patient took 25 mg of Atenolol for S.V.T. control and high blood pressure 90 minutes before the 2nd shot.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Decreased appetite, Headache, Myalgia, Pain in extremity
Clinical narrative: hand pain/leg pain/feet pain; Feet swelling; No appetite; Aches and pains; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (hand pain/leg pain/feet pain), PERIPHERAL SWELLING (Feet swelling), DECREASED APPETITE (No appetite), MYALGIA (Aches and pains) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030M20A) for COVID-19 vaccination.     Previously administered products included for Influenza: Influenza. Past adverse reactions to the above products included No adverse reaction with Influenza. Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergic to Cirpo), Asthma, Diabetes, Hypertension, Hypothyroidism, Peripheral neuropathy and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, SALBUTAMOL (ALBUTEROL HFA) for Asthma, METFORMIN, GLIPIZIDE, INSULIN GLARGINE, LIXISENATIDE (SOLIQUA) and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for Diabetes, METOPROLOL and LISINOPRIL for Hypertension, LEVOTHYROXINE for Hypothyroidism, GABAPENTIN for Peripheral neuropathy, EZETIMIBE (ZETIA), MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS] and VITAMIN B COMPLEX (VITAMIN B [VITAMIN B COMPLEX]) for an unknown indication.   On 09-Feb-2021 at 8:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (hand pain/leg pain/feet pain), PERIPHERAL SWELLING (Feet swelling), DECREASED APPETITE (No appetite), MYALGIA (Aches and pains) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (hand pain/leg pain/feet pain), PERIPHERAL SWELLING (Feet swelling), DECREASED APPETITE (No appetite), MYALGIA (Aches and pains) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Blood glucose: high (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medicines were not reported. Patient has experienced similar symptoms as was with the first dose but much worse and got recovered in 3 weeks. Patient missed two days of work due to body pain. The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-026817 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: hand pain/leg pain/feet pain; Feet swelling; No appetite; Aches and pains; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (hand pain/leg pain/feet pain), PERIPHERAL SWELLING (Feet swelling), DECREASED APPETITE (No appetite), MYALGIA (Aches and pains) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030M20A) for COVID-19 vaccination.     Previously administered products included for Influenza: Influenza. Past adverse reactions to the above products included No adverse reaction with Influenza. Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergic to Cirpo), Asthma, Diabetes, Hypertension, Hypothyroidism, Peripheral neuropathy and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, SALBUTAMOL (ALBUTEROL HFA) for Asthma, METFORMIN, GLIPIZIDE, INSULIN GLARGINE, LIXISENATIDE (SOLIQUA) and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for Diabetes, METOPROLOL and LISINOPRIL for Hypertension, LEVOTHYROXINE for Hypothyroidism, GABAPENTIN for Peripheral neuropathy, EZETIMIBE (ZETIA), MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS] and VITAMIN B COMPLEX (VITAMIN B [VITAMIN B COMPLEX]) for an unknown indication.   On 09-Feb-2021 at 8:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (hand pain/leg pain/feet pain), PERIPHERAL SWELLING (Feet swelling), DECREASED APPETITE (No appetite), MYALGIA (Aches and pains) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (hand pain/leg pain/feet pain), PERIPHERAL SWELLING (Feet swelling), DECREASED APPETITE (No appetite), MYALGIA (Aches and pains) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Blood glucose: high (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medicines were not reported. Patient has experienced similar symptoms as was with the first dose but much worse and got recovered in 3 weeks. Patient missed two days of work due to body pain. The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-026817 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, COVID-19, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Blood pressure dropped; Pain in arm; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), BLOOD PRESSURE DECREASED (Blood pressure dropped) and PAIN IN EXTREMITY (Pain in arm) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In December 2020, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced BLOOD PRESSURE DECREASED (Blood pressure dropped) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, COVID-19 (COVID-19), BLOOD PRESSURE DECREASED (Blood pressure dropped) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Covid-19 test was positive. On an unknown date, Blood pressure measurement: low (Low) On an unknown date, blood pressure dropped..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  The covid antibody infusion was also considered as a co-suspect. The event sore arm occurred in both doses of vaccine. The dechallenge result for the events were provided as not applicable and duration of therapy was given as discontinued.   This case was linked to MOD-2021-111971 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Off label use, X-ray
Clinical narrative: missed second COVID-19 vaccine; bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (missed second COVID-19 vaccine) and BRONCHITIS (bronchitis) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EN6202) for COVID-19 vaccination.     The patient's past medical history included Influenza A virus infection, Pacemaker insertion (cardiac) since an unknown date, Blood pressure high and Diabetic. Concomitant products included METFORMIN for an unknown indication.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. In March 2021, the patient experienced BRONCHITIS (bronchitis). On an unknown date, the patient experienced OFF LABEL USE (missed second COVID-19 vaccine). On 20-Apr-2021, BRONCHITIS (bronchitis) had resolved. At the time of the report, OFF LABEL USE (missed second COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment was not reported.  The caller reported the following: "that his wife said a lady that lives 6miles from the caller received the Moderna vaccine and that lady died with a blood clot in her brain"
Age: 36.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Blood pressure measurement: decreased (Low) Decreased. In December 2020, SARS-CoV-2 test: positive (Positive) Positive.     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 medication was reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) and FATIGUE (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 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 SOMNOLENCE (Sleepy) and FATIGUE (Tired). At the time of the report, SOMNOLENCE (Sleepy) and FATIGUE (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 provided.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Mobility decreased
Clinical narrative: Mobility decreased; This spontaneous case was reported by a physician and describes the occurrence of MOBILITY DECREASED (Mobility decreased) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for RA.    No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to Dose 2. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 15 mg once a day. In April 2021, the patient experienced MOBILITY DECREASED (Mobility decreased). At the time of the report, MOBILITY DECREASED (Mobility decreased) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Fatigue, Myalgia, Nasal congestion, Pain in extremity
Clinical narrative: Sore arm; Stuffy nose; Cough; Body aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NASAL CONGESTION (Stuffy nose), COUGH (Cough), MYALGIA (Body aches) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 096b21a and 032b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), NASAL CONGESTION (Stuffy nose), COUGH (Cough), MYALGIA (Body aches) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm), NASAL CONGESTION (Stuffy nose), COUGH (Cough), MYALGIA (Body aches) and FATIGUE (Fatigue) had not resolved.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (Increased joint pain in knees/Arthralgia) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis. Concurrent medical conditions included Arthralgia. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) UNK dosage form. On an unknown date, the patient experienced ARTHRALGIA (Increased joint pain in knees/Arthralgia). At the time of the report, ARTHRALGIA (Increased joint pain in knees/Arthralgia) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: First shot was bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (First shot was bad) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (First shot was bad). At the time of the report, VACCINATION COMPLICATION (First shot was bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.    This case was linked to MOD-2021-049757, MOD-2021-049757 (Patient Link).
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Slight headache; Muscle aches; Fatigued/Tired; Headache; Sore throat; Nasal cold-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Nasal cold-like symptoms), HEADACHE (Slight headache), MYALGIA (Muscle aches) and FATIGUE (Fatigued/Tired) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Slight headache) and MYALGIA (Muscle aches). In April 2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Nasal cold-like symptoms), FATIGUE (Fatigued/Tired) and HEADACHE (Headache). In April 2021, HEADACHE (Slight headache) and MYALGIA (Muscle aches) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigued/Tired) and HEADACHE (Headache) outcome was unknown and NASOPHARYNGITIS (Nasal cold-like symptoms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: (Negative) Patient checked for COVID infection which came as negative..         No relevant concomitant medications were reported.  No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-049494 (Patient Link).
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Slight headache; Muscle aches; Fatigued/Tired; Headache; Sore throat; Nasal cold-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Nasal cold-like symptoms), HEADACHE (Slight headache), MYALGIA (Muscle aches) and FATIGUE (Fatigued/Tired) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Slight headache) and MYALGIA (Muscle aches). In April 2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Nasal cold-like symptoms), FATIGUE (Fatigued/Tired) and HEADACHE (Headache). In April 2021, HEADACHE (Slight headache) and MYALGIA (Muscle aches) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigued/Tired) and HEADACHE (Headache) outcome was unknown and NASOPHARYNGITIS (Nasal cold-like symptoms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: (Negative) Patient checked for COVID infection which came as negative..         No relevant concomitant medications were reported.  No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-049494 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Injection site pain
Clinical narrative: fatigue; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and INJECTION SITE PAIN (soreness at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for an unknown indication.    Concurrent medical conditions included Uterine cancer. Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.   On 04-Feb-2021, the patient LENVATINIB MESILATE (LENVIMA) (unknown route) dosage was changed to 20 mg once a day. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and LENVATINIB MESILATE (LENVIMA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (fatigue) and INJECTION SITE PAIN (soreness at injection site). At the time of the report, FATIGUE (fatigue) and INJECTION SITE PAIN (soreness at injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  No treatment medications were provided.   This case was linked to MOD-2021-111399.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Initial additional document was received on 07-MAY-2021. It contains identification number and follow up AER number. It contains non significant information.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Decreased appetite, Diarrhoea, Headache
Clinical narrative: chills; nausea; diarrhea; loss of appetite; headache; bone pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea), DIARRHEA (diarrhea), DECREASED APPETITE (loss of appetite) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in June 2020.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced CHILLS (chills), NAUSEA (nausea), DIARRHEA (diarrhea), DECREASED APPETITE (loss of appetite), HEADACHE (headache) and BONE PAIN (bone pain). At the time of the report, CHILLS (chills), NAUSEA (nausea), DIARRHEA (diarrhea), DECREASED APPETITE (loss of appetite), HEADACHE (headache) and BONE PAIN (bone pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: chills; nausea; diarrhea; loss of appetite; headache; bone pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea), DIARRHEA (diarrhea), DECREASED APPETITE (loss of appetite) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in June 2020.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced CHILLS (chills), NAUSEA (nausea), DIARRHEA (diarrhea), DECREASED APPETITE (loss of appetite), HEADACHE (headache) and BONE PAIN (bone pain). At the time of the report, CHILLS (chills), NAUSEA (nausea), DIARRHEA (diarrhea), DECREASED APPETITE (loss of appetite), HEADACHE (headache) and BONE PAIN (bone pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: severe Headache; Fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe Headache), PYREXIA (Fever) and MYALGIA (Body ache) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (severe Headache), PYREXIA (Fever) and MYALGIA (Body ache). At the time of the report, HEADACHE (severe Headache), PYREXIA (Fever) and MYALGIA (Body ache) had resolved.            The  concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Chills, Diarrhoea
Clinical narrative: Weakness; Body ache; diarrhoea; stomach  ache; Shivering; Fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), ARTHRALGIA (Body ache), DIARRHOEA (diarrhoea), ABDOMINAL PAIN UPPER (stomach  ache) and CHILLS (Shivering) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced ASTHENIA (Weakness), ARTHRALGIA (Body ache), DIARRHOEA (diarrhoea), ABDOMINAL PAIN UPPER (stomach  ache), CHILLS (Shivering), PYREXIA (Fever) and VOMITING (vomiting). At the time of the report, ASTHENIA (Weakness), ARTHRALGIA (Body ache), DIARRHOEA (diarrhoea), ABDOMINAL PAIN UPPER (stomach  ache), CHILLS (Shivering), PYREXIA (Fever) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Weakness; Body ache; diarrhoea; stomach  ache; Shivering; Fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), ARTHRALGIA (Body ache), DIARRHOEA (diarrhoea), ABDOMINAL PAIN UPPER (stomach  ache) and CHILLS (Shivering) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced ASTHENIA (Weakness), ARTHRALGIA (Body ache), DIARRHOEA (diarrhoea), ABDOMINAL PAIN UPPER (stomach  ache), CHILLS (Shivering), PYREXIA (Fever) and VOMITING (vomiting). At the time of the report, ASTHENIA (Weakness), ARTHRALGIA (Body ache), DIARRHOEA (diarrhoea), ABDOMINAL PAIN UPPER (stomach  ache), CHILLS (Shivering), PYREXIA (Fever) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Neck pain
Clinical narrative: Pain in my neck; Joint pain in my knee; Where I recieved the shot is still sore; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in my neck), ARTHRALGIA (Joint pain in my knee) and INJECTION SITE PAIN (Where I recieved the shot is still sore) 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 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Pain in my neck), ARTHRALGIA (Joint pain in my knee) and INJECTION SITE PAIN (Where I recieved the shot is still sore). The patient was treated with Physical therapy for Neck pain; Physical therapy for Arthralgia and Physical therapy for Injection site pain. At the time of the report, NECK PAIN (Pain in my neck), ARTHRALGIA (Joint pain in my knee) and INJECTION SITE PAIN (Where I recieved the shot is still sore) outcome was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: no significant information was provided by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: fever; chills; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache). At the time of the report, PYREXIA (fever), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment details were reported.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration
Clinical narrative: Delayed dose Administration; Aching joints; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed dose Administration) and ARTHRALGIA (Aching joints) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) injection, solution for Psoriatic arthritis and 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) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form and COVID-19 VACCINE (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed dose Administration) and ARTHRALGIA (Aching joints). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed dose Administration) outcome was unknown and ARTHRALGIA (Aching joints) 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.   No concomitant medications was provided  No treatment information was provided
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Diarrhea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and PYREXIA (Fever) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and PYREXIA (Fever). At the time of the report, DIARRHOEA (Diarrhea) and PYREXIA (Fever) had resolved.            This case was linked MOD-2021-051527 (E2B Linked Report).; Sender's Comments:  MOD-2021-051527:First dose case
Age: 45.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Vaccination site pain, Vaccination site swelling
Clinical narrative: Joint range of motion decreased; Limbs stiffness; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased), MUSCULOSKELETAL STIFFNESS (Limbs stiffness), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No medical history provided by the reporter.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On 22-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). On 23-Apr-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased) and MUSCULOSKELETAL STIFFNESS (Limbs stiffness). On 23-Apr-2021, VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. At the time of the report, JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased) and MUSCULOSKELETAL STIFFNESS (Limbs stiffness) outcome was unknown and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Musculoskeletal discomfort
Clinical narrative: Shoulder discomfort; Unable to walk on her forearm crutches; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort) and GAIT INABILITY (Unable to walk on her forearm crutches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Post polio syndrome (idiopathic neuromuscular degeneration historically described as Post Polio Syndrome, with significant muscular atrophy to the legs. The patient has been unable to walk independently since 2000.).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort) and GAIT INABILITY (Unable to walk on her forearm crutches). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort) and GAIT INABILITY (Unable to walk on her forearm crutches) outcome was unknown.        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 medications of interest include an intrathecal morphine pump  which was surgically placed in September 2015.  In the ER, she was treated with a Toradol shot (dose, route unspecified) and was sent home with 800mg ibuprofen which she took for several days by an unspecified dosing regimen.     This case was linked to MOD-2021-112650 (Patient Link).   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the time of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Pain at the time of injection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Post polio syndrome and Intrathecal pump insertion (Morphine pump) in September 2015. Concurrent medical conditions included Unable to walk since 2000.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain at the time of injection). On 10-Mar-2021, VACCINATION SITE PAIN (Pain at the time of injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Pain at the time of injection) to be possibly related.    Concomitant medications included an intrathecal morphine pump surgically inserted in Sep 2015.  No treatment medications were provided by reporter.   This case was linked to MOD-2021-112646 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Fatigue; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Vaccination site pain, Fatigue and Pain (Sore Arm).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided. The Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcium, Lymphadenopathy, Pain in extremity, Vaccination site pain
Clinical narrative: Lymphadenopathy; arm very sore; injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymphadenopathy), VACCINATION SITE PAIN (injection site soreness) and PAIN IN EXTREMITY (arm very sore) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018821A) for an unknown indication.     Concurrent medical conditions included Asthma (Asthma is controlled) and Arthritis. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), IBUPROFEN (MOTRIN IB), ALPRAZOLAM (ALPROZAM), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and MARIJUANA.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site soreness). On 28-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymphadenopathy) and PAIN IN EXTREMITY (arm very sore). At the time of the report, LYMPHADENOPATHY (Lymphadenopathy), VACCINATION SITE PAIN (injection site soreness) and PAIN IN EXTREMITY (arm very sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood calcium: 1400 (High) high.         Patient was reported to  have skeletal muscular degenerative disease Patient is allergic to penicillin, Flagel, sulfa adhesive tape