chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle aches from elbow to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches from elbow to shoulder) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple myeloma. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), METOPROLOL FUMARATE (METOPROLOL [METOPROLOL FUMARATE]), DUTASTERIDE (AVODART), TAMSULOSIN, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), OXYCODONE, PANTOPRAZOLE, ACYCLOVIR [ACICLOVIR], ONDANSETRON, DEXAMETHASONE, BORTEZOMIB (VELCADE), ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D3, FISH OIL and FOLIC ACID for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced MYALGIA (Muscle aches from elbow to shoulder). At the time of the report, MYALGIA (Muscle aches from elbow to shoulder) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm is hurting at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is hurting at the injection site) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03AB21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm is hurting at the injection site). At the time of the report, VACCINATION SITE PAIN (Arm is hurting at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was not under any medication.  It was reported that patient's arm was hurting at injection site from the night of 12-Apr-2021 and was hurting at the time of reporting.  The patient did not receive any treatment for the symptom.
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea, Rash
Clinical narrative: Diapityriasis rosea; broke out in a rash, rash worse, spots with rash- on abdomen, trunk, and neck; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PITYRIASIS ROSEA (Diapityriasis rosea) and RASH (broke out in a rash, rash worse, spots with rash- on abdomen, trunk, and neck) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0021321A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PITYRIASIS ROSEA (Diapityriasis rosea) and RASH (broke out in a rash, rash worse, spots with rash- on abdomen, trunk, and neck). At the time of the report, PITYRIASIS ROSEA (Diapityriasis rosea) and RASH (broke out in a rash, rash worse, spots with rash- on abdomen, trunk, and neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included prednisone and steroid cream.  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.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: patient's medication history, updated information of events, treatment information; 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site right arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site right arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site right arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-076358 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal discomfort, SARS-CoV-2 test
Clinical narrative: Throat feels different from normal; Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) and OROPHARYNGEAL DISCOMFORT (Throat feels different from normal) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced COVID-19 (Tested positive for Covid). On an unknown date, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat feels different from normal). At the time of the report, COVID-19 (Tested positive for Covid) and OROPHARYNGEAL DISCOMFORT (Throat feels different from normal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Influenza like illness, Musculoskeletal discomfort
Clinical narrative: Arm swollen/ swollen upper arm and down arm to muscle/ arm pit swelling; Painful  arm area / sore arm above and underneath; Flu-like; Sweats; Nodules /  two large nodules and one small nodule under arm / nodules are tender /  thumb size nodules; Neck sniff; Nodules are tender; Fever up to 101.9 degrees; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen/ swollen upper arm and down arm to muscle/ arm pit swelling), PAIN IN EXTREMITY (Painful  arm area / sore arm above and underneath), INFLUENZA LIKE ILLNESS (Flu-like), HYPERHIDROSIS (Sweats) and NODULE (Nodules /  two large nodules and one small nodule under arm / nodules are tender /  thumb size nodules) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and BP (BLOOD PRESSURE) for an unknown indication.   On 10-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) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen/ swollen upper arm and down arm to muscle/ arm pit swelling), PAIN IN EXTREMITY (Painful  arm area / sore arm above and underneath), INFLUENZA LIKE ILLNESS (Flu-like), HYPERHIDROSIS (Sweats), NODULE (Nodules /  two large nodules and one small nodule under arm / nodules are tender /  thumb size nodules), MUSCULOSKELETAL DISCOMFORT (Neck sniff), TENDERNESS (Nodules are tender), PYREXIA (Fever up to 101.9 degrees) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm swollen/ swollen upper arm and down arm to muscle/ arm pit swelling), PAIN IN EXTREMITY (Painful  arm area / sore arm above and underneath), INFLUENZA LIKE ILLNESS (Flu-like), HYPERHIDROSIS (Sweats), NODULE (Nodules /  two large nodules and one small nodule under arm / nodules are tender /  thumb size nodules), MUSCULOSKELETAL DISCOMFORT (Neck sniff), TENDERNESS (Nodules are tender), PYREXIA (Fever up to 101.9 degrees) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Body temperature: 101.9 degrees f (High) high.         This case was linked to US-MODERNATX, INC.-MOD-2021-076321 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076321:Dose 1
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain in extremity, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Arm swollen/ swollen upper arm and down arm to muscle/ arm pit swelling; Painful  arm area / sore arm above and underneath; Flu-like; Sweats; Nodules /  two large nodules and one small nodule under arm / nodules are tender /  thumb size nodules; Neck sniff; Nodules are tender; Fever up to 101.9 degrees; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen/ swollen upper arm and down arm to muscle/ arm pit swelling), PAIN IN EXTREMITY (Painful  arm area / sore arm above and underneath), INFLUENZA LIKE ILLNESS (Flu-like), HYPERHIDROSIS (Sweats) and NODULE (Nodules /  two large nodules and one small nodule under arm / nodules are tender /  thumb size nodules) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and BP (BLOOD PRESSURE) for an unknown indication.   On 10-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) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen/ swollen upper arm and down arm to muscle/ arm pit swelling), PAIN IN EXTREMITY (Painful  arm area / sore arm above and underneath), INFLUENZA LIKE ILLNESS (Flu-like), HYPERHIDROSIS (Sweats), NODULE (Nodules /  two large nodules and one small nodule under arm / nodules are tender /  thumb size nodules), MUSCULOSKELETAL DISCOMFORT (Neck sniff), TENDERNESS (Nodules are tender), PYREXIA (Fever up to 101.9 degrees) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm swollen/ swollen upper arm and down arm to muscle/ arm pit swelling), PAIN IN EXTREMITY (Painful  arm area / sore arm above and underneath), INFLUENZA LIKE ILLNESS (Flu-like), HYPERHIDROSIS (Sweats), NODULE (Nodules /  two large nodules and one small nodule under arm / nodules are tender /  thumb size nodules), MUSCULOSKELETAL DISCOMFORT (Neck sniff), TENDERNESS (Nodules are tender), PYREXIA (Fever up to 101.9 degrees) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Body temperature: 101.9 degrees f (High) high.         This case was linked to US-MODERNATX, INC.-MOD-2021-076321 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076321:Dose 1
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore right injection site arm; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore right injection site arm). At the time of the report, VACCINATION SITE PAIN (sore right injection site arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) and mRNA-1273 (Unknown) was unknown.       No concomitant medications were  provided. Treatment Information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-076360 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076360:First dose
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Neck pain, Pain in extremity, Tenderness
Clinical narrative: the arm periodically falls asleep ever since the second dose; Today the worst, could not move the arm, she woke up and it was so bad, very very painful; the pain went up into the neck; mentions the trapeze as tender; pain in her arm/a lot of pain in the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm/a lot of pain in the arm of injection), MOBILITY DECREASED (Today the worst, could not move the arm, she woke up and it was so bad, very very painful), NECK PAIN (the pain went up into the neck), TENDERNESS (mentions the trapeze as tender) and HYPOAESTHESIA (the arm periodically falls asleep ever since the second dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concomitant products included ATENOLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), CYANOCOBALAMIN (B12-VITAMIIN), IRON, IBUPROFEN (MOTRIN [IBUPROFEN]), METFORMIN, POTASSIUM, ROPINIROLE HYDROCHLORIDE (REQUIP), LEVOTHYROXINE SODIUM (SYNTHROID) and TORSEMIDE for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm/a lot of pain in the arm of injection). On 14-Apr-2021, the patient experienced MOBILITY DECREASED (Today the worst, could not move the arm, she woke up and it was so bad, very very painful), NECK PAIN (the pain went up into the neck) and TENDERNESS (mentions the trapeze as tender). On an unknown date, the patient experienced HYPOAESTHESIA (the arm periodically falls asleep ever since the second dose). At the time of the report, PAIN IN EXTREMITY (pain in her arm/a lot of pain in the arm of injection), MOBILITY DECREASED (Today the worst, could not move the arm, she woke up and it was so bad, very very painful), NECK PAIN (the pain went up into the neck), TENDERNESS (mentions the trapeze as tender) and HYPOAESTHESIA (the arm periodically falls asleep ever since the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications also included Motrin.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: slightly nauseous; splitting headache yesterday; fatigue; muscle soreness; feeling very dizzy; feel like something is not right; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (slightly nauseous), HEADACHE (splitting headache yesterday), FATIGUE (fatigue), MYALGIA (muscle soreness) and DIZZINESS (feeling very dizzy) in a 56-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.     The patient's past medical history included No adverse event.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (slightly nauseous), HEADACHE (splitting headache yesterday), FATIGUE (fatigue), MYALGIA (muscle soreness), DIZZINESS (feeling very dizzy) and FEELING ABNORMAL (feel like something is not right). At the time of the report, NAUSEA (slightly nauseous), HEADACHE (splitting headache yesterday), FATIGUE (fatigue), MYALGIA (muscle soreness), DIZZINESS (feeling very dizzy) and FEELING ABNORMAL (feel like something is not right) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: slightly nauseous; splitting headache yesterday; fatigue; muscle soreness; feeling very dizzy; feel like something is not right; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (slightly nauseous), HEADACHE (splitting headache yesterday), FATIGUE (fatigue), MYALGIA (muscle soreness) and DIZZINESS (feeling very dizzy) in a 56-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.     The patient's past medical history included No adverse event.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (slightly nauseous), HEADACHE (splitting headache yesterday), FATIGUE (fatigue), MYALGIA (muscle soreness), DIZZINESS (feeling very dizzy) and FEELING ABNORMAL (feel like something is not right). At the time of the report, NAUSEA (slightly nauseous), HEADACHE (splitting headache yesterday), FATIGUE (fatigue), MYALGIA (muscle soreness), DIZZINESS (feeling very dizzy) and FEELING ABNORMAL (feel like something is not right) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative, Pain in extremity
Clinical narrative: Negative for antibodies after second dose; minimal sore arm for second dose; This spontaneous case was reported by a nurse and describes the occurrence of ANTIBODY TEST NEGATIVE (Negative for antibodies after second dose) and PAIN IN EXTREMITY (minimal sore arm for second dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A)) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN D3, ALPRAZOLAM (XANAX) and ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.   On 24-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (minimal sore arm for second dose). On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Negative for antibodies after second dose). At the time of the report, ANTIBODY TEST NEGATIVE (Negative for antibodies after second dose) and PAIN IN EXTREMITY (minimal sore arm for second dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was not provided.  Nurse reported that she had some blood work done for antibody testing (IgG) which came back negative (tested 5 weeks after completion of vaccination series).   This case was linked to MOD21-075603 (E2B Linked Report); Sender's Comments:  MOD21-075603:Cross linked case
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Back pain, Chills, Diarrhoea
Clinical narrative: neck pain; back pain; waterly diaarrhea; stomach upset; cramps; bloating; injection site warm; vaccination site pain and warm; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), BACK PAIN (back pain), DIARRHOEA (waterly diaarrhea), ABDOMINAL DISCOMFORT (stomach upset) and MUSCLE SPASMS (cramps) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Irritable bowel syndrome.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced NECK PAIN (neck pain), BACK PAIN (back pain), DIARRHOEA (waterly diaarrhea), ABDOMINAL DISCOMFORT (stomach upset), MUSCLE SPASMS (cramps), ABDOMINAL DISTENSION (bloating), INJECTION SITE WARMTH (injection site warm), VACCINATION SITE PAIN (vaccination site pain and warm), CHILLS (chills) and PYREXIA (fever). On 12-Apr-2021, NECK PAIN (neck pain), BACK PAIN (back pain), DIARRHOEA (waterly diaarrhea), ABDOMINAL DISCOMFORT (stomach upset), MUSCLE SPASMS (cramps), ABDOMINAL DISTENSION (bloating), INJECTION SITE WARMTH (injection site warm), VACCINATION SITE PAIN (vaccination site pain and warm), CHILLS (chills) and PYREXIA (fever) had resolved.            No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.   This case was linked to MOD-2021-076346 (E2B Linked Report).; Sender's Comments:  MOD-2021-076346:dose 1
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Muscle spasms, Neck pain, Pyrexia, Vaccination site pain
Clinical narrative: neck pain; back pain; waterly diaarrhea; stomach upset; cramps; bloating; injection site warm; vaccination site pain and warm; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), BACK PAIN (back pain), DIARRHOEA (waterly diaarrhea), ABDOMINAL DISCOMFORT (stomach upset) and MUSCLE SPASMS (cramps) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Irritable bowel syndrome.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced NECK PAIN (neck pain), BACK PAIN (back pain), DIARRHOEA (waterly diaarrhea), ABDOMINAL DISCOMFORT (stomach upset), MUSCLE SPASMS (cramps), ABDOMINAL DISTENSION (bloating), INJECTION SITE WARMTH (injection site warm), VACCINATION SITE PAIN (vaccination site pain and warm), CHILLS (chills) and PYREXIA (fever). On 12-Apr-2021, NECK PAIN (neck pain), BACK PAIN (back pain), DIARRHOEA (waterly diaarrhea), ABDOMINAL DISCOMFORT (stomach upset), MUSCLE SPASMS (cramps), ABDOMINAL DISTENSION (bloating), INJECTION SITE WARMTH (injection site warm), VACCINATION SITE PAIN (vaccination site pain and warm), CHILLS (chills) and PYREXIA (fever) had resolved.            No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.   This case was linked to MOD-2021-076346 (E2B Linked Report).; Sender's Comments:  MOD-2021-076346:dose 1
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste in my mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in my mouth) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced DYSGEUSIA (metallic taste in my mouth). At the time of the report, DYSGEUSIA (metallic taste in my mouth) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to US-MODERNATX, INC.-MOD-2021-076353 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Peripheral coldness, Pyrexia
Clinical narrative: random cold hands and legs; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (random cold hands and legs), CHILLS (chills) and PYREXIA (fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 01-Mar-2021, the patient experienced PERIPHERAL COLDNESS (random cold hands and legs). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 17-Feb-2021, CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, PERIPHERAL COLDNESS (random cold hands and legs) had not resolved.            No concomitant medication was provided by the reporter.  Action taken with mRNA1273 Moderna vaccine was Not Applicable     This case was linked to US-MODERNATX, INC.-MOD-2021-076306 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076306:Crossed linked
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Gait disturbance, Paraesthesia
Clinical narrative: Burning in Legs; Tingling in Legs; Can not walk properly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (Burning in Legs), PARAESTHESIA (Tingling in Legs) and GAIT DISTURBANCE (Can not walk properly) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced BURNING SENSATION (Burning in Legs), PARAESTHESIA (Tingling in Legs) and GAIT DISTURBANCE (Can not walk properly). At the time of the report, BURNING SENSATION (Burning in Legs), PARAESTHESIA (Tingling in Legs) and GAIT DISTURBANCE (Can not walk properly) outcome was unknown. Not Provided          Patient is taking concomitant medication but not provided. Patient is doing fine with her brain MRI. Treatment information was not provided by the reporter.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Swelling
Clinical narrative: swollen little ball in the armpit; Fever; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen little ball in the armpit), PYREXIA (Fever) and MYALGIA (Body Aches) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SWELLING (swollen little ball in the armpit), PYREXIA (Fever) and MYALGIA (Body Aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-May-2021, SWELLING (swollen little ball in the armpit), PYREXIA (Fever) and MYALGIA (Body Aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR Form received on 26-MAY-2021,  outcome of event was updated
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: filling "like water in the left ear"; "washing sounds" in the left ear; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (filling "like water in the left ear") and TINNITUS ("washing sounds" in the left ear) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 013A21A) for COVID-19 vaccination.     No medical history was not provided by the reporter.  Concomitant products included LOSARTAN, NIFEDIPINE and HYDROCHLOROTHIAZIDE for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021 at 3:50 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced EAR DISCOMFORT (filling "like water in the left ear") and TINNITUS ("washing sounds" in the left ear). At the time of the report, EAR DISCOMFORT (filling "like water in the left ear") and TINNITUS ("washing sounds" in the left ear) outcome was unknown. Not Provided          Treatment information was not provided by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Localised infection
Clinical narrative: Arm infection; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOCALISED INFECTION (Arm infection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOCALISED INFECTION (Arm infection). At the time of the report, LOCALISED INFECTION (Arm infection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received antibiotics as treatment medication. Concomitant medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Both of arms from top to wrist got warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Both of arms from top to wrist got warm) 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 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Both of arms from top to wrist got warm). At the time of the report, FEELING HOT (Both of arms from top to wrist got warm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Vaccination site movement impairment
Clinical narrative: She cannot move her left arm; Patient was crying as she was in so much pain; 4 hours later, she had a terrible pain in left shoulder.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (She cannot move her left arm), PAIN (Patient was crying as she was in so much pain) and ARTHRALGIA (4 hours later, she had a terrible pain in left shoulder.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (She cannot move her left arm), PAIN (Patient was crying as she was in so much pain) and ARTHRALGIA (4 hours later, she had a terrible pain in left shoulder.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (She cannot move her left arm), PAIN (Patient was crying as she was in so much pain) and ARTHRALGIA (4 hours later, she had a terrible pain in left shoulder.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Treatment medication included Ice compression.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: TCR received: patient declined further follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Eating disorder, Parosmia
Clinical narrative: felt sour cream taste in the mouth; Can´t eat; felt smells like nasty soap; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (felt sour cream taste in the mouth), EATING DISORDER (Can´t eat) and PAROSMIA (felt smells like nasty soap) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (NOS).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (felt sour cream taste in the mouth), EATING DISORDER (Can´t eat) and PAROSMIA (felt smells like nasty soap). At the time of the report, DYSGEUSIA (felt sour cream taste in the mouth), EATING DISORDER (Can´t eat) and PAROSMIA (felt smells like nasty soap) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Right now she is experiencing a fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Right now she is experiencing a fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ETANERCEPT (ENBREL), METHOTREXATE, SERTRALINE, ARIPIPRAZOLE (ABILIFY), ALPRAZOLAM (XANAX), HYDROMORPHONE, FENTANYL, PREDNISONE and OXYBUTYNIN for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PYREXIA (Right now she is experiencing a fever). At the time of the report, PYREXIA (Right now she is experiencing a fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No corrective treatment was provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of injection site pain (pain at injection site) and pain in extremity (arm in pain) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 046A21A) for COVID-19 immunization. The patient's past medical history included no adverse event. On Mar 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Mar 25, 2021, patient experienced pain in extremity (arm in pain). On Apr 14, 2021, patient experienced injection site pain (pain at injection site). At the time of the report, injection site pain (pain at injection site) and pain in extremity (arm in pain) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Palpitations
Clinical narrative: earaches; heart palpitations; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (earaches) and PALPITATIONS (heart palpitations) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (earaches) and PALPITATIONS (heart palpitations). At the time of the report, EAR PAIN (earaches) and PALPITATIONS (heart palpitations) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Consumer reported that they read on the internet that some people experience earaches and heart palpitations after receiving Moderna's COVID-19 vaccine.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Eczema, Erythema, Pruritus, Rash
Clinical narrative: reaction to "something "; very itchy; Red; Looked like measles; both hands/both legs; both arms; "all over rash"; eczema on left arm; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (eczema on left arm), ADVERSE REACTION (reaction to "something "), PRURITUS (very itchy), ERYTHEMA (Red) and RASH MORBILLIFORM (Looked like measles) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) 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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced ECZEMA (eczema on left arm). On 23-Feb-2021, the patient experienced ADVERSE REACTION (reaction to "something "), PRURITUS (very itchy), ERYTHEMA (Red), RASH MORBILLIFORM (Looked like measles), RASH (both hands/both legs), RASH (both arms) and RASH ("all over rash"). At the time of the report, ECZEMA (eczema on left arm), ADVERSE REACTION (reaction to "something "), PRURITUS (very itchy), ERYTHEMA (Red), RASH MORBILLIFORM (Looked like measles), RASH (both hands/both legs), RASH (both arms) and RASH ("all over rash") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash morbilliform
Clinical narrative: reaction to "something "; very itchy; Red; Looked like measles; both hands/both legs; both arms; "all over rash"; eczema on left arm; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (eczema on left arm), ADVERSE REACTION (reaction to "something "), PRURITUS (very itchy), ERYTHEMA (Red) and RASH MORBILLIFORM (Looked like measles) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) 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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced ECZEMA (eczema on left arm). On 23-Feb-2021, the patient experienced ADVERSE REACTION (reaction to "something "), PRURITUS (very itchy), ERYTHEMA (Red), RASH MORBILLIFORM (Looked like measles), RASH (both hands/both legs), RASH (both arms) and RASH ("all over rash"). At the time of the report, ECZEMA (eczema on left arm), ADVERSE REACTION (reaction to "something "), PRURITUS (very itchy), ERYTHEMA (Red), RASH MORBILLIFORM (Looked like measles), RASH (both hands/both legs), RASH (both arms) and RASH ("all over rash") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site mass
Clinical narrative: headache; Bumps at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Bumps at injection site) and HEADACHE (headache) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced INJECTION SITE MASS (Bumps at injection site). On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). At the time of the report, INJECTION SITE MASS (Bumps at injection site) and HEADACHE (headache) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-076398 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076398:1st dose case
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hyperhidrosis, Pain in extremity
Clinical narrative: Sweating; clogged head; head was heavy and clogged; fever; fatigue; sore injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore injection arm), HYPERHIDROSIS (Sweating), FEELING ABNORMAL (clogged head), FATIGUE (fatigue) and HEADACHE (head was heavy and clogged) in a 34-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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore injection arm) and FATIGUE (fatigue). On 09-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), FEELING ABNORMAL (clogged head), HEADACHE (head was heavy and clogged) and PYREXIA (fever). On 07-Apr-2021, PAIN IN EXTREMITY (sore injection arm) and FATIGUE (fatigue) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), FEELING ABNORMAL (clogged head), HEADACHE (head was heavy and clogged) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included paracetamol.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sweating; clogged head; head was heavy and clogged; fever; fatigue; sore injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore injection arm), HYPERHIDROSIS (Sweating), FEELING ABNORMAL (clogged head), FATIGUE (fatigue) and HEADACHE (head was heavy and clogged) in a 34-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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore injection arm) and FATIGUE (fatigue). On 09-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), FEELING ABNORMAL (clogged head), HEADACHE (head was heavy and clogged) and PYREXIA (fever). On 07-Apr-2021, PAIN IN EXTREMITY (sore injection arm) and FATIGUE (fatigue) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), FEELING ABNORMAL (clogged head), HEADACHE (head was heavy and clogged) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included paracetamol.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: upper arm injection site aching; very very tired; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (upper arm injection site aching) and FATIGUE (very very tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 25A21A and Q2AA21A) for COVID-19 vaccination.     Concurrent medical conditions included Polymyalgia rheumatica (Myalgia Rheumatica) since December 2019, Giant cell arteritis since 06-Jan-2021 and Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE) and SPIRONOLACTONE for Blood pressure high, OLMESARTAN MEDOXOMIL (BENICAR) for Polymyalgia rheumatica.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 experienced VACCINATION SITE PAIN (upper arm injection site aching) and FATIGUE (very very tired). At the time of the report, VACCINATION SITE PAIN (upper arm injection site aching) and FATIGUE (very very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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.   Patient first started with dose of 60 mg of steroid. Then on 06-Jan-2021 she was suspected to have Giant cell arteritis, the dose was decreased to 50 mg. On 26-Jan-2021 she was at 10 mg of steroid. On Feb2021 further decreased to 20 mg of steroid. On 26Feb2021, the day of first dose of vaccine the patient was taking 14 mg of steroid (lowered by patient under physician's supervision).