chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Delayed allergic reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Delayed allergic reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Delayed allergic reaction). At the time of the report, HYPERSENSITIVITY (Delayed allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Fatigue, SARS-CoV-2 test positive, Sluggishness
Clinical narrative: tested positive for COVID; a little sluggish; lost his taste; felt fatigued; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID), SLUGGISHNESS (a little sluggish), AGEUSIA (lost his taste) and FATIGUE (felt fatigued) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced SLUGGISHNESS (a little sluggish), AGEUSIA (lost his taste) and FATIGUE (felt fatigued). On 16-Jan-2021, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID), SLUGGISHNESS (a little sluggish), AGEUSIA (lost his taste) and FATIGUE (felt fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Tested positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: upper right arm developed red mark and became hard; upper right arm developed red mark and became hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (upper right arm developed red mark and became hard) and VACCINATION SITE ERYTHEMA (upper right arm developed red mark and became hard) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE INDURATION (upper right arm developed red mark and became hard) and VACCINATION SITE ERYTHEMA (upper right arm developed red mark and became hard). The patient was treated with IBUPROFEN ongoing from February 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (upper right arm developed red mark and became hard) and VACCINATION SITE ERYTHEMA (upper right arm developed red mark and became hard) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Pain in extremity, Vaccination site pruritus
Clinical narrative: Started breaking out; Arm to shoulder to elbow turned bright red/redness from elbow to shoulder.; Arm soreness; Had a lot of itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Started breaking out), ERYTHEMA (Arm to shoulder to elbow turned bright red/redness from elbow to shoulder.), PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE PRURITUS (Had a lot of itching at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event (medical history not provided). Concomitant products included FLUTICASONE for Allergy NOS, ROSUVASTATIN for High cholesterol, MACROGOL 3350 (MIRALAX) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced FEELING ABNORMAL (Started breaking out), ERYTHEMA (Arm to shoulder to elbow turned bright red/redness from elbow to shoulder.), PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE PRURITUS (Had a lot of itching at injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 05-Feb-2021, FEELING ABNORMAL (Started breaking out), ERYTHEMA (Arm to shoulder to elbow turned bright red/redness from elbow to shoulder.), PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE PRURITUS (Had a lot of itching at injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: initial additional. On 10-Jul-2021: Contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 (reaction). At the time of the report, VACCINATION COMPLICATION (reaction) outcome was unknown. Not Provided          Concomitant medications were not provided. Treatment details were not provided; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A Little Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A Little Sore Arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (A Little Sore Arm). At the time of the report, VACCINATION SITE PAIN (A Little Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Pinkish rash is now spreading down towards her elbow and the back of her arm; Rash on her arm at injection site; Itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy at injection site), RASH (Pinkish rash is now spreading down towards her elbow and the back of her arm) and VACCINATION SITE RASH (Rash on her arm at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE RASH (Rash on her arm at injection site). On 11-Feb-2021, the patient experienced RASH (Pinkish rash is now spreading down towards her elbow and the back of her arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) on 09-Feb-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (Itchy at injection site), RASH (Pinkish rash is now spreading down towards her elbow and the back of her arm) and VACCINATION SITE RASH (Rash on her arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  The patient stated that although recommended by pharmacist she had not yet taken the Benadryl tablets.   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2021: Follow up received and added new event. On 22-Apr-2021: Follow up received and contains no new information. On 13-Jul-2021: Follow-Up received and updated primary reporter contact details.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Balance disorder, Fall, Neck pain
Clinical narrative: Neck pain; Balance disorder; Asthenia; Fall; Arthralgia; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), BALANCE DISORDER (Balance disorder), ASTHENIA (Asthenia), FALL (Fall) and ARTHRALGIA (Arthralgia) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No specified medical history has been reported.  Concomitant products included TERAZOSIN, VITAMIN D2, FENOFIBRATE, HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced NECK PAIN (Neck pain), BALANCE DISORDER (Balance disorder), ASTHENIA (Asthenia), FALL (Fall) and ARTHRALGIA (Arthralgia). At the time of the report, NECK PAIN (Neck pain), BALANCE DISORDER (Balance disorder), ASTHENIA (Asthenia), FALL (Fall) and ARTHRALGIA (Arthralgia) had resolved.            For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.          Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: updated events outcome
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: classic hives; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (classic hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included BUPROPION from 12-Jan-2021 to an unknown date for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced URTICARIA (classic hives). The patient was treated with PREDNISONE for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (classic hives) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: when she tries to bend her right arm, it hurts; joint pain on her right arm; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (when she tries to bend her right arm, it hurts), ARTHRALGIA (joint pain on her right arm) and MYALGIA (muscle pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included LOSARTAN, ATENOLOL, ATORVASTATIN, GLIPIZIDE, LEVOTHYROXINE, METFORMIN and FERROUS SULFATE for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (when she tries to bend her right arm, it hurts), ARTHRALGIA (joint pain on her right arm) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (when she tries to bend her right arm, it hurts), ARTHRALGIA (joint pain on her right arm) and MYALGIA (muscle pain) 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.   Treatment  included ice pack.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up received on 22-Apr-2021 as no new information added email address for the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: He started breaking out with a rash, it was spreading; This spontaneous case was reported by a consumer and describes the occurrence of RASH (He started breaking out with a rash, it was spreading) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced RASH (He started breaking out with a rash, it was spreading). At the time of the report, RASH (He started breaking out with a rash, it was spreading) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.    Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Pain in extremity
Clinical narrative: sore back; sore went to her upper chest, no breathing problems; sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm), BACK PAIN (sore back) and CHEST PAIN (sore went to her upper chest, no breathing problems) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included blood pressure medication, cholesterol medication and anxiety medication for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore right arm). On 07-Feb-2021, the patient experienced BACK PAIN (sore back) and CHEST PAIN (sore went to her upper chest, no breathing problems). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Feb-2021, PAIN IN EXTREMITY (sore right arm) had resolved. On 09-Feb-2021, BACK PAIN (sore back) and CHEST PAIN (sore went to her upper chest, no breathing problems) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild soreness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild soreness in the injection site) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (mild soreness in the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (mild soreness in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: No specific follow-up information.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Felt sick; High fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Felt sick) and PYREXIA (High fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Heart disorder and COPD.    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 (Felt sick) and PYREXIA (High fever). At the time of the report, VACCINATION COMPLICATION (Felt sick) and PYREXIA (High fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. . No treatment related information has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Patient last name and email address updated
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A Little Sore Arm; A spontaneous report was received from a consumer concerning a 68- year old-female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm. The patient's medical history was not provided.No relevant concomitant medications were reported.   On 06-Feb-2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 06-Feb-2021,the patient experienced a little sore arm. No laboratory data was provided.Treatment information was not provided.  Action taken with mRNA-1273 in response to the events  was unknown. The outcome of the event pain in arm  was considered as not resolved at the time of the report.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Tremor
Clinical narrative: very very dizzy a lot; has had sweats; shaking; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very very dizzy a lot), HYPERHIDROSIS (has had sweats) and TREMOR (shaking) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (very very dizzy a lot), HYPERHIDROSIS (has had sweats) and TREMOR (shaking). At the time of the report, DIZZINESS (very very dizzy a lot), HYPERHIDROSIS (has had sweats) and TREMOR (shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Chills, Decreased appetite, Fatigue, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (decreased Appetite), MYALGIA (sore arm, arm pain), CHILLS (severe chills), FATIGUE (fatigue) and NAUSEA (nausea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Breast cancer, Penicillin allergy and Allergy to antibiotic (Erythromycin). Concomitant products included OMEPRAZOLE for GERD, CHLORDIAZEPOXIDE;CLIDINIUM, METHYLCELLULOSE (CITRUCEL) and LACTOBACILLUS ACIDOPHILUS (FLORASTOR [LACTOBACILLUS ACIDOPHILUS]) for Irritable bowel syndrome, RALOXIFENE for Osteoporosis NOS, VITAMIN 15, PRAVASTATIN, PYRIDOXINE, VITAMIN D3, UBIDECARENONE (CO-Q10-CHLORELLA), MACROGOL 400, PROPYLENE GLYCOL (SYSTANE) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced MYALGIA (sore arm, arm pain), CHILLS (severe chills), FATIGUE (fatigue) and NAUSEA (nausea). On an unknown date, the patient experienced DECREASED APPETITE (decreased Appetite). On 17-Jan-2021, MYALGIA (sore arm, arm pain), CHILLS (severe chills), FATIGUE (fatigue) and NAUSEA (nausea) had resolved. At the time of the report, DECREASED APPETITE (decreased Appetite) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Blood glucose: high (High) high blood sugar.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported for mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment   This case was linked to MOD-2021-252848 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Significant follow-up received and concomitant medications, Medical history was updated. Patient demographics was added. Recovery date of all the events was added. New event added.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (decreased Appetite), MYALGIA (sore arm, arm pain), CHILLS (severe chills), FATIGUE (fatigue) and NAUSEA (nausea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Breast cancer, Penicillin allergy and Allergy to antibiotic (Erythromycin). Concomitant products included OMEPRAZOLE for GERD, CHLORDIAZEPOXIDE;CLIDINIUM, METHYLCELLULOSE (CITRUCEL) and LACTOBACILLUS ACIDOPHILUS (FLORASTOR [LACTOBACILLUS ACIDOPHILUS]) for Irritable bowel syndrome, RALOXIFENE for Osteoporosis NOS, VITAMIN 15, PRAVASTATIN, PYRIDOXINE, VITAMIN D3, UBIDECARENONE (CO-Q10-CHLORELLA), MACROGOL 400, PROPYLENE GLYCOL (SYSTANE) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced MYALGIA (sore arm, arm pain), CHILLS (severe chills), FATIGUE (fatigue) and NAUSEA (nausea). On an unknown date, the patient experienced DECREASED APPETITE (decreased Appetite). On 17-Jan-2021, MYALGIA (sore arm, arm pain), CHILLS (severe chills), FATIGUE (fatigue) and NAUSEA (nausea) had resolved. At the time of the report, DECREASED APPETITE (decreased Appetite) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Blood glucose: high (High) high blood sugar.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported for mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment   This case was linked to MOD-2021-252848 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Significant follow-up received and concomitant medications, Medical history was updated. Patient demographics was added. Recovery date of all the events was added. New event added.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included Blood thinner and VITAMINS NOS for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 08-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Chills; Headache; Fever 101.3; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), MYALGIA (Sore arm) and PYREXIA (Fever 101.3) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN (MOTRIN [IBUPROFEN]) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced MYALGIA (Sore arm). On 06-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 101.3). On 08-Feb-2021, CHILLS (Chills) and PYREXIA (Fever 101.3) had resolved. At the time of the report, HEADACHE (Headache) and MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: rash arm  IS; Itch IS; Swollen IS; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash arm  IS), VACCINATION SITE PRURITUS (Itch IS) and VACCINATION SITE SWELLING (Swollen IS) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE RASH (rash arm  IS), VACCINATION SITE PRURITUS (Itch IS) and VACCINATION SITE SWELLING (Swollen IS). At the time of the report, VACCINATION SITE RASH (rash arm  IS) had resolved and VACCINATION SITE PRURITUS (Itch IS) and VACCINATION SITE SWELLING (Swollen IS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment drugs were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Rash macular
Clinical narrative: Dizziness; Fell down; Red Freckles; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red Freckles), DIZZINESS (Dizziness) and FALL (Fell down) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced RASH MACULAR (Red Freckles). On 31-Jan-2021, the patient experienced DIZZINESS (Dizziness) and FALL (Fell down). At the time of the report, RASH MACULAR (Red Freckles), DIZZINESS (Dizziness) and FALL (Fell down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include hydrocortisone of unknown dose and frequency. No concomitant medications were provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Headache, Nausea, Pyrexia
Clinical narrative: Can't eat anything but Jell-O; Stomach pain; Headache; Convulsing vomiting; stomach was having trouble like nausea; fever; lost about 10 pounds; Stomach was having trouble like nausea; Lost about 10 pounds; Fever; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lost about 10 pounds), DECREASED APPETITE (Can't eat anything but Jell-O), ABDOMINAL PAIN UPPER (Stomach pain), WEIGHT DECREASED (lost about 10 pounds) and PYREXIA (Fever) in an 84-year-old female 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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced WEIGHT DECREASED (Lost about 10 pounds) and PYREXIA (Fever). On 26-Jan-2021, the patient experienced NAUSEA (Stomach was having trouble like nausea). On 07-Jul-2021, the patient experienced WEIGHT DECREASED (lost about 10 pounds) and PYREXIA (fever). On an unknown date, the patient experienced DECREASED APPETITE (Can't eat anything but Jell-O), ABDOMINAL PAIN UPPER (Stomach pain), HEADACHE (Headache), VOMITING (Convulsing vomiting) and NAUSEA (stomach was having trouble like nausea). The patient was treated with ONDANSETRON for Nausea, at a dose of 1 dosage form. On 28-Jan-2021, PYREXIA (Fever) had resolved. At the time of the report, WEIGHT DECREASED (Lost about 10 pounds), WEIGHT DECREASED (lost about 10 pounds), PYREXIA (fever) and NAUSEA (stomach was having trouble like nausea) outcome was unknown and DECREASED APPETITE (Can't eat anything but Jell-O), ABDOMINAL PAIN UPPER (Stomach pain), NAUSEA (Stomach was having trouble like nausea), HEADACHE (Headache) and VOMITING (Convulsing vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Added information about that after discharging from hospital patient experienced with same events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Weight decreased
Clinical narrative: Can't eat anything but Jell-O; Stomach pain; Headache; Convulsing vomiting; stomach was having trouble like nausea; fever; lost about 10 pounds; Stomach was having trouble like nausea; Lost about 10 pounds; Fever; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lost about 10 pounds), DECREASED APPETITE (Can't eat anything but Jell-O), ABDOMINAL PAIN UPPER (Stomach pain), WEIGHT DECREASED (lost about 10 pounds) and PYREXIA (Fever) in an 84-year-old female 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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced WEIGHT DECREASED (Lost about 10 pounds) and PYREXIA (Fever). On 26-Jan-2021, the patient experienced NAUSEA (Stomach was having trouble like nausea). On 07-Jul-2021, the patient experienced WEIGHT DECREASED (lost about 10 pounds) and PYREXIA (fever). On an unknown date, the patient experienced DECREASED APPETITE (Can't eat anything but Jell-O), ABDOMINAL PAIN UPPER (Stomach pain), HEADACHE (Headache), VOMITING (Convulsing vomiting) and NAUSEA (stomach was having trouble like nausea). The patient was treated with ONDANSETRON for Nausea, at a dose of 1 dosage form. On 28-Jan-2021, PYREXIA (Fever) had resolved. At the time of the report, WEIGHT DECREASED (Lost about 10 pounds), WEIGHT DECREASED (lost about 10 pounds), PYREXIA (fever) and NAUSEA (stomach was having trouble like nausea) outcome was unknown and DECREASED APPETITE (Can't eat anything but Jell-O), ABDOMINAL PAIN UPPER (Stomach pain), NAUSEA (Stomach was having trouble like nausea), HEADACHE (Headache) and VOMITING (Convulsing vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Added information about that after discharging from hospital patient experienced with same events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Colitis
Clinical narrative: Colitis; pain in the stomach; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS (Colitis) and ABDOMINAL PAIN UPPER (pain in the stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0MJ20A) 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) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced COLITIS (Colitis) and ABDOMINAL PAIN UPPER (pain in the stomach). At the time of the report, COLITIS (Colitis) and ABDOMINAL PAIN UPPER (pain in the stomach) 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.   No concomitant medications were reported.  No treatment medications were provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the se events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: shoulders, kneels, hands and neck flared up more that it normally does; A spontaneous report was received from a consumer concerning herself, who is a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event shoulders, kneels, hands and neck flared up more that it normally does  The patient's medical history was osteoarthritis and rheumatoid arthritis. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the event shoulders, kneels, hands and neck flared up more that it normally does.  Treatment details included acetaminophen, tropical methyl salicylate extra Strength.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event shoulders, kneels, hands and neck flared up more that it normally does was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; A spontaneous report was received from a physician concerning a female patient (Unspecified age) who experienced COVID-19.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number: Unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, the patient undergone COVID-19 test and was diagnosed with COVID-19.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event COVID-19 was unknown.  Based on MSA comment, MAH causality updated to Not applicable
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: hot injection site; hard injection site; Vaccination site pruritus; Vaccination site rash; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE INDURATION (hard injection site), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE RASH (Vaccination site rash) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE INDURATION (hard injection site), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE RASH (Vaccination site rash). The patient was treated with PARACETAMOL (TYLENOL) for Inflammation, at a dose of 1 dosage form and IBUPROFEN for Inflammation, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE INDURATION (hard injection site), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE RASH (Vaccination site rash) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include a blood pressure medication and statin.   Treatment includes a topical anti-histamine for itching.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Non-significant follow up updated on 06-Jul-2021: updated contact information.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; A spontaneous report was received from a healthcare professional concerning a 73-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event diarrhea was unknown.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: Water blister on her left ankle and foot; A spontaneous report was received from a consumer concerning a 91-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events water blister on her left ankle and foot/blister.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) water blister on her left ankle and foot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), water blister on her left ankle and foot was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Oxygen saturation, Pain in extremity, Pollakiuria, Pyrexia
Clinical narrative: Also has some pain in arm; high fever 98.4F; has been urinating constantly; shortness of breath and is breathing heavily; oxygen level is in 91; A spontaneous report (United States) was received from a consumer concerning her spouse a 75-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high fever 98.4f, has been urinating constantly, shortness of breath and is breathing heavily, oxygen level is in 91, also has some pain in arm.  The patient's medical history was high blood pressure. Concomitant medications reported were insulin, metmorfin, lisinopril high blood pressure, glipiside, vitamin d for drug use for unknown indication.  On 7 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) through unknown route in the left arm for prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient experienced the event after midnight he has had high fever 98.4F, he has been urinating constantly, his oxygen level is in 91, he has shortness of breath and is breathing heavily. also has some pain in arm.  Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events high fever 98, 4f, has been urinating constantly, shortness of breath and is breathing heavily, oxygen level is in 91, also has some pain in arm was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Pain in extremity, Peripheral swelling, Vaccination site erythema
Clinical narrative: increased swelling of her fingers; pain in her left toe; big red blotches; hardness; redness was 2-3 inches below the injection site; pain on her shoulder/joint pain; flare up of her arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (flare up of her arthritis), PERIPHERAL SWELLING (increased swelling of her fingers), PAIN IN EXTREMITY (pain in her left toe), VACCINATION SITE RASH (big red blotches) and VACCINATION SITE INDURATION (hardness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced ARTHRITIS (flare up of her arthritis) and ARTHRALGIA (pain on her shoulder/joint pain). On 08-Feb-2021, the patient experienced PERIPHERAL SWELLING (increased swelling of her fingers), PAIN IN EXTREMITY (pain in her left toe), VACCINATION SITE RASH (big red blotches), VACCINATION SITE INDURATION (hardness) and VACCINATION SITE ERYTHEMA (redness was 2-3 inches below the injection site). At the time of the report, ARTHRITIS (flare up of her arthritis), PERIPHERAL SWELLING (increased swelling of her fingers), PAIN IN EXTREMITY (pain in her left toe), VACCINATION SITE RASH (big red blotches), VACCINATION SITE INDURATION (hardness), VACCINATION SITE ERYTHEMA (redness was 2-3 inches below the injection site) and ARTHRALGIA (pain on her shoulder/joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site rash
Clinical narrative: increased swelling of her fingers; pain in her left toe; big red blotches; hardness; redness was 2-3 inches below the injection site; pain on her shoulder/joint pain; flare up of her arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (flare up of her arthritis), PERIPHERAL SWELLING (increased swelling of her fingers), PAIN IN EXTREMITY (pain in her left toe), VACCINATION SITE RASH (big red blotches) and VACCINATION SITE INDURATION (hardness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced ARTHRITIS (flare up of her arthritis) and ARTHRALGIA (pain on her shoulder/joint pain). On 08-Feb-2021, the patient experienced PERIPHERAL SWELLING (increased swelling of her fingers), PAIN IN EXTREMITY (pain in her left toe), VACCINATION SITE RASH (big red blotches), VACCINATION SITE INDURATION (hardness) and VACCINATION SITE ERYTHEMA (redness was 2-3 inches below the injection site). At the time of the report, ARTHRITIS (flare up of her arthritis), PERIPHERAL SWELLING (increased swelling of her fingers), PAIN IN EXTREMITY (pain in her left toe), VACCINATION SITE RASH (big red blotches), VACCINATION SITE INDURATION (hardness), VACCINATION SITE ERYTHEMA (redness was 2-3 inches below the injection site) and ARTHRALGIA (pain on her shoulder/joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.