chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Influenza, Pyrexia, Vaccination site pain
Clinical narrative: Influenza A; sore arm; Wet cough; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Influenza A), COUGH (Wet cough), PYREXIA (Fever) and VACCINATION SITE PAIN (sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Influenza.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced COUGH (Wet cough) and PYREXIA (Fever). On an unknown date, the patient experienced INFLUENZA (Influenza A) and VACCINATION SITE PAIN (sore arm). The patient was treated with OSELTAMIVIR PHOSPHATE (TAMIFLU) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA (Influenza A), COUGH (Wet cough), PYREXIA (Fever) and VACCINATION SITE PAIN (sore arm) outcome was unknown.            The doctor put her on Tamiflu and patient  wants to know if it will interfere with the shot.  Concomitant medication was not provided.     This case was linked to US-MODERNATX, INC.-MOD-2021-077806 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant follow up received. TCR attached. Patient medical history of Influenza A. 2nd dose was updated. Event sore arm for few days was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077806:Husband's case crosslinked
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (pain at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included Herniated disc, Rheumatoid arthritis, Asthma and Blood pressure high. Concomitant products included LEFLUNOMIDE (ARAVA) for Rheumatoid arthritis, ADALIMUMAB (HUMIRA) for an unknown indication.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 09-Apr-2021, VACCINATION SITE PAIN (pain at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The  doctor recommended holding concomitant medication rheumatoid arthritis medication.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: TCR received on 15-Apr-2021 contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Vaccination site pain
Clinical narrative: little bit of pain on arm of injection; very intense pain on arm of injection; cannot lift her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little bit of pain on arm of injection), PAIN IN EXTREMITY (very intense pain on arm of injection) and LIMB DISCOMFORT (cannot lift her arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported ). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for COVID-19 immunization.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (little bit of pain on arm of injection), PAIN IN EXTREMITY (very intense pain on arm of injection) and LIMB DISCOMFORT (cannot lift her arm). At the time of the report, VACCINATION SITE PAIN (little bit of pain on arm of injection), PAIN IN EXTREMITY (very intense pain on arm of injection) and LIMB DISCOMFORT (cannot lift her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-075957 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Pain in jaw, Temporomandibular joint syndrome, Tooth infection, Toothache
Clinical narrative: She has been out of work sporadically; Jaw infection requiring root canal; extreme pain in tooth; jaw pain; Temporomandibular joint syndrome; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN JAW (jaw pain), TEMPOROMANDIBULAR JOINT SYNDROME (Temporomandibular joint syndrome), TOOTHACHE (extreme pain in tooth), TOOTH INFECTION (Jaw infection requiring root canal) and IMPAIRED WORK ABILITY (She has been out of work sporadically) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     no medical history was provided by reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN JAW (jaw pain) and TEMPOROMANDIBULAR JOINT SYNDROME (Temporomandibular joint syndrome). On 04-Apr-2021, the patient experienced TOOTHACHE (extreme pain in tooth). On 05-Apr-2021, the patient experienced TOOTH INFECTION (Jaw infection requiring root canal). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (She has been out of work sporadically). The patient was treated with AMOXICILLIN at a dose of 500 mg every six hours and Surgery (Diagnosed with a major jaw infection requiring a root canal.) for Tooth infection. At the time of the report, PAIN IN JAW (jaw pain), TEMPOROMANDIBULAR JOINT SYNDROME (Temporomandibular joint syndrome), TOOTHACHE (extreme pain in tooth), TOOTH INFECTION (Jaw infection requiring root canal) and IMPAIRED WORK ABILITY (She has been out of work sporadically) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: body ache; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache), FATIGUE (fatigue) and CHILLS (chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 032M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced MYALGIA (body ache), FATIGUE (fatigue) and CHILLS (chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA (body ache), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.      No concomitant medication was provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site pain). On 19-Mar-2021, VACCINATION SITE PAIN (injection site pain) had resolved. Not Provided          No relevant concomitant medication was reported . Patient was wondering that whether should take Tylenol or any over the counter pain medication that would help relieve her symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2021-077831 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077831:Second dose
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Diarrhoea, Fatigue, Headache
Clinical narrative: Little fever; Fatigue; Muscle aches; Nausea; Headache; Diarrhea; Lost bit of taste; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), AGEUSIA (Lost bit of taste), PAIN IN EXTREMITY (Pain in the arm), PYREXIA (Little fever) and FATIGUE (Fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm). On 11-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), AGEUSIA (Lost bit of taste), PYREXIA (Little fever), FATIGUE (Fatigue), MYALGIA (Muscle aches), NAUSEA (Nausea) and HEADACHE (Headache). On 26-Mar-2021, PAIN IN EXTREMITY (Pain in the arm) had resolved. On 13-Apr-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, AGEUSIA (Lost bit of taste), PYREXIA (Little fever), FATIGUE (Fatigue), MYALGIA (Muscle aches), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Little fever; Fatigue; Muscle aches; Nausea; Headache; Diarrhea; Lost bit of taste; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), AGEUSIA (Lost bit of taste), PAIN IN EXTREMITY (Pain in the arm), PYREXIA (Little fever) and FATIGUE (Fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm). On 11-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), AGEUSIA (Lost bit of taste), PYREXIA (Little fever), FATIGUE (Fatigue), MYALGIA (Muscle aches), NAUSEA (Nausea) and HEADACHE (Headache). On 26-Mar-2021, PAIN IN EXTREMITY (Pain in the arm) had resolved. On 13-Apr-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, AGEUSIA (Lost bit of taste), PYREXIA (Little fever), FATIGUE (Fatigue), MYALGIA (Muscle aches), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling sensation; Numbness; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness). At the time of the report, PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not reported. No treatment medication was not reported   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up received on 18-MAY-2021 contains significant information includes, Event outcome.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: fever; muscle ache; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (muscle ache), HEADACHE (headache) and NAUSEA (nausea) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported.).    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (fever), MYALGIA (muscle ache), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, PYREXIA (fever), MYALGIA (muscle ache), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient wanted to know if the side effects after first dose of Covid-19 vaccination were normal, if other people were experiencing it and how long would they last.  Treatment medication included Tylenol (acetaminophen).
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: swelling in both legs; swelling in both ankles; Top of feet swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in both legs), JOINT SWELLING (swelling in both ankles) and PERIPHERAL SWELLING (Top of feet swollen) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZOA) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Joints swelled up.), High cholesterol and Blood pressure high. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterosis, LEVOTHYROXINE, AMLODIPINE and TELMISARTAN for an unknown indication.    On 15-Feb-2021 at 8:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling in both legs) and PERIPHERAL SWELLING (Top of feet swollen). 08-Mar-2021, the patient experienced JOINT SWELLING (swelling in both ankles). At the time of the report, PERIPHERAL SWELLING (swelling in both legs), JOINT SWELLING (swelling in both ankles) and PERIPHERAL SWELLING (Top of feet swollen) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included slept with feet on pillow for 5 nights.   This case was linked to US-MODERNATX, INC.-MOD-2021-079544 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Updated contact details (address), time of vaccine shot, patient demographic details. Added concomitant products, event (top of feet swelling).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079544:second dose vaccination
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Head discomfort, Headache, Pain in extremity, Pharyngeal swelling
Clinical narrative: Throat got swollen; Throat got tight; Diarrhea; Head felt like it was in a vice; Vomited; Headache was terrible; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PHARYNGEAL SWELLING (Throat got swollen), THROAT TIGHTNESS (Throat got tight), DIARRHOEA (Diarrhea) and HEAD DISCOMFORT (Head felt like it was in a vice) in an 81-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 Blood pressure high, High cholesterol and Glaucoma. Concurrent medical conditions included Ragweed allergy.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 22-Mar-2021, the patient experienced PHARYNGEAL SWELLING (Throat got swollen), THROAT TIGHTNESS (Throat got tight), DIARRHOEA (Diarrhea), HEAD DISCOMFORT (Head felt like it was in a vice), VOMITING (Vomited) and HEADACHE (Headache was terrible). At the time of the report, PAIN IN EXTREMITY (Sore arm), PHARYNGEAL SWELLING (Throat got swollen), THROAT TIGHTNESS (Throat got tight), DIARRHOEA (Diarrhea), HEAD DISCOMFORT (Head felt like it was in a vice), VOMITING (Vomited) and HEADACHE (Headache was terrible) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter stated that the patient normally gets reactions for flu shots.   This case was linked to US-MODERNATX, INC.-MOD-2021-078039 (E2B Linked Report).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness, Vomiting
Clinical narrative: Throat got swollen; Throat got tight; Diarrhea; Head felt like it was in a vice; Vomited; Headache was terrible; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PHARYNGEAL SWELLING (Throat got swollen), THROAT TIGHTNESS (Throat got tight), DIARRHOEA (Diarrhea) and HEAD DISCOMFORT (Head felt like it was in a vice) in an 81-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 Blood pressure high, High cholesterol and Glaucoma. Concurrent medical conditions included Ragweed allergy.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 22-Mar-2021, the patient experienced PHARYNGEAL SWELLING (Throat got swollen), THROAT TIGHTNESS (Throat got tight), DIARRHOEA (Diarrhea), HEAD DISCOMFORT (Head felt like it was in a vice), VOMITING (Vomited) and HEADACHE (Headache was terrible). At the time of the report, PAIN IN EXTREMITY (Sore arm), PHARYNGEAL SWELLING (Throat got swollen), THROAT TIGHTNESS (Throat got tight), DIARRHOEA (Diarrhea), HEAD DISCOMFORT (Head felt like it was in a vice), VOMITING (Vomited) and HEADACHE (Headache was terrible) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter stated that the patient normally gets reactions for flu shots.   This case was linked to US-MODERNATX, INC.-MOD-2021-078039 (E2B Linked Report).
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) 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 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 15-Apr-2021 for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (Headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Hypersomnia
Clinical narrative: invalid dosing interval outside 37 days; muscle ache; headache, fatigue and body ache are impacting acitivites of daily living; Fever; chills; Headache; fatigue; Swelling; redness right arm; body ache; over sleeping; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING (Swelling), ERYTHEMA (redness right arm), PAIN (body ache), HYPERSOMNIA (over sleeping) and INTENTIONAL PRODUCT USE ISSUE (invalid dosing interval outside 37 days) in a 38-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.     Concurrent medical conditions included Chronic headaches.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced SWELLING (Swelling), ERYTHEMA (redness right arm), PAIN (body ache), HYPERSOMNIA (over sleeping), MYALGIA (muscle ache), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (headache, fatigue and body ache are impacting acitivites of daily living), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headache) and FATIGUE (fatigue). On 15-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (invalid dosing interval outside 37 days). On 15-Apr-2021, SWELLING (Swelling), ERYTHEMA (redness right arm), HYPERSOMNIA (over sleeping), INTENTIONAL PRODUCT USE ISSUE (invalid dosing interval outside 37 days), MYALGIA (muscle ache), PYREXIA (Fever) and CHILLS (chills) had resolved. At the time of the report, PAIN (body ache), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (headache, fatigue and body ache are impacting acitivites of daily living), HEADACHE (Headache) and FATIGUE (fatigue) 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 treatment information was reported.  Patient race was reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue, Loss of personal independence in daily activities, Myalgia, Pain, Pyrexia
Clinical narrative: invalid dosing interval outside 37 days; muscle ache; headache, fatigue and body ache are impacting acitivites of daily living; Fever; chills; Headache; fatigue; Swelling; redness right arm; body ache; over sleeping; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING (Swelling), ERYTHEMA (redness right arm), PAIN (body ache), HYPERSOMNIA (over sleeping) and INTENTIONAL PRODUCT USE ISSUE (invalid dosing interval outside 37 days) in a 38-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.     Concurrent medical conditions included Chronic headaches.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced SWELLING (Swelling), ERYTHEMA (redness right arm), PAIN (body ache), HYPERSOMNIA (over sleeping), MYALGIA (muscle ache), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (headache, fatigue and body ache are impacting acitivites of daily living), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headache) and FATIGUE (fatigue). On 15-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (invalid dosing interval outside 37 days). On 15-Apr-2021, SWELLING (Swelling), ERYTHEMA (redness right arm), HYPERSOMNIA (over sleeping), INTENTIONAL PRODUCT USE ISSUE (invalid dosing interval outside 37 days), MYALGIA (muscle ache), PYREXIA (Fever) and CHILLS (chills) had resolved. At the time of the report, PAIN (body ache), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (headache, fatigue and body ache are impacting acitivites of daily living), HEADACHE (Headache) and FATIGUE (fatigue) 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 treatment information was reported.  Patient race was reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: invalid dosing interval outside 37 days; muscle ache; headache, fatigue and body ache are impacting acitivites of daily living; Fever; chills; Headache; fatigue; Swelling; redness right arm; body ache; over sleeping; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING (Swelling), ERYTHEMA (redness right arm), PAIN (body ache), HYPERSOMNIA (over sleeping) and INTENTIONAL PRODUCT USE ISSUE (invalid dosing interval outside 37 days) in a 38-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.     Concurrent medical conditions included Chronic headaches.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced SWELLING (Swelling), ERYTHEMA (redness right arm), PAIN (body ache), HYPERSOMNIA (over sleeping), MYALGIA (muscle ache), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (headache, fatigue and body ache are impacting acitivites of daily living), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headache) and FATIGUE (fatigue). On 15-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (invalid dosing interval outside 37 days). On 15-Apr-2021, SWELLING (Swelling), ERYTHEMA (redness right arm), HYPERSOMNIA (over sleeping), INTENTIONAL PRODUCT USE ISSUE (invalid dosing interval outside 37 days), MYALGIA (muscle ache), PYREXIA (Fever) and CHILLS (chills) had resolved. At the time of the report, PAIN (body ache), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (headache, fatigue and body ache are impacting acitivites of daily living), HEADACHE (Headache) and FATIGUE (fatigue) 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 treatment information was reported.  Patient race was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye pruritus, Vaccination site pain, Vision blurred
Clinical narrative: hard time seeing, eyes get dry and get blurry due to her allergies; eyes get itchy; eyes get dry; sore left arm that only hurt when she put her hand on the arm just where they put in the injection; This spontaneous case was reported by a patient and describes the occurrence of VISION BLURRED (hard time seeing, eyes get dry and get blurry due to her allergies), EYE PRURITUS (eyes get itchy), DRY EYE (eyes get dry) and VACCINATION SITE PAIN (sore left arm that only hurt when she put her hand on the arm just where they put in the injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic sinusitis (eyes get dry and itchy due to her sinus allergies).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left arm that only hurt when she put her hand on the arm just where they put in the injection). On 15-Apr-2021, the patient experienced VISION BLURRED (hard time seeing, eyes get dry and get blurry due to her allergies), EYE PRURITUS (eyes get itchy) and DRY EYE (eyes get dry). On 31-Mar-2021, VACCINATION SITE PAIN (sore left arm that only hurt when she put her hand on the arm just where they put in the injection) had resolved. At the time of the report, VISION BLURRED (hard time seeing, eyes get dry and get blurry due to her allergies), EYE PRURITUS (eyes get itchy) and DRY EYE (eyes get dry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included eye drops she uses when her eyes get dry and itchy due to her sinus allergies.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Nausea, Pyrexia
Clinical narrative: high fever; upset stomach; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever), ABDOMINAL DISCOMFORT (upset stomach), NAUSEA (nausea) and HEADACHE (headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 038B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Apr-2021, the patient experienced PYREXIA (high fever), ABDOMINAL DISCOMFORT (upset stomach), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, PYREXIA (high fever), ABDOMINAL DISCOMFORT (upset stomach), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown. Not Provided          No treatment medications were provided No concomitant medications were provided
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen at the injection site; Arm was painful at the injection site; I couldn't lift my arm over my head; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't lift my arm over my head), NAUSEA (Nauseated), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE PAIN (Arm was painful at the injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were reported.     On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't lift my arm over my head), NAUSEA (Nauseated) and VACCINATION SITE PAIN (Arm was painful at the injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen at the injection site). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't lift my arm over my head), NAUSEA (Nauseated), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE PAIN (Arm was painful at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2021-077863 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Headache, Pain
Clinical narrative: Her period came 2 weeks ago (26Mar2021), then today; diarrhea; chills; really bad body aches; headache; injection site pain & swelling; injection site pain & swelling; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Her period came 2 weeks ago (26Mar2021), then today), DIARRHOEA (diarrhea), CHILLS (chills), PAIN (really bad body aches) and HEADACHE (headache) in a 50-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 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced DIARRHOEA (diarrhea), CHILLS (chills), PAIN (really bad body aches), HEADACHE (headache), VACCINATION SITE SWELLING (injection site pain & swelling) and VACCINATION SITE PAIN (injection site pain & swelling). On 15-Apr-2021, the patient experienced POLYMENORRHOEA (Her period came 2 weeks ago (26Mar2021), then today). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at an unspecified dose and frequency. At the time of the report, POLYMENORRHOEA (Her period came 2 weeks ago (26Mar2021), then today), DIARRHOEA (diarrhea), CHILLS (chills), PAIN (really bad body aches), HEADACHE (headache), VACCINATION SITE SWELLING (injection site pain & swelling) and VACCINATION SITE PAIN (injection site pain & swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 99.3 (Inconclusive) fever 99.3°F.         Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant medication was not reported.   This case was linked to MOD-2021-077860 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea, Vaccination site pain, Vaccination site swelling
Clinical narrative: Her period came 2 weeks ago (26Mar2021), then today; diarrhea; chills; really bad body aches; headache; injection site pain & swelling; injection site pain & swelling; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Her period came 2 weeks ago (26Mar2021), then today), DIARRHOEA (diarrhea), CHILLS (chills), PAIN (really bad body aches) and HEADACHE (headache) in a 50-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 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced DIARRHOEA (diarrhea), CHILLS (chills), PAIN (really bad body aches), HEADACHE (headache), VACCINATION SITE SWELLING (injection site pain & swelling) and VACCINATION SITE PAIN (injection site pain & swelling). On 15-Apr-2021, the patient experienced POLYMENORRHOEA (Her period came 2 weeks ago (26Mar2021), then today). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at an unspecified dose and frequency. At the time of the report, POLYMENORRHOEA (Her period came 2 weeks ago (26Mar2021), then today), DIARRHOEA (diarrhea), CHILLS (chills), PAIN (really bad body aches), HEADACHE (headache), VACCINATION SITE SWELLING (injection site pain & swelling) and VACCINATION SITE PAIN (injection site pain & swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 99.3 (Inconclusive) fever 99.3°F.         Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant medication was not reported.   This case was linked to MOD-2021-077860 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Animal bite, Product dose omission issue, Product supply issue
Clinical narrative: product administration interrupted; Passed the 37 day mark to get the second dose; was bitten by a dog and had to get a tetanus injection; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT SUPPLY ISSUE (product administration interrupted), PRODUCT DOSE OMISSION ISSUE (Passed the 37 day mark to get the second dose) and ANIMAL BITE (was bitten by a dog and had to get a tetanus injection) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-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 PRODUCT SUPPLY ISSUE (product administration interrupted), PRODUCT DOSE OMISSION ISSUE (Passed the 37 day mark to get the second dose) and ANIMAL BITE (was bitten by a dog and had to get a tetanus injection). At the time of the report, PRODUCT SUPPLY ISSUE (product administration interrupted), PRODUCT DOSE OMISSION ISSUE (Passed the 37 day mark to get the second dose) and ANIMAL BITE (was bitten by a dog and had to get a tetanus injection) 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.       No treatment information provided no concomitant medication provided   This case was linked to MOD-2021-077753 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up received and updated the Second Dose  date; Sender's Comments:  MOD-2021-077753:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Erythema, Pain, Pruritus
Clinical narrative: itching not at the injection site but lower than the injection site. - right arm; about a quarter size rectangular shaped rash; a big lump (was swollen) - right arm; redness; body was hurting again; aches on lower back; aches on knees; Pain was unbearable; body aches - on lower back; body aches - on knees; sciatica; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching not at the injection site but lower than the injection site. - right arm), RASH (about a quarter size rectangular shaped rash), SWELLING (a big lump (was swollen) - right arm), ERYTHEMA (redness) and BACK PAIN (body aches - on lower back) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced BACK PAIN (body aches - on lower back), ARTHRALGIA (body aches - on knees) and SCIATICA (sciatica). On 12-Apr-2021, the patient experienced PAIN (body was hurting again), BACK PAIN (aches on lower back), ARTHRALGIA (aches on knees) and PAIN (Pain was unbearable). On an unknown date, the patient experienced PRURITUS (itching not at the injection site but lower than the injection site. - right arm), RASH (about a quarter size rectangular shaped rash), SWELLING (a big lump (was swollen) - right arm) and ERYTHEMA (redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. On 10-Apr-2021, BACK PAIN (body aches - on lower back), ARTHRALGIA (body aches - on knees) and SCIATICA (sciatica) had resolved. At the time of the report, PRURITUS (itching not at the injection site but lower than the injection site. - right arm), RASH (about a quarter size rectangular shaped rash), SWELLING (a big lump (was swollen) - right arm), ERYTHEMA (redness), PAIN (body was hurting again), BACK PAIN (aches on lower back), ARTHRALGIA (aches on knees) and PAIN (Pain was unbearable) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment Benadryl, Three rounds of Tylenol two 500mg tablets every 24 hours.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Sciatica, Swelling
Clinical narrative: itching not at the injection site but lower than the injection site. - right arm; about a quarter size rectangular shaped rash; a big lump (was swollen) - right arm; redness; body was hurting again; aches on lower back; aches on knees; Pain was unbearable; body aches - on lower back; body aches - on knees; sciatica; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching not at the injection site but lower than the injection site. - right arm), RASH (about a quarter size rectangular shaped rash), SWELLING (a big lump (was swollen) - right arm), ERYTHEMA (redness) and BACK PAIN (body aches - on lower back) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced BACK PAIN (body aches - on lower back), ARTHRALGIA (body aches - on knees) and SCIATICA (sciatica). On 12-Apr-2021, the patient experienced PAIN (body was hurting again), BACK PAIN (aches on lower back), ARTHRALGIA (aches on knees) and PAIN (Pain was unbearable). On an unknown date, the patient experienced PRURITUS (itching not at the injection site but lower than the injection site. - right arm), RASH (about a quarter size rectangular shaped rash), SWELLING (a big lump (was swollen) - right arm) and ERYTHEMA (redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. On 10-Apr-2021, BACK PAIN (body aches - on lower back), ARTHRALGIA (body aches - on knees) and SCIATICA (sciatica) had resolved. At the time of the report, PRURITUS (itching not at the injection site but lower than the injection site. - right arm), RASH (about a quarter size rectangular shaped rash), SWELLING (a big lump (was swollen) - right arm), ERYTHEMA (redness), PAIN (body was hurting again), BACK PAIN (aches on lower back), ARTHRALGIA (aches on knees) and PAIN (Pain was unbearable) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment Benadryl, Three rounds of Tylenol two 500mg tablets every 24 hours.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided by the reporter and no concomitant medication reported.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of SAR-COV-2 virus test positive and mRNA-1273 is assessed as not applicable.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: legs and feet cramping; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (legs and feet cramping) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included APIXABAN (ELIQUIS), AMLODIPINE and SPIRONOLACTONE 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 10-Apr-2021, the patient experienced MUSCLE SPASMS (legs and feet cramping). At the time of the report, MUSCLE SPASMS (legs and feet cramping) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: felt hurt in the right arm and lasted for less than a day.; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (felt hurt in the right arm and lasted for less than a day.) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol, Anxiety, Blood pressure, GERD, Thyroid disorder and Sexual dysfunction. Concomitant products included ATORVASTATIN, LORAZEPAM (ATIVAN), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ), LOSARTAN, AMLODIPINE, ASA, OMEPRAZOLE, LEVOTHYROXINE SODIUM (SYNTHROID) and TADALAFIL (CIALIS) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (felt hurt in the right arm and lasted for less than a day.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (felt hurt in the right arm and lasted for less than a day.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-077876 (E2B Linked Report).; Sender's Comments:  MOD-2021-077876:second dose