chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication and treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 16-Mar-2021, VACCINATION SITE PAIN (soreness at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not unknown by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-081645 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081645:Case for dose 2
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Illness, Myalgia, Nausea
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Received 1st Moderna vaccine, has been sick since), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), CHILLS (chills) and NAUSEA (nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high, Shellfish allergy, Penicillin allergy, Drug allergy (Allergy to Keppra), Sulfonamide allergy (Allergy to sulfa) and Latex allergy. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ILLNESS (Received 1st Moderna vaccine, has been sick since), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), CHILLS (chills), NAUSEA (nausea), MYALGIA (body aches) and PYREXIA (fever). At the time of the report, ILLNESS (Received 1st Moderna vaccine, has been sick since), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), CHILLS (chills), NAUSEA (nausea) and MYALGIA (body aches) outcome was unknown and PYREXIA (fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test negative: Took 2 Covid tests which were negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use and treatment information was not provided. The reporter (patient's wife) gave consent for follow up.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Received 1st Moderna vaccine, has been sick since), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), CHILLS (chills) and NAUSEA (nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high, Shellfish allergy, Penicillin allergy, Drug allergy (Allergy to Keppra), Sulfonamide allergy (Allergy to sulfa) and Latex allergy. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ILLNESS (Received 1st Moderna vaccine, has been sick since), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), CHILLS (chills), NAUSEA (nausea), MYALGIA (body aches) and PYREXIA (fever). At the time of the report, ILLNESS (Received 1st Moderna vaccine, has been sick since), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), CHILLS (chills), NAUSEA (nausea) and MYALGIA (body aches) outcome was unknown and PYREXIA (fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test negative: Took 2 Covid tests which were negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use and treatment information was not provided. The reporter (patient's wife) gave consent for follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site became itchy; Injection site became itchy, red; Injection site became itchy, red and swollen; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Injection Site), VACCINATION SITE PRURITUS (Injection site became itchy), VACCINATION SITE ERYTHEMA (Injection site became itchy, red) and VACCINATION SITE SWELLING (Injection site became itchy, red and swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Seasonal allergy (Seasonal allergy uses Inhalers). Concomitant products included CAFFEINE, EPHEDRINE HYDROCHLORIDE, HERBAL EXTRACT NOS, POTASSIUM IODIDE, SODIUM BENZOATE (ASTHMALGINE) for an unknown indication.    On 15-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 VACCINATION SITE PAIN (Sore Injection Site). On 16-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site became itchy), VACCINATION SITE ERYTHEMA (Injection site became itchy, red) and VACCINATION SITE SWELLING (Injection site became itchy, red and swollen). The patient was treated with CORTISONE at an unspecified dose and frequency. On 17-Apr-2021, VACCINATION SITE PAIN (Sore Injection Site) had resolved. On 20-Apr-2021, VACCINATION SITE PRURITUS (Injection site became itchy) and VACCINATION SITE SWELLING (Injection site became itchy, red and swollen) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Injection site became itchy, red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included use of asthma inhalers.  The patient received treatment with cortisone cream on the injection site.  The patient's second dose was scheduled for May-2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Cough, Dysphonia, Dyspnoea
Clinical narrative: headache; body aches; fever; hoarse voice; trouble breathing; coughing; pain in chest / sore chest; tightness in chest; increased heart rate and pulse; rash on upper chest; lips started swelling up; hives; diagnosed it as a general allergic reaction to the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache), MYALGIA (body aches), PYREXIA (fever), DYSPNOEA (trouble breathing) and COUGH (coughing) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 047A12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021 at 2:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (trouble breathing), CHEST DISCOMFORT (tightness in chest), HEART RATE INCREASED (increased heart rate and pulse), RASH (rash on upper chest), LIP SWELLING (lips started swelling up), URTICARIA (hives) and HYPERSENSITIVITY (diagnosed it as a general allergic reaction to the vaccine). 14-Apr-2021, the patient experienced COUGH (coughing) and CHEST PAIN (pain in chest / sore chest). On 15-Apr-2021, the patient experienced HEADACHE (headache), MYALGIA (body aches), PYREXIA (fever) and DYSPHONIA (hoarse voice). At the time of the report, HEADACHE (headache), MYALGIA (body aches), PYREXIA (fever), DYSPNOEA (trouble breathing), COUGH (coughing), CHEST PAIN (pain in chest / sore chest), CHEST DISCOMFORT (tightness in chest), HEART RATE INCREASED (increased heart rate and pulse), RASH (rash on upper chest), LIP SWELLING (lips started swelling up), URTICARIA (hives), HYPERSENSITIVITY (diagnosed it as a general allergic reaction to the vaccine) and DYSPHONIA (hoarse voice) was resolving.            No concomitant medications were reported.  Treatment of the events included Benadry and her asthma inhaler.  The patient was transported to the ER but discharged that day.   This case was linked to US-MODERNATX, INC.-MOD-2021-071088 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071088:1st dose events
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hypersensitivity, Lip swelling, Myalgia
Clinical narrative: headache; body aches; fever; hoarse voice; trouble breathing; coughing; pain in chest / sore chest; tightness in chest; increased heart rate and pulse; rash on upper chest; lips started swelling up; hives; diagnosed it as a general allergic reaction to the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache), MYALGIA (body aches), PYREXIA (fever), DYSPNOEA (trouble breathing) and COUGH (coughing) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 047A12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021 at 2:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (trouble breathing), CHEST DISCOMFORT (tightness in chest), HEART RATE INCREASED (increased heart rate and pulse), RASH (rash on upper chest), LIP SWELLING (lips started swelling up), URTICARIA (hives) and HYPERSENSITIVITY (diagnosed it as a general allergic reaction to the vaccine). 14-Apr-2021, the patient experienced COUGH (coughing) and CHEST PAIN (pain in chest / sore chest). On 15-Apr-2021, the patient experienced HEADACHE (headache), MYALGIA (body aches), PYREXIA (fever) and DYSPHONIA (hoarse voice). At the time of the report, HEADACHE (headache), MYALGIA (body aches), PYREXIA (fever), DYSPNOEA (trouble breathing), COUGH (coughing), CHEST PAIN (pain in chest / sore chest), CHEST DISCOMFORT (tightness in chest), HEART RATE INCREASED (increased heart rate and pulse), RASH (rash on upper chest), LIP SWELLING (lips started swelling up), URTICARIA (hives), HYPERSENSITIVITY (diagnosed it as a general allergic reaction to the vaccine) and DYSPHONIA (hoarse voice) was resolving.            No concomitant medications were reported.  Treatment of the events included Benadry and her asthma inhaler.  The patient was transported to the ER but discharged that day.   This case was linked to US-MODERNATX, INC.-MOD-2021-071088 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071088:1st dose events
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: headache; body aches; fever; hoarse voice; trouble breathing; coughing; pain in chest / sore chest; tightness in chest; increased heart rate and pulse; rash on upper chest; lips started swelling up; hives; diagnosed it as a general allergic reaction to the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache), MYALGIA (body aches), PYREXIA (fever), DYSPNOEA (trouble breathing) and COUGH (coughing) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 047A12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021 at 2:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (trouble breathing), CHEST DISCOMFORT (tightness in chest), HEART RATE INCREASED (increased heart rate and pulse), RASH (rash on upper chest), LIP SWELLING (lips started swelling up), URTICARIA (hives) and HYPERSENSITIVITY (diagnosed it as a general allergic reaction to the vaccine). 14-Apr-2021, the patient experienced COUGH (coughing) and CHEST PAIN (pain in chest / sore chest). On 15-Apr-2021, the patient experienced HEADACHE (headache), MYALGIA (body aches), PYREXIA (fever) and DYSPHONIA (hoarse voice). At the time of the report, HEADACHE (headache), MYALGIA (body aches), PYREXIA (fever), DYSPNOEA (trouble breathing), COUGH (coughing), CHEST PAIN (pain in chest / sore chest), CHEST DISCOMFORT (tightness in chest), HEART RATE INCREASED (increased heart rate and pulse), RASH (rash on upper chest), LIP SWELLING (lips started swelling up), URTICARIA (hives), HYPERSENSITIVITY (diagnosed it as a general allergic reaction to the vaccine) and DYSPHONIA (hoarse voice) was resolving.            No concomitant medications were reported.  Treatment of the events included Benadry and her asthma inhaler.  The patient was transported to the ER but discharged that day.   This case was linked to US-MODERNATX, INC.-MOD-2021-071088 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071088:1st dose events
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm with both vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm with both vaccinations) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm with both vaccinations). At the time of the report, PAIN IN EXTREMITY (Sore Arm with both vaccinations) outcome was unknown. Not Provided          Concomitant product use was not provided.  Treatment information was not provided. Action taken in response to mRNA-1273 was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-081630, US-MODERNATX, INC.-MOD-2021-081770 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Non significant info received. TCR form attached. No new information was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081630:Same patient, First Dose US-MODERNATX, INC.-MOD-2021-081770:This case is for the reporter's husband
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Musculoskeletal stiffness, Myalgia, Vaccination site pain
Clinical narrative: stiffness specifically on her upper legs, shoulders and back; felt like somebody body slammed her; She had body ache; tenderness on the injection site; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness specifically on her upper legs, shoulders and back), MALAISE (felt like somebody body slammed her), MYALGIA (She had body ache) and VACCINATION SITE PAIN (tenderness on the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes (type-2) on 17-Mar-2021, Hypertension in December 2001 and Obesity. Concomitant products included VALSARTAN, METFORMIN, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and CETIRIZINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (tenderness on the injection site). On 19-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness specifically on her upper legs, shoulders and back), MALAISE (felt like somebody body slammed her) and MYALGIA (She had body ache). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness specifically on her upper legs, shoulders and back), MALAISE (felt like somebody body slammed her) and VACCINATION SITE PAIN (tenderness on the injection site) outcome was unknown and MYALGIA (She had body ache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient received 2 doses of acetaminophen (Tylenol) and felt better. concomitant medication was reported , treatment medication two Ibuprofen, and the symptoms disappeared and never came back .   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: followup received on 21-may-2021 significant information was added
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Pain that radiates to neck and shoulder/began the pain that radiates to shoulder and neck which is ongoing; arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain that radiates to neck and shoulder/began the pain that radiates to shoulder and neck which is ongoing) and VACCINATION SITE PAIN (arm pain at injection site) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm pain at injection site). On 20-Apr-2021, the patient experienced PAIN (Pain that radiates to neck and shoulder/began the pain that radiates to shoulder and neck which is ongoing). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 18-Apr-2021, VACCINATION SITE PAIN (arm pain at injection site) had resolved. At the time of the report, PAIN (Pain that radiates to neck and shoulder/began the pain that radiates to shoulder and neck which is ongoing) had not resolved.            No concomitant medication were reported.  Treatment medication included Ibuprofen.   This case was linked to US-MODERNATX, INC.-MOD-2021-081636 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081636:Case for dose 1
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Caller is breastfeeding and received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Caller is breastfeeding and received the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during breast feeding.    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 EXPOSURE VIA BREAST MILK (Caller is breastfeeding and received the vaccine). At the time of the report, EXPOSURE VIA BREAST MILK (Caller is breastfeeding and received the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: fever; lymph node swelling in left arm; chills; fever; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (chills), PYREXIA (fever), RASH (rash on the face, neck and waist) and LYMPHADENOPATHY (lymph node swelling in left arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 CHILLS (chills) and PYREXIA (fever). On 18-Apr-2021, the patient experienced RASH (rash on the face, neck and waist) and LYMPHADENOPATHY (lymph node swelling in left arm). At the time of the report, CHILLS (chills), PYREXIA (fever), RASH (rash on the face, neck and waist) and LYMPHADENOPATHY (lymph node swelling in left arm) 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 spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (chills), PYREXIA (fever), RASH (rash on the face, neck and waist) and LYMPHADENOPATHY (lymph node swelling in left arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 CHILLS (chills) and PYREXIA (fever). On 18-Apr-2021, the patient experienced RASH (rash on the face, neck and waist) and LYMPHADENOPATHY (lymph node swelling in left arm). At the time of the report, CHILLS (chills), PYREXIA (fever), RASH (rash on the face, neck and waist) and LYMPHADENOPATHY (lymph node swelling in left arm) 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.   A healthcare professional called to report that a patient received the first dose of the COVID-19 vaccine on 14APR2021 and started experiencing symptoms of rash on the face, neck and waist. The patient also reported lymph node swelling in her left arm.   Treatment information included was an unknown dose of Benadryl   This case was linked to US-MODERNATX, INC.-MOD-2021-081439 (Linked Report).   This case was linked to US-MODERNATX, INC.-MOD-2021-081439 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081439:
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: receiving the second dose after the 28 days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (iving the second dose after the 28 days) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (iving the second dose after the 28 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (iving the second dose after the 28 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment was reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Four dime size hives on right side of face; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (Four dime size hives on right side of face) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-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 URTICARIA (Four dime size hives on right side of face). On 17-Apr-2021, URTICARIA (Four dime size hives on right side of face) had resolved. 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.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Illness, Product dose omission issue, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of diarrhea, illness (sick), product dose omission issue (did not receive 2nd dose between days 25 and 35/unable to get 2nd dose) and pyrexia (low-grade fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 022M20A) for COVID-19 immunization. No medical history reported. On Feb 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 3, 2021, patient had diarrhea and pyrexia (low-grade fever). On an unknown date, patient experienced illness (sick) and product dose omission issue (did not receive 2nd dose between days 25 and 35/unable to get 2nd dose). At the time of the report, diarrhea, illness (sick) and pyrexia (low-grade fever) outcome: unknown; and product dose omission issue (did not receive 2nd dose between days 25 and 35/unable to get 2nd dose) resolved.The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. Treatment included ibuprofen for low-grade fever.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Psychotic disorder
Clinical narrative: Severe psychotic episodes; This spontaneous case was reported by an other caregiver and describes the occurrence of PSYCHOTIC DISORDER (Severe psychotic episodes) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.    On 09-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 PSYCHOTIC DISORDER (Severe psychotic episodes). At the time of the report, PSYCHOTIC DISORDER (Severe psychotic episodes) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment of this event was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: lost her apatite; stomach was a little jumpy; chills; Mild Fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost her apatite), ABDOMINAL DISCOMFORT (stomach was a little jumpy), CHILLS (chills), PYREXIA (Mild Fever) and FATIGUE (tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and unknown) for COVID-19 vaccination.     Concurrent medical conditions included Cataracts.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (lost her apatite), ABDOMINAL DISCOMFORT (stomach was a little jumpy), CHILLS (chills), PYREXIA (Mild Fever) and FATIGUE (tired). At the time of the report, DECREASED APPETITE (lost her apatite), ABDOMINAL DISCOMFORT (stomach was a little jumpy), CHILLS (chills), PYREXIA (Mild Fever) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081723 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081723:1st dose events
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: rash on her abdomen; itchy; full body rash like hives; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on her abdomen), PRURITUS (itchy) and URTICARIA (full body rash like hives) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash on her abdomen), PRURITUS (itchy) and URTICARIA (full body rash like hives). At the time of the report, RASH (rash on her abdomen), PRURITUS (itchy) and URTICARIA (full body rash like hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-081665 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081665:CROSSLINKED WITH DOSE 2
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: full body rash like hives; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (full body rash like hives) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (full body rash like hives). At the time of the report, URTICARIA (full body rash like hives) outcome was unknown.            No concomitant medications were reported.   The patient took Benadryl as treatment for the events.   This case was linked to US-MODERNATX, INC.-MOD-2021-081658 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081658:CROSSLINKED WITH DOSE 1
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the site of the injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (soreness at the site of the injection) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the site of the injection). On 29-Mar-2021, VACCINATION SITE PAIN (soreness at the site of the injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Itches so bad; red lump spot in the middle where the vaccine was given; red lump spot in the middle where the vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itches so bad), VACCINATION SITE INDURATION (red lump spot in the middle where the vaccine was given) and VACCINATION SITE ERYTHEMA (red lump spot in the middle where the vaccine was given) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itches so bad), VACCINATION SITE INDURATION (red lump spot in the middle where the vaccine was given) and VACCINATION SITE ERYTHEMA (red lump spot in the middle where the vaccine was given). At the time of the report, VACCINATION SITE PRURITUS (Itches so bad), VACCINATION SITE INDURATION (red lump spot in the middle where the vaccine was given) and VACCINATION SITE ERYTHEMA (red lump spot in the middle where the vaccine was given) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient does not take any concomitant medications.  Treatment was reported as none.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Dysphagia, Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It is been 36 days since first dose), MUSCLE SPASMS (Cramps), ILLNESS (Got sick), INFLAMMATION (Inflammation) and ASTHENIA (Weak) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder. Concomitant products included VITAMINS NOS, OMEPRAZOLE and PARACETAMOL (TYLENOL ARTHRITIS) for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced MUSCLE SPASMS (Cramps), ILLNESS (Got sick), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Stomach aches), DYSPHAGIA (Swallowing issues), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigued). On 17-Apr-2021, the patient experienced ILLNESS (Sick for 3 weeks). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It is been 36 days since first dose), INFLAMMATION (Inflammation) and FEELING ABNORMAL (Felt like somebody poisoned me). On 20-Apr-2021, MUSCLE SPASMS (Cramps), ILLNESS (Got sick), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Stomach aches), DYSPHAGIA (Swallowing issues), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigued) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (It is been 36 days since first dose) outcome was unknown and ILLNESS (Sick for 3 weeks) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications include vitamins and thyroid medications. Treatment for the event included ibuprofen, omeprazole. Patient received the first dose of the Moderna COVID-19 Vaccine on 7Apr2021, since then she is been sick for like three weeks. She was scheduled for her second dose on 9May2021 but she did not receive the dose. It is now been 36 days since she took her first dose and she wanted to know how long can she wait after the first dose to receive the second dose and if she has to repeat the vaccine. Consent for safety team to follow-up was given. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: significant follow up: Event added as missed dose, concomitant medications added. On 21-May-2021: non significant info received. On 21-May-2021: Significant follow up :- Events added :- inflammation, missed dose.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Illness, Inflammation, Muscle spasms
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It is been 36 days since first dose), MUSCLE SPASMS (Cramps), ILLNESS (Got sick), INFLAMMATION (Inflammation) and ASTHENIA (Weak) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder. Concomitant products included VITAMINS NOS, OMEPRAZOLE and PARACETAMOL (TYLENOL ARTHRITIS) for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced MUSCLE SPASMS (Cramps), ILLNESS (Got sick), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Stomach aches), DYSPHAGIA (Swallowing issues), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigued). On 17-Apr-2021, the patient experienced ILLNESS (Sick for 3 weeks). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It is been 36 days since first dose), INFLAMMATION (Inflammation) and FEELING ABNORMAL (Felt like somebody poisoned me). On 20-Apr-2021, MUSCLE SPASMS (Cramps), ILLNESS (Got sick), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Stomach aches), DYSPHAGIA (Swallowing issues), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigued) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (It is been 36 days since first dose) outcome was unknown and ILLNESS (Sick for 3 weeks) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications include vitamins and thyroid medications. Treatment for the event included ibuprofen, omeprazole. Patient received the first dose of the Moderna COVID-19 Vaccine on 7Apr2021, since then she is been sick for like three weeks. She was scheduled for her second dose on 9May2021 but she did not receive the dose. It is now been 36 days since she took her first dose and she wanted to know how long can she wait after the first dose to receive the second dose and if she has to repeat the vaccine. Consent for safety team to follow-up was given. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: significant follow up: Event added as missed dose, concomitant medications added. On 21-May-2021: non significant info received. On 21-May-2021: Significant follow up :- Events added :- inflammation, missed dose.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It is been 36 days since first dose), MUSCLE SPASMS (Cramps), ILLNESS (Got sick), INFLAMMATION (Inflammation) and ASTHENIA (Weak) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder. Concomitant products included VITAMINS NOS, OMEPRAZOLE and PARACETAMOL (TYLENOL ARTHRITIS) for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced MUSCLE SPASMS (Cramps), ILLNESS (Got sick), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Stomach aches), DYSPHAGIA (Swallowing issues), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigued). On 17-Apr-2021, the patient experienced ILLNESS (Sick for 3 weeks). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It is been 36 days since first dose), INFLAMMATION (Inflammation) and FEELING ABNORMAL (Felt like somebody poisoned me). On 20-Apr-2021, MUSCLE SPASMS (Cramps), ILLNESS (Got sick), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Stomach aches), DYSPHAGIA (Swallowing issues), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigued) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (It is been 36 days since first dose) outcome was unknown and ILLNESS (Sick for 3 weeks) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications include vitamins and thyroid medications. Treatment for the event included ibuprofen, omeprazole. Patient received the first dose of the Moderna COVID-19 Vaccine on 7Apr2021, since then she is been sick for like three weeks. She was scheduled for her second dose on 9May2021 but she did not receive the dose. It is now been 36 days since she took her first dose and she wanted to know how long can she wait after the first dose to receive the second dose and if she has to repeat the vaccine. Consent for safety team to follow-up was given. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: significant follow up: Event added as missed dose, concomitant medications added. On 21-May-2021: non significant info received. On 21-May-2021: Significant follow up :- Events added :- inflammation, missed dose.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Vaccination site pain
Clinical narrative: feels like a needle is stuck in his muscle.; Arm of injection stinging; Arm of injection hurts; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (feels like a needle is stuck in his muscle.), PAIN (Arm of injection stinging) and VACCINATION SITE PAIN (Arm of injection hurts) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Oral surgery.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (Arm of injection stinging) and VACCINATION SITE PAIN (Arm of injection hurts). On an unknown date, the patient experienced PARAESTHESIA (feels like a needle is stuck in his muscle.). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (feels like a needle is stuck in his muscle.), PAIN (Arm of injection stinging) and VACCINATION SITE PAIN (Arm of injection hurts) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications  includes Antibiotic, Pain medications.   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Follow up received on 22-MAY-2021. Attached ADR form contain non significant information. On 24-May-2021: Follow up received on 24-MAY-2021. Contain significant information additional event added
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Myalgia
Clinical narrative: Redness; Fatigue; Chills; Sore arm; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Redness), MYALGIA (Sore arm), FATIGUE (Fatigue) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to allopathic drugs (Acyclovir), Allergy to chemicals (blue paint), Allergy to allopathic drugs (Dilantin), Allergy to allopathic drugs (Pristiq) and Allergy to allopathic drugs (Prolensa). Concomitant products included EPINEPHRINE (EPIPEN 2-PAK) for Angioedema, SUMATRIPTAN SUCCINATE for Complicated migraine, MACROGOL 3350 (MIRALAX) from 09-Nov-2020 to an unknown date for Dysuria, FAMCICLOVIR from 23-Nov-2021 to an unknown date for Herpes simplex oesophagitis, SUMATRIPTAN for Migraine, ONDANSETRON (ONDASETRON [ONDANSETRON]) for Nausea, GABAPENTIN (NEURONTIN) from 16-Dec-2020 to an unknown date for Neuralgia NOS, CLONAZEPAM, ESTRADIOL, ESTRADIOL, DICLOFENAC SODIUM, CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]), ONDANSETRON HYDROCHLORIDE (ONDASETRON [ONDANSETRON HYDROCHLORIDE]) from 16-Nov-2020 to an unknown date, VALACICLOVIR HYDROCHLORIDE (VALTREX) from 16-Nov-2020 to an unknown date, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, VORICONAZOLE and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) 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 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 05-Feb-2021, the patient experienced MYALGIA (Sore arm). On 02-May-2021, the patient experienced FATIGUE (Fatigue) and CHILLS (Chills). On an unknown date, the patient experienced ERYTHEMA (Redness). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ONDANSETRON (ZOFRAN MELT) ongoing since an unknown date at an unspecified dose and frequency and OXYCODONE HYDROCHLORIDE (OXYCODON) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), MYALGIA (Sore arm), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include opioid   This case was linked to US-MODERNATX, INC.-MOD-2021-081720 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Added concomitant medications; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081720:1st dose of vaccine