chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site pruritus, Injection site swelling
Clinical narrative: Brown discoloration at the injection site; injection site itchy; injection site raised up; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (Brown discoloration at the injection site), INJECTION SITE PRURITUS (injection site itchy) and INJECTION SITE SWELLING (injection site raised up) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE DISCOLOURATION (Brown discoloration at the injection site), INJECTION SITE PRURITUS (injection site itchy) and INJECTION SITE SWELLING (injection site raised up). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and BETAMETHASONE (CELESTONE [BETAMETHASONE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE DISCOLOURATION (Brown discoloration at the injection site), INJECTION SITE PRURITUS (injection site itchy) and INJECTION SITE SWELLING (injection site raised up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants medications also included Birth control pills
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm only hurt a little; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (arm only hurt a little) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 017B21A)) for COVID-19 vaccination.     No medical history was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm only hurt a little). At the time of the report, PAIN IN EXTREMITY (arm only hurt a little) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use included cholesterol medication Treatment information not provided.  Action taken with mRNA-1273 was not applicable
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 52 days since 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (52 days since 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (52 days since 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (52 days since 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-223807 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-Jun-2021: Second dose events were updated.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching everywhere started from face, back of ears, back of arms, little on back, down to knee and feet, bottom; rash everywhere started from face, back of ears, back of arms, little on back, down to knee and feet, bottom; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching everywhere started from face, back of ears, back of arms, little on back, down to knee and feet, bottom) and RASH (rash everywhere started from face, back of ears, back of arms, little on back, down to knee and feet, bottom) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer since an unknown date and Lobectomy (thyroid) since an unknown date.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (itching everywhere started from face, back of ears, back of arms, little on back, down to knee and feet, bottom) and RASH (rash everywhere started from face, back of ears, back of arms, little on back, down to knee and feet, bottom). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) on 08-Feb-2021 for Adverse reaction, at a dose of 1 dosage form once a day; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) on 08-Feb-2021 for Adverse reaction, at a dose of 1 dosage form once a day; PREDNISONE on 08-Feb-2021 for Adverse reaction, at a dose of 1 dosage form, for 4 days and DOXEPIN for Itching, at a dose of 1 dosage form. At the time of the report, PRURITUS (itching everywhere started from face, back of ears, back of arms, little on back, down to knee and feet, bottom) had resolved and RASH (rash everywhere started from face, back of ears, back of arms, little on back, down to knee and feet, bottom) had not resolved.            Patient was not taking any concomitant medications.  Patient's experienced rash and itching again on 07-MAR-2021.   This case was linked to MOD-2021-037221 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Outcome of events and treatment medication updated
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Rash
Clinical narrative: Nausea; Rashes all over the body,rash on lower back,rash on legs; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), RASH (Rashes all over the body,rash on lower back,rash on legs) and PRURITUS (Itchiness) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NAUSEA (Nausea), RASH (Rashes all over the body,rash on lower back,rash on legs) and PRURITUS (Itchiness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea), RASH (Rashes all over the body,rash on lower back,rash on legs) and PRURITUS (Itchiness) outcome was unknown.            no concomitant medications are provided. Patient is schedule to meet with a dermatologist..   This case was linked to US-MODERNATX, INC.-MOD-2021-067707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067707:1st dose
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: arm hurt; chills; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Inhaler daily for asthma), Blood pressure high and Obesity. Concomitant products included MONTELUKAST for Allergy, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and LABETALOL for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (arm hurt) had not resolved and CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment to the events not provided.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Headache; It continues to grow; red, warm, itchy spot; red, warm, itchy spot; red, warm, itchy spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (red, warm, itchy spot), CONDITION AGGRAVATED (It continues to grow), VACCINATION SITE PRURITUS (red, warm, itchy spot), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (red, warm, itchy spot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031AZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).  On 26-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 VACCINATION SITE WARMTH (red, warm, itchy spot), VACCINATION SITE PRURITUS (red, warm, itchy spot) and VACCINATION SITE ERYTHEMA (red, warm, itchy spot). On 01-Apr-2021, the patient experienced CONDITION AGGRAVATED (It continues to grow). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (red, warm, itchy spot), CONDITION AGGRAVATED (It continues to grow), VACCINATION SITE PRURITUS (red, warm, itchy spot) and VACCINATION SITE ERYTHEMA (red, warm, itchy spot) had not resolved and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medication reported. Spot went away on 29 Mar 2021 and returned on 01 Apr 2021, larger in size. The patient reported it continued to grow. Treatment included Tylenol and Ibuprofen.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Rash
Clinical narrative: nausea; Rashes all over the body/Rashes on lower back/Rashes on legs; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), RASH (Rashes all over the body/Rashes on lower back/Rashes on legs) and PRURITUS (Itchiness) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced NAUSEA (nausea), RASH (Rashes all over the body/Rashes on lower back/Rashes on legs) and PRURITUS (Itchiness). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) ongoing since an unknown date at an unspecified dose and frequency and HYDROCORTISONE ACETATE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), RASH (Rashes all over the body/Rashes on lower back/Rashes on legs) and PRURITUS (Itchiness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was reported  Action taken with mRNA-1273 was not applicable
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: feeling way, way tired; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site) and FATIGUE (feeling way, way tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 018A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 01-Apr-2021, the patient experienced FATIGUE (feeling way, way tired). On 27-Mar-2021, VACCINATION SITE PAIN (soreness at the injection site) had resolved. At the time of the report, FATIGUE (feeling way, way tired) outcome was unknown. Not Provided          He has been doing rigorous dieting and is not sure whether this is coming from that or the vaccine.  No concomitant product use was reported No treatment information was provided  Action taken with mRNA-1273 was not applicable
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever; This spontaneous case was reported by an other and describes the occurrence of PYREXIA (Low grade fever) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Low grade fever). On 06-Mar-2021, PYREXIA (Low grade fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PYREXIA (Low grade fever) to be probably related.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site warmth, Vaccination site pain
Clinical narrative: Warm to touch; sore arm and arm hurting; Joint pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to touch), VACCINATION SITE PAIN (sore arm and arm hurting), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Blood pressure high, Obesity and Allergy. Concomitant products included MONTELUKAST for Allergy, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and LABETALOL for an unknown indication.   On 12-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 1 dosage form. On 04-Apr-2021, the patient experienced INJECTION SITE WARMTH (Warm to touch), VACCINATION SITE PAIN (sore arm and arm hurting), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue). At the time of the report, INJECTION SITE WARMTH (Warm to touch) and VACCINATION SITE PAIN (sore arm and arm hurting) had not resolved and ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) had resolved.            Patient was also taking Inhaler daily for asthma as concomitant medication  No treatment information was provided  Action taken with mRNA-1273 was not applicable
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Stomatitis
Clinical narrative: mouth sores; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (mouth sores) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History Information was reported.  Concomitant products included GUSELKUMAB (TREMFYA) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced STOMATITIS (mouth sores). At the time of the report, STOMATITIS (mouth sores) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Myalgia, Oropharyngeal pain, Pain
Clinical narrative: weakness; sore throat; shortness of breath; Feel achy; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), OROPHARYNGEAL PAIN (sore throat), DYSPNOEA (shortness of breath), PAIN (Feel achy) and MYALGIA (muscle ache) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O25B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included GLUCOSAMINE for Joint pain.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced ASTHENIA (weakness), OROPHARYNGEAL PAIN (sore throat), DYSPNOEA (shortness of breath), PAIN (Feel achy) and MYALGIA (muscle ache). At the time of the report, ASTHENIA (weakness) and MYALGIA (muscle ache) had not resolved, OROPHARYNGEAL PAIN (sore throat) and PAIN (Feel achy) outcome was unknown and DYSPNOEA (shortness of breath) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also includes vitamin supplements.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-067884 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067884:
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Productive cough
Clinical narrative: had a higher concentration, build up of mucous and phlegm; It has been more difficult to breathe every morning.; This spontaneous case was reported by a patient and describes the occurrence of PRODUCTIVE COUGH (had a higher concentration, build up of mucous and phlegm) and DYSPNOEA (It has been more difficult to breathe every morning.) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (had a higher concentration, build up of mucous and phlegm) and DYSPNOEA (It has been more difficult to breathe every morning.). At the time of the report, PRODUCTIVE COUGH (had a higher concentration, build up of mucous and phlegm) and DYSPNOEA (It has been more difficult to breathe every morning.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.  It has been more difficult to breathe every morning and is taking him 3-4 hours more than usual to get ready in the morning. He has not taken any treatments.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: The Vaccine Leaked down his Arm/Patient Did not receive a Full Dose; The Vaccine Leaked down his Arm; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (The Vaccine Leaked down his Arm/Patient Did not receive a Full Dose) and DEVICE CONNECTION ISSUE (The Vaccine Leaked down his Arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced UNDERDOSE (The Vaccine Leaked down his Arm/Patient Did not receive a Full Dose) and DEVICE CONNECTION ISSUE (The Vaccine Leaked down his Arm). On 16-Mar-2021, DEVICE CONNECTION ISSUE (The Vaccine Leaked down his Arm) had resolved. At the time of the report, UNDERDOSE (The Vaccine Leaked down his Arm/Patient Did not receive a Full Dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported  No treatment information was provided
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Cardiac disorder, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: gastro pains; diarrhea; felt like someone was sticking needles in my heart; couldn't get out the bed; no appetite; lost about 7 pounds; very tired; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN (gastro pains), DIARRHOEA (diarrhea), CARDIAC DISORDER (felt like someone was sticking needles in my heart), BEDRIDDEN (couldn't get out the bed) and DECREASED APPETITE (no appetite) in a 90-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.     The patient's past medical history included Breast cancer.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced GASTROINTESTINAL PAIN (gastro pains), DIARRHOEA (diarrhea), CARDIAC DISORDER (felt like someone was sticking needles in my heart), BEDRIDDEN (couldn't get out the bed), DECREASED APPETITE (no appetite), WEIGHT DECREASED (lost about 7 pounds) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Feb-2021, BEDRIDDEN (couldn't get out the bed) had resolved. On 01-Mar-2021, GASTROINTESTINAL PAIN (gastro pains), DIARRHOEA (diarrhea) and CARDIAC DISORDER (felt like someone was sticking needles in my heart) had resolved. At the time of the report, DECREASED APPETITE (no appetite), WEIGHT DECREASED (lost about 7 pounds) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported   This case was linked to US-MODERNATX, INC.-MOD-2021-067748 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067748:Original Case : MOD-2021-067715
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal pain, Weight decreased
Clinical narrative: gastro pains; diarrhea; felt like someone was sticking needles in my heart; couldn't get out the bed; no appetite; lost about 7 pounds; very tired; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN (gastro pains), DIARRHOEA (diarrhea), CARDIAC DISORDER (felt like someone was sticking needles in my heart), BEDRIDDEN (couldn't get out the bed) and DECREASED APPETITE (no appetite) in a 90-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.     The patient's past medical history included Breast cancer.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced GASTROINTESTINAL PAIN (gastro pains), DIARRHOEA (diarrhea), CARDIAC DISORDER (felt like someone was sticking needles in my heart), BEDRIDDEN (couldn't get out the bed), DECREASED APPETITE (no appetite), WEIGHT DECREASED (lost about 7 pounds) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Feb-2021, BEDRIDDEN (couldn't get out the bed) had resolved. On 01-Mar-2021, GASTROINTESTINAL PAIN (gastro pains), DIARRHOEA (diarrhea) and CARDIAC DISORDER (felt like someone was sticking needles in my heart) had resolved. At the time of the report, DECREASED APPETITE (no appetite), WEIGHT DECREASED (lost about 7 pounds) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported   This case was linked to US-MODERNATX, INC.-MOD-2021-067748 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067748:Original Case : MOD-2021-067715
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: really itchy; rash around injection site like round red mark; swelling; really sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really sore arm), PRURITUS (really itchy), VACCINATION SITE RASH (rash around injection site like round red mark) and VACCINATION SITE SWELLING (swelling) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (really sore arm). On 04-Apr-2021, the patient experienced PRURITUS (really itchy), VACCINATION SITE RASH (rash around injection site like round red mark) and VACCINATION SITE SWELLING (swelling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Apr-2021, PAIN IN EXTREMITY (really sore arm) had resolved. At the time of the report, PRURITUS (really itchy), VACCINATION SITE RASH (rash around injection site like round red mark) and VACCINATION SITE SWELLING (swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported Treatment information also included cold compresses
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: slipped and hurt her ankle; fever (T100.9F); chills; sweaty; right arm really hurt; body aches (felt like a truck had run her over); This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), PAIN IN EXTREMITY (right arm really hurt), PAIN (body aches (felt like a truck had run her over)), ARTHRALGIA (slipped and hurt her ankle) and PYREXIA (fever (T100.9F)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HYPERHIDROSIS (sweaty), PAIN IN EXTREMITY (right arm really hurt), PAIN (body aches (felt like a truck had run her over)) and CHILLS (chills). 02-Apr-2021, the patient experienced PYREXIA (fever (T100.9F)). On 03-Apr-2021, the patient experienced ARTHRALGIA (slipped and hurt her ankle). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 03-Apr-2021, HYPERHIDROSIS (sweaty), PAIN IN EXTREMITY (right arm really hurt), PAIN (body aches (felt like a truck had run her over)), ARTHRALGIA (slipped and hurt her ankle) and CHILLS (chills) had resolved. On 04-Apr-2021, PYREXIA (fever (T100.9F)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.9 f (abnormal) 100.9 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: slipped and hurt her ankle; fever (T100.9F); chills; sweaty; right arm really hurt; body aches (felt like a truck had run her over); This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), PAIN IN EXTREMITY (right arm really hurt), PAIN (body aches (felt like a truck had run her over)), ARTHRALGIA (slipped and hurt her ankle) and PYREXIA (fever (T100.9F)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HYPERHIDROSIS (sweaty), PAIN IN EXTREMITY (right arm really hurt), PAIN (body aches (felt like a truck had run her over)) and CHILLS (chills). 02-Apr-2021, the patient experienced PYREXIA (fever (T100.9F)). On 03-Apr-2021, the patient experienced ARTHRALGIA (slipped and hurt her ankle). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 03-Apr-2021, HYPERHIDROSIS (sweaty), PAIN IN EXTREMITY (right arm really hurt), PAIN (body aches (felt like a truck had run her over)), ARTHRALGIA (slipped and hurt her ankle) and CHILLS (chills) had resolved. On 04-Apr-2021, PYREXIA (fever (T100.9F)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.9 f (abnormal) 100.9 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site rash
Clinical narrative: rash at injection site; arm felt funny; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at injection site) and LIMB DISCOMFORT (arm felt funny) in a 3-week-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE RASH (rash at injection site) and LIMB DISCOMFORT (arm felt funny). At the time of the report, VACCINATION SITE RASH (rash at injection site) and LIMB DISCOMFORT (arm felt funny) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site erythema (patient reports red patch on her arm on injected site looks like a bug bite) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; .5 milliliter. On Apr 3, 2021, patient experienced vaccination site erythema (patient reports red patch on her arm on injected site that looks like a bug bite). The patient treated with hydrocortisone, at an unspecified dose and frequency. At the time of the report, vaccination site erythema (patient reports red patch on her arm on injected site looks like a bug bite) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Nausea
Clinical narrative: tested positive for covid; cough; nausea; fever; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid), COUGH (cough), NAUSEA (nausea), PYREXIA (fever) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and ZINC for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced COUGH (cough), NAUSEA (nausea), PYREXIA (fever), HEADACHE (headache) and FATIGUE (tired). On 30-Mar-2021, the patient experienced COVID-19 (tested positive for covid). The patient was treated with CEFDINIR at a dose of 1 dosage form and PREDNISOLONE at a dose of 1 dosage form. At the time of the report, COVID-19 (tested positive for covid), COUGH (cough), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (tired) outcome was unknown and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant medications also include-  allergy pill.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for covid; cough; nausea; fever; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid), COUGH (cough), NAUSEA (nausea), PYREXIA (fever) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and ZINC for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced COUGH (cough), NAUSEA (nausea), PYREXIA (fever), HEADACHE (headache) and FATIGUE (tired). On 30-Mar-2021, the patient experienced COVID-19 (tested positive for covid). The patient was treated with CEFDINIR at a dose of 1 dosage form and PREDNISOLONE at a dose of 1 dosage form. At the time of the report, COVID-19 (tested positive for covid), COUGH (cough), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (tired) outcome was unknown and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant medications also include-  allergy pill.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip swelling
Clinical narrative: Swollen upper lip; Headache for a few days; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen upper lip) and HEADACHE (Headache for a few days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced HEADACHE (Headache for a few days). On 02-Apr-2021, the patient experienced LIP SWELLING (Swollen upper lip). At the time of the report, LIP SWELLING (Swollen upper lip) and HEADACHE (Headache for a few days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       02Apr2021 the patient had swollen upper lip and she went to Urgent care where she was given Steroid shot. The patient is scared to receive the second dose. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: TCR form is attached email id of the reporter updated.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Pain in arm; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue). In March 2021, PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness; Room is spinning/vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and VERTIGO (Room is spinning/vertigo) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and VERTIGO (Room is spinning/vertigo). The patient was treated with MECLIZINE [MECLOZINE] at a dose of 2.5 milligram. At the time of the report, DIZZINESS (Dizziness) and VERTIGO (Room is spinning/vertigo) had not resolved. Not Provided           This side effect presented itself about one week after the administration of the second dose and has continued up to this time. She went to her Doctor's office for treatment and was diagnosed with Vertigo and given medication. Side effects are still present currently.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up information received on 18-May-2021 and no new information was added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Mobility decreased, Myalgia
Clinical narrative: Could not pick her arm up over her head until day 3; Bad headache along the level of a migraine; Every muscle was hurting; Headache was intense and painful; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could not pick her arm up over her head until day 3), MIGRAINE (Bad headache along the level of a migraine), MYALGIA (Every muscle was hurting) and HEADACHE (Headache was intense and painful) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced MIGRAINE (Bad headache along the level of a migraine), MYALGIA (Every muscle was hurting) and HEADACHE (Headache was intense and painful). On 02-Apr-2021, the patient experienced MOBILITY DECREASED (Could not pick her arm up over her head until day 3). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MOBILITY DECREASED (Could not pick her arm up over her head until day 3), MIGRAINE (Bad headache along the level of a migraine) and MYALGIA (Every muscle was hurting) outcome was unknown and HEADACHE (Headache was intense and painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants were not provided. Treatment was not provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: A bit of the dose was running down his arm when the dose pulled the needle out; A bit of the dose was running down his arm when the dose pulled the needle out; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (A bit of the dose was running down his arm when the dose pulled the needle out) and DEVICE CONNECTION ISSUE (A bit of the dose was running down his arm when the dose pulled the needle out) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced UNDERDOSE (A bit of the dose was running down his arm when the dose pulled the needle out) and DEVICE CONNECTION ISSUE (A bit of the dose was running down his arm when the dose pulled the needle out). On 05-Apr-2021, UNDERDOSE (A bit of the dose was running down his arm when the dose pulled the needle out) and DEVICE CONNECTION ISSUE (A bit of the dose was running down his arm when the dose pulled the needle out) had resolved. Not Provided          Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 virus after the first vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 virus after the first vaccine dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 virus after the first vaccine dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 virus after the first vaccine dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       No treatment were listed in the source document.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Lip swelling, Pyrexia
Clinical narrative: Lip Swelling; cough; fever; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (Lip Swelling), COUGH (cough), PYREXIA (fever) and CHILLS (chills) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 061L20A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included USTEKINUMAB (STELARA) for Crohn's disease.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced COUGH (cough), PYREXIA (fever) and CHILLS (chills). On 31-Jan-2021, the patient experienced LIP SWELLING (Lip Swelling). At the time of the report, LIP SWELLING (Lip Swelling) had not resolved and COUGH (cough), PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had her Stelara shot 1week after vaccination based on Guidance given by her GI doctor.13 days after the first dose patient had a Chocolate cupcake which she had it previously following which her Lip swelled up so much that it looked like she got punched real hard. Treatment Medicines include Benadryl and Epipen   This case was linked to MOD-2021-067744 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site rash
Clinical narrative: Fatigued; Rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE and VACCINATION SITE RASH in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03A221A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced FATIGUE and VACCINATION SITE RASH. At the time of the report, FATIGUE and VACCINATION SITE RASH outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-068362, MOD-2021-068362.   Most recent FOLLOW-UP information incorporated above On 17-May-2021: Follow up received on 17-may-2021 content non significant information.