chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second 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 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Second dose administered with Pfizer COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Second dose administered with Pfizer COVID-19 Vaccine) in a 40-year-old male patient 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.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 05-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Second dose administered with Pfizer COVID-19 Vaccine). On 05-Jul-2021, INTERCHANGE OF VACCINE PRODUCTS (Second dose administered with Pfizer COVID-19 Vaccine) 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.   No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: under 18-year-old received the first dose of moderna; Second dose administered with Pfizer COVID-19 Vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18-year-old received the first dose of moderna) and INTERCHANGE OF VACCINE PRODUCTS (Second dose administered with Pfizer COVID-19 Vaccine) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18-year-old received the first dose of moderna) and INTERCHANGE OF VACCINE PRODUCTS (Second dose administered with Pfizer COVID-19 Vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18-year-old received the first dose of moderna) and INTERCHANGE OF VACCINE PRODUCTS (Second dose administered with Pfizer COVID-19 Vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.   Patient stated that first dose was received on 2021 and also stated that second dose with Pfizer COVID-19 Vaccine was received on 03 or 04JUL2021
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Back pain, Off label use
Clinical narrative: 1st dose Astrazeneca; 2nd dose Moderna; low back pain; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (1st dose Astrazeneca; 2nd dose Moderna) and BACK PAIN (low back pain) 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 COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (1st dose Astrazeneca; 2nd dose Moderna) and BACK PAIN (low back pain). At the time of the report, OFF LABEL USE (1st dose Astrazeneca; 2nd dose Moderna) and BACK PAIN (low back pain) outcome was unknown.            No concomitant medication were reported  No treatment medication were provided
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: injection site red after two weeks; injection site hot after two weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site red after two weeks) and VACCINATION SITE WARMTH (injection site hot after two weeks) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site red after two weeks) and VACCINATION SITE WARMTH (injection site hot after two weeks). At the time of the report, VACCINATION SITE ERYTHEMA (injection site red after two weeks) and VACCINATION SITE WARMTH (injection site hot after two weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Erythema, Feeling hot, Flushing
Clinical narrative: Diarrhea; Sneezing; Feeling hot; Flushing; HIVES; Redness; Chill; Nausea; I had the same reaction to the second dose for the rash, although not as extensive on the arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), SNEEZING (Sneezing), FEELING HOT (Feeling hot), FLUSHING (Flushing) and URTICARIA (HIVES) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 3IL20A and 01B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Malabsorption (Fructose malabsorption). Concurrent medical conditions included Allergy to metals, GERD since 01-Jan-2015, Allergy to chemicals (MCI allergy), Allergy (Balsam) and Allergy to chemicals (Limonene allergy).   On 20-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021 at 6:30 AM, the patient experienced RASH (I had the same reaction to the second dose for the rash, although not as extensive on the arm). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), SNEEZING (Sneezing), FEELING HOT (Feeling hot), FLUSHING (Flushing), URTICARIA (HIVES), ERYTHEMA (Redness), CHILLS (Chill) and NAUSEA (Nausea). On 01-Mar-2021 at 6:30 AM, RASH (I had the same reaction to the second dose for the rash, although not as extensive on the arm) had resolved. At the time of the report, DIARRHOEA (Diarrhea), SNEEZING (Sneezing), FEELING HOT (Feeling hot), FLUSHING (Flushing), URTICARIA (HIVES), ERYTHEMA (Redness), CHILLS (Chill) and NAUSEA (Nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Antihistamines are used as treatment medication.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash, Sneezing, Urticaria
Clinical narrative: Diarrhea; Sneezing; Feeling hot; Flushing; HIVES; Redness; Chill; Nausea; I had the same reaction to the second dose for the rash, although not as extensive on the arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), SNEEZING (Sneezing), FEELING HOT (Feeling hot), FLUSHING (Flushing) and URTICARIA (HIVES) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 3IL20A and 01B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Malabsorption (Fructose malabsorption). Concurrent medical conditions included Allergy to metals, GERD since 01-Jan-2015, Allergy to chemicals (MCI allergy), Allergy (Balsam) and Allergy to chemicals (Limonene allergy).   On 20-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021 at 6:30 AM, the patient experienced RASH (I had the same reaction to the second dose for the rash, although not as extensive on the arm). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), SNEEZING (Sneezing), FEELING HOT (Feeling hot), FLUSHING (Flushing), URTICARIA (HIVES), ERYTHEMA (Redness), CHILLS (Chill) and NAUSEA (Nausea). On 01-Mar-2021 at 6:30 AM, RASH (I had the same reaction to the second dose for the rash, although not as extensive on the arm) had resolved. At the time of the report, DIARRHOEA (Diarrhea), SNEEZING (Sneezing), FEELING HOT (Feeling hot), FLUSHING (Flushing), URTICARIA (HIVES), ERYTHEMA (Redness), CHILLS (Chill) and NAUSEA (Nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Antihistamines are used as treatment medication.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose administered on 01May2021, second dose not administered yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose administered on 01May2021, second dose not administered yet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose administered on 01May2021, second dose not administered yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose administered on 01May2021, second dose not administered yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing after vaccination). At the time of the report, COUGH (Coughing after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Connective tissue disorder, Myalgia
Clinical narrative: Muscular achyness; Polymyalgia rheumatica like syndrome; This spontaneous case was reported by a physician and describes the occurrence of CONNECTIVE TISSUE DISORDER (Polymyalgia rheumatica like syndrome) and MYALGIA (Muscular achyness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was not provided by reporter.  Concomitant products included LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZIDE), MELOXICAM and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 26-May-2021, the patient experienced CONNECTIVE TISSUE DISORDER (Polymyalgia rheumatica like syndrome). On an unknown date, the patient experienced MYALGIA (Muscular achyness). The patient was treated with PREDNISONE for Pain, at a dose of UNK dosage form. At the time of the report, CONNECTIVE TISSUE DISORDER (Polymyalgia rheumatica like syndrome) and MYALGIA (Muscular achyness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter mentioned that stopped rosuvastatin calcium as therapeutic measure, but it did not help with the muscle pain.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Hypokinesia, Illness, Influenza like illness
Clinical narrative: Can Hardly Move when Sick (2 days on, 2 days off); Flu like symptoms comes and goes every 2-3 days; Dizzy comes and goes every 2-3 days; Wheezing comes and goes every 2-3 days; Coughing only when Fever Starts; Sick/Sick 2 days on, 2 days off; Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick/Sick 2 days on, 2 days off), PYREXIA (Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range)), HYPOKINESIA (Can Hardly Move when Sick (2 days on, 2 days off)), INFLUENZA LIKE ILLNESS (Flu like symptoms comes and goes every 2-3 days) and DIZZINESS (Dizzy comes and goes every 2-3 days) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced ILLNESS (Sick/Sick 2 days on, 2 days off) and PYREXIA (Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range)). On 29-Jun-2021, the patient experienced HYPOKINESIA (Can Hardly Move when Sick (2 days on, 2 days off)), INFLUENZA LIKE ILLNESS (Flu like symptoms comes and goes every 2-3 days), DIZZINESS (Dizzy comes and goes every 2-3 days), WHEEZING (Wheezing comes and goes every 2-3 days) and COUGH (Coughing only when Fever Starts). On 26-Jun-2021, ILLNESS (Sick/Sick 2 days on, 2 days off) outcome was unknown. At the time of the report, PYREXIA (Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range)), HYPOKINESIA (Can Hardly Move when Sick (2 days on, 2 days off)), INFLUENZA LIKE ILLNESS (Flu like symptoms comes and goes every 2-3 days), DIZZINESS (Dizzy comes and goes every 2-3 days), WHEEZING (Wheezing comes and goes every 2-3 days) and COUGH (Coughing only when Fever Starts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were not provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Wheezing
Clinical narrative: Can Hardly Move when Sick (2 days on, 2 days off); Flu like symptoms comes and goes every 2-3 days; Dizzy comes and goes every 2-3 days; Wheezing comes and goes every 2-3 days; Coughing only when Fever Starts; Sick/Sick 2 days on, 2 days off; Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick/Sick 2 days on, 2 days off), PYREXIA (Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range)), HYPOKINESIA (Can Hardly Move when Sick (2 days on, 2 days off)), INFLUENZA LIKE ILLNESS (Flu like symptoms comes and goes every 2-3 days) and DIZZINESS (Dizzy comes and goes every 2-3 days) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced ILLNESS (Sick/Sick 2 days on, 2 days off) and PYREXIA (Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range)). On 29-Jun-2021, the patient experienced HYPOKINESIA (Can Hardly Move when Sick (2 days on, 2 days off)), INFLUENZA LIKE ILLNESS (Flu like symptoms comes and goes every 2-3 days), DIZZINESS (Dizzy comes and goes every 2-3 days), WHEEZING (Wheezing comes and goes every 2-3 days) and COUGH (Coughing only when Fever Starts). On 26-Jun-2021, ILLNESS (Sick/Sick 2 days on, 2 days off) outcome was unknown. At the time of the report, PYREXIA (Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range)), HYPOKINESIA (Can Hardly Move when Sick (2 days on, 2 days off)), INFLUENZA LIKE ILLNESS (Flu like symptoms comes and goes every 2-3 days), DIZZINESS (Dizzy comes and goes every 2-3 days), WHEEZING (Wheezing comes and goes every 2-3 days) and COUGH (Coughing only when Fever Starts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 29 patients received Moderna Covid-19 vaccine after 30 day refrigerator beyond use date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (29 patients received Moderna Covid-19 vaccine after 30 day refrigerator beyond use date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (29 patients received Moderna Covid-19 vaccine after 30 day refrigerator beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (29 patients received Moderna Covid-19 vaccine after 30 day refrigerator beyond use date) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Erythema, Rash, Sensitive skin
Clinical narrative: PATIENT REPORTS DEVELOPING RASH WITH LITTLE RED DOTS ON CHEST; DIARRHEA; PATIENT REPORTS DEVELOPING RASH WITH LITTLE RED DOTS ON CHEST; CHILLS; Sensitive skin; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (PATIENT REPORTS DEVELOPING RASH WITH LITTLE RED DOTS ON CHEST), DIARRHOEA (DIARRHEA), RASH (PATIENT REPORTS DEVELOPING RASH WITH LITTLE RED DOTS ON CHEST), CHILLS (CHILLS) and SENSITIVE SKIN (Sensitive skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.  Concurrent medical conditions included Psoriasis (Patients has Psoriasis for years.) and Allergic reaction to drug (Allergic to Benadryl rashes worsen with the use of Benadryl liquid.).   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 29-May-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 ERYTHEMA (PATIENT REPORTS DEVELOPING RASH WITH LITTLE RED DOTS ON CHEST), DIARRHOEA (DIARRHEA), RASH (PATIENT REPORTS DEVELOPING RASH WITH LITTLE RED DOTS ON CHEST), CHILLS (CHILLS) and SENSITIVE SKIN (Sensitive skin). At the time of the report, ERYTHEMA (PATIENT REPORTS DEVELOPING RASH WITH LITTLE RED DOTS ON CHEST), DIARRHOEA (DIARRHEA) and CHILLS (CHILLS) had resolved, RASH (PATIENT REPORTS DEVELOPING RASH WITH LITTLE RED DOTS ON CHEST) had not resolved and SENSITIVE SKIN (Sensitive skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant followup Outcome of events was updated.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Pyrexia, Vaccination complication
Clinical narrative: very bad reaction; diarrhea; 104 temp; chills; vomiting; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (very bad reaction), DIARRHOEA (diarrhea), PYREXIA (104 temp), CHILLS (chills) and VOMITING (vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (very bad reaction), DIARRHOEA (diarrhea), PYREXIA (104 temp), CHILLS (chills) and VOMITING (vomiting). At the time of the report, VACCINATION COMPLICATION (very bad reaction), DIARRHOEA (diarrhea), PYREXIA (104 temp), CHILLS (chills) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 temp chills.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: very bad reaction; diarrhea; 104 temp; chills; vomiting; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (very bad reaction), DIARRHOEA (diarrhea), PYREXIA (104 temp), CHILLS (chills) and VOMITING (vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (very bad reaction), DIARRHOEA (diarrhea), PYREXIA (104 temp), CHILLS (chills) and VOMITING (vomiting). At the time of the report, VACCINATION COMPLICATION (very bad reaction), DIARRHOEA (diarrhea), PYREXIA (104 temp), CHILLS (chills) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 temp chills.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 27FEB2021 ,received the second dose in the Moderna COVID-19 vaccine series on 28Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 27FEB2021 ,received the second dose in the Moderna COVID-19 vaccine series on 28Apr2021) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 27FEB2021 ,received the second dose in the Moderna COVID-19 vaccine series on 28Apr2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 27FEB2021 ,received the second dose in the Moderna COVID-19 vaccine series on 28Apr2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment information not provided. Concomitant medications were not provided.   This case was linked to MOD-2021-044506 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Connective tissue disorder, Loss of personal independence in daily activities, Musculoskeletal stiffness, Myalgia
Clinical narrative: could hardly get out of bed in the morning; muscular achyness, muscle pain; connective tissue disorder nos; stiffness in the shoulders, buttocks and upper thives; This spontaneous case was reported by a health care professional and describes the occurrence of CONNECTIVE TISSUE DISORDER (connective tissue disorder nos), MUSCULOSKELETAL STIFFNESS (stiffness in the shoulders, buttocks and upper thives), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could hardly get out of bed in the morning) and MYALGIA (muscular achyness, muscle pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZIDE), MELOXICAM and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced CONNECTIVE TISSUE DISORDER (connective tissue disorder nos) and MUSCULOSKELETAL STIFFNESS (stiffness in the shoulders, buttocks and upper thives). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could hardly get out of bed in the morning) and MYALGIA (muscular achyness, muscle pain). The patient was treated with PREDNISONE for Pain, at a dose of 10 mg. At the time of the report, CONNECTIVE TISSUE DISORDER (connective tissue disorder nos), MUSCULOSKELETAL STIFFNESS (stiffness in the shoulders, buttocks and upper thives), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could hardly get out of bed in the morning) and MYALGIA (muscular achyness, muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: 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.   This case was linked to MOD-2021-246715 (Patient Link).; 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: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: My rash cleared up in  week; This spontaneous case was reported by a consumer and describes the occurrence of RASH (My rash cleared up in  week) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (My rash cleared up in  week). At the time of the report, RASH (My rash cleared up in  week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant products and Treatment medication were reported. No treatment medication was reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: tremors; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (tremors) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2021, the patient experienced TREMOR (tremors). At the time of the report, TREMOR (tremors) outcome was unknown.            Patient started to experienced tremors on the day of second dose, first on the left arm, and then on the right arm  as well, lasting for about 3 hours. Then on the 28-Jun-2021,  she experienced tremors again in both arms lasting around 6 hours, so patient went to the emergency room  where she was administered 1.5 liters of IV saline fluids, and run some blood work  that came back normal. Emergency room  doctors thought patient may have been dehydrated, and ruled out Rhabdomyolysis with the blood work. Then, in 02-July-2021 patient experienced tremors, only on the right arm, and again on 04-Jul-2021, only in the right arm.  This time they were multiple episodes of short duration, around 5 minutes, and less intense.   This case was linked to MOD-2021-246747 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: she did have COVID Arm 10 days after first vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Jul-2021 and was forwarded to Moderna on 05-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she did have COVID Arm 10 days after first vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (she did have COVID Arm 10 days after first vaccine). At the time of the report, VACCINATION COMPLICATION (she did have COVID Arm 10 days after first vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-018064 (Patient Link).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Dizziness, Illness, Influenza like illness
Clinical narrative: sick for 2 days then well for 2 days, and sick again for 2; Can Hardly Move when Sick (2 days on, 2 days off); Flu like symptoms comes and goes every 2-3 days; Dizzy comes and goes every 2-3 days; Wheezing comes and goes every 2-3 days; Cough when fever starts; Sick; Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 2 days then well for 2 days, and sick again for 2), MOBILITY DECREASED (Can Hardly Move when Sick (2 days on, 2 days off)), INFLUENZA LIKE ILLNESS (Flu like symptoms comes and goes every 2-3 days), DIZZINESS (Dizzy comes and goes every 2-3 days) and WHEEZING (Wheezing comes and goes every 2-3 days) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced ILLNESS (Sick) and PYREXIA (Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range)). On 29-Jun-2021, the patient experienced ILLNESS (sick for 2 days then well for 2 days, and sick again for 2), MOBILITY DECREASED (Can Hardly Move when Sick (2 days on, 2 days off)), INFLUENZA LIKE ILLNESS (Flu like symptoms comes and goes every 2-3 days), DIZZINESS (Dizzy comes and goes every 2-3 days), WHEEZING (Wheezing comes and goes every 2-3 days) and COUGH (Cough when fever starts). On 26-Jun-2021, ILLNESS (Sick) had resolved. At the time of the report, ILLNESS (sick for 2 days then well for 2 days, and sick again for 2), MOBILITY DECREASED (Can Hardly Move when Sick (2 days on, 2 days off)), INFLUENZA LIKE ILLNESS (Flu like symptoms comes and goes every 2-3 days), DIZZINESS (Dizzy comes and goes every 2-3 days), WHEEZING (Wheezing comes and goes every 2-3 days) and COUGH (Cough when fever starts) outcome was unknown and PYREXIA (Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Body temperature: 99.8 - 101.5 °F.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported. Treatment information was unknown.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pyrexia, Wheezing
Clinical narrative: sick for 2 days then well for 2 days, and sick again for 2; Can Hardly Move when Sick (2 days on, 2 days off); Flu like symptoms comes and goes every 2-3 days; Dizzy comes and goes every 2-3 days; Wheezing comes and goes every 2-3 days; Cough when fever starts; Sick; Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 2 days then well for 2 days, and sick again for 2), MOBILITY DECREASED (Can Hardly Move when Sick (2 days on, 2 days off)), INFLUENZA LIKE ILLNESS (Flu like symptoms comes and goes every 2-3 days), DIZZINESS (Dizzy comes and goes every 2-3 days) and WHEEZING (Wheezing comes and goes every 2-3 days) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced ILLNESS (Sick) and PYREXIA (Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range)). On 29-Jun-2021, the patient experienced ILLNESS (sick for 2 days then well for 2 days, and sick again for 2), MOBILITY DECREASED (Can Hardly Move when Sick (2 days on, 2 days off)), INFLUENZA LIKE ILLNESS (Flu like symptoms comes and goes every 2-3 days), DIZZINESS (Dizzy comes and goes every 2-3 days), WHEEZING (Wheezing comes and goes every 2-3 days) and COUGH (Cough when fever starts). On 26-Jun-2021, ILLNESS (Sick) had resolved. At the time of the report, ILLNESS (sick for 2 days then well for 2 days, and sick again for 2), MOBILITY DECREASED (Can Hardly Move when Sick (2 days on, 2 days off)), INFLUENZA LIKE ILLNESS (Flu like symptoms comes and goes every 2-3 days), DIZZINESS (Dizzy comes and goes every 2-3 days), WHEEZING (Wheezing comes and goes every 2-3 days) and COUGH (Cough when fever starts) outcome was unknown and PYREXIA (Fever ranging from 99.8 F to 101.5F  (First days after vaccination the fever was in the higher range)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Body temperature: 99.8 - 101.5 °F.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported. Treatment information was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: direct relative got the first dose of the Moderna vaccine on 25May2021 and has not got the second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (direct relative got the first dose of the Moderna vaccine on 25May2021 and has not got the second dose yet) 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 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (direct relative got the first dose of the Moderna vaccine on 25May2021 and has not got the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (direct relative got the first dose of the Moderna vaccine on 25May2021 and has not got the second dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.  The second vaccine was scheduled for 22-JUN-2021.  No Treatment information was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Fatigue, Headache, Heart rate, Hot flush
Clinical narrative: Since the 1st dose my period is missing; Could not sleep all night; I had normal reactions; Hot flashes; Severe headache; Fever; Fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (Since the 1st dose my period is missing), INSOMNIA (Could not sleep all night), HOT FLUSH (Hot flashes), PAIN IN EXTREMITY (Sore arm) and UNEVALUABLE EVENT (I had normal reactions) in a 51-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.     Concurrent medical conditions included Hypothyroidism.   On 02-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jul-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and FATIGUE (Fatigue). On 04-Jul-2021, the patient experienced HEADACHE (Severe headache). On 05-Jul-2021, the patient experienced HOT FLUSH (Hot flashes). On an unknown date, the patient experienced AMENORRHOEA (Since the 1st dose my period is missing), INSOMNIA (Could not sleep all night) and UNEVALUABLE EVENT (I had normal reactions). At the time of the report, AMENORRHOEA (Since the 1st dose my period is missing), INSOMNIA (Could not sleep all night), HOT FLUSH (Hot flashes), PAIN IN EXTREMITY (Sore arm), UNEVALUABLE EVENT (I had normal reactions), PYREXIA (Fever), FATIGUE (Fatigue) and HEADACHE (Severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2021, Heart rate: 95 bpm (High) Heart rate is 95 bpm (normal rate is about 60 bpm).         Treatment information not provided. List of concomitant medications were not given.   This case was linked to MOD-2021-246762 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Non-Significant follow-up
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Pyrexia, Unevaluable event
Clinical narrative: Since the 1st dose my period is missing; Could not sleep all night; I had normal reactions; Hot flashes; Severe headache; Fever; Fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (Since the 1st dose my period is missing), INSOMNIA (Could not sleep all night), HOT FLUSH (Hot flashes), PAIN IN EXTREMITY (Sore arm) and UNEVALUABLE EVENT (I had normal reactions) in a 51-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.     Concurrent medical conditions included Hypothyroidism.   On 02-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Jul-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and FATIGUE (Fatigue). On 04-Jul-2021, the patient experienced HEADACHE (Severe headache). On 05-Jul-2021, the patient experienced HOT FLUSH (Hot flashes). On an unknown date, the patient experienced AMENORRHOEA (Since the 1st dose my period is missing), INSOMNIA (Could not sleep all night) and UNEVALUABLE EVENT (I had normal reactions). At the time of the report, AMENORRHOEA (Since the 1st dose my period is missing), INSOMNIA (Could not sleep all night), HOT FLUSH (Hot flashes), PAIN IN EXTREMITY (Sore arm), UNEVALUABLE EVENT (I had normal reactions), PYREXIA (Fever), FATIGUE (Fatigue) and HEADACHE (Severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2021, Heart rate: 95 bpm (High) Heart rate is 95 bpm (normal rate is about 60 bpm).         Treatment information not provided. List of concomitant medications were not given.   This case was linked to MOD-2021-246762 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Non-Significant follow-up
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Illness, Myalgia, Pruritus, Skin mass
Clinical narrative: Itchy bumps on top of head/itchy bumps on cheeks/itchy bumps on  forehead/itchy bumps on her back; Itchy bumps on top of head/itchy bumps on cheeks/itchy bumps on  forehead/itchy bumps on her back; Generalized body aches; Extremely sick; No energy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick), ASTHENIA (No energy), SKIN MASS (Itchy bumps on top of head/itchy bumps on cheeks/itchy bumps on  forehead/itchy bumps on her back), PRURITUS (Itchy bumps on top of head/itchy bumps on cheeks/itchy bumps on  forehead/itchy bumps on her back) and MYALGIA (Generalized body aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ESCITALOPRAM and FAMOTIDINE for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced ILLNESS (Extremely sick), ASTHENIA (No energy) and MYALGIA (Generalized body aches). On 28-Feb-2021, the patient experienced SKIN MASS (Itchy bumps on top of head/itchy bumps on cheeks/itchy bumps on  forehead/itchy bumps on her back) and PRURITUS (Itchy bumps on top of head/itchy bumps on cheeks/itchy bumps on  forehead/itchy bumps on her back). On 14-Feb-2021, ILLNESS (Extremely sick), ASTHENIA (No energy) and MYALGIA (Generalized body aches) had resolved. At the time of the report, SKIN MASS (Itchy bumps on top of head/itchy bumps on cheeks/itchy bumps on  forehead/itchy bumps on her back) and PRURITUS (Itchy bumps on top of head/itchy bumps on cheeks/itchy bumps on  forehead/itchy bumps on her back) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes a Medrol dose pack and a steroid cream..
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Kidney transplant. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available). On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative. No relevant concomitant medications were reported. No treatment information was provided.