chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: All my chest is swollen and my arm; The inflammation in my axilla is still present; All my chest is swollen and my arm; Chills; My right axilla is swollen; Fever; Body pain; Headache; Very intense right arm  pain; Body is cold; Bone pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Body is cold), BONE PAIN (Bone pain), PERIPHERAL SWELLING (All my chest is swollen and my arm), INFLAMMATION (The inflammation in my axilla is still present) and SWELLING (All my chest is swollen and my arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL and CREATINE, INULIN, LEVOGLUTAMIDE, LYSINE, PROTEINS NOS, SPIRULINA SPP., TAURINE, VITAMINS NOS (VEGAN PROTEIN) for an unknown indication.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced FEELING COLD (Body is cold), BONE PAIN (Bone pain) and PAIN IN EXTREMITY (Very intense right arm  pain   ). On 16-May-2021, the patient experienced SWELLING (All my chest is swollen and my arm), CHILLS (Chills), LYMPHADENOPATHY (My right axilla is swollen), PYREXIA (Fever), MYALGIA (Body pain) and HEADACHE (Headache). On 17-May-2021, the patient experienced INFLAMMATION (The inflammation in my axilla is still present). On an unknown date, the patient experienced PERIPHERAL SWELLING (All my chest is swollen and my arm). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) (oral) at a dose of 500 gram twice a day and IBUPROFEN (oral) at a dose of 800 gram twice a day. At the time of the report, FEELING COLD (Body is cold), BONE PAIN (Bone pain), PERIPHERAL SWELLING (All my chest is swollen and my arm), SWELLING (All my chest is swollen and my arm), PAIN IN EXTREMITY (Very intense right arm  pain   ), CHILLS (Chills), LYMPHADENOPATHY (My right axilla is swollen), PYREXIA (Fever), MYALGIA (Body pain) and HEADACHE (Headache) outcome was unknown and INFLAMMATION (The inflammation in my axilla is still present) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Delirium, Myalgia, Pyrexia, Tonsillar hypertrophy
Clinical narrative: Delirium; Swelling tonsils; Vomiting; Chills; Body ache; On and off fever (98 to 101 degrees Fahrenheit); This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirium), TONSILLAR HYPERTROPHY (Swelling tonsils), VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (Body ache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced DELIRIUM (Delirium), TONSILLAR HYPERTROPHY (Swelling tonsils), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Body ache) and PYREXIA (On and off fever (98 to 101 degrees Fahrenheit)). At the time of the report, DELIRIUM (Delirium), TONSILLAR HYPERTROPHY (Swelling tonsils), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Body ache) and PYREXIA (On and off fever (98 to 101 degrees Fahrenheit)) outcome was unknown.            No concomitant medications provided. Treatment of these events were not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Delirium; Swelling tonsils; Vomiting; Chills; Body ache; On and off fever (98 to 101 degrees Fahrenheit); This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirium), TONSILLAR HYPERTROPHY (Swelling tonsils), VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (Body ache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced DELIRIUM (Delirium), TONSILLAR HYPERTROPHY (Swelling tonsils), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Body ache) and PYREXIA (On and off fever (98 to 101 degrees Fahrenheit)). At the time of the report, DELIRIUM (Delirium), TONSILLAR HYPERTROPHY (Swelling tonsils), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Body ache) and PYREXIA (On and off fever (98 to 101 degrees Fahrenheit)) outcome was unknown.            No concomitant medications provided. Treatment of these events were not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; 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: Wrong technique in product usage process
Clinical narrative: 5 patients received a vaccine dose that was refrozen/one patient received it 9 days ago and the other 4 received it 7 days ago; 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 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (5 patients received a vaccine dose that was refrozen/one patient received it 9 days ago and the other 4 received it 7 days ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (5 patients received a vaccine dose that was refrozen/one patient received it 9 days ago and the other 4 received it 7 days ago). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (5 patients received a vaccine dose that was refrozen/one patient received it 9 days ago and the other 4 received it 7 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurting a bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurting a bit) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced PAIN IN EXTREMITY (Arm hurting a bit). At the time of the report, PAIN IN EXTREMITY (Arm hurting a bit) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient confirmed that he received both Moderna vaccines and not Pfizer. It was reported the patient received the second dose of the vaccine on 14-Jun-2021.  No Concomitant  information was  provided. No Treatment information was  provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up reiceved on 27-Jul-2021.  Significant Follow up received.  Event outcome updated to resolved.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: After receiving the first dose of vaccine on 05Mar2021, the patient went for antibody test ) and received a negative test result; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (After receiving the first dose of vaccine on 05Mar2021, the patient went for antibody test ) and received a negative test result) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Osteoporosis in 2006. Concurrent medical conditions included Allergy to antibiotic (minocin). Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis, CALCIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (After receiving the first dose of vaccine on 05Mar2021, the patient went for antibody test ) and received a negative test result). On 14-May-2021, SARS-COV-2 ANTIBODY TEST NEGATIVE (After receiving the first dose of vaccine on 05Mar2021, the patient went for antibody test ) and received a negative test result) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 antibody test: negative (Negative) negative. On 05-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No information regarding corrective treatment was reported by the patient.   This case was linked to MOD-2021-141821 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up received which included patient details, patient medical history and concomitant medications.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: did not received the second dose of the Moderna vaccine before the 36th day after the first one; Got the first dose of the Moderna vaccine on 20Jan2021 and 3 days ago took the first dose of the Pfizer vaccine; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Got the first dose of the Moderna vaccine on 20Jan2021 and 3 days ago took the first dose of the Pfizer vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not received the second dose of the Moderna vaccine before the 36th day after the first one) in a 57-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.    Concurrent medical conditions included Hypertension (The patient is taking high blood pressure medication).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Got the first dose of the Moderna vaccine on 20Jan2021 and 3 days ago took the first dose of the Pfizer vaccine). On 16-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not received the second dose of the Moderna vaccine before the 36th day after the first one). At the time of the report, PRODUCT ADMINISTRATION ERROR (Got the first dose of the Moderna vaccine on 20Jan2021 and 3 days ago took the first dose of the Pfizer vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not received the second dose of the Moderna vaccine before the 36th day after the first one) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Blood urine present, Body temperature, Chills
Clinical narrative: I was shaking; my breathing was fast; I was unable to stand; my heart rate was extremely high 115 to 120; my blood pressure was high; I was peeing straight blood; really sleepy; Chills; Fever 100.4 F; Very Cold; Lethargic; Low energy; Mild Body Ache, Body aches; Tired; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (Lethargic), ASTHENIA (Low energy), NASOPHARYNGITIS (Very Cold), TREMOR (I was shaking) and RESPIRATORY RATE INCREASED (my breathing was fast) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included UTI.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced LETHARGY (Lethargic), ASTHENIA (Low energy), HEADACHE (Headache), MYALGIA (Mild Body Ache, Body aches) and FATIGUE (Tired). On 18-May-2021, the patient experienced NASOPHARYNGITIS (Very Cold), CHILLS (Chills) and PYREXIA (Fever 100.4 F). On an unknown date, the patient experienced TREMOR (I was shaking), RESPIRATORY RATE INCREASED (my breathing was fast), DYSSTASIA (I was unable to stand), HEART RATE INCREASED (my heart rate was extremely high 115 to 120), HYPERTENSION (my blood pressure was high), BLOOD URINE PRESENT (I was peeing straight blood) and SOMNOLENCE (really sleepy). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Tiredness, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Body temperature, at a dose of 1 dosage form. On 16-May-2021, LETHARGY (Lethargic), ASTHENIA (Low energy), HEADACHE (Headache) and FATIGUE (Tired) had resolved, MYALGIA (Mild Body Ache, Body aches) had not resolved. At the time of the report, NASOPHARYNGITIS (Very Cold), TREMOR (I was shaking), RESPIRATORY RATE INCREASED (my breathing was fast), DYSSTASIA (I was unable to stand), HEART RATE INCREASED (my heart rate was extremely high 115 to 120), HYPERTENSION (my blood pressure was high), BLOOD URINE PRESENT (I was peeing straight blood), SOMNOLENCE (really sleepy), CHILLS (Chills) and PYREXIA (Fever 100.4 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) blood pressure expected to be high but it was normal. On an unknown date, Body temperature: 103.5 (High) temperature was high. On an unknown date, Electrocardiogram: 115-120 (High) heart rate was extremely high. On an unknown date, X-ray: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21-Jun-2021 as reporter, new events and treatment details were added
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Electrocardiogram, Fatigue, Headache, Heart rate increased
Clinical narrative: I was shaking; my breathing was fast; I was unable to stand; my heart rate was extremely high 115 to 120; my blood pressure was high; I was peeing straight blood; really sleepy; Chills; Fever 100.4 F; Very Cold; Lethargic; Low energy; Mild Body Ache, Body aches; Tired; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (Lethargic), ASTHENIA (Low energy), NASOPHARYNGITIS (Very Cold), TREMOR (I was shaking) and RESPIRATORY RATE INCREASED (my breathing was fast) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included UTI.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced LETHARGY (Lethargic), ASTHENIA (Low energy), HEADACHE (Headache), MYALGIA (Mild Body Ache, Body aches) and FATIGUE (Tired). On 18-May-2021, the patient experienced NASOPHARYNGITIS (Very Cold), CHILLS (Chills) and PYREXIA (Fever 100.4 F). On an unknown date, the patient experienced TREMOR (I was shaking), RESPIRATORY RATE INCREASED (my breathing was fast), DYSSTASIA (I was unable to stand), HEART RATE INCREASED (my heart rate was extremely high 115 to 120), HYPERTENSION (my blood pressure was high), BLOOD URINE PRESENT (I was peeing straight blood) and SOMNOLENCE (really sleepy). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Tiredness, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Body temperature, at a dose of 1 dosage form. On 16-May-2021, LETHARGY (Lethargic), ASTHENIA (Low energy), HEADACHE (Headache) and FATIGUE (Tired) had resolved, MYALGIA (Mild Body Ache, Body aches) had not resolved. At the time of the report, NASOPHARYNGITIS (Very Cold), TREMOR (I was shaking), RESPIRATORY RATE INCREASED (my breathing was fast), DYSSTASIA (I was unable to stand), HEART RATE INCREASED (my heart rate was extremely high 115 to 120), HYPERTENSION (my blood pressure was high), BLOOD URINE PRESENT (I was peeing straight blood), SOMNOLENCE (really sleepy), CHILLS (Chills) and PYREXIA (Fever 100.4 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) blood pressure expected to be high but it was normal. On an unknown date, Body temperature: 103.5 (High) temperature was high. On an unknown date, Electrocardiogram: 115-120 (High) heart rate was extremely high. On an unknown date, X-ray: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21-Jun-2021 as reporter, new events and treatment details were added
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Lethargy, Myalgia, Nasopharyngitis, Pyrexia
Clinical narrative: I was shaking; my breathing was fast; I was unable to stand; my heart rate was extremely high 115 to 120; my blood pressure was high; I was peeing straight blood; really sleepy; Chills; Fever 100.4 F; Very Cold; Lethargic; Low energy; Mild Body Ache, Body aches; Tired; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (Lethargic), ASTHENIA (Low energy), NASOPHARYNGITIS (Very Cold), TREMOR (I was shaking) and RESPIRATORY RATE INCREASED (my breathing was fast) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included UTI.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced LETHARGY (Lethargic), ASTHENIA (Low energy), HEADACHE (Headache), MYALGIA (Mild Body Ache, Body aches) and FATIGUE (Tired). On 18-May-2021, the patient experienced NASOPHARYNGITIS (Very Cold), CHILLS (Chills) and PYREXIA (Fever 100.4 F). On an unknown date, the patient experienced TREMOR (I was shaking), RESPIRATORY RATE INCREASED (my breathing was fast), DYSSTASIA (I was unable to stand), HEART RATE INCREASED (my heart rate was extremely high 115 to 120), HYPERTENSION (my blood pressure was high), BLOOD URINE PRESENT (I was peeing straight blood) and SOMNOLENCE (really sleepy). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Tiredness, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Body temperature, at a dose of 1 dosage form. On 16-May-2021, LETHARGY (Lethargic), ASTHENIA (Low energy), HEADACHE (Headache) and FATIGUE (Tired) had resolved, MYALGIA (Mild Body Ache, Body aches) had not resolved. At the time of the report, NASOPHARYNGITIS (Very Cold), TREMOR (I was shaking), RESPIRATORY RATE INCREASED (my breathing was fast), DYSSTASIA (I was unable to stand), HEART RATE INCREASED (my heart rate was extremely high 115 to 120), HYPERTENSION (my blood pressure was high), BLOOD URINE PRESENT (I was peeing straight blood), SOMNOLENCE (really sleepy), CHILLS (Chills) and PYREXIA (Fever 100.4 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) blood pressure expected to be high but it was normal. On an unknown date, Body temperature: 103.5 (High) temperature was high. On an unknown date, Electrocardiogram: 115-120 (High) heart rate was extremely high. On an unknown date, X-ray: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21-Jun-2021 as reporter, new events and treatment details were added
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate increased, Somnolence, Tremor, X-ray
Clinical narrative: I was shaking; my breathing was fast; I was unable to stand; my heart rate was extremely high 115 to 120; my blood pressure was high; I was peeing straight blood; really sleepy; Chills; Fever 100.4 F; Very Cold; Lethargic; Low energy; Mild Body Ache, Body aches; Tired; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (Lethargic), ASTHENIA (Low energy), NASOPHARYNGITIS (Very Cold), TREMOR (I was shaking) and RESPIRATORY RATE INCREASED (my breathing was fast) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included UTI.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced LETHARGY (Lethargic), ASTHENIA (Low energy), HEADACHE (Headache), MYALGIA (Mild Body Ache, Body aches) and FATIGUE (Tired). On 18-May-2021, the patient experienced NASOPHARYNGITIS (Very Cold), CHILLS (Chills) and PYREXIA (Fever 100.4 F). On an unknown date, the patient experienced TREMOR (I was shaking), RESPIRATORY RATE INCREASED (my breathing was fast), DYSSTASIA (I was unable to stand), HEART RATE INCREASED (my heart rate was extremely high 115 to 120), HYPERTENSION (my blood pressure was high), BLOOD URINE PRESENT (I was peeing straight blood) and SOMNOLENCE (really sleepy). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Tiredness, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Body temperature, at a dose of 1 dosage form. On 16-May-2021, LETHARGY (Lethargic), ASTHENIA (Low energy), HEADACHE (Headache) and FATIGUE (Tired) had resolved, MYALGIA (Mild Body Ache, Body aches) had not resolved. At the time of the report, NASOPHARYNGITIS (Very Cold), TREMOR (I was shaking), RESPIRATORY RATE INCREASED (my breathing was fast), DYSSTASIA (I was unable to stand), HEART RATE INCREASED (my heart rate was extremely high 115 to 120), HYPERTENSION (my blood pressure was high), BLOOD URINE PRESENT (I was peeing straight blood), SOMNOLENCE (really sleepy), CHILLS (Chills) and PYREXIA (Fever 100.4 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) blood pressure expected to be high but it was normal. On an unknown date, Body temperature: 103.5 (High) temperature was high. On an unknown date, Electrocardiogram: 115-120 (High) heart rate was extremely high. On an unknown date, X-ray: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21-Jun-2021 as reporter, new events and treatment details were added
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 immunisation.     Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE on 15-Mar-2021.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient received pneumonia vaccine between 1st and 2nd dose.  No treatment information was reported.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Dry mouth, Oropharyngeal pain
Clinical narrative: Sore throat; Lower back pain (rated as 9/10),; Dry mouth; Pain on both legs (7/10); Severe chills; Pain on joints - elbows and knees (5/10 when lying down, 9/10 when walking); This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), BACK PAIN (Lower back pain (rated as 9/10), ), DRY MOUTH (Dry mouth), PAIN IN EXTREMITY (Pain on both legs (7/10)) and CHILLS (Severe chills) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), BACK PAIN (Lower back pain (rated as 9/10), ), DRY MOUTH (Dry mouth), PAIN IN EXTREMITY (Pain on both legs (7/10)), CHILLS (Severe chills) and ARTHRALGIA (Pain on joints - elbows and knees (5/10 when lying down, 9/10 when walking)). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), BACK PAIN (Lower back pain (rated as 9/10), ), DRY MOUTH (Dry mouth), PAIN IN EXTREMITY (Pain on both legs (7/10)), CHILLS (Severe chills) and ARTHRALGIA (Pain on joints - elbows and knees (5/10 when lying down, 9/10 when walking)) had not resolved.            The concomitant medications were not provided. The treatment information was not provided.  The action taken with mRNA 1273 with the events were considered as not applicable.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore throat; Lower back pain (rated as 9/10),; Dry mouth; Pain on both legs (7/10); Severe chills; Pain on joints - elbows and knees (5/10 when lying down, 9/10 when walking); This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), BACK PAIN (Lower back pain (rated as 9/10), ), DRY MOUTH (Dry mouth), PAIN IN EXTREMITY (Pain on both legs (7/10)) and CHILLS (Severe chills) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), BACK PAIN (Lower back pain (rated as 9/10), ), DRY MOUTH (Dry mouth), PAIN IN EXTREMITY (Pain on both legs (7/10)), CHILLS (Severe chills) and ARTHRALGIA (Pain on joints - elbows and knees (5/10 when lying down, 9/10 when walking)). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), BACK PAIN (Lower back pain (rated as 9/10), ), DRY MOUTH (Dry mouth), PAIN IN EXTREMITY (Pain on both legs (7/10)), CHILLS (Severe chills) and ARTHRALGIA (Pain on joints - elbows and knees (5/10 when lying down, 9/10 when walking)) had not resolved.            The concomitant medications were not provided. The treatment information was not provided.  The action taken with mRNA 1273 with the events were considered as not applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: Pregnant at the time of first dose; Interval between doses > 42 days; This spontaneous retrospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant at the time of first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between doses > 42 days) in a 42-year-old female patient (gravida 1, para 1) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant at the time of first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between doses > 42 days). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant at the time of first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between doses > 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: Lack of vaccine efficacy; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Lack of vaccine efficacy) 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 Organ transplant.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 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 SARS-COV-2 ANTIBODY TEST NEGATIVE (Lack of vaccine efficacy). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Lack of vaccine efficacy) outcome was unknown.            Concomitant product use was not provided. No treatment was reported. Action taken in response to mRNA-1273 was not applicable.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot, Pruritus
Clinical narrative: Burning neck; Itching on neck; Hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning neck), PRURITUS (Itching on neck) and FEELING HOT (Hot to touch) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced BURNING SENSATION (Burning neck), PRURITUS (Itching on neck) and FEELING HOT (Hot to touch). On 12-Apr-2021, BURNING SENSATION (Burning neck), PRURITUS (Itching on neck) and FEELING HOT (Hot to touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided. The treatment information was not provided.   This case was linked to MOD-2021-141839.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Menopause delayed
Clinical narrative: she has had her menstrual cycle come back; This spontaneous case was reported by a patient and describes the occurrence of MENOPAUSE DELAYED (she has had her menstrual cycle come back) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 MENOPAUSE DELAYED (she has had her menstrual cycle come back). At the time of the report, MENOPAUSE DELAYED (she has had her menstrual cycle come back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Another person had a cold for 14 days; 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 NASOPHARYNGITIS (Another person had a cold for 14 days) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Another person had a cold for 14 days). At the time of the report, NASOPHARYNGITIS (Another person had a cold for 14 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Taste of vaccine in mouth; This spontaneous case was reported by a patient and describes the occurrence of TASTE DISORDER (Taste of vaccine in mouth) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced TASTE DISORDER (Taste of vaccine in mouth). At the time of the report, TASTE DISORDER (Taste of vaccine in mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Mobility decreased, Vaccination site pain
Clinical narrative: Not been able to move left arm; Pain in the site of the injection; Experience chills; Feeling cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling cold), MOBILITY DECREASED (Not been able to move left arm), VACCINATION SITE PAIN (Pain in the site of the injection) and CHILLS (Experience chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041821A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced FEELING COLD (Feeling cold), VACCINATION SITE PAIN (Pain in the site of the injection) and CHILLS (Experience chills). On an unknown date, the patient experienced MOBILITY DECREASED (Not been able to move left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING COLD (Feeling cold), MOBILITY DECREASED (Not been able to move left arm), VACCINATION SITE PAIN (Pain in the site of the injection) and CHILLS (Experience chills) outcome was unknown.            No concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: people she knows had side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (people she knows had side effects) 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 ADVERSE REACTION (people she knows had side effects). At the time of the report, ADVERSE REACTION (people she knows had side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   Reporter did not allow further contact.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 patients receive dose Moderna vaccine - punctured more than 12 hours ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients receive dose Moderna vaccine - punctured more than 12 hours ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients receive dose Moderna vaccine - punctured more than 12 hours ago). On 17-May-2021, EXPIRED PRODUCT ADMINISTERED (5 patients receive dose Moderna vaccine - punctured more than 12 hours ago) 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 medication information was provided. No treatment medication information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Motion sickness, Nausea, SARS-CoV-2 antibody test negative
Clinical narrative: "motion sickness" for 48 hours; Nausea; This spontaneous case was reported by a pharmacist and describes the occurrence of MOTION SICKNESS ("motion sickness" for 48 hours) and NAUSEA (Nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to drug and Osteoporosis since 2006. Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis, MULTIVITAMIN [VITAMINS NOS] and CALCIUM for an unknown indication.   On 04-Jan-2021 at 7:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced MOTION SICKNESS ("motion sickness" for 48 hours) and NAUSEA (Nausea). At the time of the report, MOTION SICKNESS ("motion sickness" for 48 hours) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, SARS-CoV-2 antibody test negative: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No information regarding treatment was reported by the patient.   This case was linked to MOD-2021-141731 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Added Patient BMI, race information, relevant history, Concomitant medications, Onset date and outcome.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Vaccination complication
Clinical narrative: he had a reaction to the Moderna vaccine that caused him to go to the hospital; Two different doses administrated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (he had a reaction to the Moderna vaccine that caused him to go to the hospital) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH 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 and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (he had a reaction to the Moderna vaccine that caused him to go to the hospital) (seriousness criterion hospitalization) and INTERCHANGE OF VACCINE PRODUCTS (Two different doses administrated). At the time of the report, VACCINATION COMPLICATION (he had a reaction to the Moderna vaccine that caused him to go to the hospital) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Two different doses administrated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event Vaccination Complication, a causal relationship cannot be excluded. A causality assessment of Interchange of Vaccination Products is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received provided reporter contact details, patient details and additional events. Case upgraded to serious.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event Vaccination Complication, a causal relationship cannot be excluded. A causality assessment of Interchange of Vaccination Products is not applicable.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Skin exfoliation
Clinical narrative: Burning , Itching , redness on top of both feet; Burning , Itching , redness on top of both feet; Burning , Itching , redness on top of both feet .; Skin came off after scratching; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning , Itching , redness on top of both feet .), SKIN EXFOLIATION (Skin came off after scratching), PRURITUS (Burning , Itching , redness on top of both feet) and ERYTHEMA (Burning , Itching , redness on top of both feet) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, the patient experienced BURNING SENSATION (Burning , Itching , redness on top of both feet .) and SKIN EXFOLIATION (Skin came off after scratching). On an unknown date, the patient experienced PRURITUS (Burning , Itching , redness on top of both feet) and ERYTHEMA (Burning , Itching , redness on top of both feet). At the time of the report, BURNING SENSATION (Burning , Itching , redness on top of both feet .), SKIN EXFOLIATION (Skin came off after scratching), PRURITUS (Burning , Itching , redness on top of both feet) and ERYTHEMA (Burning , Itching , redness on top of both feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications was not provided.   This case was linked to MOD-2021-141781 (Patient Link).