chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Rash, Sunburn, Urticaria, Vaccination site erythema
Clinical narrative: Hives all over the body; Sun burns/couldn't stay under sun for 5 min; Allergic reaction to any of the ingredients of Moderna COVID-19 vaccine; Bad skin rash all over the body; Itchy; Red spot around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives all over the body), SUNBURN (Sun burns/couldn't stay under sun for 5 min), ALLERGY TO VACCINE (Allergic reaction to any of the ingredients of Moderna COVID-19 vaccine), RASH (Bad skin rash all over the body) and VACCINATION SITE PRURITUS (Itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. P38A21A and 0LYM20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for Hypothyroidism, CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for Panic attacks, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy). In April 2021, the patient experienced URTICARIA (Hives all over the body), SUNBURN (Sun burns/couldn't stay under sun for 5 min), ALLERGY TO VACCINE (Allergic reaction to any of the ingredients of Moderna COVID-19 vaccine) and RASH (Bad skin rash all over the body). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red spot around the injection site). On 03-Apr-2021, VACCINATION SITE PRURITUS (Itchy) had resolved. At the time of the report, URTICARIA (Hives all over the body), SUNBURN (Sun burns/couldn't stay under sun for 5 min), ALLERGY TO VACCINE (Allergic reaction to any of the ingredients of Moderna COVID-19 vaccine) and RASH (Bad skin rash all over the body) outcome was unknown and VACCINATION SITE ERYTHEMA (Red spot around the injection site) had resolved.            No treatment products were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Hives all over the body; Sun burns/couldn't stay under sun for 5 min; Allergic reaction to any of the ingredients of Moderna COVID-19 vaccine; Bad skin rash all over the body; Itchy; Red spot around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives all over the body), SUNBURN (Sun burns/couldn't stay under sun for 5 min), ALLERGY TO VACCINE (Allergic reaction to any of the ingredients of Moderna COVID-19 vaccine), RASH (Bad skin rash all over the body) and VACCINATION SITE PRURITUS (Itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. P38A21A and 0LYM20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for Hypothyroidism, CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for Panic attacks, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy). In April 2021, the patient experienced URTICARIA (Hives all over the body), SUNBURN (Sun burns/couldn't stay under sun for 5 min), ALLERGY TO VACCINE (Allergic reaction to any of the ingredients of Moderna COVID-19 vaccine) and RASH (Bad skin rash all over the body). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red spot around the injection site). On 03-Apr-2021, VACCINATION SITE PRURITUS (Itchy) had resolved. At the time of the report, URTICARIA (Hives all over the body), SUNBURN (Sun burns/couldn't stay under sun for 5 min), ALLERGY TO VACCINE (Allergic reaction to any of the ingredients of Moderna COVID-19 vaccine) and RASH (Bad skin rash all over the body) outcome was unknown and VACCINATION SITE ERYTHEMA (Red spot around the injection site) had resolved.            No treatment products were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: developed gastro problems; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (developed gastro problems) and DIARRHOEA (Diarrhea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2020, the patient experienced ABDOMINAL DISCOMFORT (developed gastro problems) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (developed gastro problems) and DIARRHOEA (Diarrhea) 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.   Treatment information not provided. Concomitant medications were not provided.   This case was linked to MOD-2021-215957 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Dyspnoea, Rash, Rash macular
Clinical narrative: Burning; Hard to breathe; Red splotches on the arms and torso; Terrible rash on the face/Terrible rash on neck; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning), DYSPNOEA (Hard to breathe), RASH MACULAR (Red splotches on the arms and torso) and RASH (Terrible rash on the face/Terrible rash on neck) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol and Hypertension. Concomitant products included PRAVASTATIN for High cholesterol, AMLODIPINE, LABETALOL, POTASSIUM and FUROSEMIDE for Hypertension.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced BURNING SENSATION (Burning), DYSPNOEA (Hard to breathe), RASH MACULAR (Red splotches on the arms and torso) and RASH (Terrible rash on the face/Terrible rash on neck). At the time of the report, BURNING SENSATION (Burning), DYSPNOEA (Hard to breathe), RASH MACULAR (Red splotches on the arms and torso) and RASH (Terrible rash on the face/Terrible rash on neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Antihistamine and Aloe.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments   This case was linked to MOD-2021-216334 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Additional information received on 02-JUL-2021 contained significant information.Outcome of event updated to Recovered
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Treatment information not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count, White blood cell count decreased
Clinical narrative: WBC decreased; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (WBC decreased) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L02A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included WBC decreased since January 2020. Concomitant products included FLUOXETINE, ROSUVASTATIN, AMLODIPINE, CALCIUM, VITAMIN D NOS and VITAMIN B NOS for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced WHITE BLOOD CELL COUNT DECREASED (WBC decreased). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (WBC decreased) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2020, Blood count (3.8-10.8): low (Low) Low. On 14-Jan-2021, Blood count (3.8-10.8): 3.7 (Low) chronic low WBC..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events not provided.  Patient's WBC was low and 5 months later she has performed lab test again with low results. Her treating physician referred that her WBC low was normal for her.   This case was linked to MOD-2021-018445 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product dose omission issue
Clinical narrative: received her first dose on April 23, 2021; Expired dose was administered to 1 patient; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received her first dose on April 23, 2021) and EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to 1 patient) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (received her first dose on April 23, 2021) and EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to 1 patient). On 10-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to 1 patient) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (received her first dose on April 23, 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Updated Contact number and an Event. On 03-Aug-2021: Non-significant follow up received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: i had a severe reaction to my first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (i had a severe reaction to my first dose) 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 VACCINATION COMPLICATION (i had a severe reaction to my first dose). At the time of the report, VACCINATION COMPLICATION (i had a severe reaction to my first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Taste disorder
Clinical narrative: funny feeling or numbness (like novocaine) on the left side of his mouth; bad taste; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (funny feeling or numbness (like novocaine) on the left side of his mouth) and TASTE DISORDER (bad taste) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (funny feeling or numbness (like novocaine) on the left side of his mouth) and TASTE DISORDER (bad taste). At the time of the report, HYPOAESTHESIA ORAL (funny feeling or numbness (like novocaine) on the left side of his mouth) and TASTE DISORDER (bad taste) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable  No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.       Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: knot underneath; started to feel pain in that area; red; swollen; pain is severe; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (started to feel pain in that area), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PAIN (pain is severe) and VACCINATION SITE MASS (knot underneath) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DULAGLUTIDE (TRULICITY), METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), CLOPIDOGREL BISULFATE (PLAVIX), LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, Amitryptiline, LAMOTRIGINE, MIDODRINE, DESVENLAFAXINE, DIAZEPAM, OXYCODONE, TIZANIDINE, CETIRIZINE, METOPROLOL, PREGABALIN, PREGABALIN (LYRICA) and PANTOPRAZOLE for an unknown indication.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced VACCINATION SITE PAIN (started to feel pain in that area), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (pain is severe). On 10-Jun-2021, the patient experienced VACCINATION SITE MASS (knot underneath). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (started to feel pain in that area), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PAIN (pain is severe) and VACCINATION SITE MASS (knot underneath) 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.   Concomitant: OTC vitamins Treatment  Ice pack
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received Moderna vaccine under 18 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine under 18 years of age) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine under 18 years of age). On 09-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine under 18 years of age) 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.   17 years and 11 months old patient received vaccine. The patient's family member stated that they had  contacted the patient's HCP  who said it was ok to receive the Moderna vaccine, since its only one month less to become 18 years old. No information available regarding any side effect reported after receiving the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: She is currently experiencing covid symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (She is currently experiencing covid symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (She is currently experiencing covid symptoms). At the time of the report, SUSPECTED COVID-19 (She is currently experiencing covid symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Diarrhoea, Pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: Arm started to burn; Intense itching on her face, chest, and all over her body; Diarrhea; Bumps; Very red; Painful; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (arm started to burn), PRURITUS (intense itching on her face, chest, and all over her body), DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (bumps) and VACCINATION SITE ERYTHEMA (very red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (allergic reaction to the vaccine).    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced BURNING SENSATION (arm started to burn), PRURITUS (intense itching on her face, chest, and all over her body), DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (bumps), VACCINATION SITE ERYTHEMA (very red) and VACCINATION SITE PAIN (painful). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 08-Jun-2021, VACCINATION SITE PAIN (painful) had resolved. On 09-Jun-2021, BURNING SENSATION (arm started to burn) and VACCINATION SITE ERYTHEMA (very red) had resolved. On 10-Jun-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, PRURITUS (intense itching on her face, chest, and all over her body) and VACCINATION SITE SWELLING (bumps) 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.   Patient is not on any concomitant medications currently.  Patient received the shot on her right (dominant) arm. She states that as soon as the needle came out after administration, her arm started to burn and became very red and painful. She put ice on her arm for 20 minutes and repeated it throughout the day. In about 24 hours, the redness and burning were gone. She says that on the same day she received her shot, she started experiencing intense itching on her face, chest, and all over her body. She says that there is no visible rash but she does feel some bumps.   Patient has been taking Benadryl for itching, but it does not seem to help. She also experienced diarrhea which started on the same day as receiving the 1st dose. She had diarrhea for two days and says that it has improved today on 10-Jun-2021.  She has not taken any medications for the diarrhea but has kept herself hydrated. She is hesitant to receive her 2nd dose due to these reactions.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Arm started to burn; Intense itching on her face, chest, and all over her body; Diarrhea; Bumps; Very red; Painful; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (arm started to burn), PRURITUS (intense itching on her face, chest, and all over her body), DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (bumps) and VACCINATION SITE ERYTHEMA (very red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (allergic reaction to the vaccine).    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced BURNING SENSATION (arm started to burn), PRURITUS (intense itching on her face, chest, and all over her body), DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (bumps), VACCINATION SITE ERYTHEMA (very red) and VACCINATION SITE PAIN (painful). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 08-Jun-2021, VACCINATION SITE PAIN (painful) had resolved. On 09-Jun-2021, BURNING SENSATION (arm started to burn) and VACCINATION SITE ERYTHEMA (very red) had resolved. On 10-Jun-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, PRURITUS (intense itching on her face, chest, and all over her body) and VACCINATION SITE SWELLING (bumps) 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.   Patient is not on any concomitant medications currently.  Patient received the shot on her right (dominant) arm. She states that as soon as the needle came out after administration, her arm started to burn and became very red and painful. She put ice on her arm for 20 minutes and repeated it throughout the day. In about 24 hours, the redness and burning were gone. She says that on the same day she received her shot, she started experiencing intense itching on her face, chest, and all over her body. She says that there is no visible rash but she does feel some bumps.   Patient has been taking Benadryl for itching, but it does not seem to help. She also experienced diarrhea which started on the same day as receiving the 1st dose. She had diarrhea for two days and says that it has improved today on 10-Jun-2021.  She has not taken any medications for the diarrhea but has kept herself hydrated. She is hesitant to receive her 2nd dose due to these reactions.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Shortness of breath; Dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and DIZZINESS (Dizzy spells) 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 DYSPNOEA (Shortness of breath) and DIZZINESS (Dizzy spells). At the time of the report, DYSPNOEA (Shortness of breath) and DIZZINESS (Dizzy spells) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: She administered Moderna COVID19 Vaccine to three sixteen years old individuals; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She administered Moderna COVID19 Vaccine to three sixteen years old individuals) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She administered Moderna COVID19 Vaccine to three sixteen years old individuals). On 09-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She administered Moderna COVID19 Vaccine to three sixteen years old individuals) 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.   Doctor confirmed that she administered Moderna COVID19 Vaccine to  three sixteen years old individuals on 09June2021.  Concomitant product use was not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up received: Ethnicity updated and Reporter added.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash erythematous
Clinical narrative: Red rash from belly button up to neck; Was very tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Was very tired) and RASH ERYTHEMATOUS (Red rash from belly button up to neck) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 06C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever, Allergy to antibiotic (Clindamycin which causes rash), COPD and Cholesterol. Concomitant products included ATORVASTATIN, VITAMIN D3 and CALCIUM for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Was very tired). On 10-Jun-2021, the patient experienced RASH ERYTHEMATOUS (Red rash from belly button up to neck). On 12-Jun-2021, RASH ERYTHEMATOUS (Red rash from belly button up to neck) had resolved. At the time of the report, FATIGUE (Was very tired) outcome was unknown.            No treatment information was provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up received on 02-JUL-2021 contains information about patient demographics and allergies of patient.Updated information on doses of vaccination,and concomitant medications were added.event outcome was updated and newevent added.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Influenza like illness
Clinical narrative: Vaccine dose was administered from the vial punctured for > 12 hours; Flu like symptoms; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Long term) and Hyperlipidaemia (Long term). Concomitant products included SIMVASTATIN for Hyperlipidaemia, AMLODIPINE, CARVEDILOL and OLMESARTAN for Hypertension.   On 09-Jun-2021 at 8:31 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 09-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 09-Jun-2021 at 8:31 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours). On 09-Jun-2021 at 8:31 AM, EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) had resolved. On 11-Jun-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INFLUENZA LIKE ILLNESS (Flu like symptoms) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours).    Concomitant include Ivtz taken at a dose of 25.   Patient was given Moderna vaccine forty-six hours after the vial was punctured. As per the manufacturer patient was encouraged to be re-vaccinated due to lack of effacious. Patient declined to be re-vaccinated due to the flu like symptoms that were resolved forty-eight hours after receiving the vaccine. Patient felt vaccine was effective.  No treatment details  were provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received contains updated information on patient demographics, medical history, concomitants, route of suspect drug, event added.
Sex: U
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: My arm keeps jump; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (My arm keeps jump) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (My arm keeps jump). At the time of the report, MUSCLE TWITCHING (My arm keeps jump) outcome was unknown.            No relevant Concomitant Medications were reported. No Treatment Information Provided.
Sex: U
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of oral herpes (woke up with cold scores) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient had oral herpes (woke up with cold scores). At the time of the report, oral herpes (woke up with cold scores) outcome: unknown. No concomitant medication or treatment information provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Racing heart; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Racing heart) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Racing heart). At the time of the report, PALPITATIONS (Racing heart) outcome was unknown.            The patient was taking no concomitant medication.  Patient went to the emergency room 3.5 weeks after second shot with a racing heart.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose in 6 weeks; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose in 6 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 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 (second dose in 6 weeks). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose in 6 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: Swetted down; Fever; vomiting; Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Swetted down), DIARRHOEA (Diarrhoea), PYREXIA (Fever) and VOMITING (vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021 at 9:30 AM, the patient experienced DIARRHOEA (Diarrhoea). On 18-Jan-2021 at 10:30 AM, the patient experienced VOMITING (vomiting). On an unknown date, the patient experienced HYPERHIDROSIS (Swetted down) and PYREXIA (Fever). On 19-Jan-2021, DIARRHOEA (Diarrhoea) and VOMITING (vomiting) had resolved. At the time of the report, HYPERHIDROSIS (Swetted down) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No information regarding concomitant medication was provided. No information regarding treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Four patients received vaccine that was left out room temperature for over 12 hours after being punctured; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Four patients received vaccine that was left out room temperature for over 12 hours after being punctured) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Four patients received vaccine that was left out room temperature for over 12 hours after being punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Four patients received vaccine that was left out room temperature for over 12 hours after being punctured) 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 relevant concomitant medications were reported. No treatment information was provided.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: vaccine administered to a sixteen year old; Off label use in unapproved age group; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to a sixteen year old) and OFF LABEL USE (Off label use in unapproved age group) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination.     Concurrent medical conditions included Hearing reduced since 23-Jun-2021, Obesity since 23-Jun-2021 and Penicillin allergy. Concomitant products included MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) from 23-Jun-2021 to an unknown date for Contraception.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to a sixteen year old) and OFF LABEL USE (Off label use in unapproved age group). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to a sixteen year old) and OFF LABEL USE (Off label use in unapproved age group) 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.   Patient received a Moderna vaccine that was not age-indicated. Patient did not experience any adverse event at any time. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: added reporter details. added current  conditions. added concomitants. added no adrs after receiving vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received first dose on 26Apr2021 and second dose on 12May2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 26Apr2021 and second dose on 12May2021) 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 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 26Apr2021 and second dose on 12May2021). On 12-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 26Apr2021 and second dose on 12May2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Gait disturbance, Myalgia, Pain
Clinical narrative: walking difficulty; Widespread Pain; Had muscle pain every day since then.; Had  fatigue every day since then.; Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (walking difficulty), PAIN (Widespread Pain), MYALGIA (Had muscle pain every day since then.), FATIGUE (Had  fatigue every day since then.) and ARTHRALGIA (Knee pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer on 18-Nov-2013. Concurrent medical conditions included Plastic sensitivity (Plastic Tape), Drug allergy (Betadyne), Fibromyalgia (Widespread pain and fatigue) since 05-Jan-2011 and Osteoarthritis (Joint inflammation and pain) since 12-Mar-2021. Concomitant products included ANASTROZOLE from 15-Jan-2018 to an unknown date for Breast cancer, BUPROPIONE from 01-Jan-2016 to an unknown date for Depression, VALSARTAN from 18-Nov-2019 to an unknown date and HYDROCHLOROTHIAZIDE from 06-Aug-2020 to an unknown date for Hypertension.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-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 GAIT DISTURBANCE (walking difficulty), PAIN (Widespread Pain), MYALGIA (Had muscle pain every day since then.), FATIGUE (Had  fatigue every day since then.) and ARTHRALGIA (Knee pain). The patient was treated with GABAPENTIN (NEURONTIN) for Pain and Muscle pain, at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (walking difficulty), PAIN (Widespread Pain), MYALGIA (Had muscle pain every day since then.), FATIGUE (Had  fatigue every day since then.) and ARTHRALGIA (Knee pain) outcome was unknown.            She decide she will begin physical therapy on 28-Jul-2021 she will follow up with orthopedic surgeon and pain specialist on 28-Jul-2021.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 22-Jul-2021 and contain significant information. Reporter phone number, state, patient demographic, concomitant medication, treatment medications and event has been updated.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Muscular weakness, Pain in extremity
Clinical narrative: Could not get out of bed; Muscle weakness; Fever; Sore arm; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness), PYREXIA (Fever), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, APIXABAN (ELIQUIS), AMLODIPINE and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness), PYREXIA (Fever), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue). On 10-Jun-2021, the patient experienced LETHARGY (Could not get out of bed). On 10-Jun-2021, PYREXIA (Fever), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, MUSCULAR WEAKNESS (Muscle weakness) and LETHARGY (Could not get out of bed) outcome was unknown.            Case crosslinked with Patient's wife's case - MOD21-109695  Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Could not get out of bed; Muscle weakness; Fever; Sore arm; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness), PYREXIA (Fever), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, APIXABAN (ELIQUIS), AMLODIPINE and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness), PYREXIA (Fever), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue). On 10-Jun-2021, the patient experienced LETHARGY (Could not get out of bed). On 10-Jun-2021, PYREXIA (Fever), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, MUSCULAR WEAKNESS (Muscle weakness) and LETHARGY (Could not get out of bed) outcome was unknown.            Case crosslinked with Patient's wife's case - MOD21-109695  Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Cold sores/blisters in roof of mouth cleared up; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Cold sores/blisters in roof of mouth cleared up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03621A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Cold sores/blisters in roof of mouth cleared up). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Cold sores/blisters in roof of mouth cleared up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided