chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received a non Moderna vaccine as the second dose, instead the Moderna vaccine used in the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received a non Moderna vaccine as the second dose, instead the Moderna vaccine used in the 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 17-Jul-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received a non Moderna vaccine as the second dose, instead the Moderna vaccine used in the 1st dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received a non Moderna vaccine as the second dose, instead the Moderna vaccine used in the 1st dose) 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.   Patient took Moderna vaccine as first dose 28 days ago the date she took Pfizer vaccine as second dose.  No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient didn't receive the 2nd dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient didn't receive the 2nd dose of the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient didn't receive the 2nd dose of the Moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient didn't receive the 2nd dose of the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: coughing fits; This spontaneous case was reported by a patient and describes the occurrence of COUGH (coughing fits) 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 COUGH (coughing fits). At the time of the report, COUGH (coughing fits) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: became sick due to other issues; did not get his second shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (became sick due to other issues) and PRODUCT DOSE OMISSION ISSUE (did not get his second shot) 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 No adverse reaction.    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 ILLNESS (became sick due to other issues) and PRODUCT DOSE OMISSION ISSUE (did not get his second shot). At the time of the report, ILLNESS (became sick due to other issues) and PRODUCT DOSE OMISSION ISSUE (did not get his second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant product use was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Heavy menstrual bleeding
Clinical narrative: having 1 missed period; having a heavy flow period; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (having 1 missed period) and HEAVY MENSTRUAL BLEEDING (having a heavy flow period) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMENORRHOEA (having 1 missed period) and HEAVY MENSTRUAL BLEEDING (having a heavy flow period). At the time of the report, AMENORRHOEA (having 1 missed period) and HEAVY MENSTRUAL BLEEDING (having a heavy flow period) outcome was unknown.            No relevant concomitant medications was reported.  Treatment information was not provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chromaturia, Diarrhoea, Fatigue, Nausea
Clinical narrative: fatigue; Diarrhea; yellowing of urine.; nausea in response to food; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (yellowing of urine.), NAUSEA (nausea in response to food), ARTHRALGIA (joint pain), DIARRHOEA (Diarrhea) and FATIGUE (fatigue) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) and METOPROLOL for an unknown indication.    On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jul-2021, the patient experienced CHROMATURIA (yellowing of urine.), NAUSEA (nausea in response to food) and ARTHRALGIA (joint pain). On 07-Jul-2021, the patient experienced DIARRHOEA (Diarrhea). On 18-Jul-2021, the patient experienced FATIGUE (fatigue). At the time of the report, CHROMATURIA (yellowing of urine.), NAUSEA (nausea in response to food), ARTHRALGIA (joint pain), DIARRHOEA (Diarrhea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site pain
Clinical narrative: arm was sore for 2 days; I never got my 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm was sore for 2 days) and PRODUCT DOSE OMISSION ISSUE (I never got my 2nd dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Thyroid disorder NOS. Concomitant products included METOPROLOL and ENALAPRIL for Blood pressure increased, LEVOTHYROXINE for Thyroid disorder NOS.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced MYALGIA (arm was sore for 2 days) and PRODUCT DOSE OMISSION ISSUE (I never got my 2nd dose). On 15-Apr-2021, PRODUCT DOSE OMISSION ISSUE (I never got my 2nd dose) had resolved. On 17-Apr-2021, MYALGIA (arm was sore for 2 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore for 2 days) and PRODUCT DOSE OMISSION ISSUE (I never got my 2nd dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Thyroid disorder NOS. Concomitant products included METOPROLOL and ENALAPRIL for Blood pressure increased, LEVOTHYROXINE for Thyroid disorder NOS.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm was sore for 2 days) and PRODUCT DOSE OMISSION ISSUE (I never got my 2nd dose). On 15-Apr-2021, PRODUCT DOSE OMISSION ISSUE (I never got my 2nd dose) had resolved. On 17-Apr-2021, VACCINATION SITE PAIN (arm was sore for 2 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Arm is so extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm is so extremely sore) 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) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced MYALGIA (Arm is so extremely sore). At the time of the report, MYALGIA (Arm is so extremely sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported.  Treatment information were not reported.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: chills; Nausea; Has temperature of 101; This spontaneous case was reported by a pharmacist and describes the occurrence of CHILLS (chills), NAUSEA (Nausea) and PYREXIA (Has temperature of 101) in a 21-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), NAUSEA (Nausea) and PYREXIA (Has temperature of 101). At the time of the report, CHILLS (chills), NAUSEA (Nausea) and PYREXIA (Has temperature of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (abnormal) Has temp 101.     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 concomitant medications were not reported. No treatment information was reported.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination complication
Clinical narrative: really tired; "COVID arm"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("COVID arm") and FATIGUE (really tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION COMPLICATION ("COVID arm"). On 02-May-2021, the patient experienced FATIGUE (really tired). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION ("COVID arm") and FATIGUE (really tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-260201 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Her arm is red; Her arm is swollen/Her arm is very tight; Her arm is painful; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (Her arm is red), VACCINATION SITE SWELLING (Her arm is swollen/Her arm is very tight) and VACCINATION SITE PAIN (Her arm is painful) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CEPHAELIS SPP. FLUID EXTRACT, CITRIC ACID, PROMETHAZINE HYDROCHLORIDE, SULFOGAIACOL (PHENERGAN COMPOUND EXPECTORANT) for Nausea, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), BACLOFEN, GABAPENTIN, GLYCOPYRRONIUM BROMIDE (GLYCOPYRROLATE), CEFALEXIN MONOHYDRATE (LEXIPRON), OXYCODONE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), CARBIDOPA MONOHYDRATE, LEVODOPA (SINEMET), QUETIAPINE FUMARATE (SEROQUEL), VITAMIN D NOS and ALPRAZOLAM (XANAX) for an unknown indication.    On 15-Jul-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 VACCINATION SITE ERYTHEMA (Her arm is red), VACCINATION SITE SWELLING (Her arm is swollen/Her arm is very tight) and VACCINATION SITE PAIN (Her arm is painful). At the time of the report, VACCINATION SITE ERYTHEMA (Her arm is red), VACCINATION SITE SWELLING (Her arm is swollen/Her arm is very tight) and VACCINATION SITE PAIN (Her arm is painful) 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.   Treatment information was not provided.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Palpitations, Rash erythematous, Rash pruritic
Clinical narrative: Rash erythematous; Rash pruritic; skin warm; Myalgia; heart racing; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing), DIZZINESS (Dizziness), RASH ERYTHEMATOUS (Rash erythematous), RASH PRURITIC (Rash pruritic) and SKIN WARM (skin warm) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced PALPITATIONS (heart racing). 17-Jul-2021, the patient experienced DIZZINESS (Dizziness) and MYALGIA (Myalgia). On 18-Jul-2021, the patient experienced RASH ERYTHEMATOUS (Rash erythematous), RASH PRURITIC (Rash pruritic) and SKIN WARM (skin warm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form; HYDROCORTISONE for Rash, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form. On 17-Jul-2021, PALPITATIONS (heart racing), DIZZINESS (Dizziness) and MYALGIA (Myalgia) had resolved. At the time of the report, RASH ERYTHEMATOUS (Rash erythematous), RASH PRURITIC (Rash pruritic) and SKIN WARM (skin warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Rash erythematous; Rash pruritic; skin warm; Myalgia; heart racing; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing), DIZZINESS (Dizziness), RASH ERYTHEMATOUS (Rash erythematous), RASH PRURITIC (Rash pruritic) and SKIN WARM (skin warm) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced PALPITATIONS (heart racing). 17-Jul-2021, the patient experienced DIZZINESS (Dizziness) and MYALGIA (Myalgia). On 18-Jul-2021, the patient experienced RASH ERYTHEMATOUS (Rash erythematous), RASH PRURITIC (Rash pruritic) and SKIN WARM (skin warm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form; HYDROCORTISONE for Rash, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form. On 17-Jul-2021, PALPITATIONS (heart racing), DIZZINESS (Dizziness) and MYALGIA (Myalgia) had resolved. At the time of the report, RASH ERYTHEMATOUS (Rash erythematous), RASH PRURITIC (Rash pruritic) and SKIN WARM (skin warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Erythema, Feeling hot, Malaise
Clinical narrative: patient wasn't feeling well; Feet were swelling every day; Feet and Legs feel hot; Skin on her legs is weird, somewhat like a burn; Feet turned very red, like on fire red/redness spread to both of her legs; Toes turned purple on the back side; Dizzy for a couple days; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Feet were swelling every day), ERYTHEMA (Feet turned very red, like on fire red/redness spread to both of her legs), SKIN DISCOLOURATION (Toes turned purple on the back side), FEELING HOT (Feet and Legs feel hot) and SKIN DISCOMFORT (Skin on her legs is weird, somewhat like a burn) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced DIZZINESS (Dizzy for a couple days). On 29-May-2021, the patient experienced ERYTHEMA (Feet turned very red, like on fire red/redness spread to both of her legs) and SKIN DISCOLOURATION (Toes turned purple on the back side). In June 2021, the patient experienced PERIPHERAL SWELLING (Feet were swelling every day), FEELING HOT (Feet and Legs feel hot) and SKIN DISCOMFORT (Skin on her legs is weird, somewhat like a burn). On an unknown date, the patient experienced MALAISE (patient wasn't feeling well). The patient was treated with PREDNISONE for Adverse event, at a dose of 20 mg once a day; PREDNISONE ongoing since an unknown date for Adverse event, at a dose of 20 mg once a day and PREDNISONE for Adverse event, at a dose of 20 mg once a day. In June 2021, DIZZINESS (Dizzy for a couple days) had resolved. In July 2021, PERIPHERAL SWELLING (Feet were swelling every day) had resolved. At the time of the report, ERYTHEMA (Feet turned very red, like on fire red/redness spread to both of her legs) had resolved and SKIN DISCOLOURATION (Toes turned purple on the back side), FEELING HOT (Feet and Legs feel hot), SKIN DISCOMFORT (Skin on her legs is weird, somewhat like a burn) and MALAISE (patient wasn't feeling well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) everything came out fine.         No concomitant medications were given by the reporter.  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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin discolouration, Skin discomfort
Clinical narrative: patient wasn't feeling well; Feet were swelling every day; Feet and Legs feel hot; Skin on her legs is weird, somewhat like a burn; Feet turned very red, like on fire red/redness spread to both of her legs; Toes turned purple on the back side; Dizzy for a couple days; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Feet were swelling every day), ERYTHEMA (Feet turned very red, like on fire red/redness spread to both of her legs), SKIN DISCOLOURATION (Toes turned purple on the back side), FEELING HOT (Feet and Legs feel hot) and SKIN DISCOMFORT (Skin on her legs is weird, somewhat like a burn) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced DIZZINESS (Dizzy for a couple days). On 29-May-2021, the patient experienced ERYTHEMA (Feet turned very red, like on fire red/redness spread to both of her legs) and SKIN DISCOLOURATION (Toes turned purple on the back side). In June 2021, the patient experienced PERIPHERAL SWELLING (Feet were swelling every day), FEELING HOT (Feet and Legs feel hot) and SKIN DISCOMFORT (Skin on her legs is weird, somewhat like a burn). On an unknown date, the patient experienced MALAISE (patient wasn't feeling well). The patient was treated with PREDNISONE for Adverse event, at a dose of 20 mg once a day; PREDNISONE ongoing since an unknown date for Adverse event, at a dose of 20 mg once a day and PREDNISONE for Adverse event, at a dose of 20 mg once a day. In June 2021, DIZZINESS (Dizzy for a couple days) had resolved. In July 2021, PERIPHERAL SWELLING (Feet were swelling every day) had resolved. At the time of the report, ERYTHEMA (Feet turned very red, like on fire red/redness spread to both of her legs) had resolved and SKIN DISCOLOURATION (Toes turned purple on the back side), FEELING HOT (Feet and Legs feel hot), SKIN DISCOMFORT (Skin on her legs is weird, somewhat like a burn) and MALAISE (patient wasn't feeling well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) everything came out fine.         No concomitant medications were given by the reporter.  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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Vaccination site discolouration, Vaccination site pain, Vaccination site swelling
Clinical narrative: small, little black and blue, lump; Pain getting worse; small, little black and blue, lump/"somebody punches in her lump."; painful/It has been painful, and the pain comes and goes but now the pain is staying longer; pain radiated and traveled up to the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (small, little black and blue, lump), CONDITION AGGRAVATED (Pain getting worse), VACCINATION SITE SWELLING (small, little black and blue, lump/"somebody punches in her lump."), VACCINATION SITE PAIN (painful/It has been painful, and the pain comes and goes but now the pain is staying longer) and ARTHRALGIA (pain radiated and traveled up to the shoulder) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-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 VACCINATION SITE DISCOLOURATION (small, little black and blue, lump), CONDITION AGGRAVATED (Pain getting worse), VACCINATION SITE SWELLING (small, little black and blue, lump/"somebody punches in her lump."), VACCINATION SITE PAIN (painful/It has been painful, and the pain comes and goes but now the pain is staying longer) and ARTHRALGIA (pain radiated and traveled up to the shoulder). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (small, little black and blue, lump), CONDITION AGGRAVATED (Pain getting worse), VACCINATION SITE SWELLING (small, little black and blue, lump/"somebody punches in her lump."), VACCINATION SITE PAIN (painful/It has been painful, and the pain comes and goes but now the pain is staying longer) and ARTHRALGIA (pain radiated and traveled up to the shoulder) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.   This case was linked to MOD-2021-260186 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient hasn't received 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Pyrexia
Clinical narrative: Administered on inner thigh; fever; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered on inner thigh) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concomitant products included HYDROXYZINE, HYDROMORPHONE HYDROCHLORIDE (DILAUDID), DIAZEPAM, Pepcid, BACLOFEN, Dicyclovir, Zofran, CLONIDINE, TRAZODONE, Fluticasone nasal spray, TRIAMCINOLONE, Lidocaine patch, Albuterol, Benadryl and MUPIROCIN for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered on inner thigh) and PYREXIA (fever). On 23-Apr-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Administered on inner thigh) had resolved. At the time of the report, PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided by the reporter.   This case was linked to MOD-2021-260234 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Malaise, Myalgia, Pyrexia
Clinical narrative: diarrhea; not feeling good; feeling yucky; aches and pain; feverish; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), MALAISE (not feeling good), FEELING ABNORMAL (feeling yucky), MYALGIA (aches and pain) and PYREXIA (feverish) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024m20a and 044a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Irritable bowel syndrome and Constipation. Concomitant products included LORAZEPAM for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced MALAISE (not feeling good), FEELING ABNORMAL (feeling yucky), MYALGIA (aches and pain) and PYREXIA (feverish). On 29-Mar-2021, the patient experienced DIARRHOEA (diarrhea). On 21-Mar-2021, FEELING ABNORMAL (feeling yucky) had resolved. On 22-Mar-2021, MALAISE (not feeling good), MYALGIA (aches and pain) and PYREXIA (feverish) had resolved. At the time of the report, DIARRHOEA (diarrhea) had not resolved.            Patient  reported that she will be in the future seeing a gastroenterologist and a lot of tests were performed on the patient but nothing wrong was found on her stool.  No information on treatment is provided by the reporter.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Chills, Cold sweat, Dyspnoea
Clinical narrative: shortness of breath; felt like she was running a fever; chills; nausea; headache (felt like her eyes were being taken out with a spoon); high blood sugar level readings; couldn't eat; clammy; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (high blood sugar level readings), FEEDING DISORDER (couldn't eat), COLD SWEAT (clammy), DYSPNOEA (shortness of breath) and NAUSEA (nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021 and Hysterectomy. Concurrent medical conditions included Diabetic (Patient is a newly diagnosed diabetic, taking Metformin once a day, not insulin-dependent.), Leukemia (in remission), Benign lymphoma, Drug allergy, Dust allergy, Pollen allergy and Allergy to animal (The patient is allergic to bees and needed EpiPen due to bees.). Concomitant products included BENAZEPRIL for Hypertension, METHOCARBAMOL (ROBAXIN), GABAPENTIN, SUCRALFATE (CARAFATE) and MELOXICAM for an unknown indication.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced BLOOD GLUCOSE INCREASED (high blood sugar level readings), FEEDING DISORDER (couldn't eat), COLD SWEAT (clammy), NAUSEA (nausea) and HEADACHE (headache (felt like her eyes were being taken out with a spoon)). On 13-Jul-2021, the patient experienced DYSPNOEA (shortness of breath), PYREXIA (felt like she was running a fever) and CHILLS (chills). The patient was treated with METFORMIN at an unspecified dose and frequency; INSULIN at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and BUDESONIDE, LEVOSALBUTAMOL HYDROCHLORIDE (NEBULAIR) at an unspecified dose and frequency. At the time of the report, BLOOD GLUCOSE INCREASED (high blood sugar level readings), FEEDING DISORDER (couldn't eat), COLD SWEAT (clammy), DYSPNOEA (shortness of breath), NAUSEA (nausea), HEADACHE (headache (felt like her eyes were being taken out with a spoon)), PYREXIA (felt like she was running a fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: other (abnormal) 378, other (abnormal) 400, other (abnormal) 518 and other (abnormal) 270.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Headache, Nausea, Pyrexia
Clinical narrative: shortness of breath; felt like she was running a fever; chills; nausea; headache (felt like her eyes were being taken out with a spoon); high blood sugar level readings; couldn't eat; clammy; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (high blood sugar level readings), FEEDING DISORDER (couldn't eat), COLD SWEAT (clammy), DYSPNOEA (shortness of breath) and NAUSEA (nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021 and Hysterectomy. Concurrent medical conditions included Diabetic (Patient is a newly diagnosed diabetic, taking Metformin once a day, not insulin-dependent.), Leukemia (in remission), Benign lymphoma, Drug allergy, Dust allergy, Pollen allergy and Allergy to animal (The patient is allergic to bees and needed EpiPen due to bees.). Concomitant products included BENAZEPRIL for Hypertension, METHOCARBAMOL (ROBAXIN), GABAPENTIN, SUCRALFATE (CARAFATE) and MELOXICAM for an unknown indication.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced BLOOD GLUCOSE INCREASED (high blood sugar level readings), FEEDING DISORDER (couldn't eat), COLD SWEAT (clammy), NAUSEA (nausea) and HEADACHE (headache (felt like her eyes were being taken out with a spoon)). On 13-Jul-2021, the patient experienced DYSPNOEA (shortness of breath), PYREXIA (felt like she was running a fever) and CHILLS (chills). The patient was treated with METFORMIN at an unspecified dose and frequency; INSULIN at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and BUDESONIDE, LEVOSALBUTAMOL HYDROCHLORIDE (NEBULAIR) at an unspecified dose and frequency. At the time of the report, BLOOD GLUCOSE INCREASED (high blood sugar level readings), FEEDING DISORDER (couldn't eat), COLD SWEAT (clammy), DYSPNOEA (shortness of breath), NAUSEA (nausea), HEADACHE (headache (felt like her eyes were being taken out with a spoon)), PYREXIA (felt like she was running a fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: other (abnormal) 378, other (abnormal) 400, other (abnormal) 518 and other (abnormal) 270.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient having side effects from second Covid Shot; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Patient having side effects from second Covid Shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 VACCINATION COMPLICATION (Patient having side effects from second Covid Shot). At the time of the report, VACCINATION COMPLICATION (Patient having side effects from second Covid Shot) outcome was unknown. Vaccination adverse reaction      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up Information contains No NewInformation.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: potential Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (potential Adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (potential Adverse event). At the time of the report, VACCINATION COMPLICATION (potential Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No information on treatment is provided by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: swollen site; she experienced swollen site, red; severe itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen site), VACCINATION SITE ERYTHEMA (she experienced swollen site, red) and PRURITUS (severe itchiness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     The patient's past medical history included Arm fracture (Both of her arms have atrophied and she also has a fractured and dislocated right arm.) and Chemotherapy. Concurrent medical conditions included Drug allergy (Allergic to Phenergan, Bactrim, Flagyl, Benzomites PO), Allergy to antibiotic (Tetracycline), Iodine allergy, Adhesive tape allergy (IV site tape) and Autoimmune disorder. Concomitant products included HYDROXYZINE, HYDROMORPHONE HYDROCHLORIDE (DILAUDID), DIAZEPAM, Pepcid, BACLOFEN, ONDANSETRON (ZOFRAN [ONDANSETRON]), CLONIDINE, FLUTICASONE, TRIAMCINOLONE, LIDOCAINE, SALBUTAMOL (ALBUTEROL HFA), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) and MUPIROCIN for an unknown indication, TRAZODONE.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced VACCINATION SITE SWELLING (swollen site), VACCINATION SITE ERYTHEMA (she experienced swollen site, red) and PRURITUS (severe itchiness). At the time of the report, VACCINATION SITE SWELLING (swollen site), VACCINATION SITE ERYTHEMA (she experienced swollen site, red) and PRURITUS (severe itchiness) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment medications were provided   This case was linked to MOD-2021-260213 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: "a little pain on the arm"; arm "a little bit swollen"; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN ("a little pain on the arm") and VACCINATION SITE SWELLING (arm "a little bit swollen") in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN ("a little pain on the arm") and VACCINATION SITE SWELLING (arm "a little bit swollen"). On 12-Mar-2021, VACCINATION SITE PAIN ("a little pain on the arm") and VACCINATION SITE SWELLING (arm "a little bit swollen") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2021-260254 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Delayed reaction with her throat closing up.; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Delayed reaction with her throat closing up.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROAT TIGHTNESS (Delayed reaction with her throat closing up.). At the time of the report, THROAT TIGHTNESS (Delayed reaction with her throat closing up.) outcome was unknown.            No concomitant medications were reported. Treatment medication was not reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dysgeusia, Feeling hot
Clinical narrative: diarrhea; stomach cramps; vomiting; excruciating headache/mild headache; had chills; had  cold; body was warm and had chills; pain in sinus; was nauseated/mild nausea; had metal taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (had metal taste), NASOPHARYNGITIS (had  cold), FEELING HOT (body was warm and had chills), SINUS PAIN (pain in sinus) and DIARRHOEA (diarrhea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced DYSGEUSIA (had metal taste) and NAUSEA (was nauseated/mild nausea). On 16-Jul-2021, the patient experienced NASOPHARYNGITIS (had  cold), FEELING HOT (body was warm and had chills), SINUS PAIN (pain in sinus), CHILLS (had chills) and HEADACHE (excruciating headache/mild headache). On 18-Jul-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps) and VOMITING (vomiting). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, DYSGEUSIA (had metal taste), NASOPHARYNGITIS (had  cold), FEELING HOT (body was warm and had chills), SINUS PAIN (pain in sinus), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps), CHILLS (had chills), VOMITING (vomiting), HEADACHE (excruciating headache/mild headache) and NAUSEA (was nauseated/mild nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Nausea, Sinus pain, Vomiting
Clinical narrative: diarrhea; stomach cramps; vomiting; excruciating headache/mild headache; had chills; had  cold; body was warm and had chills; pain in sinus; was nauseated/mild nausea; had metal taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (had metal taste), NASOPHARYNGITIS (had  cold), FEELING HOT (body was warm and had chills), SINUS PAIN (pain in sinus) and DIARRHOEA (diarrhea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced DYSGEUSIA (had metal taste) and NAUSEA (was nauseated/mild nausea). On 16-Jul-2021, the patient experienced NASOPHARYNGITIS (had  cold), FEELING HOT (body was warm and had chills), SINUS PAIN (pain in sinus), CHILLS (had chills) and HEADACHE (excruciating headache/mild headache). On 18-Jul-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps) and VOMITING (vomiting). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, DYSGEUSIA (had metal taste), NASOPHARYNGITIS (had  cold), FEELING HOT (body was warm and had chills), SINUS PAIN (pain in sinus), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps), CHILLS (had chills), VOMITING (vomiting), HEADACHE (excruciating headache/mild headache) and NAUSEA (was nauseated/mild nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: on and off severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (on and off severe diarrhea) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (on and off severe diarrhea). At the time of the report, DIARRHOEA (on and off severe diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.