chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain in extremity, Vaccination site mass
Clinical narrative: Diarrhea for over 72 hours; Lump near the injection site; Arm pain; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea for over 72 hours), VACCINATION SITE MASS (Lump near the injection site), PAIN IN EXTREMITY (Arm pain) and FATIGUE (Extreme fatigue) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and FATIGUE (Extreme fatigue). On 01-Mar-2021, the patient experienced DIARRHOEA (Diarrhea for over 72 hours) and VACCINATION SITE MASS (Lump near the injection site). On 03-Mar-2021, DIARRHOEA (Diarrhea for over 72 hours) had resolved. At the time of the report, VACCINATION SITE MASS (Lump near the injection site), PAIN IN EXTREMITY (Arm pain) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received first Moderna vaccine on 2-27-2021. Patient stated she had arm pain, and extreme fatigue. Patient stated that it was odd that she still had lump near the injection site today.Patient stated she had diarrhea for over 72 hours
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia, Vaccination site pain
Clinical narrative: Limb discomfort; Vaccination site pain; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Limb discomfort), VACCINATION SITE PAIN (Vaccination site pain) and MYALGIA (Myalgia) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Nickel sensitivity and Drug allergy. Concomitant products included IBUPROFEN 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 16-Feb-2021, the patient experienced LIMB DISCOMFORT (Limb discomfort), VACCINATION SITE PAIN (Vaccination site pain) and MYALGIA (Myalgia). At the time of the report, LIMB DISCOMFORT (Limb discomfort), VACCINATION SITE PAIN (Vaccination site pain) and MYALGIA (Myalgia) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus
Clinical narrative: Pain in her arm; Itchiness on the injection site; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain in her arm and itchiness on the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On unknown date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) pain in her arm and itchiness on the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain in her arm and itchiness on the injection site was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: Swelling arm; Sharp pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm) and PAIN (Sharp 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling arm) and PAIN (Sharp pain). At the time of the report, PERIPHERAL SWELLING (Swelling arm) and PAIN (Sharp pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No concomitant medications were reported. No treatment related information has been reported.   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Headache; Muscle pain; Joint pain; Nausea; Chills; Fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and CHILLS (Chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 113A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, 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) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever) and VOMITING (vomiting). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse reaction, at a dose of 4 Tab once a day. On 28-Feb-2021, HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever) and VOMITING (vomiting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headache; Muscle pain; Joint pain; Nausea; Chills; Fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and CHILLS (Chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 113A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, 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) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever) and VOMITING (vomiting). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse reaction, at a dose of 4 Tab once a day. On 28-Feb-2021, HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever) and VOMITING (vomiting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm was sore at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was reported.  No relevant concomitant medications were reported.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE PAIN (arm was sore at the injection site). At the time of the report, INJECTION SITE PAIN (arm was sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Diarrhoea, Erythema, Fatigue, Induration
Clinical narrative: Diarrhea; Tenderness if she pokes the injection site; Arm swollen; Inflammation hardness; Inflammation hardness; Allergic reaction; Felt a little tired and the arm was hurting a bit; Little tired; Forehead, nose and cheeks got really red and burning, Burning sensation in face, Burning sensation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction), PAIN IN EXTREMITY (Felt a little tired and the arm was hurting a bit), FATIGUE (Little tired), ERYTHEMA (Forehead, nose and cheeks got really red and burning, Burning sensation in face, Burning sensation) and DIARRHOEA (Diarrhea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to animal (allergic to duck), Allergy to animals (allergic to turkey), Drug allergy (allergic to Cataprist,), Drug allergy (allergic to Januvia), Drug allergy (allergic to Keflex.), Diabetes mellitus, Hypertension and Hypercholesterolaemia.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction), PAIN IN EXTREMITY (Felt a little tired and the arm was hurting a bit), FATIGUE (Little tired) and ERYTHEMA (Forehead, nose and cheeks got really red and burning, Burning sensation in face, Burning sensation). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Tenderness if she pokes the injection site), PERIPHERAL SWELLING (Arm swollen), INFLAMMATION (Inflammation hardness) and INDURATION (Inflammation hardness). At the time of the report, ALLERGY TO VACCINE (Allergic reaction), FATIGUE (Little tired), ERYTHEMA (Forehead, nose and cheeks got really red and burning, Burning sensation in face, Burning sensation), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Tenderness if she pokes the injection site), PERIPHERAL SWELLING (Arm swollen), INFLAMMATION (Inflammation hardness) and INDURATION (Inflammation hardness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: Diarrhea; Tenderness if she pokes the injection site; Arm swollen; Inflammation hardness; Inflammation hardness; Allergic reaction; Felt a little tired and the arm was hurting a bit; Little tired; Forehead, nose and cheeks got really red and burning, Burning sensation in face, Burning sensation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction), PAIN IN EXTREMITY (Felt a little tired and the arm was hurting a bit), FATIGUE (Little tired), ERYTHEMA (Forehead, nose and cheeks got really red and burning, Burning sensation in face, Burning sensation) and DIARRHOEA (Diarrhea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to animal (allergic to duck), Allergy to animals (allergic to turkey), Drug allergy (allergic to Cataprist,), Drug allergy (allergic to Januvia), Drug allergy (allergic to Keflex.), Diabetes mellitus, Hypertension and Hypercholesterolaemia.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction), PAIN IN EXTREMITY (Felt a little tired and the arm was hurting a bit), FATIGUE (Little tired) and ERYTHEMA (Forehead, nose and cheeks got really red and burning, Burning sensation in face, Burning sensation). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Tenderness if she pokes the injection site), PERIPHERAL SWELLING (Arm swollen), INFLAMMATION (Inflammation hardness) and INDURATION (Inflammation hardness). At the time of the report, ALLERGY TO VACCINE (Allergic reaction), FATIGUE (Little tired), ERYTHEMA (Forehead, nose and cheeks got really red and burning, Burning sensation in face, Burning sensation), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Tenderness if she pokes the injection site), PERIPHERAL SWELLING (Arm swollen), INFLAMMATION (Inflammation hardness) and INDURATION (Inflammation hardness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fever of 100.6F; chills; fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100.6F), CHILLS, FATIGUE (fatigue) and PAIN IN EXTREMITY (sore arm) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Fever of 100.6F), CHILLS, FATIGUE (fatigue) and PAIN IN EXTREMITY (sore arm). At the time of the report, PYREXIA (Fever of 100.6F), CHILLS, FATIGUE (fatigue) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Electrocardiogram, Hypertension, Myalgia
Clinical narrative: chest pain; high blood pressure; soreness; terrible shoulder pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (terrible shoulder pain), MYALGIA (soreness), CHEST PAIN (chest pain) and HYPERTENSION (high blood pressure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced ARTHRALGIA (terrible shoulder pain). On 19-Feb-2021, the patient experienced MYALGIA (soreness). On 22-Feb-2021, the patient experienced HYPERTENSION (high blood pressure). On 24-Feb-2021, the patient experienced CHEST PAIN (chest pain). On 23-Jan-2021, ARTHRALGIA (terrible shoulder pain) outcome was unknown. At the time of the report, MYALGIA (soreness), CHEST PAIN (chest pain) and HYPERTENSION (high blood pressure) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Electrocardiogram: normal.         Upon internal review on 21-May-2021, the age was corrected to unknown.   This case was linked to MOD21-041389 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Ear pain, Movement disorder, Neck pain, Pain
Clinical narrative: pain/severe pain all the way on my left side; severe pain in my arm - left; severe pain moves to the neck - left side; severe pain moves to the ear - left side; I can barely move around; it's been very difficult; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain/severe pain all the way on my left side), PAIN IN EXTREMITY (severe pain in my arm - left), NECK PAIN (severe pain moves to the neck - left side), EAR PAIN (severe pain moves to the ear - left side) and MOVEMENT DISORDER (I can barely move around) in a female patient of an unknown age 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.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain/severe pain all the way on my left side), PAIN IN EXTREMITY (severe pain in my arm - left), NECK PAIN (severe pain moves to the neck - left side), EAR PAIN (severe pain moves to the ear - left side), MOVEMENT DISORDER (I can barely move around) and DISCOMFORT (it's been very difficult). At the time of the report, PAIN (pain/severe pain all the way on my left side), PAIN IN EXTREMITY (severe pain in my arm - left), NECK PAIN (severe pain moves to the neck - left side), EAR PAIN (severe pain moves to the ear - left side), MOVEMENT DISORDER (I can barely move around) and DISCOMFORT (it's been very difficult) outcome was unknown. Not Provided      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.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain/severe pain all the way on my left side; severe pain in my arm - left; severe pain moves to the neck - left side; severe pain moves to the ear - left side; I can barely move around; it's been very difficult; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain/severe pain all the way on my left side), PAIN IN EXTREMITY (severe pain in my arm - left), NECK PAIN (severe pain moves to the neck - left side), EAR PAIN (severe pain moves to the ear - left side) and MOVEMENT DISORDER (I can barely move around) in a female patient of an unknown age 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.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain/severe pain all the way on my left side), PAIN IN EXTREMITY (severe pain in my arm - left), NECK PAIN (severe pain moves to the neck - left side), EAR PAIN (severe pain moves to the ear - left side), MOVEMENT DISORDER (I can barely move around) and DISCOMFORT (it's been very difficult). At the time of the report, PAIN (pain/severe pain all the way on my left side), PAIN IN EXTREMITY (severe pain in my arm - left), NECK PAIN (severe pain moves to the neck - left side), EAR PAIN (severe pain moves to the ear - left side), MOVEMENT DISORDER (I can barely move around) and DISCOMFORT (it's been very difficult) outcome was unknown. Not Provided      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.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site rash, Pain, Vaccination site hypersensitivity, Vaccination site warmth
Clinical narrative: arm was very very sore - left arm; rash at the vaccination site - left arm; middle of it is hard kind of like a mosquito bite - at the vaccination site - left arm; COVID arm; warm to the touch - at the vaccination site - left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (arm was very very sore - left arm), INJECTION SITE RASH (rash at the vaccination site - left arm), INJECTION SITE INDURATION (middle of it is hard kind of like a mosquito bite - at the vaccination site - left arm), VACCINATION SITE HYPERSENSITIVITY (COVID arm) and VACCINATION SITE WARMTH (warm to the touch - at the vaccination site - left arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced INJECTION SITE RASH (rash at the vaccination site - left arm), INJECTION SITE INDURATION (middle of it is hard kind of like a mosquito bite - at the vaccination site - left arm), VACCINATION SITE HYPERSENSITIVITY (COVID arm) and VACCINATION SITE WARMTH (warm to the touch - at the vaccination site - left arm). On an unknown date, the patient experienced PAIN (arm was very very sore - left arm). At the time of the report, PAIN (arm was very very sore - left arm), INJECTION SITE RASH (rash at the vaccination site - left arm), INJECTION SITE INDURATION (middle of it is hard kind of like a mosquito bite - at the vaccination site - left arm), VACCINATION SITE HYPERSENSITIVITY (COVID arm) and VACCINATION SITE WARMTH (warm to the touch - at the vaccination site - left arm) 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.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Fatigue; Chills; Nausea; Vomiting; Headache; Muscle pain; Joint pain; Felt a little under the weather; A spontaneous report was received from a consumer concerning a 81-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt a little under the weather/malaise, fatigue, headache, muscle pain/ myalgia, joint pain/ arthralgia, chills, nausea, vomiting. The patient's medical history was not provided. Concomitant medications reported were lisinopril, Vitamin D, Vitamin B for used for unknown indication.  On 6 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 042L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the event(s) felt a little under the weather . On 16 Feb 2021, the patient experienced the event(s) fatigue. chills, nausea, vomiting, headache, muscle pain, joint pain.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event(s) headache was considered resolved on 17 Feb 2021.The outcome of event(s) muscle pain was considered resolved on 17 Feb 2021.The outcome of event(s) joint pain was considered resolved on 17 Feb 2021. The outcome of event(s), felt a little under the weather, fatigue,chills,nausea,vomiting was unknown.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: Fatigue; Chills; Nausea; Vomiting; Headache; Muscle pain; Joint pain; Felt a little under the weather; A spontaneous report was received from a consumer concerning a 81-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt a little under the weather/malaise, fatigue, headache, muscle pain/ myalgia, joint pain/ arthralgia, chills, nausea, vomiting. The patient's medical history was not provided. Concomitant medications reported were lisinopril, Vitamin D, Vitamin B for used for unknown indication.  On 6 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 042L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the event(s) felt a little under the weather . On 16 Feb 2021, the patient experienced the event(s) fatigue. chills, nausea, vomiting, headache, muscle pain, joint pain.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event(s) headache was considered resolved on 17 Feb 2021.The outcome of event(s) muscle pain was considered resolved on 17 Feb 2021.The outcome of event(s) joint pain was considered resolved on 17 Feb 2021. The outcome of event(s), felt a little under the weather, fatigue,chills,nausea,vomiting was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain in extremity, Pruritus, Urticaria, Vaccination site pain
Clinical narrative: their arm hurt; it was more sore than ever had with any vaccine; Itching was behind their ears,Itching was in the chest,it was not extensive it was just a little line across their chest; slight allergic reaction; small itchy patch hot of hives; small itchy patch hot of hives; This spontaneous case was reported by a physician and describes the occurrence of HYPERSENSITIVITY (slight allergic reaction), PRURITUS (small itchy patch hot of hives), URTICARIA (small itchy patch hot of hives), PAIN IN EXTREMITY (their arm hurt) and PRURITUS (Itching was behind their ears,Itching was in the chest,it was not extensive it was just a little line across their chest) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced HYPERSENSITIVITY (slight allergic reaction), PRURITUS (small itchy patch hot of hives), URTICARIA (small itchy patch hot of hives) and PRURITUS (Itching was behind their ears,Itching was in the chest,it was not extensive it was just a little line across their chest). On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (their arm hurt) and VACCINATION SITE PAIN (it was more sore than ever had with any vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. On 17-Jan-2021, PAIN IN EXTREMITY (their arm hurt) and VACCINATION SITE PAIN (it was more sore than ever had with any vaccine) had resolved. On 18-Jan-2021, HYPERSENSITIVITY (slight allergic reaction), PRURITUS (small itchy patch hot of hives), URTICARIA (small itchy patch hot of hives) and PRURITUS (Itching was behind their ears,Itching was in the chest,it was not extensive it was just a little line across their chest) had resolved. Not Provided      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.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: runny nose; fever of 107; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and PYREXIA (fever of 107) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (fever of 107). On an unknown date, the patient experienced RHINORRHOEA (runny nose). At the time of the report, RHINORRHOEA (runny nose) and PYREXIA (fever of 107) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Pyrexia: 107 Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Diarrhoea
Clinical narrative: diarrhea; blood sugar went up to 340 when it is usually in the 100's; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and BLOOD GLUCOSE INCREASED (blood sugar went up to 340 when it is usually in the 100's) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood sugar increased. Concomitant products included METFORMIN for Blood sugar increased.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar went up to 340 when it is usually in the 100's). On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) and BLOOD GLUCOSE INCREASED (blood sugar went up to 340 when it is usually in the 100's) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Metformin was doubled in dosage to treat the event of Elevated blood pressure.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site dysaesthesia
Clinical narrative: discomfort in his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DYSAESTHESIA (discomfort in his arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE and ROSUVASTATIN for an unknown indication.   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 VACCINATION SITE DYSAESTHESIA (discomfort in his arm). At the time of the report, VACCINATION SITE DYSAESTHESIA (discomfort in his arm) 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 treatment information was provided.   This case was linked to MOD21-032046 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pruritus, Rash
Clinical narrative: Rash on her arm; Felt a little itchy; Felt like an insect bit her at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE DISCOMFORT (Felt like an insect bit her at the injection site), RASH (Rash on her arm) and INJECTION SITE PRURITUS (Felt a little itchy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced INJECTION SITE DISCOMFORT (Felt like an insect bit her at the injection site) and INJECTION SITE PRURITUS (Felt a little itchy). On an unknown date, the patient experienced RASH (Rash on her arm). At the time of the report, INJECTION SITE DISCOMFORT (Felt like an insect bit her at the injection site), RASH (Rash on her arm) and INJECTION SITE PRURITUS (Felt a little itchy) 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 reported. Treatment information was not provided.; 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site induration, Vaccination site pain, White blood cell count
Clinical narrative: Pain at the injection site; A kind of "ball" at the injection site; The vaccine "did not enter at all" into the muscle; A spontaneous report was received from a consumer concerning a 57 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain, injection site induration and incorrect route of product administration.   The patient's medical history, was not provided by the reporter.No concomitant medications were reported.   On 11 Jan 2021, about 7 days  prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot #:unknown) through  an unknown route in the right arm for prophylaxis of COVID-19 infection.   On 17 Jan 2021, patient experienced pain at the injection site, a kind of ball at the injection site and said that it felt  like the vaccine"did not enter at all" into the muscle.   No treatment information was included.   Patient had low blood cell count.  Action taken with mRNA-1273 in response to the events was not applicable  The events, pain at the injection site, a kind of ball at the injection site and the vaccine did not enter in to the muscle were considered as unknown.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with associated injection site pain and injection site induration
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: chest pain; tired; dizzy weak; short pain on head; sick; difficulty breathing; ARM HURT; feverish; A spontaneous report was received from a  consumer concerning an  78 -year old,  male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and    experienced arm hurt, fever, fatigue, illness, chest  pain, dizziness, shortness of breath, headache.  The patient's medical history, was not provided by the reporter, included no known allergies,  Concomitant medications reported were blood pressure medicine and diabetes medicine.   On  09 Feb 2021 prior to the onset of the symptoms, the patient received their first  of two planned doses of mRNA-1273 (Batch number Unknown)  for prophylaxis of COVID-19 infection   On 09 Feb 2021 patient experienced the events arm hurt, feverish, headache, and next day he woke up and felt really bad, sick, tired, dizzy, weak, difficulty in breathing, short pain on head.   Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events,therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events arm hurt, fever, fatigue, illness, chest  pain, dizziness, shortness of breath, headache were unknown
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain in extremity, Pyrexia
Clinical narrative: chest pain; tired; dizzy weak; short pain on head; sick; difficulty breathing; ARM HURT; feverish; A spontaneous report was received from a  consumer concerning an  78 -year old,  male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and    experienced arm hurt, fever, fatigue, illness, chest  pain, dizziness, shortness of breath, headache.  The patient's medical history, was not provided by the reporter, included no known allergies,  Concomitant medications reported were blood pressure medicine and diabetes medicine.   On  09 Feb 2021 prior to the onset of the symptoms, the patient received their first  of two planned doses of mRNA-1273 (Batch number Unknown)  for prophylaxis of COVID-19 infection   On 09 Feb 2021 patient experienced the events arm hurt, feverish, headache, and next day he woke up and felt really bad, sick, tired, dizzy, weak, difficulty in breathing, short pain on head.   Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events,therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events arm hurt, fever, fatigue, illness, chest  pain, dizziness, shortness of breath, headache were unknown
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Tenderness
Clinical narrative: tender; itchy; red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash), PRURITUS (itchy) and TENDERNESS (tender) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 immunisation.     Concomitant products included LEVOTHYROXINE and IBUPROFEN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RASH ERYTHEMATOUS (red rash). On 09-Feb-2021, the patient experienced PRURITUS (itchy). On 10-Feb-2021, the patient experienced TENDERNESS (tender). At the time of the report, RASH ERYTHEMATOUS (red rash), PRURITUS (itchy) and TENDERNESS (tender) 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.    Treatment details included None.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: itchiness; rash; redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), RASH (rash) and ERYTHEMA (redness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PRURITUS (itchiness), RASH (rash) and ERYTHEMA (redness). On 11-Feb-2021, PRURITUS (itchiness) and ERYTHEMA (redness) had resolved. At the time of the report, RASH (rash) had not 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.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced RASH ERYTHEMATOUS (red rash). At the time of the report, RASH ERYTHEMATOUS (red rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Chest pain; difficulty in breathing; Dizzy weak; Tired; short pain on head; Blur vision; Extreme pain on arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blur vision), PAIN IN EXTREMITY (Extreme pain on arm), CHEST PAIN (Chest pain), DYSPNOEA (difficulty in breathing) and DIZZINESS (Dizzy weak) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history Provided.). Concurrent medical conditions included Drug allergy (Sulfur Allergy.).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VISION BLURRED (Blur vision), PAIN IN EXTREMITY (Extreme pain on arm) and HEADACHE (Headache). On 11-Feb-2021, the patient experienced CHEST PAIN (Chest pain), DYSPNOEA (difficulty in breathing), DIZZINESS (Dizzy weak), FATIGUE (Tired) and HEADACHE (short pain on head). At the time of the report, VISION BLURRED (Blur vision), PAIN IN EXTREMITY (Extreme pain on arm), CHEST PAIN (Chest pain), DYSPNOEA (difficulty in breathing), DIZZINESS (Dizzy weak), FATIGUE (Tired), HEADACHE (Headache) and HEADACHE (short pain on head) 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.   Concomitant included Blood pressure medicine and Diabetes Medicine Treatment information not provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vision blurred
Clinical narrative: Chest pain; difficulty in breathing; Dizzy weak; Tired; short pain on head; Blur vision; Extreme pain on arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blur vision), PAIN IN EXTREMITY (Extreme pain on arm), CHEST PAIN (Chest pain), DYSPNOEA (difficulty in breathing) and DIZZINESS (Dizzy weak) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history Provided.). Concurrent medical conditions included Drug allergy (Sulfur Allergy.).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VISION BLURRED (Blur vision), PAIN IN EXTREMITY (Extreme pain on arm) and HEADACHE (Headache). On 11-Feb-2021, the patient experienced CHEST PAIN (Chest pain), DYSPNOEA (difficulty in breathing), DIZZINESS (Dizzy weak), FATIGUE (Tired) and HEADACHE (short pain on head). At the time of the report, VISION BLURRED (Blur vision), PAIN IN EXTREMITY (Extreme pain on arm), CHEST PAIN (Chest pain), DYSPNOEA (difficulty in breathing), DIZZINESS (Dizzy weak), FATIGUE (Tired), HEADACHE (Headache) and HEADACHE (short pain on head) 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.   Concomitant included Blood pressure medicine and Diabetes Medicine Treatment information not provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Injection site reaction, Pruritus, Rash erythematous
Clinical narrative: felt like bee sting or sunburn; red, not like a fire red but reddened; warmer to touch than rest of skin; itching; reaction on skin around injection site,small at that time and is slowly getting bigger,4 inches by 2.5 inches; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (felt like bee sting or sunburn), ERYTHEMA (red, not like a fire red but reddened), FEELING HOT (warmer to touch than rest of skin), PRURITUS (itching) and INJECTION SITE REACTION (reaction on skin around injection site,small at that time and is slowly getting bigger,4 inches by 2.5 inches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included Thyroid disorder, Swelling of legs, Depression, Metabolic syndrome, Acid reflux (oesophageal) and Spinal stenosis. Concurrent medical conditions included Hypertension, Cholesterol and Bee sting hypersensitivity. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), ATORVASTATIN for Cholesterol, SERTRALINE for Depression, METOPROLOL SUCCINATE (TOPROL XL) for Hypertension, METFORMIN for Metabolic syndrome, GABAPENTIN for Pain, IBUPROFEN for Spinal stenosis, BUMETANIDE (BUMEX) for Swelling of legs, LEVOTHYROXINE for Thyroid disorder, HYDROCHLOROTHIAZIDE (THIAZIDE), ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM AND VITAMIN D), GLUCOSAMINE and COLECALCIFEROL, UBIDECARENONE (CO-Q10+VITAMIN D3) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced RASH ERYTHEMATOUS (felt like bee sting or sunburn), ERYTHEMA (red, not like a fire red but reddened), FEELING HOT (warmer to touch than rest of skin), PRURITUS (itching) and INJECTION SITE REACTION (reaction on skin around injection site,small at that time and is slowly getting bigger,4 inches by 2.5 inches). At the time of the report, RASH ERYTHEMATOUS (felt like bee sting or sunburn), ERYTHEMA (red, not like a fire red but reddened), FEELING HOT (warmer to touch than rest of skin), PRURITUS (itching) and INJECTION SITE REACTION (reaction on skin around injection site,small at that time and is slowly getting bigger,4 inches by 2.5 inches) 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.   Treatment information not provided