chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Headache, Nausea, Pain
Clinical narrative: lost taste; rather the taste of things is different; severe effects chills; fever; nausea; headache; body ache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (body ache), AGEUSIA (lost taste), TASTE DISORDER (rather the taste of things is different), CHILLS (severe effects chills) and PYREXIA (fever) in a 70-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 01-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) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (body ache), CHILLS (severe effects chills), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache). On 02-Feb-2021, the patient experienced AGEUSIA (lost taste) and TASTE DISORDER (rather the taste of things is different). At the time of the report, PAIN (body ache), AGEUSIA (lost taste), TASTE DISORDER (rather the taste of things is different), CHILLS (severe effects chills), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Taste disorder
Clinical narrative: lost taste; rather the taste of things is different; severe effects chills; fever; nausea; headache; body ache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (body ache), AGEUSIA (lost taste), TASTE DISORDER (rather the taste of things is different), CHILLS (severe effects chills) and PYREXIA (fever) in a 70-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 01-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) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (body ache), CHILLS (severe effects chills), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache). On 02-Feb-2021, the patient experienced AGEUSIA (lost taste) and TASTE DISORDER (rather the taste of things is different). At the time of the report, PAIN (body ache), AGEUSIA (lost taste), TASTE DISORDER (rather the taste of things is different), CHILLS (severe effects chills), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Injection site swelling, Nasopharyngitis, Pain in extremity
Clinical narrative: had diarrhea; has a bump in her left arm; felt tired; Had some cold; sore left arm that went all the way to the neck; This spontaneous case was reported by an other health professional and describes the occurrence of PAIN IN EXTREMITY (sore left arm that went all the way to the neck), NASOPHARYNGITIS (Had some cold), DIARRHOEA (had diarrhea), FATIGUE (felt tired) and INJECTION SITE SWELLING (has a bump in her left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cholesterol.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore left arm that went all the way to the neck). On 28-Jan-2021, the patient experienced NASOPHARYNGITIS (Had some cold) and FATIGUE (felt tired). On 01-Feb-2021, the patient experienced DIARRHOEA (had diarrhea) and INJECTION SITE SWELLING (has a bump in her left arm). The patient was treated with PARACETAMOL (TYLENOL) on 25-Jan-2021 for Back pain, at an unspecified dose and frequency. On 28-Jan-2021, PAIN IN EXTREMITY (sore left arm that went all the way to the neck), NASOPHARYNGITIS (Had some cold) and FATIGUE (felt tired) had resolved. At the time of the report, DIARRHOEA (had diarrhea) outcome was unknown and INJECTION SITE SWELLING (has a bump in her left arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included a diabetes medication and a cholesterol medication.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site inflammation, Peripheral swelling, Rash, Rash pruritic
Clinical narrative: inflamed; secondary rash like a thin line from the arm to her wrist; very itchy; The actual injection site was red; threw up 3 times; large round rash,almost 3 quarters of the left arm; wasn't really itchy; hot to touch; whole left arm was swollen down to the left hand; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (wasn't really itchy), FEELING HOT (hot to touch), PERIPHERAL SWELLING (whole left arm was swollen down to the left hand), INJECTION SITE INFLAMMATION (inflamed) and RASH (large round rash,almost 3 quarters of the left arm) in a 34-year-old female 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 Depression, Anxiety, Allergy and Heartburn. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZIRTEK) for Allergy, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression and Anxiety, OMEPRAZOLE for Heartburn, LISINOPRIL for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced RASH PRURITIC (wasn't really itchy), FEELING HOT (hot to touch), PERIPHERAL SWELLING (whole left arm was swollen down to the left hand), RASH (large round rash,almost 3 quarters of the left arm) and VOMITING (threw up 3 times). On 30-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (inflamed), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (The actual injection site was red) and RASH (secondary rash like a thin line from the arm to her wrist). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg once a day. At the time of the report, RASH PRURITIC (wasn't really itchy), FEELING HOT (hot to touch), PERIPHERAL SWELLING (whole left arm was swollen down to the left hand), INJECTION SITE INFLAMMATION (inflamed), RASH (large round rash,almost 3 quarters of the left arm), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (The actual injection site was red), VOMITING (threw up 3 times) and RASH (secondary rash like a thin line from the arm to her wrist) 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.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vomiting
Clinical narrative: inflamed; secondary rash like a thin line from the arm to her wrist; very itchy; The actual injection site was red; threw up 3 times; large round rash,almost 3 quarters of the left arm; wasn't really itchy; hot to touch; whole left arm was swollen down to the left hand; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (wasn't really itchy), FEELING HOT (hot to touch), PERIPHERAL SWELLING (whole left arm was swollen down to the left hand), INJECTION SITE INFLAMMATION (inflamed) and RASH (large round rash,almost 3 quarters of the left arm) in a 34-year-old female 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 Depression, Anxiety, Allergy and Heartburn. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZIRTEK) for Allergy, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression and Anxiety, OMEPRAZOLE for Heartburn, LISINOPRIL for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced RASH PRURITIC (wasn't really itchy), FEELING HOT (hot to touch), PERIPHERAL SWELLING (whole left arm was swollen down to the left hand), RASH (large round rash,almost 3 quarters of the left arm) and VOMITING (threw up 3 times). On 30-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (inflamed), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (The actual injection site was red) and RASH (secondary rash like a thin line from the arm to her wrist). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg once a day. At the time of the report, RASH PRURITIC (wasn't really itchy), FEELING HOT (hot to touch), PERIPHERAL SWELLING (whole left arm was swollen down to the left hand), INJECTION SITE INFLAMMATION (inflamed), RASH (large round rash,almost 3 quarters of the left arm), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (The actual injection site was red), VOMITING (threw up 3 times) and RASH (secondary rash like a thin line from the arm to her wrist) 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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling of 1 lymph node above the collar bone; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling of 1 lymph node above the collar bone) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced LYMPHADENOPATHY (swelling of 1 lymph node above the collar bone). At the time of the report, LYMPHADENOPATHY (swelling of 1 lymph node above the collar bone) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment information not provided by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Vomiting
Clinical narrative: chest pain; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and VOMITING (vomiting) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), VERAPAMIL, LOSARTAN, SERTRALINE, HYDROCHLOROTHIAZIDE, CETIRIZINE HYDROCHLORIDE, FLUTICASONE PROPIONATE, VITAMIN E NOS and VITAMIN D3 for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced CHEST PAIN (chest pain) and VOMITING (vomiting). At the time of the report, CHEST PAIN (chest pain) and VOMITING (vomiting) 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.   Concomitant medications also included silver centrum. Treatment details was not reported by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Pollakiuria, Vaccination site pain
Clinical narrative: Weakness (particularly after eating a cake today),; Had a lack of appetite; Going to the bathroom frequently; Tenderness at the site where she received her vaccine; Unusually fatigue/feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness (particularly after eating a cake today)), DECREASED APPETITE (Had a lack of appetite), POLLAKIURIA (Going to the bathroom frequently), VACCINATION SITE PAIN (Tenderness at the site where she received her vaccine) and FATIGUE (Unusually fatigue/feeling very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ASTHENIA (Weakness (particularly after eating a cake today)), DECREASED APPETITE (Had a lack of appetite), POLLAKIURIA (Going to the bathroom frequently), VACCINATION SITE PAIN (Tenderness at the site where she received her vaccine) and FATIGUE (Unusually fatigue/feeling very tired). At the time of the report, ASTHENIA (Weakness (particularly after eating a cake today)), DECREASED APPETITE (Had a lack of appetite), POLLAKIURIA (Going to the bathroom frequently), VACCINATION SITE PAIN (Tenderness at the site where she received her vaccine) and FATIGUE (Unusually fatigue/feeling very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhoids, Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: bruise at the injection site, like blue and different colors; hemorrhoids and tended to bleed; bled at the site of the injection; A spontaneous report was received from a healthcare professional concerning a 60-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bled at the site of the injection, bruise at the injection site, like blue and different colors and hemorrhoids.  The patient's medical history was not reported. Products known to have been use by patient, with in last two week  included vitamin C and vitamin D3.   On 22-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 062G20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.    On 22-Jan- 2021, same day of receiving vaccine, the patient experienced bled at the site of the injection. On an unknown date, the patient experienced bruise at the injection site, like blue and different colors and had hemorrhoids. Treatment information was not provided.   Action taken with mrna-1273 in response to the events was not reported.   The outcome of events experienced bled at the site of the injection , bruise at the injection site, like blue and different colors and hemorrhoids were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Injection site pain, Pyrexia
Clinical narrative: Fever of 102F; headache; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102F), HEADACHE (headache) and INJECTION SITE PAIN (arm soreness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PYREXIA (Fever of 102F), HEADACHE (headache) and INJECTION SITE PAIN (arm soreness). On 29-Jan-2021, PYREXIA (Fever of 102F), HEADACHE (headache) and INJECTION SITE PAIN (arm soreness) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: increased (High) 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain
Clinical narrative: Had an allergy; Is hurting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Had an allergy) and PAIN (Is hurting) in an 87-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Had an allergy) and PAIN (Is hurting). At the time of the report, HYPERSENSITIVITY (Had an allergy) and PAIN (Is hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment information was provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: lower back pain in muscle; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain in muscle) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced BACK PAIN (lower back pain in muscle). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, BACK PAIN (lower back pain in muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and PYREXIA (fever) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced FATIGUE (fatigue). On 29-Jan-2021, the patient experienced PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 28-Jan-2021, FATIGUE (fatigue) had resolved. At the time of the report, PYREXIA (fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were Mood stabilizers, Anti-anxiety.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) 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.   Concomitant medication was not provided by the reporter.  The treatment information was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pain in extremity, Paraesthesia oral
Clinical narrative: Fever; Chills; She felt tired; Face was swollen around jawline on left side; Left arm was very sore and throbbing at injection site; Pain in both shoulders/pain in back of right knee; Lip tingled; Throat opened like she was going to throw up; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Lip tingled), PAIN IN EXTREMITY (Left arm was very sore and throbbing at injection site), SWELLING FACE (Face was swollen around jawline on left side), VOMITING (Throat opened like she was going to throw up) and ARTHRALGIA (Pain in both shoulders/pain in back of right knee) in a 79-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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PARAESTHESIA ORAL (Lip tingled) and VOMITING (Throat opened like she was going to throw up). On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Left arm was very sore and throbbing at injection site) and ARTHRALGIA (Pain in both shoulders/pain in back of right knee). On 20-Jan-2021, the patient experienced SWELLING FACE (Face was swollen around jawline on left side). On 22-Jan-2021, the patient experienced FATIGUE (She felt tired). On 27-Jan-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (Lip tingled), PAIN IN EXTREMITY (Left arm was very sore and throbbing at injection site), SWELLING FACE (Face was swollen around jawline on left side), VOMITING (Throat opened like she was going to throw up), ARTHRALGIA (Pain in both shoulders/pain in back of right knee), FATIGUE (She felt tired), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment:Tylenol   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: contact info updated On 05-Apr-2021: Source Document attached
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face, Vomiting
Clinical narrative: Fever; Chills; She felt tired; Face was swollen around jawline on left side; Left arm was very sore and throbbing at injection site; Pain in both shoulders/pain in back of right knee; Lip tingled; Throat opened like she was going to throw up; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Lip tingled), PAIN IN EXTREMITY (Left arm was very sore and throbbing at injection site), SWELLING FACE (Face was swollen around jawline on left side), VOMITING (Throat opened like she was going to throw up) and ARTHRALGIA (Pain in both shoulders/pain in back of right knee) in a 79-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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PARAESTHESIA ORAL (Lip tingled) and VOMITING (Throat opened like she was going to throw up). On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Left arm was very sore and throbbing at injection site) and ARTHRALGIA (Pain in both shoulders/pain in back of right knee). On 20-Jan-2021, the patient experienced SWELLING FACE (Face was swollen around jawline on left side). On 22-Jan-2021, the patient experienced FATIGUE (She felt tired). On 27-Jan-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (Lip tingled), PAIN IN EXTREMITY (Left arm was very sore and throbbing at injection site), SWELLING FACE (Face was swollen around jawline on left side), VOMITING (Throat opened like she was going to throw up), ARTHRALGIA (Pain in both shoulders/pain in back of right knee), FATIGUE (She felt tired), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment:Tylenol   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: contact info updated On 05-Apr-2021: Source Document attached
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: point of injection on his left arm aches; left arm is a bit swollen and hurts if lifted; A spontaneous report was received from a Consumer concerning a 85-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain and swelling at the vaccination site.  The patient's medical history was not provided. Concomitant medications reported were Vitamins, Losartan, Amlodipine Besylate, Glipizide, Simvastatin, Aspirin, fenofibrate, meclizine.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) in the left arm for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced the left arm ache and a bit swollen and hurts if lifted.  Treatment details was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Experienced some adverse effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experienced some adverse effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experienced some adverse effects). At the time of the report, VACCINATION COMPLICATION (Experienced some adverse effects) 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: Injection site erythema, Injection site swelling
Clinical narrative: Turn very red and swollen; Turn very red and swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Turn very red and swollen) and INJECTION SITE SWELLING (Turn very red and swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Turn very red and swollen) and INJECTION SITE SWELLING (Turn very red and swollen). At the time of the report, INJECTION SITE ERYTHEMA (Turn very red and swollen) and INJECTION SITE SWELLING (Turn very red and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Red Injection Site; Swollen Injection Site; Tender Injection Site; Injection Site feels like a whelk; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE PAIN (Tender Injection Site) and VACCINATION SITE REACTION (Injection Site feels like a whelk) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore Injection Site). On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE PAIN (Tender Injection Site) and VACCINATION SITE REACTION (Injection Site feels like a whelk). On 24-Jan-2021, VACCINATION SITE PAIN (Sore Injection Site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE PAIN (Tender Injection Site) and VACCINATION SITE REACTION (Injection Site feels like a whelk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye disorder, Headache, Pyrexia, Rhinorrhoea
Clinical narrative: eye problems / "like eyes are not in synch"/ "like one eye is sort of off"; Feeling sleepy; Itching at the injection site where the vaccinator placed latex band aid; Headaches, mainly over the right eye but is also over the left eye; Fever; On and off chilly feeling; Runny watering nose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHINORRHOEA (Runny watering nose), EYE DISORDER (eye problems / "like eyes are not in synch"/ "like one eye is sort of off"), SOMNOLENCE (Feeling sleepy), VACCINATION SITE PRURITUS (Itching at the injection site where the vaccinator placed latex band aid) and HEADACHE (Headaches, mainly over the right eye but is also over the left eye) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism, Runny nose (in winters), Latex allergy, Drug allergy (erythromycin and flecainide combination: developed atrial fibrillation) and Eyeglasses wearer (driving glass). Concomitant products included LEVOTHYROXINE, DULOXETINE HYDROCHLORIDE (CYMBALTA), VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Jan-2021, the patient experienced RHINORRHOEA (Runny watering nose), SOMNOLENCE (Feeling sleepy), VACCINATION SITE PRURITUS (Itching at the injection site where the vaccinator placed latex band aid), HEADACHE (Headaches, mainly over the right eye but is also over the left eye), PYREXIA (Fever) and CHILLS (On and off chilly feeling). On 02-Feb-2021, the patient experienced EYE DISORDER (eye problems / "like eyes are not in synch"/ "like one eye is sort of off"). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at an unspecified dose and frequency. On 03-Feb-2021, SOMNOLENCE (Feeling sleepy), VACCINATION SITE PRURITUS (Itching at the injection site where the vaccinator placed latex band aid), HEADACHE (Headaches, mainly over the right eye but is also over the left eye), PYREXIA (Fever) and CHILLS (On and off chilly feeling) had resolved. At the time of the report, RHINORRHOEA (Runny watering nose) outcome was unknown and EYE DISORDER (eye problems / "like eyes are not in synch"/ "like one eye is sort of off") had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pruritus
Clinical narrative: eye problems / "like eyes are not in synch"/ "like one eye is sort of off"; Feeling sleepy; Itching at the injection site where the vaccinator placed latex band aid; Headaches, mainly over the right eye but is also over the left eye; Fever; On and off chilly feeling; Runny watering nose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHINORRHOEA (Runny watering nose), EYE DISORDER (eye problems / "like eyes are not in synch"/ "like one eye is sort of off"), SOMNOLENCE (Feeling sleepy), VACCINATION SITE PRURITUS (Itching at the injection site where the vaccinator placed latex band aid) and HEADACHE (Headaches, mainly over the right eye but is also over the left eye) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism, Runny nose (in winters), Latex allergy, Drug allergy (erythromycin and flecainide combination: developed atrial fibrillation) and Eyeglasses wearer (driving glass). Concomitant products included LEVOTHYROXINE, DULOXETINE HYDROCHLORIDE (CYMBALTA), VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Jan-2021, the patient experienced RHINORRHOEA (Runny watering nose), SOMNOLENCE (Feeling sleepy), VACCINATION SITE PRURITUS (Itching at the injection site where the vaccinator placed latex band aid), HEADACHE (Headaches, mainly over the right eye but is also over the left eye), PYREXIA (Fever) and CHILLS (On and off chilly feeling). On 02-Feb-2021, the patient experienced EYE DISORDER (eye problems / "like eyes are not in synch"/ "like one eye is sort of off"). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at an unspecified dose and frequency. On 03-Feb-2021, SOMNOLENCE (Feeling sleepy), VACCINATION SITE PRURITUS (Itching at the injection site where the vaccinator placed latex band aid), HEADACHE (Headaches, mainly over the right eye but is also over the left eye), PYREXIA (Fever) and CHILLS (On and off chilly feeling) had resolved. At the time of the report, RHINORRHOEA (Runny watering nose) outcome was unknown and EYE DISORDER (eye problems / "like eyes are not in synch"/ "like one eye is sort of off") had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Joint pain in legs; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain in legs) and HEADACHE (Headache) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced ARTHRALGIA (Joint pain in legs) and HEADACHE (Headache). At the time of the report, ARTHRALGIA (Joint pain in legs) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus, Vaccination site bruising
Clinical narrative: these little spots of blood under the skin like its trying to come up; rash around that area where I was given the vaccine; like my arm started itching; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like arm started itching, little spots of blood under the skin like its trying to come up and rash around that area where I was given the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the event, like arm started itching. On an unknown date, the patient experienced the events, little spots of blood under the skin like its trying to come up and rash around that area where I was given the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, arm started itching, little spots of blood under the skin like its trying to come up, rash around that area where I was given the vaccine was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 031M20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma since 2016, COPD since 2013, Peripheral vascular disorder since 2016, Penicillin allergy (Rash as child) and Osteoporosis since 2019. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 2020 to an unknown date for Asthma, IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (IPRATROPIUM/ALBUTEROL) from 2012 to an unknown date for COPD, MACROGOL 400, PROPYLENE GLYCOL (SYSTANE) for Dry eye syndrome, ABALOPARATIDE from 09-Jan-2020 to an unknown date and ABALOPARATIDE (TYMLOS) from 01-Sep-2020 to an unknown date for Osteoporosis, GLUCOSAMINE & CHONDORITIN for Prophylaxis, VITAMIN D NOS for Vitamin D decreased, LEVOTHYROXINE from 08-Sep-1986 to an unknown date and LEVOTHYROXINE SODIUM (SYNTHYROID) from 09-Aug-1986 to an unknown date for an unknown indication. On 12-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021 at 4:00 PM, the patient experienced DIZZINESS (Dizzy). On 12-Jan-2021 at 6:30 PM, DIZZINESS (Dizzy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Heart rate: unknown (normal) Okay. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant medications also included Doctor dry eye formula Bid PO for Dry eye syndrome. No treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Follow-up received updated patient details, medical history, concomitant medications, second dose information. On 14-Apr-2021: Follow-up received updated past medical history start dates and additional concomitant medications.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Flatulence, Weight decreased
Clinical narrative: loaded with gas; diarrhea; lost about 4 pounds in a few hours; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FLATULENCE (loaded with gas), DIARRHOEA (diarrhea) and WEIGHT DECREASED (lost about 4 pounds in a few hours) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced FLATULENCE (loaded with gas), DIARRHOEA (diarrhea) and WEIGHT DECREASED (lost about 4 pounds in a few hours). At the time of the report, FLATULENCE (loaded with gas), DIARRHOEA (diarrhea) and WEIGHT DECREASED (lost about 4 pounds in a few hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Patient went to Emergency room to make sure she was not dehydrated and it was reported that she was fine.  Patient did not take any treatment medications for the symptoms
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Vaccination site reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and VACCINATION SITE REACTION (Injection site reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles) and VACCINATION SITE REACTION (Injection site reactions). At the time of the report, HERPES ZOSTER (Shingles) and VACCINATION SITE REACTION (Injection site reactions) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were provided by the reporter.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Lost sense of smell; Lost sense of taste; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lost sense of smell/anosmia and taste/ ageusia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, approximately three days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 025I20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient lost sense of smell and taste. The patient did not receive any treatment to alleviate the symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events lost sense of smell and taste was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extreme exhaustion/really really tired; This spontaneous case was reported by an other caregiver and describes the occurrence of FATIGUE (extreme exhaustion/really really tired) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (extreme exhaustion/really really tired). At the time of the report, FATIGUE (extreme exhaustion/really really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.