chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site bruising, Vaccination site papule
Clinical narrative: It has bruiser; Soreness; Bump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (It has bruiser), PAIN (Soreness) and VACCINATION SITE PAPULE (Bump at injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 007M20A) for COVID-19 vaccination.     Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (Soreness) and VACCINATION SITE PAPULE (Bump at injection site). On 03-Mar-2021, the patient experienced VACCINATION SITE BRUISING (It has bruiser). At the time of the report, VACCINATION SITE BRUISING (It has bruiser) had not resolved and PAIN (Soreness) and VACCINATION SITE PAPULE (Bump at injection site) had resolved.            No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: chills; headache; fever; A spontaneous report was received from  a 74 year old male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills,pyrexia and head ache.  The patient's medical history was not provided. Concomitant medications include atorvastatin and atenolol.  On 11 jan 2021, the patient received first of two planned doses of mRNA-1273 (012L20A )for prophylaxis of COVID-19 infection.   On 8 feb2021, prior to the onset of events patient received second dose of mRNA-1273 (010M20A)for prophylaxis of COVID-19 infection.   ON 8 feb 2021 after the vaccination patient experienced chills,pyrexia and head ache.  outcome of the events are unknown.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Temperature today which was102 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature today which was102 degrees) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included METFORMIN and VITAMINS NOS for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (Temperature today which was102 degrees). At the time of the report, PYREXIA (Temperature today which was102 degrees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medicine.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Headache, Pain
Clinical narrative: Weakness; Dizziness; Headache; No appetite; Really thirsty; Body aching; A spontaneous report was received from a consumer concerning a 65-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events weakness, dizziness, headache, no appetite, really thirsty, body aching.  The patient's medical history was not provided. Concomitant medications reported were Thyroid, Calcium, Metformin, Delaxitin, Melatomin, Low dose aspirn for drug use for unknown indication.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) weakness, dizziness, headache, no appetite, really thirsty, body aching.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), weakness, dizziness, headache, no appetite, really thirsty, body aching was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Weakness; Dizziness; Headache; No appetite; Really thirsty; Body aching; A spontaneous report was received from a consumer concerning a 65-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events weakness, dizziness, headache, no appetite, really thirsty, body aching.  The patient's medical history was not provided. Concomitant medications reported were Thyroid, Calcium, Metformin, Delaxitin, Melatomin, Low dose aspirn for drug use for unknown indication.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) weakness, dizziness, headache, no appetite, really thirsty, body aching.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), weakness, dizziness, headache, no appetite, really thirsty, body aching was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: down for the day; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (down for the day) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025020A) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (down for the day). At the time of the report, VACCINATION COMPLICATION (down for the day) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, after 2nd dose the patient was down for the day and had to call in sick from work.  No corrective treatment was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Site of injection is itching; Site of injection has red mark (3 inches); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark (3 inches)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 22-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 VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark (3 inches)). At the time of the report, VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark (3 inches)) 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain in extremity, Vaccination site pain
Clinical narrative: my stomach flip flop; twinge when I move my arm; Pain around injection site.; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (my stomach flip flop), PAIN IN EXTREMITY (twinge when I move my arm) and VACCINATION SITE PAIN (Pain around injection site.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Urinary tract disorder NOS and Macular degeneration. Concomitant products included ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION AREDS) for Macular degeneration, CRANBERRY [VACCINIUM MACROCARPON] for Urinary tract disorder NOS.    On 10-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 ABDOMINAL DISCOMFORT (my stomach flip flop), PAIN IN EXTREMITY (twinge when I move my arm) and VACCINATION SITE PAIN (Pain around injection site.). At the time of the report, ABDOMINAL DISCOMFORT (my stomach flip flop), PAIN IN EXTREMITY (twinge when I move my arm) and VACCINATION SITE PAIN (Pain around injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's concomitant medications included, blood pressure medication.  No corrective treatment was provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on her arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness on her arm). On 26-Feb-2021, VACCINATION SITE PAIN (Soreness on her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant Medication was provided. No treatment  was provided.  Description:25Feb2021 and 26Feb2021 she experienced soreness on her arm.   This case was linked to MOD-2021-100002 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 30 Apr 2021:Updated event outcome to resolved.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: after 3 days of the shot she had huge spot red, major area with redness and hives.; broke out in hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out in hives) and ERYTHEMA (after 3 days of the shot she had huge spot red, major area with redness and hives.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 URTICARIA (broke out in hives). On 07-Feb-2021, the patient experienced ERYTHEMA (after 3 days of the shot she had huge spot red, major area with redness and hives.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 07-Feb-2021 at a dose of 1 dosage form; PREDNISONE on 07-Feb-2021 at a dose of 1 dosage form and PEPTIDES NOS on 07-Feb-2021 at a dose of 1 dosage form. At the time of the report, URTICARIA (broke out in hives) and ERYTHEMA (after 3 days of the shot she had huge spot red, major area with redness and hives.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen  arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen  arm) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen  arm). At the time of the report, PERIPHERAL SWELLING (Swollen  arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: the arm was really tender; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (the arm was really tender) 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 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 TENDERNESS (the arm was really tender). At the time of the report, TENDERNESS (the arm was really tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling; body ache; Pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling), MYALGIA (body ache), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (Pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-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 24-Jan-2021, the patient experienced ARTHRALGIA (joint pain). On 24-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling), MYALGIA (body ache) and VACCINATION SITE PAIN (Pain). At the time of the report, VACCINATION SITE SWELLING (swelling), MYALGIA (body ache), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (Pain) outcome was unknown.            No concomitant medications were reported.   No corrective treatment was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity
Clinical narrative: Sore arm; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and NAUSEA (Nausea). The patient was treated with HYDROCODONE for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Pain in extremity
Clinical narrative: Dizziness; Arm Pain; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills) and NAUSEA (Nausea) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The consumer stated she believes it was a combination of the shot and the outside temperature as patient passed out when he went outside and again 3 hours later when he was in the house which prompted a call to emergency services.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-255280, MOD-2021-255280 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Event outcome for all the events were updated from unknown to resolved.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pyrexia
Clinical narrative: stomach ache; fever that peaked at 101.7°F; This spontaneous case was reported by a consumer and describes the occurrence of   in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with IBUPROFEN at an unspecified dose and frequency.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Pyrexia: 101.7 (High) Patient experienced 101.7 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years of age patient received the 1st dose of Moderna COVID-19 vaccine; A spontaneous report () was received from a nurse concerning a 17-years-old female patient, who received moderna's covid-19 vaccine (mrna-1273).  The patient's medical history included asthma. Concomitant medications reported included corticoid steroid inhalator for asthma.  On 30 JAN 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly in the left deltoid arm for prophylaxis of COVID-19 infection.  On 30 JAN 2021, the patient received mRNA-1273 vaccine when she was 17 years old. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was unknown.  The outcome of the event, vaccine administration at inappropriate age was unknown.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 012M20A) with no associated AEs reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Mydriasis, Periorbital swelling, Skin swelling, Swelling
Clinical narrative: little bit of swelling on her nose; glasses making imprint on her face; eyes were puffy; ears felt like when you are on the mountains and you need to pop them; difficulty reading; felt like her pupils were dilated; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (little bit of swelling on her nose), SKIN SWELLING (glasses making imprint on her face), PERIORBITAL SWELLING (eyes were puffy), EAR DISCOMFORT (ears felt like when you are on the mountains and you need to pop them) and VISION BLURRED (difficulty reading) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for Covid-19 Vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Severe reaction to Tamiflu).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced SWELLING (little bit of swelling on her nose), SKIN SWELLING (glasses making imprint on her face), PERIORBITAL SWELLING (eyes were puffy), EAR DISCOMFORT (ears felt like when you are on the mountains and you need to pop them), VISION BLURRED (difficulty reading) and MYDRIASIS (felt like her pupils were dilated). At the time of the report, SWELLING (little bit of swelling on her nose), SKIN SWELLING (glasses making imprint on her face), PERIORBITAL SWELLING (eyes were puffy), EAR DISCOMFORT (ears felt like when you are on the mountains and you need to pop them), VISION BLURRED (difficulty reading) and MYDRIASIS (felt like her pupils were dilated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-056424 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056424:Mother Case MOD21-047898
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: little bit of swelling on her nose; glasses making imprint on her face; eyes were puffy; ears felt like when you are on the mountains and you need to pop them; difficulty reading; felt like her pupils were dilated; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (little bit of swelling on her nose), SKIN SWELLING (glasses making imprint on her face), PERIORBITAL SWELLING (eyes were puffy), EAR DISCOMFORT (ears felt like when you are on the mountains and you need to pop them) and VISION BLURRED (difficulty reading) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for Covid-19 Vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Severe reaction to Tamiflu).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced SWELLING (little bit of swelling on her nose), SKIN SWELLING (glasses making imprint on her face), PERIORBITAL SWELLING (eyes were puffy), EAR DISCOMFORT (ears felt like when you are on the mountains and you need to pop them), VISION BLURRED (difficulty reading) and MYDRIASIS (felt like her pupils were dilated). At the time of the report, SWELLING (little bit of swelling on her nose), SKIN SWELLING (glasses making imprint on her face), PERIORBITAL SWELLING (eyes were puffy), EAR DISCOMFORT (ears felt like when you are on the mountains and you need to pop them), VISION BLURRED (difficulty reading) and MYDRIASIS (felt like her pupils were dilated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-056424 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056424:Mother Case MOD21-047898
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue, 48 hours later; Fever, lasted 3 days; Chills, 12 hours later; Headache, 12 hours later; Soreness in the injection arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Soreness in the injection arm), PYREXIA (Fever, lasted 3 days), CHILLS (Chills, 12 hours later), HEADACHE (Headache, 12 hours later) and FATIGUE (Fatigue, 48 hours later) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced VACCINATION SITE PAIN (Soreness in the injection arm). On 28-Dec-2020, the patient experienced PYREXIA (Fever, lasted 3 days). 28-Dec-2020, the patient experienced CHILLS (Chills, 12 hours later) and HEADACHE (Headache, 12 hours later). On 29-Dec-2020, the patient experienced FATIGUE (Fatigue, 48 hours later). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Soreness in the injection arm), PYREXIA (Fever, lasted 3 days), CHILLS (Chills, 12 hours later), HEADACHE (Headache, 12 hours later) and FATIGUE (Fatigue, 48 hours later) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, SARS-CoV-2 test: positive Positive. On 27-Dec-2020, Body temperature: 102.5 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Fatigue, 48 hours later; Fever, lasted 3 days; Chills, 12 hours later; Headache, 12 hours later; Soreness in the injection arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Soreness in the injection arm), PYREXIA (Fever, lasted 3 days), CHILLS (Chills, 12 hours later), HEADACHE (Headache, 12 hours later) and FATIGUE (Fatigue, 48 hours later) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced VACCINATION SITE PAIN (Soreness in the injection arm). On 28-Dec-2020, the patient experienced PYREXIA (Fever, lasted 3 days). 28-Dec-2020, the patient experienced CHILLS (Chills, 12 hours later) and HEADACHE (Headache, 12 hours later). On 29-Dec-2020, the patient experienced FATIGUE (Fatigue, 48 hours later). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Soreness in the injection arm), PYREXIA (Fever, lasted 3 days), CHILLS (Chills, 12 hours later), HEADACHE (Headache, 12 hours later) and FATIGUE (Fatigue, 48 hours later) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, SARS-CoV-2 test: positive Positive. On 27-Dec-2020, Body temperature: 102.5 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Neck pain
Clinical narrative: Neck Pain; Fatigue; Muscle Pain; Fever - Temperature of 102.0F; Headache; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck Pain), FATIGUE (Fatigue), MYALGIA (Muscle Pain), PYREXIA (Fever - Temperature of 102.0F) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blind (diagnosed as being Blind), Diabetes (has Diabetes) and Heart disorder (has different Heart Problems). Concomitant products included INSULIN DETEMIR (LEVEMIR) for Diabetes, CLONIDINE and HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN AND HYDROCHLOROTHIAZIDE) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced NECK PAIN (Neck Pain), FATIGUE (Fatigue), MYALGIA (Muscle Pain), PYREXIA (Fever - Temperature of 102.0F), HEADACHE (Headache) and ARTHRALGIA (Joint pain). On 11-Feb-2021, FATIGUE (Fatigue), MYALGIA (Muscle Pain), PYREXIA (Fever - Temperature of 102.0F) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, NECK PAIN (Neck Pain) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Pyrexia: 102 (High) 102.0F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In addition to above patient reported using Carzidol as concomitant medication. No treatment medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Neck Pain; Fatigue; Muscle Pain; Fever - Temperature of 102.0F; Headache; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck Pain), FATIGUE (Fatigue), MYALGIA (Muscle Pain), PYREXIA (Fever - Temperature of 102.0F) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blind (diagnosed as being Blind), Diabetes (has Diabetes) and Heart disorder (has different Heart Problems). Concomitant products included INSULIN DETEMIR (LEVEMIR) for Diabetes, CLONIDINE and HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN AND HYDROCHLOROTHIAZIDE) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced NECK PAIN (Neck Pain), FATIGUE (Fatigue), MYALGIA (Muscle Pain), PYREXIA (Fever - Temperature of 102.0F), HEADACHE (Headache) and ARTHRALGIA (Joint pain). On 11-Feb-2021, FATIGUE (Fatigue), MYALGIA (Muscle Pain), PYREXIA (Fever - Temperature of 102.0F) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, NECK PAIN (Neck Pain) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Pyrexia: 102 (High) 102.0F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In addition to above patient reported using Carzidol as concomitant medication. No treatment medications were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Sore arm; Light headed; Unable to raise his arm or open a bottle; Stiff arm with no strength in his arm; Fatigued; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Light headed), MUSCULAR WEAKNESS (Unable to raise his arm or open a bottle), MUSCULOSKELETAL STIFFNESS (Stiff arm with no strength in his arm) and FATIGUE (Fatigued) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 reported medical history).    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 (Sore arm), DIZZINESS (Light headed), MUSCULAR WEAKNESS (Unable to raise his arm or open a bottle), MUSCULOSKELETAL STIFFNESS (Stiff arm with no strength in his arm), FATIGUE (Fatigued) and HEADACHE (Headache). On 02-Mar-2021, DIZZINESS (Light headed), FATIGUE (Fatigued) and HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), MUSCULAR WEAKNESS (Unable to raise his arm or open a bottle) and MUSCULOSKELETAL STIFFNESS (Stiff arm with no strength in his arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; Light headed; Unable to raise his arm or open a bottle; Stiff arm with no strength in his arm; Fatigued; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Light headed), MUSCULAR WEAKNESS (Unable to raise his arm or open a bottle), MUSCULOSKELETAL STIFFNESS (Stiff arm with no strength in his arm) and FATIGUE (Fatigued) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 reported medical history).    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 (Sore arm), DIZZINESS (Light headed), MUSCULAR WEAKNESS (Unable to raise his arm or open a bottle), MUSCULOSKELETAL STIFFNESS (Stiff arm with no strength in his arm), FATIGUE (Fatigued) and HEADACHE (Headache). On 02-Mar-2021, DIZZINESS (Light headed), FATIGUE (Fatigued) and HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), MUSCULAR WEAKNESS (Unable to raise his arm or open a bottle) and MUSCULOSKELETAL STIFFNESS (Stiff arm with no strength in his arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Pruritus
Clinical narrative: rash around injection site - left arm; headache; chills; real tired; itchy around injection site - left arm; red around injection site - left arm; welts around injection site - left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash around injection site - left arm), HEADACHE (headache), CHILLS (chills), FATIGUE (real tired) and PRURITUS (itchy around injection site - left arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash around injection site - left arm), HEADACHE (headache), CHILLS (chills), FATIGUE (real tired), PRURITUS (itchy around injection site - left arm), ERYTHEMA (red around injection site - left arm) and URTICARIA (welts around injection site - left arm). At the time of the report, RASH (rash around injection site - left arm), HEADACHE (headache), CHILLS (chills), FATIGUE (real tired), PRURITUS (itchy around injection site - left arm), ERYTHEMA (red around injection site - left arm) and URTICARIA (welts around injection site - left 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 Concomitant medication were reported. Treatment medication was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash around injection site - left arm; headache; chills; real tired; itchy around injection site - left arm; red around injection site - left arm; welts around injection site - left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash around injection site - left arm), HEADACHE (headache), CHILLS (chills), FATIGUE (real tired) and PRURITUS (itchy around injection site - left arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash around injection site - left arm), HEADACHE (headache), CHILLS (chills), FATIGUE (real tired), PRURITUS (itchy around injection site - left arm), ERYTHEMA (red around injection site - left arm) and URTICARIA (welts around injection site - left arm). At the time of the report, RASH (rash around injection site - left arm), HEADACHE (headache), CHILLS (chills), FATIGUE (real tired), PRURITUS (itchy around injection site - left arm), ERYTHEMA (red around injection site - left arm) and URTICARIA (welts around injection site - left 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 Concomitant medication were reported. Treatment medication was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reaction) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION COMPLICATION (severe reaction). At the time of the report, VACCINATION COMPLICATION (severe reaction) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Lacrimation increased, Nasal congestion, Pain in extremity, Rhinorrhoea, Tremor
Clinical narrative: slipping nose; shaking in the body; eyes are watering; normal sore arm; congestion; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (slipping nose), TREMOR (shaking in the body), LACRIMATION INCREASED (eyes are watering), PAIN IN EXTREMITY (normal sore arm) and NASAL CONGESTION (congestion) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (slipping nose), TREMOR (shaking in the body), LACRIMATION INCREASED (eyes are watering), PAIN IN EXTREMITY (normal sore arm) and NASAL CONGESTION (congestion). At the time of the report, RHINORRHOEA (slipping nose), TREMOR (shaking in the body), LACRIMATION INCREASED (eyes are watering), PAIN IN EXTREMITY (normal sore arm) and NASAL CONGESTION (congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Urticaria
Clinical narrative: a lot of itching on her right wrist and Itching started on chin then through body; Itching and welts on her face; Arm is still sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (a lot of itching on her right wrist and Itching started on chin then through body), URTICARIA (Itching and welts on her face) and PAIN IN EXTREMITY (Arm is still sore) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (a lot of itching on her right wrist and Itching started on chin then through body), URTICARIA (Itching and welts on her face) and PAIN IN EXTREMITY (Arm is still sore). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BANOPHEN) at a dose of 25 milligram. At the time of the report, PRURITUS (a lot of itching on her right wrist and Itching started on chin then through body) and URTICARIA (Itching and welts on her face) was resolving and PAIN IN EXTREMITY (Arm is still sore) 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 information was not reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Periorbital swelling, Sinus headache, Swelling of eyelid
Clinical narrative: puffy left side; eyes hurting; sinus headaches; eyelids swollen and hurting behind her eyes; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL SWELLING (puffy left side), EYE PAIN (eyes hurting), SINUS HEADACHE (sinus headaches) and SWELLING OF EYELID (eyelids swollen and hurting behind her eyes) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIORBITAL SWELLING (puffy left side), EYE PAIN (eyes hurting), SINUS HEADACHE (sinus headaches) and SWELLING OF EYELID (eyelids swollen and hurting behind her eyes). At the time of the report, PERIORBITAL SWELLING (puffy left side), EYE PAIN (eyes hurting), SINUS HEADACHE (sinus headaches) and SWELLING OF EYELID (eyelids swollen and hurting behind her eyes) outcome was unknown.            No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (Achy). At the time of the report, PAIN (Achy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Follow-up received on 13-jun-2021 and does not have any new information
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Flushing, Heart rate, Pyrexia, Rash
Clinical narrative: rash all over trunk; patient experienced 101 F. fever; chills; flushing; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flushing), RASH (rash all over trunk), PYREXIA (patient experienced 101 F. fever) and CHILLS (chills) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced FLUSHING (flushing), PYREXIA (patient experienced 101 F. fever) and CHILLS (chills). On 12-Feb-2021, the patient experienced RASH (rash all over trunk). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FLUSHING (flushing), RASH (rash all over trunk), PYREXIA (patient experienced 101 F. fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Heart rate: elevated (Inconclusive) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.