chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nasopharyngitis, Pain in extremity, Peripheral swelling
Clinical narrative: has a bump in her left arm; had diarrhea; 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 care professional and describes the occurrence of PAIN IN EXTREMITY (sore left arm that went all the way to the neck), NASOPHARYNGITIS (Had some cold), PERIPHERAL SWELLING (has a bump in her left arm), DIARRHOEA (had diarrhea) and FATIGUE (felt tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Back pain and Cholesterol. Concurrent medical conditions included Diabetes.    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 PERIPHERAL SWELLING (has a bump in her left arm) and DIARRHOEA (had diarrhea). On 28-Jan-2021, PAIN IN EXTREMITY (sore left arm that went all the way to the neck) outcome was unknown. At the time of the report, NASOPHARYNGITIS (Had some cold), PERIPHERAL SWELLING (has a bump in her left arm), DIARRHOEA (had diarrhea) and FATIGUE (felt tired) 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.
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Vaccination complication
Clinical narrative: Had Side Effects; Having a hard time urinating; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had Side Effects) and DYSURIA (Having a hard time urinating) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DYSURIA (Having a hard time urinating). On an unknown date, the patient experienced VACCINATION COMPLICATION (Had Side Effects). At the time of the report, VACCINATION COMPLICATION (Had Side Effects) and DYSURIA (Having a hard time urinating) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: No specific follow-up information recorded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash on the stomach/ rash all over chest, arms, thighs/ rashes keep on going away and coming back; hives all over stomach; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (hives all over stomach) and RASH (Rash on the stomach/ rash all over chest, arms, thighs/ rashes keep on going away and coming back) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ORAL CONTRACEPTIVE NOS for Birth control pill, BROMOCRIPTINE for an unknown indication.    On 17-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 URTICARIA (hives all over stomach). On an unknown date, the patient experienced RASH (Rash on the stomach/ rash all over chest, arms, thighs/ rashes keep on going away and coming back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC HIVES RELIEF) for Hives, at a dose of UNK, q12h. At the time of the report, URTICARIA (hives all over stomach) and RASH (Rash on the stomach/ rash all over chest, arms, thighs/ rashes keep on going away and coming back) 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore from 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore from 1st vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 PAIN IN EXTREMITY (Arm was sore from 1st vaccine). At the time of the report, PAIN IN EXTREMITY (Arm was sore from 1st vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information was provided. Conmeds were not provided.    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Pain
Clinical narrative: Muscle spams in both low legs; Painful legs, goes up and down; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle spams in both low legs) and PAIN (Painful legs, goes up and down) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced MUSCLE SPASMS (Muscle spams in both low legs) and PAIN (Painful legs, goes up and down). At the time of the report, MUSCLE SPASMS (Muscle spams in both low legs) and PAIN (Painful legs, goes up and down) 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: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011I20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Dyslipidemia.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, COVID-19: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: addt'l info uploaded
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: positive test, came down with the COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive test, came down with the COVID) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced COVID-19 (positive test, came down with the COVID). At the time of the report, COVID-19 (positive test, came down with the COVID) 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 concomitants or treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Coughing; Headaches; Feverish feeling; Nausea; Muscle pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COUGH (Coughing), HEADACHE (Headaches), PYREXIA (Feverish feeling), NAUSEA (Nausea) and MYALGIA (Muscle pain) 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 COUGH (Coughing), HEADACHE (Headaches), PYREXIA (Feverish feeling), NAUSEA (Nausea) and MYALGIA (Muscle pain). At the time of the report, COUGH (Coughing), HEADACHE (Headaches), PYREXIA (Feverish feeling), NAUSEA (Nausea) and MYALGIA (Muscle pain) 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Pain in extremity, Swelling
Clinical narrative: Arm was hurting; Both armpits and breasts were swollen; Breasts were tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting), SWELLING (Both armpits and breasts were swollen) and BREAST TENDERNESS (Breasts were tender) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was hurting), SWELLING (Both armpits and breasts were swollen) and BREAST TENDERNESS (Breasts were tender). At the time of the report, PAIN IN EXTREMITY (Arm was hurting), SWELLING (Both armpits and breasts were swollen) and BREAST TENDERNESS (Breasts were tender) 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.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Balance disorder, Chills, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: sore left arm; stiff left arm, stiff neck; muscle spasm all over the body inlcuding his stomach muscle was contracting; stomach upset; blurry eyes; could not keep his balance; chills (no fever); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), MUSCULOSKELETAL STIFFNESS (stiff left arm, stiff neck), MUSCLE SPASMS (muscle spasm all over the body inlcuding his stomach muscle was contracting), ABDOMINAL DISCOMFORT (stomach upset) and VISION BLURRED (blurry eyes) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), MUSCULOSKELETAL STIFFNESS (stiff left arm, stiff neck), MUSCLE SPASMS (muscle spasm all over the body inlcuding his stomach muscle was contracting), ABDOMINAL DISCOMFORT (stomach upset), VISION BLURRED (blurry eyes), BALANCE DISORDER (could not keep his balance) and CHILLS (chills (no fever)). On 21-Feb-2021, PAIN IN EXTREMITY (sore left arm), MUSCULOSKELETAL STIFFNESS (stiff left arm, stiff neck), MUSCLE SPASMS (muscle spasm all over the body inlcuding his stomach muscle was contracting), ABDOMINAL DISCOMFORT (stomach upset), VISION BLURRED (blurry eyes), BALANCE DISORDER (could not keep his balance) and CHILLS (chills (no fever)) had 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.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vision blurred
Clinical narrative: sore left arm; stiff left arm, stiff neck; muscle spasm all over the body inlcuding his stomach muscle was contracting; stomach upset; blurry eyes; could not keep his balance; chills (no fever); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), MUSCULOSKELETAL STIFFNESS (stiff left arm, stiff neck), MUSCLE SPASMS (muscle spasm all over the body inlcuding his stomach muscle was contracting), ABDOMINAL DISCOMFORT (stomach upset) and VISION BLURRED (blurry eyes) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), MUSCULOSKELETAL STIFFNESS (stiff left arm, stiff neck), MUSCLE SPASMS (muscle spasm all over the body inlcuding his stomach muscle was contracting), ABDOMINAL DISCOMFORT (stomach upset), VISION BLURRED (blurry eyes), BALANCE DISORDER (could not keep his balance) and CHILLS (chills (no fever)). On 21-Feb-2021, PAIN IN EXTREMITY (sore left arm), MUSCULOSKELETAL STIFFNESS (stiff left arm, stiff neck), MUSCLE SPASMS (muscle spasm all over the body inlcuding his stomach muscle was contracting), ABDOMINAL DISCOMFORT (stomach upset), VISION BLURRED (blurry eyes), BALANCE DISORDER (could not keep his balance) and CHILLS (chills (no fever)) had 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.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain upper, Diarrhoea, Headache
Clinical narrative: brick in her stomach; headache; very sore arm; severe stomach cramps; vomited; diarrhea; stomach ache; A spontaneous report was received from a concerning female patient of 68 years old, who was administered with Moderna's COVID-19 vaccine for prophylaxis of COVID-19 infection.  On 22-FEB-2021, the patient was administered with a first dose of mRNA-1273 vaccine. The patient's medical history was allergies as provided.  Concomitant medications were not provided.  The adverse events such as headache, very sore arm, stomach pain and vomiting were experienced on 19-FEB-2021.On 20-FEB-2021, patient felt diarrhea all day and was recovered on the same day.  The treatment for the adverse event were: For the symptoms: Kaopectate for the stomach symptoms and Advil for the headache. Other: Vascepa, Prozac, Synthroid, Trazodone, Seroquel, baby Aspirin and Effient, provided by the patient.  Action taken with the dose of mRNA-1273 vaccine was not reported. Consent to follow up from safety was provided by the patient.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: brick in her stomach; headache; very sore arm; severe stomach cramps; vomited; diarrhea; stomach ache; A spontaneous report was received from a concerning female patient of 68 years old, who was administered with Moderna's COVID-19 vaccine for prophylaxis of COVID-19 infection.  On 22-FEB-2021, the patient was administered with a first dose of mRNA-1273 vaccine. The patient's medical history was allergies as provided.  Concomitant medications were not provided.  The adverse events such as headache, very sore arm, stomach pain and vomiting were experienced on 19-FEB-2021.On 20-FEB-2021, patient felt diarrhea all day and was recovered on the same day.  The treatment for the adverse event were: For the symptoms: Kaopectate for the stomach symptoms and Advil for the headache. Other: Vascepa, Prozac, Synthroid, Trazodone, Seroquel, baby Aspirin and Effient, provided by the patient.  Action taken with the dose of mRNA-1273 vaccine was not reported. Consent to follow up from safety was provided by the patient.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    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 HEADACHE (severe headache). At the time of the report, HEADACHE (severe headache) 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.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Amnesia
Clinical narrative: short term memory loss; lost sense of taste; A spontaneous report was received from a concerning male patient of 67 years old, who was administered with Moderna's COVID-19 vaccine for prophylaxis of COVID-19 infection. On 18-FEB-2021, patient received the first dose of mRNA-1273 vaccine. The patient's medical history was not provided.  Concomitant medications were not provided by the patient.  Patient experienced the adverse event such as short term memory loss, lost sense of taste and stated that these events were not reported prior to the vaccine administration.  The treatment for the adverse events was not provided by the patient.  Action taken with the dose of mRNA-1273 vaccine was not reported. Consent to follow up from safety was provided by the patient.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full body Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Full body Rash) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history reported by the reporter.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced RASH (Full body Rash). At the time of the report, RASH (Full body Rash) outcome was unknown. Not Provided          Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Non-significant follow-up received on 20-Apr-2021, appended in the case on 27-Apr-2021.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red itchy patch around the injection site; Red itchy patch around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Red itchy patch around the injection site) and VACCINATION SITE ERYTHEMA (Red itchy patch around the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L70A) for COVID-19 vaccination.     Concomitant products included ACYCLOVIR [ACICLOVIR] and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 20-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 VACCINATION SITE ERYTHEMA (Red itchy patch around the injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Red itchy patch around the injection site). At the time of the report, VACCINATION SITE PRURITUS (Red itchy patch around the injection site) and VACCINATION SITE ERYTHEMA (Red itchy patch around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pruritus, Rash
Clinical narrative: Rash; Itch; hurt arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (hurt arm), RASH (Rash) and PRURITUS (Itch) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced LIMB DISCOMFORT (hurt arm). On 17-Feb-2021, the patient experienced RASH (Rash) and PRURITUS (Itch). At the time of the report, LIMB DISCOMFORT (hurt arm), RASH (Rash) and PRURITUS (Itch) 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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate, Heart rate increased, Nausea
Clinical narrative: heartrate 90-100 bpm; fever; chills; arm hurts; nausea; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (heartrate 90-100 bpm), PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (arm hurts) and NAUSEA (nausea) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021 at 1:00 PM, 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 an unknown date, the patient experienced HEART RATE INCREASED (heartrate 90-100 bpm), PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (arm hurts) and NAUSEA (nausea). At the time of the report, HEART RATE INCREASED (heartrate 90-100 bpm), PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (arm hurts) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 f 102 F. On an unknown date, Heart rate: 90-100 90-100 beats per minute.     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.   The patient was taking beta blocker for her heart.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: heartrate 90-100 bpm; fever; chills; arm hurts; nausea; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (heartrate 90-100 bpm), PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (arm hurts) and NAUSEA (nausea) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021 at 1:00 PM, 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 an unknown date, the patient experienced HEART RATE INCREASED (heartrate 90-100 bpm), PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (arm hurts) and NAUSEA (nausea). At the time of the report, HEART RATE INCREASED (heartrate 90-100 bpm), PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (arm hurts) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 f 102 F. On an unknown date, Heart rate: 90-100 90-100 beats per minute.     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.   The patient was taking beta blocker for her heart.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash
Clinical narrative: Hands are always tingling; Rash, pretty much every where except face and legs; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Hands are always tingling) and RASH (Rash, pretty much every where except face and legs) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE and IRBESARTAN for an unknown indication.   On 20-Jan-2021, 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 16-Feb-2021, the patient experienced PARAESTHESIA (Hands are always tingling) and RASH (Rash, pretty much every where except face and legs). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Hands are always tingling) and RASH (Rash, pretty much every where except face and legs) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-043765 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-043765:Same patient, 1st dose
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain in extremity
Clinical narrative: little sore right arm; stomach quizzing, did not threw up; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (little sore right arm) and ABDOMINAL DISCOMFORT (stomach quizzing, did not threw up) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (little sore right arm) and ABDOMINAL DISCOMFORT (stomach quizzing, did not threw up). On 12-Feb-2021, PAIN IN EXTREMITY (little sore right arm) and ABDOMINAL DISCOMFORT (stomach quizzing, did not threw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: warm; Rash at the injection site; Itching at the injection site; a little bit swollen; Redness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE WARMTH (warm), INJECTION SITE RASH (Rash at the injection site), INJECTION SITE PRURITUS (Itching at the injection site), INJECTION SITE SWELLING (a little bit swollen) and INJECTION SITE ERYTHEMA (Redness at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM, CALCIUM and CLONAZEPAM (CLONAPAM) 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 24-Jan-2021, the patient experienced INJECTION SITE WARMTH (warm), INJECTION SITE RASH (Rash at the injection site), INJECTION SITE PRURITUS (Itching at the injection site), INJECTION SITE SWELLING (a little bit swollen) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, INJECTION SITE WARMTH (warm), INJECTION SITE RASH (Rash at the injection site), INJECTION SITE PRURITUS (Itching at the injection site), INJECTION SITE SWELLING (a little bit swollen) and INJECTION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pyrexia
Clinical narrative: Uncontrollable cough; Fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Uncontrollable cough) and PYREXIA (Fever of 101) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Bronchial asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), LOSARTAN and METFORMIN for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced COUGH (Uncontrollable cough) and PYREXIA (Fever of 101). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and OXYMETAZOLINE HYDROCHLORIDE (CORICIDIN [OXYMETAZOLINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Uncontrollable cough) and PYREXIA (Fever of 101) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: 101 f 101 F.     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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Sore arm/arm was really hurting; Swollen arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm/arm was really hurting), PERIPHERAL SWELLING (Swollen arm) and FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm/arm was really hurting), PERIPHERAL SWELLING (Swollen arm) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm/arm was really hurting), PERIPHERAL SWELLING (Swollen arm) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Heart rate increased, Pain in extremity, Paraesthesia
Clinical narrative: Thirsty; Tired; little tingling on my left cheek (face); Runny nose; Felt like a stab in my calf; R arm tingling; Upset stomach; Increased HR; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (little tingling on my left cheek (face)), RHINORRHOEA (Runny nose), PAIN IN EXTREMITY (Felt like a stab in my calf), PARAESTHESIA (R arm tingling) and ABDOMINAL DISCOMFORT (Upset stomach) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-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 PARAESTHESIA (little tingling on my left cheek (face)), RHINORRHOEA (Runny nose), PAIN IN EXTREMITY (Felt like a stab in my calf), PARAESTHESIA (R arm tingling), ABDOMINAL DISCOMFORT (Upset stomach), HEART RATE INCREASED (Increased HR), THIRST (Thirsty) and FATIGUE (Tired). On 31-Jan-2021, PARAESTHESIA (little tingling on my left cheek (face)), RHINORRHOEA (Runny nose), PAIN IN EXTREMITY (Felt like a stab in my calf), PARAESTHESIA (R arm tingling), ABDOMINAL DISCOMFORT (Upset stomach), HEART RATE INCREASED (Increased HR) and FATIGUE (Tired) had resolved. At the time of the report, THIRST (Thirsty) was resolving.        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.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Thirst
Clinical narrative: Thirsty; Tired; little tingling on my left cheek (face); Runny nose; Felt like a stab in my calf; R arm tingling; Upset stomach; Increased HR; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (little tingling on my left cheek (face)), RHINORRHOEA (Runny nose), PAIN IN EXTREMITY (Felt like a stab in my calf), PARAESTHESIA (R arm tingling) and ABDOMINAL DISCOMFORT (Upset stomach) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-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 PARAESTHESIA (little tingling on my left cheek (face)), RHINORRHOEA (Runny nose), PAIN IN EXTREMITY (Felt like a stab in my calf), PARAESTHESIA (R arm tingling), ABDOMINAL DISCOMFORT (Upset stomach), HEART RATE INCREASED (Increased HR), THIRST (Thirsty) and FATIGUE (Tired). On 31-Jan-2021, PARAESTHESIA (little tingling on my left cheek (face)), RHINORRHOEA (Runny nose), PAIN IN EXTREMITY (Felt like a stab in my calf), PARAESTHESIA (R arm tingling), ABDOMINAL DISCOMFORT (Upset stomach), HEART RATE INCREASED (Increased HR) and FATIGUE (Tired) had resolved. At the time of the report, THIRST (Thirsty) was resolving.        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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash papular
Clinical narrative: Arm had a reaction with big swelling; it's still red and itchy; it's still red and itchy; Bumps in arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm had a reaction with big swelling), ERYTHEMA (it's still red and itchy), PRURITUS (it's still red and itchy) and RASH PAPULAR (Bumps in arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0121A0A/ 012NE0A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm had a reaction with big swelling), ERYTHEMA (it's still red and itchy), PRURITUS (it's still red and itchy) and RASH PAPULAR (Bumps in arm). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm had a reaction with big swelling), ERYTHEMA (it's still red and itchy) and PRURITUS (it's still red and itchy) was resolving and RASH PAPULAR (Bumps in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site rash
Clinical narrative: Rash at injection site that grew to between 6-7 inches in diameter; Pain in the arm; Swelling in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), PERIPHERAL SWELLING (Swelling in the arm) and VACCINATION SITE RASH (Rash at injection site that grew to between 6-7 inches in diameter) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm) and PERIPHERAL SWELLING (Swelling in the arm). On 19-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at injection site that grew to between 6-7 inches in diameter). At the time of the report, PAIN IN EXTREMITY (Pain in the arm), PERIPHERAL SWELLING (Swelling in the arm) and VACCINATION SITE RASH (Rash at injection site that grew to between 6-7 inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: fevers higher than usual; Muscle pain; Fatigue; Body aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), PYREXIA (fevers higher than usual), MYALGIA (Muscle pain) and FATIGUE (Fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, 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 17-Feb-2021, the patient experienced PAIN (Body aches), MYALGIA (Muscle pain) and FATIGUE (Fatigue). On an unknown date, the patient experienced PYREXIA (fevers higher than usual). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Feb-2021, PAIN (Body aches), MYALGIA (Muscle pain) and FATIGUE (Fatigue) had resolved. At the time of the report, PYREXIA (fevers higher than usual) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; Painful Arm (Injection Site); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VACCINATION SITE PAIN (Painful Arm (Injection Site)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for an unknown indication.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Painful Arm (Injection Site)). At the time of the report, HEADACHE (Headache) and VACCINATION SITE PAIN (Painful Arm (Injection Site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pruritus, Injection site rash, Pruritus, Rash
Clinical narrative: rash on her arm; itches; Knot on the injection site; Itchiness in knot; rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Knot on the injection site), INJECTION SITE PRURITUS (Itchiness in knot) and INJECTION SITE RASH (rash on the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE MASS (Knot on the injection site), INJECTION SITE PRURITUS (Itchiness in knot) and INJECTION SITE RASH (rash on the injection site). At the time of the report, INJECTION SITE MASS (Knot on the injection site), INJECTION SITE PRURITUS (Itchiness in knot) and INJECTION SITE RASH (rash on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Feb-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Stomatitis, Swollen tongue, Tongue coated
Clinical narrative: Tongue had a white coating; Red spots in mouth; Tongue is swollen; This spontaneous case was reported by a consumer and describes the occurrence of   in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment of the event was not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dysphonia, Erythema, Full blood count, Hypoaesthesia oral
Clinical narrative: Face was pretty red; throat started to tighten; (throat) feeling really scratchy; started to lose voice; inside of my mouth and my lips started getting tangly; (inside of my mouth and my lips) prickly, (inside of my mouth and my lips) non-feeling; vaccination reaction; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Face was pretty red), THROAT TIGHTNESS (throat started to tighten), THROAT IRRITATION ((throat) feeling really scratchy), DYSPHONIA (started to lose voice) and STOMATITIS (inside of my mouth and my lips started getting tangly) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy and Allergy (allergic to preservatives).    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced ERYTHEMA (Face was pretty red), THROAT TIGHTNESS (throat started to tighten), THROAT IRRITATION ((throat) feeling really scratchy), DYSPHONIA (started to lose voice), STOMATITIS (inside of my mouth and my lips started getting tangly), HYPOAESTHESIA ORAL ((inside of my mouth and my lips) prickly, (inside of my mouth and my lips) non-feeling) and VACCINATION SITE REACTION (vaccination reaction). The patient was treated with EPINEPHRINE at a dose of half dose. At the time of the report, ERYTHEMA (Face was pretty red), THROAT TIGHTNESS (throat started to tighten), THROAT IRRITATION ((throat) feeling really scratchy), DYSPHONIA (started to lose voice), STOMATITIS (inside of my mouth and my lips started getting tangly), HYPOAESTHESIA ORAL ((inside of my mouth and my lips) prickly, (inside of my mouth and my lips) non-feeling) and VACCINATION SITE REACTION (vaccination reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal. On an unknown date, Full blood count: normal. On an unknown date, Oxygen saturation: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Doctor recommends not to get the second dose and to contact primary doctor and go to an allergist specialist.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Non-significant Follow up- Contact information updated