chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Lost sense of taste and smell; Lost sense of taste and smell; Diarrhea; Coughing; Coughing; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Lost sense of taste and smell), AGEUSIA (Lost sense of taste and smell), DIARRHOEA (Diarrhea), COUGH (Coughing) and PYREXIA (Coughing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), COUGH (Coughing), PYREXIA (Coughing) and FATIGUE (Fatigue). On 14-Mar-2021, the patient experienced ANOSMIA (Lost sense of taste and smell) and AGEUSIA (Lost sense of taste and smell). At the time of the report, ANOSMIA (Lost sense of taste and smell), AGEUSIA (Lost sense of taste and smell), DIARRHOEA (Diarrhea), COUGH (Coughing), PYREXIA (Coughing) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment drugs included no concomitant drugs included   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Significant Followup Appended
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pain, Pyrexia, Vaccination site movement impairment
Clinical narrative: Body ache; Fever; Difficulty to move the arm; Pulsating pain moving down to my finger tip and then to my neck; Injection site muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty to move the arm), PAIN (Pulsating pain moving down to my finger tip and then to my neck), INJECTION SITE PAIN (Injection site muscle pain), MYALGIA (Body ache) and PYREXIA (Fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 012M20A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.   On 11-Mar-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 11-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty to move the arm), PAIN (Pulsating pain moving down to my finger tip and then to my neck) and INJECTION SITE PAIN (Injection site muscle pain). On 12-Mar-2021, the patient experienced MYALGIA (Body ache) and PYREXIA (Fever). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty to move the arm), PAIN (Pulsating pain moving down to my finger tip and then to my neck), INJECTION SITE PAIN (Injection site muscle pain), MYALGIA (Body ache) and PYREXIA (Fever) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-044110 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Injection site pain
Clinical narrative: Painful stomach cramping; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Painful stomach cramping) and INJECTION SITE PAIN (Injection site soreness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FISH OIL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site soreness). On 14-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Painful stomach cramping). On 12-Mar-2021, INJECTION SITE PAIN (Injection site soreness) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Painful stomach cramping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications included activated charcoal. No laboratory details were  provided.  No treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain in extremity
Clinical narrative: Chronic cough; soreness of left arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Chronic cough) and PAIN IN EXTREMITY (soreness of left arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-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 COUGH (Chronic cough) and PAIN IN EXTREMITY (soreness of left arm). At the time of the report, COUGH (Chronic cough) and PAIN IN EXTREMITY (soreness of left arm) outcome was unknown. Not Provided          The patient had chronic cough ever since a day or two after second dose.  The patient had used unspecified medication for treatment of cough.   Action taken with mRNA-1273 in response to the events was not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Coordination abnormal, Cough, Feeling abnormal, Myalgia, Pain in extremity
Clinical narrative: non stop coughing; pain in left arm, pain traveling down down the arm to her hand; brain fog; very uncoordinated; aches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (non stop coughing), PAIN IN EXTREMITY (pain in left arm, pain traveling down down the arm to her hand), FEELING ABNORMAL (brain fog), COORDINATION ABNORMAL (very uncoordinated) and MYALGIA (aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CARBIDOPA, LEVODOPA (LEVODOPA + CARBIDOPA FAIRMED), CLONIDINE, LEVOTHYROXINE SODIUM (LEVOXYL) and FAMOTIDINE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced COUGH (non stop coughing), PAIN IN EXTREMITY (pain in left arm, pain traveling down down the arm to her hand), FEELING ABNORMAL (brain fog), COORDINATION ABNORMAL (very uncoordinated) and MYALGIA (aches). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency; BENZONATATE (TESSALON PERLE) at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; GUAIFENESIN (MUCINEX) at an unspecified dose and frequency and SALBUTAMOL (ALBUTEROL HFA) at an unspecified dose and frequency. On 12-Mar-2021, PAIN IN EXTREMITY (pain in left arm, pain traveling down down the arm to her hand), FEELING ABNORMAL (brain fog), COORDINATION ABNORMAL (very uncoordinated) and MYALGIA (aches) had resolved. At the time of the report, COUGH (non stop coughing) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Vaccination complication
Clinical narrative: feelin like she just needed to go to bed, feeling like "someone pulled all my stuffing out",; no energy; severe headache for 24 hours; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feelin like she just needed to go to bed, feeling like "someone pulled all my stuffing out",), ASTHENIA (no energy), HEADACHE (severe headache for 24 hours) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL HYDROCHLORIDE (INDERAL) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION COMPLICATION (feelin like she just needed to go to bed, feeling like "someone pulled all my stuffing out",). 12-Mar-2021, the patient experienced ASTHENIA (no energy), HEADACHE (severe headache for 24 hours) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 13-Mar-2021, HEADACHE (severe headache for 24 hours) had resolved. On 14-Mar-2021, VACCINATION COMPLICATION (feelin like she just needed to go to bed, feeling like "someone pulled all my stuffing out",), ASTHENIA (no energy) and FATIGUE (Fatigue) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: At the injection location on her arm it feels quite warm to the touch . More hot. Started date : 11MAR2021; The injection site also itches Started; Last 5 days she has an ongoing rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Last 5 days she has an ongoing rash), VACCINATION SITE WARMTH (At the injection location on her arm it feels quite warm to the touch . More hot. Started date : 11MAR2021) and VACCINATION SITE PRURITUS (The injection site also itches Started) in an 80-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 300042722) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced RASH (Last 5 days she has an ongoing rash). On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (The injection site also itches Started). On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (At the injection location on her arm it feels quite warm to the touch . More hot. Started date : 11MAR2021). At the time of the report, RASH (Last 5 days she has an ongoing rash), VACCINATION SITE WARMTH (At the injection location on her arm it feels quite warm to the touch . More hot. Started date : 11MAR2021) and VACCINATION SITE PRURITUS (The injection site also itches Started) outcome was unknown.        The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feel really ill after the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE. At the time of the report, MALAISE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Depressed mood, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: Arm was a little sore; No appetite; Cannot do anything; A terrible feeling; Feeling more tired/ very very tired; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore), DECREASED APPETITE (No appetite), DEPRESSED MOOD (Cannot do anything), FEELING ABNORMAL (A terrible feeling) and FATIGUE (Feeling more tired/ very very tired) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 0I5M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ALPRAZOLAM (XANAX) and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore), DECREASED APPETITE (No appetite), DEPRESSED MOOD (Cannot do anything), FEELING ABNORMAL (A terrible feeling) and FATIGUE (Feeling more tired/ very very tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm was a little sore), DECREASED APPETITE (No appetite), DEPRESSED MOOD (Cannot do anything), FEELING ABNORMAL (A terrible feeling) and FATIGUE (Feeling more tired/ very very tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taking an unspecified high blood pressure medication.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: hives; allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and HYPERSENSITIVITY (allergic reaction) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Thyroid cancer.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 12-Mar-2021, the patient experienced URTICARIA (hives) and HYPERSENSITIVITY (allergic reaction). At the time of the report, URTICARIA (hives) and HYPERSENSITIVITY (allergic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.      Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (did some suffer from vertigo but unsure if its coming back with being dizzy) and DIZZINESS (at night in bed when she turns she gets dizzy) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Vertigo. Concomitant products included MELATONIN for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VERTIGO (did some suffer from vertigo but unsure if its coming back with being dizzy) and DIZZINESS (at night in bed when she turns she gets dizzy). At the time of the report, VERTIGO (did some suffer from vertigo but unsure if its coming back with being dizzy) and DIZZINESS (at night in bed when she turns she gets dizzy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Concomitant products includes Afib medication, BP medications too.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: soreness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (soreness) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 07-Mar-2021, PAIN (soreness) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-044142, MOD-2021-044135 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: stool had a weird strong odor; urine had a weird strong odor; induration at injection site; Itchy at injection site; swollen at the injection site; sore at the injection site; red at injection site; fatigue; headache; This spontaneous case was reported by a nurse and describes the occurrence of ABNORMAL FAECES (stool had a weird strong odor), URINE ODOUR ABNORMAL (urine had a weird strong odor), INJECTION SITE INDURATION (induration at injection site), INJECTION SITE PRURITUS (Itchy at injection site) and INJECTION SITE SWELLING (swollen at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asymptomatic COVID-19 in September 2020.    On 26-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 INJECTION SITE INDURATION (induration at injection site), INJECTION SITE PRURITUS (Itchy at injection site), INJECTION SITE SWELLING (swollen at the injection site), INJECTION SITE PAIN (sore at the injection site), INJECTION SITE ERYTHEMA (red at injection site), FATIGUE (fatigue) and HEADACHE (headache). On 28-Feb-2021, the patient experienced ABNORMAL FAECES (stool had a weird strong odor) and URINE ODOUR ABNORMAL (urine had a weird strong odor). On 01-Mar-2021, INJECTION SITE INDURATION (induration at injection site), INJECTION SITE PRURITUS (Itchy at injection site), INJECTION SITE SWELLING (swollen at the injection site), INJECTION SITE PAIN (sore at the injection site), INJECTION SITE ERYTHEMA (red at injection site), FATIGUE (fatigue) and HEADACHE (headache) had resolved. At the time of the report, ABNORMAL FAECES (stool had a weird strong odor) and URINE ODOUR ABNORMAL (urine had a weird strong odor) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 antibody test positive: positve (Positive) Positive by IgG antibody test. In January 2021, SARS-CoV-2 antibody test positive: negative (Negative) Negative by IgG antibody test.     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 product use was not provided.  The patient reported that she had not eaten anything new or taken any new medication since the vaccine. Treatment for headache, fatigue, and swollen, induration, sore, itchy, and red at injection site included paracetamol and ice at the injection site.   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, SARS-CoV-2 antibody test positive, Urine odour abnormal
Clinical narrative: stool had a weird strong odor; urine had a weird strong odor; induration at injection site; Itchy at injection site; swollen at the injection site; sore at the injection site; red at injection site; fatigue; headache; This spontaneous case was reported by a nurse and describes the occurrence of ABNORMAL FAECES (stool had a weird strong odor), URINE ODOUR ABNORMAL (urine had a weird strong odor), INJECTION SITE INDURATION (induration at injection site), INJECTION SITE PRURITUS (Itchy at injection site) and INJECTION SITE SWELLING (swollen at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asymptomatic COVID-19 in September 2020.    On 26-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 INJECTION SITE INDURATION (induration at injection site), INJECTION SITE PRURITUS (Itchy at injection site), INJECTION SITE SWELLING (swollen at the injection site), INJECTION SITE PAIN (sore at the injection site), INJECTION SITE ERYTHEMA (red at injection site), FATIGUE (fatigue) and HEADACHE (headache). On 28-Feb-2021, the patient experienced ABNORMAL FAECES (stool had a weird strong odor) and URINE ODOUR ABNORMAL (urine had a weird strong odor). On 01-Mar-2021, INJECTION SITE INDURATION (induration at injection site), INJECTION SITE PRURITUS (Itchy at injection site), INJECTION SITE SWELLING (swollen at the injection site), INJECTION SITE PAIN (sore at the injection site), INJECTION SITE ERYTHEMA (red at injection site), FATIGUE (fatigue) and HEADACHE (headache) had resolved. At the time of the report, ABNORMAL FAECES (stool had a weird strong odor) and URINE ODOUR ABNORMAL (urine had a weird strong odor) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 antibody test positive: positve (Positive) Positive by IgG antibody test. In January 2021, SARS-CoV-2 antibody test positive: negative (Negative) Negative by IgG antibody test.     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 product use was not provided.  The patient reported that she had not eaten anything new or taken any new medication since the vaccine. Treatment for headache, fatigue, and swollen, induration, sore, itchy, and red at injection site included paracetamol and ice at the injection site.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: Flu like symptoms; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and HEADACHE (Headache) had resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-May-2021 and included significant information Outcome of all the events were updated to resolved.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea that is not going away; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea that is not going away) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced NAUSEA (Nausea that is not going away). At the time of the report, NAUSEA (Nausea that is not going away) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive after first dose) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced COVID-19 (tested positive after first dose). At the time of the report, COVID-19 (tested positive after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, SARS-CoV-2 test: positive (Positive) tested covid-19 positive on 06'march..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-044057, MOD-2021-046748 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Malaise, Pyrexia, Rash
Clinical narrative: Not feeling well; Face feel hot; Rash; Fever with high temperature; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), FEELING HOT (Face feel hot), RASH (Rash) and PYREXIA (Fever with high temperature) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     no medical history was provided by reporter.  Concomitant products included ANASTROZOLE for an unknown indication.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Mar-2021, the patient experienced PYREXIA (Fever with high temperature). On 15-Mar-2021, the patient experienced MALAISE (Not feeling well), FEELING HOT (Face feel hot) and RASH (Rash). At the time of the report, MALAISE (Not feeling well), FEELING HOT (Face feel hot) and PYREXIA (Fever with high temperature) had resolved and RASH (Rash) had not resolved.            No treatment information was provided. Action taken with mRNA-123 is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow up was received on 24 may 2021 patient stated about event duration and outcome of the events was updated
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: headache; nauseous; tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nauseous) and FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine (migraines.).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, 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 experienced HEADACHE (headache), NAUSEA (nauseous) and FATIGUE (tired). At the time of the report, HEADACHE (headache), NAUSEA (nauseous) and FATIGUE (tired) outcome was unknown. Not Provided          No concomitant medications were provided.  No treatment medications were provided.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: cold; Fever with temperature of 105; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) and PYREXIA (Fever with temperature of 105) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (oesophageal) and Cholesterol.    On 26-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 NASOPHARYNGITIS (cold) and PYREXIA (Fever with temperature of 105). At the time of the report, NASOPHARYNGITIS (cold) and PYREXIA (Fever with temperature of 105) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 040B21A) for COVID-19 vaccination.     Past medical history not provided.  Concomitant products included PSYLLIUM HYDROPHILIC MUCILLOID (METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]) for Constipation, UBIDECARENONE (CO Q10) for Fertilization, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ESTRADIOL for Pregnancy, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for Vitamin D low.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 10-Feb-2021 and the estimated date of delivery was 14-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 12-Mar-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Pregnancy test: Positive. On 17-Mar-2021, Blood test: (Inconclusive) Appropriate. On 17-Mar-2021, Ultrasound scan: (Inconclusive) healthy egg sack in appropriate position. On 01-Apr-2021, Blood test: (Inconclusive) Appropriate. On 01-Apr-2021, Ultrasound scan: (Inconclusive) healthy foetus, heartbeat. On 20-Apr-2021, Blood test: Appropriate. On 20-Apr-2021, Ultrasound scan: healthy fetus, heartbeat.         Patient has prior history of alcohol use. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Medication history added, Second dose information added, laboratory details added
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     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 14-Mar-2021, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details not provided. Treatment information not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Disorientation, Feeling abnormal
Clinical narrative: I didn't feel good; Disorientated; I ached all over my body; Weakness; I was shaking like crazy; I felt like I was running a fever, and I was 100.3 F; Headache; I still feel foggy; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (I didn't feel good), DISORIENTATION (Disorientated), PAIN (I ached all over my body), ASTHENIA (Weakness) and FEELING ABNORMAL (I still feel foggy) in a 70-year-old female 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 Coronavirus infection.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced MALAISE (I didn't feel good), DISORIENTATION (Disorientated), PAIN (I ached all over my body), ASTHENIA (Weakness), CHILLS (I was shaking like crazy), PYREXIA (I felt like I was running a fever, and I was 100.3 F) and HEADACHE (Headache). In March 2021, the patient experienced FEELING ABNORMAL (I still feel foggy). The patient was treated with ACETYLSALICYLIC ACID at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 13-Mar-2021, PYREXIA (I felt like I was running a fever, and I was 100.3 F) had resolved. At the time of the report, MALAISE (I didn't feel good), PAIN (I ached all over my body), ASTHENIA (Weakness), CHILLS (I was shaking like crazy) and HEADACHE (Headache) had resolved, DISORIENTATION (Disorientated) outcome was unknown and FEELING ABNORMAL (I still feel foggy) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 100.3f (High) 100.3F and 102.3f (High) 102.3F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was high blood pressure medication NOS and cholesterol medication NOS.  On 12-Mar-2021, the patient felt like they were running a fever and they were, 100.3F. After that, they became disorientated, their fever was 102.3F. They felt like they had the coronavirus all over again.  Treatment included acetylsalicylic acid (Aspirin) and ibuprofen (Motrin).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: I didn't feel good; Disorientated; I ached all over my body; Weakness; I was shaking like crazy; I felt like I was running a fever, and I was 100.3 F; Headache; I still feel foggy; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (I didn't feel good), DISORIENTATION (Disorientated), PAIN (I ached all over my body), ASTHENIA (Weakness) and FEELING ABNORMAL (I still feel foggy) in a 70-year-old female 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 Coronavirus infection.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced MALAISE (I didn't feel good), DISORIENTATION (Disorientated), PAIN (I ached all over my body), ASTHENIA (Weakness), CHILLS (I was shaking like crazy), PYREXIA (I felt like I was running a fever, and I was 100.3 F) and HEADACHE (Headache). In March 2021, the patient experienced FEELING ABNORMAL (I still feel foggy). The patient was treated with ACETYLSALICYLIC ACID at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 13-Mar-2021, PYREXIA (I felt like I was running a fever, and I was 100.3 F) had resolved. At the time of the report, MALAISE (I didn't feel good), PAIN (I ached all over my body), ASTHENIA (Weakness), CHILLS (I was shaking like crazy) and HEADACHE (Headache) had resolved, DISORIENTATION (Disorientated) outcome was unknown and FEELING ABNORMAL (I still feel foggy) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 100.3f (High) 100.3F and 102.3f (High) 102.3F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was high blood pressure medication NOS and cholesterol medication NOS.  On 12-Mar-2021, the patient felt like they were running a fever and they were, 100.3F. After that, they became disorientated, their fever was 102.3F. They felt like they had the coronavirus all over again.  Treatment included acetylsalicylic acid (Aspirin) and ibuprofen (Motrin).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Arm very very sore; Shoulder is hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm very very sore) and ARTHRALGIA (Shoulder is hurting) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm very very sore) and ARTHRALGIA (Shoulder is hurting). At the time of the report, PAIN IN EXTREMITY (Arm very very sore) and ARTHRALGIA (Shoulder is hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Vaccination site erythema, Vaccination site rash
Clinical narrative: felt heated/warm at the same arm of the injection; Headache; Rash that felt heated/warm at the same arm of the injection; Red at the same arm of the injection; soreness; Felt ill; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt ill), VACCINATION SITE WARMTH (felt heated/warm at the same arm of the injection), HEADACHE (Headache), VACCINATION SITE RASH (Rash that felt heated/warm at the same arm of the injection) and VACCINATION SITE ERYTHEMA (Red at the same arm of the injection) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced MALAISE (Felt ill). On an unknown date, the patient experienced VACCINATION SITE WARMTH (felt heated/warm at the same arm of the injection), HEADACHE (Headache), VACCINATION SITE RASH (Rash that felt heated/warm at the same arm of the injection), VACCINATION SITE ERYTHEMA (Red at the same arm of the injection) and MYALGIA (soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (Felt ill) had resolved and VACCINATION SITE WARMTH (felt heated/warm at the same arm of the injection), HEADACHE (Headache), VACCINATION SITE RASH (Rash that felt heated/warm at the same arm of the injection), VACCINATION SITE ERYTHEMA (Red at the same arm of the injection) and MYALGIA (soreness) outcome was unknown.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: felt heated/warm at the same arm of the injection; Headache; Rash that felt heated/warm at the same arm of the injection; Red at the same arm of the injection; soreness; Felt ill; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt ill), VACCINATION SITE WARMTH (felt heated/warm at the same arm of the injection), HEADACHE (Headache), VACCINATION SITE RASH (Rash that felt heated/warm at the same arm of the injection) and VACCINATION SITE ERYTHEMA (Red at the same arm of the injection) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced MALAISE (Felt ill). On an unknown date, the patient experienced VACCINATION SITE WARMTH (felt heated/warm at the same arm of the injection), HEADACHE (Headache), VACCINATION SITE RASH (Rash that felt heated/warm at the same arm of the injection), VACCINATION SITE ERYTHEMA (Red at the same arm of the injection) and MYALGIA (soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (Felt ill) had resolved and VACCINATION SITE WARMTH (felt heated/warm at the same arm of the injection), HEADACHE (Headache), VACCINATION SITE RASH (Rash that felt heated/warm at the same arm of the injection), VACCINATION SITE ERYTHEMA (Red at the same arm of the injection) and MYALGIA (soreness) outcome was unknown.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst, Tissue rupture, Vaccination site pain
Clinical narrative: bloody tissue; very thirsty; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TISSUE RUPTURE (bloody tissue), THIRST (very thirsty) and VACCINATION SITE PAIN (pain at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M(N)20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 TISSUE RUPTURE (bloody tissue), THIRST (very thirsty) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, TISSUE RUPTURE (bloody tissue), THIRST (very thirsty) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include Nexium. Treatment details was not provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Mass, Pruritus
Clinical narrative: hard knot; red circle; warm; itching; This spontaneous case was reported by a consumer and describes the occurrence of MASS (hard knot), ERYTHEMA (red circle), FEELING HOT (warm) and PRURITUS (itching) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, ATENOLOL and SIMVASTATIN for an unknown indication.    On 04-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 MASS (hard knot), ERYTHEMA (red circle), FEELING HOT (warm) and PRURITUS (itching). At the time of the report, MASS (hard knot), ERYTHEMA (red circle), FEELING HOT (warm) and PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; A spontaneous report was received on 12 Mar 2021, from a consumer concerning a unknown aged female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed fever.  The patient's medical history was not provided. Concomitant medications were not reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, after receiving mRNA-1273, the patient developed fever. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event fever was not reported.