chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site mass
Clinical narrative: Severe cramping; Low grade fever; muscle aches; Fatigue; headache; Chills; explosive watery diarrhea; Nausea; left arm is heavy, sore and has a knot on it; left arm is heavy, sore and has a knot on it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm is heavy, sore and has a knot on it), INJECTION SITE MASS (left arm is heavy, sore and has a knot on it), MUSCLE SPASMS (Severe cramping), DIARRHOEA (explosive watery diarrhea) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (left arm is heavy, sore and has a knot on it), INJECTION SITE MASS (left arm is heavy, sore and has a knot on it), DIARRHOEA (explosive watery diarrhea), NAUSEA (Nausea), MYALGIA (muscle aches), FATIGUE (Fatigue), HEADACHE (headache) and CHILLS (Chills). On 06-Apr-2021, the patient experienced MUSCLE SPASMS (Severe cramping) and PYREXIA (Low grade fever). On 07-Apr-2021, DIARRHOEA (explosive watery diarrhea), PYREXIA (Low grade fever) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm is heavy, sore and has a knot on it), INJECTION SITE MASS (left arm is heavy, sore and has a knot on it), MUSCLE SPASMS (Severe cramping), NAUSEA (Nausea), MYALGIA (muscle aches), FATIGUE (Fatigue) and HEADACHE (headache) had not resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-070515, MOD-2021-070515 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Severe cramping; Low grade fever; muscle aches; Fatigue; headache; Chills; explosive watery diarrhea; Nausea; left arm is heavy, sore and has a knot on it; left arm is heavy, sore and has a knot on it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm is heavy, sore and has a knot on it), INJECTION SITE MASS (left arm is heavy, sore and has a knot on it), MUSCLE SPASMS (Severe cramping), DIARRHOEA (explosive watery diarrhea) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (left arm is heavy, sore and has a knot on it), INJECTION SITE MASS (left arm is heavy, sore and has a knot on it), DIARRHOEA (explosive watery diarrhea), NAUSEA (Nausea), MYALGIA (muscle aches), FATIGUE (Fatigue), HEADACHE (headache) and CHILLS (Chills). On 06-Apr-2021, the patient experienced MUSCLE SPASMS (Severe cramping) and PYREXIA (Low grade fever). On 07-Apr-2021, DIARRHOEA (explosive watery diarrhea), PYREXIA (Low grade fever) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm is heavy, sore and has a knot on it), INJECTION SITE MASS (left arm is heavy, sore and has a knot on it), MUSCLE SPASMS (Severe cramping), NAUSEA (Nausea), MYALGIA (muscle aches), FATIGUE (Fatigue) and HEADACHE (headache) had not resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-070515, MOD-2021-070515 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant and received 1st dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant and received 1st dose) in a 22-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025b21a) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Craniosynostosis with youngest child). Concurrent medical conditions included Allergic reaction to antibiotics, Allergic reaction to antibiotics, Allergic reaction to antibiotics and Drug allergy. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], ESCITALOPRAM OXALATE (LEXAPRO) and CLONAZEPAM (KLONOPIN) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 12-Jun-2021. On 07-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant and received 1st dose). On 07-Apr-2021, EXPOSURE DURING PREGNANCY (Pregnant and received 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Laboratory test includes Dating ultrasound-Normal , Anatomy ultrasound-Normal, Ultrasound to look for Craniosyntosis- Normal .  Medical history include Craniosyntosis with youngest child.  Concomitant medication include iron supplement.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: This spontaneous prospective pregnancy case reported by a consumer, describes the occurrence of maternal exposure during pregnancy (pregnant patient received 2 vaccines) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 12, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was Jul 23, 2021. On Feb 12, 2021, patient experienced maternal exposure during pregnancy (pregnant patient received 2 vaccines). On Mar 12, 2021, maternal exposure during pregnancy (pregnant patient received 2 vaccines) resolved. Diagnostic results: On an unknown date: Pregnancy test: Positive. On an unknown date, Ultrasound scan: Normal. No concomitant medication or treatment information reported. Patient reported an ultrasound was completed on an unknown date and resulted in normal findings. The patient's pregnancy test was positive on Nov 10, 2020.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Somnolence
Clinical narrative: sleepy; woozy; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (woozy) in a 65-year-old male 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 AMLODIPINE, LISINOPRIL and ATENOLOL for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (woozy). At the time of the report, DIZZINESS (woozy) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-070732 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up information received on 08-Jul-2021 contains .
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Injection site rash
Clinical narrative: moderate reaction; red bad rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (moderate reaction) and INJECTION SITE RASH (red bad rash at injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (moderate reaction) and INJECTION SITE RASH (red bad rash at injection site). At the time of the report, ADVERSE REACTION (moderate reaction) and INJECTION SITE RASH (red bad rash at injection site) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-020908 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-020908:Crosslinked (First dose)
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (felt a pain/sensation from the top of his right arm to his right elbow) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011A21A) for COVID-19 immunization. Concomitant products included amlodipine, lisinopril and atenolol for an unknown indication. On Feb 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 26, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 26, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced pain in extremity (felt a pain/sensation from the top of his right arm to his right elbow). On Mar 31, 2021, pain in extremity (felt a pain/sensation from the top of his right arm to his right elbow) resolved. Treatment details not reported. This case linked to MOD-2021-070694 (patient link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site (right deltoid) warm to the touch; Injection site (right deltoid) swelling, itching; Injection site (right deltoid) swelling; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Injection site (right deltoid) warm to the touch), VACCINATION SITE PRURITUS (Injection site (right deltoid) swelling, itching) and VACCINATION SITE SWELLING (Injection site (right deltoid) swelling) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site (right deltoid) warm to the touch), VACCINATION SITE PRURITUS (Injection site (right deltoid) swelling, itching) and VACCINATION SITE SWELLING (Injection site (right deltoid) swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site (right deltoid) warm to the touch), VACCINATION SITE PRURITUS (Injection site (right deltoid) swelling, itching) and VACCINATION SITE SWELLING (Injection site (right deltoid) swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was a registered nurse who was calling on behalf of their patient who received their second dose of vaccination and had an adverse reaction. On 05-Apr-2021, the patient reached out to one of the registered nurses at the clinic and reported that they had injection site swelling, itching and it was warm to the touch.   Reportedly, the reaction started approximately 5 hours post receiving the second dose. The patient also reported that they experienced the same reaction with the first dose as well.   The patient was taking Benadryl at home.  No Concomitant product use was reported.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-070850 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up was received on 21-May-2021 and does not contain any new or significant information.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site warmth; Injection site Itching; Injection site swelling; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PRURITUS (Injection site Itching) and VACCINATION SITE SWELLING (Injection site swelling) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PRURITUS (Injection site Itching) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PRURITUS (Injection site Itching) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications reported. Treatment medication  included Benadryl.   This case was linked to MOD-2021-070802 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-MAY-2021 contains no new information.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache a pain sale of 5 or 6/10.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache a pain sale of 5 or 6/10.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for Hypertension, HYDROCHLOROTHIAZIDE and METOPROLOL for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced HEADACHE (headache a pain sale of 5 or 6/10.). At the time of the report, HEADACHE (headache a pain sale of 5 or 6/10.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included ibuprofen.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on his arms, arm pits, chest and back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on his arms, arm pits, chest and back) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced RASH (Rash on his arms, arm pits, chest and back). At the time of the report, RASH (Rash on his arms, arm pits, chest and back) 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 information was reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Patient received his second dose 10 days earlier than due; This spontaneous case was reported by a physician and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Patient received his second dose 10 days earlier than due) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products were not provided.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient received his second dose 10 days earlier than due). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Patient received his second dose 10 days earlier than due) outcome was unknown. Not Provided   Treatment products were not provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: Ankle very swollen; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Ankle very swollen) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced JOINT SWELLING (Ankle very swollen). At the time of the report, JOINT SWELLING (Ankle very swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Treatment information not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Illness, Nausea
Clinical narrative: cough; sore throat; very nauseated; fatigue; dizzy; sick; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ILLNESS (sick), COUGH (cough), OROPHARYNGEAL PAIN (sore throat) and NAUSEA (very nauseated) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DIZZINESS (dizzy) and ILLNESS (sick). On an unknown date, the patient experienced COUGH (cough), OROPHARYNGEAL PAIN (sore throat), NAUSEA (very nauseated) and FATIGUE (fatigue). At the time of the report, DIZZINESS (dizzy), ILLNESS (sick), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), NAUSEA (very nauseated) and FATIGUE (fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, SARS-CoV-1 test: positive (Positive) positive [rapid antigen test for COVID].     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. There is no treatment taken.; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, Based on the mechanism of action of mRNA -1273, causal association between the event of SAR-COV-2 test positive and mRNA-1273 is assessed as not applicable.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-1 test
Clinical narrative: cough; sore throat; very nauseated; fatigue; dizzy; sick; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ILLNESS (sick), COUGH (cough), OROPHARYNGEAL PAIN (sore throat) and NAUSEA (very nauseated) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DIZZINESS (dizzy) and ILLNESS (sick). On an unknown date, the patient experienced COUGH (cough), OROPHARYNGEAL PAIN (sore throat), NAUSEA (very nauseated) and FATIGUE (fatigue). At the time of the report, DIZZINESS (dizzy), ILLNESS (sick), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), NAUSEA (very nauseated) and FATIGUE (fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, SARS-CoV-1 test: positive (Positive) positive [rapid antigen test for COVID].     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. There is no treatment taken.; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, Based on the mechanism of action of mRNA -1273, causal association between the event of SAR-COV-2 test positive and mRNA-1273 is assessed as not applicable.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Neuralgia, Pain in extremity, Pruritus
Clinical narrative: Sore left arm; Nerve pain; Itching; shingles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), HERPES ZOSTER (shingles), NEURALGIA (Nerve pain) and PRURITUS (Itching) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, High cholesterol, Type 2 diabetes mellitus and Allergy to antibiotic. Concomitant products included METFORMIN, ATORVASTATIN, TELMISARTAN, ASPIRIN [ACETYLSALICYLIC ACID] and CARVEDILOL (COREG) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced HERPES ZOSTER (shingles). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore left arm), NEURALGIA (Nerve pain) and PRURITUS (Itching). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency; GABAPENTIN for Nerve pain, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Sore left arm), NEURALGIA (Nerve pain) and PRURITUS (Itching) outcome was unknown and HERPES ZOSTER (shingles) had not resolved. Not Provided          Treatment details include antiviral  drug as per his dermatologist. .   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Significant follow up
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Rhinorrhoea
Clinical narrative: Runny nose after 2nd dose; Sore arm after 2nd dose; Headache after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose after 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose) and HEADACHE (Headache after 2nd dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose after 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose) and HEADACHE (Headache after 2nd dose). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (Runny nose after 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose) and HEADACHE (Headache after 2nd dose) had resolved.            No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.     Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Outcome of events were updated.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Had fever (100.9°F); Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had fever (100.9°F)) and FATIGUE (Fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B and 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SINUPROL for Heart disorder, LISINOPRIL and OMEPRAZOLE for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (Had fever (100.9°F)) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Had fever (100.9°F)) and FATIGUE (Fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Body temperature: 100.9 degree f (High) 100.9 degree F.         No treatment information was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Illness, SARS-CoV-2 test
Clinical narrative: Lost taste; Lost smell; Got very sick; This spontaneous case was reported by an other caregiver and describes the occurrence of AGEUSIA (Lost taste), ANOSMIA (Lost smell) and ILLNESS (Got very sick) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Lost taste), ANOSMIA (Lost smell) and ILLNESS (Got very sick). At the time of the report, AGEUSIA (Lost taste), ANOSMIA (Lost smell) and ILLNESS (Got very sick) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for Covid infection.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-071416, MOD-2021-072067, MOD-2021-070997, MOD-2021-077195, MOD-2021-071383 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Aches; FEVER; Vomiting; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), PYREXIA (FEVER), VOMITING (Vomiting), NAUSEA (Nausea) and HEADACHE (Headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (Aches), PYREXIA (FEVER), VOMITING (Vomiting), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, PAIN (Aches), PYREXIA (FEVER), VOMITING (Vomiting), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporte
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 042L20A) 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) (unknown route) 1 dosage form. On 13-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 VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown. Not Provided. No concomitant and treatment information was reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up document is received on 13-MAY-2021 and it doesn't have any new information.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: running nose; possible sore throat; Cold; coughing; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (running nose), OROPHARYNGEAL PAIN (possible sore throat), NASOPHARYNGITIS (Cold) and COUGH (coughing) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced RHINORRHOEA (running nose), OROPHARYNGEAL PAIN (possible sore throat), NASOPHARYNGITIS (Cold) and COUGH (coughing). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (running nose), OROPHARYNGEAL PAIN (possible sore throat), NASOPHARYNGITIS (Cold) and COUGH (coughing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anosmia, Dysgeusia, Feeling cold, Illness
Clinical narrative: Felt more sickness; Symptoms of sicker stomach; Strange taste in the mouth; Feeling cold; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt more sickness), ABDOMINAL DISCOMFORT (Symptoms of sicker stomach), DYSGEUSIA (Strange taste in the mouth), FEELING COLD (Feeling cold) and ANOSMIA (Loss of smell) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ILLNESS (Felt more sickness), ABDOMINAL DISCOMFORT (Symptoms of sicker stomach), DYSGEUSIA (Strange taste in the mouth), FEELING COLD (Feeling cold) and ANOSMIA (Loss of smell). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (Felt more sickness), ABDOMINAL DISCOMFORT (Symptoms of sicker stomach), DYSGEUSIA (Strange taste in the mouth), FEELING COLD (Feeling cold) and ANOSMIA (Loss of smell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was pending for a Covid test report. Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vertigo
Clinical narrative: vertigo; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), PYREXIA (fever) and CHILLS (chills) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo), PYREXIA (fever) and CHILLS (chills). At the time of the report, VERTIGO (vertigo), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No Concomitant medications were provided. No Treatment History was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pruritus, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is aching), PAIN IN EXTREMITY (sore arm), PAIN (Body aches), INJECTION SITE PRURITUS (Arm was often itchy in the area of the shot) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to antibiotic (augmentin), Blood pressure high (since many years), High cholesterol (since many years), Acid reflux (oesophageal) (since many years), Anxiety depression (since many years) and Breast cancer since 2017. Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), METOPROLOL for Blood pressure high, ANASTROZOLE (ARIMIDEX) for Breast cancer, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, SIMVASTATIN (ZOCOR) for High cholesterol. On 10-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm is aching) and HEADACHE (Headache). On 08-Apr-2021 at 6:00 AM, the patient experienced PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever). On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced INJECTION SITE PRURITUS (Arm was often itchy in the area of the shot). On 08-Apr-2021, PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm is aching) and HEADACHE (Headache) outcome was unknown and PAIN IN EXTREMITY (sore arm) and INJECTION SITE PRURITUS (Arm was often itchy in the area of the shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up was received include event, concomitant medications, patients demographics updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is aching), PAIN IN EXTREMITY (sore arm), PAIN (Body aches), INJECTION SITE PRURITUS (Arm was often itchy in the area of the shot) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to antibiotic (augmentin), Blood pressure high (since many years), High cholesterol (since many years), Acid reflux (oesophageal) (since many years), Anxiety depression (since many years) and Breast cancer since 2017. Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), METOPROLOL for Blood pressure high, ANASTROZOLE (ARIMIDEX) for Breast cancer, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, SIMVASTATIN (ZOCOR) for High cholesterol. On 10-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm is aching) and HEADACHE (Headache). On 08-Apr-2021 at 6:00 AM, the patient experienced PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever). On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced INJECTION SITE PRURITUS (Arm was often itchy in the area of the shot). On 08-Apr-2021, PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm is aching) and HEADACHE (Headache) outcome was unknown and PAIN IN EXTREMITY (sore arm) and INJECTION SITE PRURITUS (Arm was often itchy in the area of the shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up was received include event, concomitant medications, patients demographics updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red spot the side of a tennis ball at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red spot the side of a tennis ball at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot the side of a tennis ball at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red spot the side of a tennis ball at the injection site) outcome was unknown.            No concomitant medication information provided. No treatment information provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Influenza like illness, Insomnia, Malaise
Clinical narrative: Feeling ill / Malaise; Sick in bed all day; Lot of pain that she described as flu-like; Fatigue; Sore arm; Not sleeping well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MALAISE (Feeling ill / Malaise), ILLNESS (Sick in bed all day), INFLUENZA LIKE ILLNESS (Lot of pain that she described as flu-like) and INSOMNIA (Not sleeping well) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046a21a and 029a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included MULTIVITAMINS [VITAMINS NOS], SELEGILINE (EMSAM) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Not sleeping well). On 03-Apr-2021, the patient experienced MALAISE (Feeling ill / Malaise), ILLNESS (Sick in bed all day), INFLUENZA LIKE ILLNESS (Lot of pain that she described as flu-like) and FATIGUE (Fatigue). On 03-Apr-2021, ILLNESS (Sick in bed all day) had resolved. On 04-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, MALAISE (Feeling ill / Malaise), INFLUENZA LIKE ILLNESS (Lot of pain that she described as flu-like), INSOMNIA (Not sleeping well) and FATIGUE (Fatigue) outcome was unknown. Not Provided          The patient believes the vaccine triggered her immune system to experience a fight or flight response. She states her immune system doesn't cope well with viruses. Patient states she would be hesitant to take ever take the vaccine again. Treatment details included Aspirin to cope with the pain.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Feeling ill / Malaise; Sick in bed all day; Lot of pain that she described as flu-like; Fatigue; Sore arm; Not sleeping well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MALAISE (Feeling ill / Malaise), ILLNESS (Sick in bed all day), INFLUENZA LIKE ILLNESS (Lot of pain that she described as flu-like) and INSOMNIA (Not sleeping well) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046a21a and 029a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included MULTIVITAMINS [VITAMINS NOS], SELEGILINE (EMSAM) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Not sleeping well). On 03-Apr-2021, the patient experienced MALAISE (Feeling ill / Malaise), ILLNESS (Sick in bed all day), INFLUENZA LIKE ILLNESS (Lot of pain that she described as flu-like) and FATIGUE (Fatigue). On 03-Apr-2021, ILLNESS (Sick in bed all day) had resolved. On 04-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, MALAISE (Feeling ill / Malaise), INFLUENZA LIKE ILLNESS (Lot of pain that she described as flu-like), INSOMNIA (Not sleeping well) and FATIGUE (Fatigue) outcome was unknown. Not Provided          The patient believes the vaccine triggered her immune system to experience a fight or flight response. She states her immune system doesn't cope well with viruses. Patient states she would be hesitant to take ever take the vaccine again. Treatment details included Aspirin to cope with the pain.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke into target hives after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke into target hives after vaccination) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Broke into target hives after vaccination). At the time of the report, URTICARIA (Broke into target hives after vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke into target hives after vaccination) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Broke into target hives after vaccination). At the time of the report, URTICARIA (Broke into target hives after vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Presyncope
Clinical narrative: Dizziness; Weakness; Feels like I am going to fall down when I am standing; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, ASTHENIA, and PRESYNCOPE 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 No adverse event (No reported medical history).    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced DIZZINESS, ASTHENIA, and PRESYNCOPE. At the time of the report, DIZZINESS, ASTHENIA, and PRESYNCOPE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ulcer
Clinical narrative: ulcers on top of and under her tongue.; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ULCER (ulcers on top of and under her tongue.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced ULCER (ulcers on top of and under her tongue.). At the time of the report, ULCER (ulcers on top of and under her tongue.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received the vaccination about 48 hours ago and has developed ulcers on top of and under her tongue.