chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Erythema, Headache, Herpes zoster, Pain in extremity
Clinical narrative: sore arm; swollen arm; red arm; chest hurting on her left side; even her teeth hurt; little bumps she felt with her fingers; redness the size of a dime around the injection site; severe headaches; Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm) and CHEST PAIN (chest hurting on her left side) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure management and Nerve pain. Concomitant products included GABAPENTIN for Nerve pain, ZOLPIDEM TARTRATE (AMBIEN) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), CHEST PAIN (chest hurting on her left side), TOOTHACHE (even her teeth hurt), VACCINATION SITE MASS (little bumps she felt with her fingers), VACCINATION SITE ERYTHEMA (redness the size of a dime around the injection site) and HEADACHE (severe headaches). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Adverse event, at an unspecified dose and frequency and OXYCODONE for Adverse event, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), CHEST PAIN (chest hurting on her left side), TOOTHACHE (even her teeth hurt), VACCINATION SITE MASS (little bumps she felt with her fingers), VACCINATION SITE ERYTHEMA (redness the size of a dime around the injection site) and HEADACHE (severe headaches) outcome was unknown. Not Provided          Other concomitant medications included blood pressure and antacid medications.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Toothache, Vaccination site erythema, Vaccination site mass
Clinical narrative: sore arm; swollen arm; red arm; chest hurting on her left side; even her teeth hurt; little bumps she felt with her fingers; redness the size of a dime around the injection site; severe headaches; Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm) and CHEST PAIN (chest hurting on her left side) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure management and Nerve pain. Concomitant products included GABAPENTIN for Nerve pain, ZOLPIDEM TARTRATE (AMBIEN) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), CHEST PAIN (chest hurting on her left side), TOOTHACHE (even her teeth hurt), VACCINATION SITE MASS (little bumps she felt with her fingers), VACCINATION SITE ERYTHEMA (redness the size of a dime around the injection site) and HEADACHE (severe headaches). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Adverse event, at an unspecified dose and frequency and OXYCODONE for Adverse event, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), CHEST PAIN (chest hurting on her left side), TOOTHACHE (even her teeth hurt), VACCINATION SITE MASS (little bumps she felt with her fingers), VACCINATION SITE ERYTHEMA (redness the size of a dime around the injection site) and HEADACHE (severe headaches) outcome was unknown. Not Provided          Other concomitant medications included blood pressure and antacid medications.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itchy left arm; Red right arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy left arm) and ERYTHEMA (Red right arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 023M26A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PRURITUS (Itchy left arm) and ERYTHEMA (Red right arm). On 10-Apr-2021, PRURITUS (Itchy left arm) and ERYTHEMA (Red right arm) had resolved. Not Provided          Concomitant medication was not provided by the reporter.  Treatment medication included Triamcinolone Acetonide Cream prescribed by doctor.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-May-2021 and Updated AE contact information and event outcome was updated..
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Product administration error, Vaccination site pain
Clinical narrative: feels like if someone is chopping her arm off; Patient partially blames the lack of efficacy on poor administration by the pharmacist; feels like if someone is chopping her arm off, wose than child birth; continuous stabbing pain at the injection site/Left arm painful after second shot; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING ABNORMAL (feels like if someone is chopping her arm off), PRODUCT ADMINISTRATION ERROR (Patient partially blames the lack of efficacy on poor administration by the pharmacist), PAIN (feels like if someone is chopping her arm off, wose than child birth) and VACCINATION SITE PAIN (continuous stabbing pain at the injection site/Left arm painful after second shot) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced FEELING ABNORMAL (feels like if someone is chopping her arm off), PRODUCT ADMINISTRATION ERROR (Patient partially blames the lack of efficacy on poor administration by the pharmacist), PAIN (feels like if someone is chopping her arm off, wose than child birth) and VACCINATION SITE PAIN (continuous stabbing pain at the injection site/Left arm painful after second shot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and OXYCODONE for Adverse event, at an unspecified dose and frequency. On 05-Apr-2021, PRODUCT ADMINISTRATION ERROR (Patient partially blames the lack of efficacy on poor administration by the pharmacist) had resolved. At the time of the report, FEELING ABNORMAL (feels like if someone is chopping her arm off), PAIN (feels like if someone is chopping her arm off, wose than child birth) and VACCINATION SITE PAIN (continuous stabbing pain at the injection site/Left arm painful after second shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that she felt pain in waves, worse than child birth. She could not use her arm. On 21-Apr-2021, antibody test to Covid-19 came back negative. The patient treated the symptoms with ice pack.   This case was linked to MOD-2021-100703 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Reporter details, product information and relevant test updated.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: reddish-itchy rash on arm at injection site; reddish-itchy rash on arm at injection site; reddish-itchy rash on arm at injection site; pain and fever at injection site; pain and fever at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (reddish-itchy rash on arm at injection site), PYREXIA (pain and fever at injection site), VACCINATION SITE PAIN (pain and fever at injection site), VACCINATION SITE ERYTHEMA (reddish-itchy rash on arm at injection site) and VACCINATION SITE RASH (reddish-itchy rash on arm at injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (pain and fever at injection site) and VACCINATION SITE PAIN (pain and fever at injection site). On 06-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (reddish-itchy rash on arm at injection site), VACCINATION SITE ERYTHEMA (reddish-itchy rash on arm at injection site) and VACCINATION SITE RASH (reddish-itchy rash on arm at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 01-Apr-2021, PYREXIA (pain and fever at injection site) and VACCINATION SITE PAIN (pain and fever at injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (reddish-itchy rash on arm at injection site), VACCINATION SITE ERYTHEMA (reddish-itchy rash on arm at injection site) and VACCINATION SITE RASH (reddish-itchy rash on arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that rash was very annoying.  The patient has used an ice pack which provided only temporary relief.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Feeling abnormal, Headache, Nausea
Clinical narrative: Brain fog; headache; nausea; RN administered 1 ml instead of 0.5ml of Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Brain fog), HEADACHE (headache), NAUSEA (nausea) and ACCIDENTAL OVERDOSE (RN administered 1 ml instead of 0.5ml of Moderna vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 06-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (RN administered 1 ml instead of 0.5ml of Moderna vaccine). On 07-Apr-2021, the patient experienced FEELING ABNORMAL (Brain fog), HEADACHE (headache) and NAUSEA (nausea). On 06-Apr-2021, ACCIDENTAL OVERDOSE (RN administered 1 ml instead of 0.5ml of Moderna vaccine) had resolved. At the time of the report, FEELING ABNORMAL (Brain fog), HEADACHE (headache) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  The patient did not receive any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: updated event outcome. On 22-Jul-2021: Follow-up contains no significant information.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Pruritus
Clinical narrative: arm got bright red from elbow to shoulder; arm got warm from elbow to shoulder; arm got itchy from elbow to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm got bright red from elbow to shoulder), INJECTION SITE WARMTH (arm got warm from elbow to shoulder) and PRURITUS (arm got itchy from elbow to shoulder) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced ERYTHEMA (arm got bright red from elbow to shoulder), INJECTION SITE WARMTH (arm got warm from elbow to shoulder) and PRURITUS (arm got itchy from elbow to shoulder). At the time of the report, ERYTHEMA (arm got bright red from elbow to shoulder), INJECTION SITE WARMTH (arm got warm from elbow to shoulder) and PRURITUS (arm got itchy from elbow to shoulder) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include alcohol and skin lotion.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of herpes zoster (shingles on the right arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030A21A) for COVID-19 immunization. The patient's past medical history included shingles. Concurrent medical conditions included thyroid disorder (NOS), blood pressure management and cholesterol. Concomitant products included vitamins (NOS) for an unknown indication. On Mar 17, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced herpes zoster (shingles on the right arm). At the time of the report, herpes zoster (shingles on the right arm): resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Other concomitant medications included thyroid medication, cholesterol medication and blood pressure medicine. The patient did not receive any treatment medication.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: asthma attack; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (asthma attack) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced ASTHMA (asthma attack). On 31-Mar-2021, ASTHMA (asthma attack) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided Treatment medication include inhaler.
Sex: F
Vaccine: COVID19
Symptoms: Amniocentesis, Exposure during pregnancy, Glucose tolerance test, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Ex-alcohol user (a little the 1st month). Concomitant products included IRON for Iron supplementation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 04-Apr-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 17-Sep-2020 and the estimated date of delivery was 24-Jun-2021. On 04-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy.  On 04-Apr-2021, EXPOSURE DURING PREGNANCY (Pregnant patient) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Pregnancy test: postitive Positive. On an unknown date, Amniocentesis: normal Normal. On an unknown date, Glucose tolerance test: normal Normal. On an unknown date, Ultrasound scan: normal Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Estimated date of conception was reported as 20-Sep-2020.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Second dose has been missed; Tested positive for COVID19; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose has been missed) and COVID-19 (Tested positive for COVID19) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID19). On 07-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose has been missed). On 07-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Second dose has been missed) had resolved. At the time of the report, COVID-19 (Tested positive for COVID19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, SARS-CoV-2 test: 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 were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up received on 23-Jun-2021 contains no significant information
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Herpes zoster, Pain, Paraesthesia
Clinical narrative: shingles all over; Pain; Burning; Tingling; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles all over), PAIN (Pain), BURNING SENSATION (Burning) and PARAESTHESIA (Tingling) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 028L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure management.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN (Pain), BURNING SENSATION (Burning) and PARAESTHESIA (Tingling). On 26-Mar-2021, the patient experienced HERPES ZOSTER (shingles all over). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at a dose of 1 dosage form; GABAPENTIN (NEURONTIN) at a dose of 1 dosage form; PREGABALIN (LYRICA) at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (shingles all over) had resolved and PAIN (Pain), BURNING SENSATION (Burning) and PARAESTHESIA (Tingling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included steroid cream.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18/05/2021 ADR form included with new events and treatments.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration interrupted, Product availability issue
Clinical narrative: Having trouble getting getting second vaccine; More than 36 days have passed since first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT AVAILABILITY ISSUE (Having trouble getting getting second vaccine) and PRODUCT ADMINISTRATION INTERRUPTED (More than 36 days have passed since first shot) in an 80-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 (No reported medical history).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PRODUCT AVAILABILITY ISSUE (Having trouble getting getting second vaccine) and PRODUCT ADMINISTRATION INTERRUPTED (More than 36 days have passed since first shot). At the time of the report, PRODUCT AVAILABILITY ISSUE (Having trouble getting getting second vaccine) and PRODUCT ADMINISTRATION INTERRUPTED (More than 36 days have passed since first shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient is having trouble getting their second dose of vaccine because  decided to vaccinate more people and did not have enough vaccine for second inoculations.; Sender's Comments: This report refers to a case of Product dose omission issue and product administration interrupted, for mRNA-1273, lot # unknown,  with no associated AEs.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site discolouration, Vaccination site pain
Clinical narrative: Vaccination site bruising; Vaccination site discoloration; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Vaccination site bruising), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and VACCINATION SITE PAIN (Sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-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 BRUISING (Vaccination site bruising), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE BRUISING (Vaccination site bruising), VACCINATION SITE DISCOLOURATION (Vaccination site discoloration) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under the recommended age of 18 received the first dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under the recommended age of 18 received the first dose) in a 16-year-old female 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) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under the recommended age of 18 received the first dose). On 11-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under the recommended age of 18 received the first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm to the touch (not hot); Itching around the area where she got the shot; large swelling around the area where she got the shot; Red around the area where she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch (not hot)), VACCINATION SITE PRURITUS (Itching around the area where she got the shot), VACCINATION SITE SWELLING (large swelling around the area where she got the shot) and VACCINATION SITE ERYTHEMA (Red around the area where she got the shot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to the touch (not hot)), VACCINATION SITE PRURITUS (Itching around the area where she got the shot), VACCINATION SITE SWELLING (large swelling around the area where she got the shot) and VACCINATION SITE ERYTHEMA (Red around the area where she got the shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm to the touch (not hot)), VACCINATION SITE PRURITUS (Itching around the area where she got the shot), VACCINATION SITE SWELLING (large swelling around the area where she got the shot) and VACCINATION SITE ERYTHEMA (Red around the area where she got the shot) outcome was unknown.            The patient reported that area where she got shot was the size of a quarter and then it ended up being the size of an orange. Concomitant medications included blood pressure and diabetic medicines.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Discomfort, Herpes zoster, Neuralgia, Pain in extremity
Clinical narrative: looks like shingles, it hurts her nerves; a very uncomfortable pain in all her left side; looks like shingles, it hurts her nerves; overall rash all around the upper thigh, the front and back and her butt, has pain in it; pain up and down her leg and her back; pain up and down her leg and her back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain up and down her leg and her back), BACK PAIN (pain up and down her leg and her back), NEURALGIA (looks like shingles, it hurts her nerves), DISCOMFORT (a very uncomfortable pain in all her left side) and HERPES ZOSTER (looks like shingles, it hurts her nerves) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus, Kidney infection NOS, Blood pressure high (Improvement, changed medication) and Drug allergy. Concomitant products included AMLODIPINE and OLMESARTAN for Blood pressure, GLIMEPIRIDE for Diabetes, ALLOPURINOL for Gout, PANTOPRAZOLE for Stomach ache, METOPROLOL SUCCINATE, PREDNISONE and FUROSEMIDE for an unknown indication.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain up and down her leg and her back), BACK PAIN (pain up and down her leg and her back) and RASH (overall rash all around the upper thigh, the front and back and her butt, has pain in it). On an unknown date, the patient experienced NEURALGIA (looks like shingles, it hurts her nerves), DISCOMFORT (a very uncomfortable pain in all her left side) and HERPES ZOSTER (looks like shingles, it hurts her nerves). At the time of the report, PAIN IN EXTREMITY (pain up and down her leg and her back) had not resolved and BACK PAIN (pain up and down her leg and her back), NEURALGIA (looks like shingles, it hurts her nerves), DISCOMFORT (a very uncomfortable pain in all her left side), HERPES ZOSTER (looks like shingles, it hurts her nerves) and RASH (overall rash all around the upper thigh, the front and back and her butt, has pain in it) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medication included torisemide. The patient received unspecified medication for pain up and down her leg and her back.   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: Reporter details, patient demographics, medical history, concomitant medications and event information updated
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: looks like shingles, it hurts her nerves; a very uncomfortable pain in all her left side; looks like shingles, it hurts her nerves; overall rash all around the upper thigh, the front and back and her butt, has pain in it; pain up and down her leg and her back; pain up and down her leg and her back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain up and down her leg and her back), BACK PAIN (pain up and down her leg and her back), NEURALGIA (looks like shingles, it hurts her nerves), DISCOMFORT (a very uncomfortable pain in all her left side) and HERPES ZOSTER (looks like shingles, it hurts her nerves) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus, Kidney infection NOS, Blood pressure high (Improvement, changed medication) and Drug allergy. Concomitant products included AMLODIPINE and OLMESARTAN for Blood pressure, GLIMEPIRIDE for Diabetes, ALLOPURINOL for Gout, PANTOPRAZOLE for Stomach ache, METOPROLOL SUCCINATE, PREDNISONE and FUROSEMIDE for an unknown indication.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain up and down her leg and her back), BACK PAIN (pain up and down her leg and her back) and RASH (overall rash all around the upper thigh, the front and back and her butt, has pain in it). On an unknown date, the patient experienced NEURALGIA (looks like shingles, it hurts her nerves), DISCOMFORT (a very uncomfortable pain in all her left side) and HERPES ZOSTER (looks like shingles, it hurts her nerves). At the time of the report, PAIN IN EXTREMITY (pain up and down her leg and her back) had not resolved and BACK PAIN (pain up and down her leg and her back), NEURALGIA (looks like shingles, it hurts her nerves), DISCOMFORT (a very uncomfortable pain in all her left side), HERPES ZOSTER (looks like shingles, it hurts her nerves) and RASH (overall rash all around the upper thigh, the front and back and her butt, has pain in it) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medication included torisemide. The patient received unspecified medication for pain up and down her leg and her back.   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: Reporter details, patient demographics, medical history, concomitant medications and event information updated
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain down his right leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain down his right leg) 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 Viral infection. Concomitant products included FAMCICLOVIR for Antiviral treatment.   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 PAIN IN EXTREMITY (Pain down his right leg). At the time of the report, PAIN IN EXTREMITY (Pain down his right leg) outcome was unknown. Not Provided           Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product administered to patient of inappropriate age
Clinical narrative: tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine; first dose administered to patient under 18 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered to patient under 18 years of age) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered to patient under 18 years of age). On 28-Mar-2021, the patient experienced COVID-19 (tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine). At the time of the report, COVID-19 (tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered to patient under 18 years of age) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided.  Treatment medication were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Event added.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: very tired and experienced fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired and experienced fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Bronchitis, Anxiety, Panic attack and Ulcer. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety and Panic attacks, SERTRALINE, LOSARTAN, ROSUVASTATIN, ACETYLSALICYLIC ACID (ASPRIN) and HYDROCHLOROTHIAZIDE 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 an unknown date, the patient experienced FATIGUE (very tired and experienced fatigue). At the time of the report, FATIGUE (very tired and experienced fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient slept for 6-7 hours. Treatment information was not reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Severe fatigue; Muscle aches, body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Severe fatigue) and MYALGIA (Muscle aches, body aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D NOS for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (Severe fatigue) and MYALGIA (Muscle aches, body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 15-Mar-2021, FATIGUE (Severe fatigue) and MYALGIA (Muscle aches, body aches) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness
Clinical narrative: Felt sick; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick) and FATIGUE (Fatigue) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020 and COVID-19 in December 2020.    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 ILLNESS (Felt sick) and FATIGUE (Fatigue). At the time of the report, ILLNESS (Felt sick) and FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The reporter called in on behalf of their husband who have received both the doses of the Moderna COVID-19 vaccine. On 10-Mar-2021 the patient received their first dose and on 07-Apr-2021, the patient received their second dose.  Following the first dose of the vaccine the patient felt sick and fatigue. The reporter also informed that these side effects subsided after a few days.   Reportedly, the patient had previous COVID-19 infections in July and December of 2020.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-069672 (E2B Linked Report). This case was linked to MOD-2021-069672 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069672:First Dose of husband
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound scan
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Alcohol use stopped in 29-DEc-2020). Family history included Prostate cancer (Paternal grandfather), Gestational diabetes (Mother) and Diabetes (Father and grandfather). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 03-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 29-Dec-2020 and the estimated date of delivery was 04-Oct-2021. On 03-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Ultrasound scan: normal (normal) Ultrasound scan normal. On 15-Mar-2021, Ultrasound scan: normal (normal) Ultrasound scan normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes Green Tea for sleep.  No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Most of the vaccine leaked; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Most of the vaccine leaked) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021 at 2:02 AM, 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 06-Apr-2021, the patient experienced UNDERDOSE (Most of the vaccine leaked). On 06-Apr-2021, UNDERDOSE (Most of the vaccine leaked) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter who was a Nurse was reporting on behalf of a patient who received their second dose of Moderna COVID19 Vaccine on 06-Apr-2021 at their clinic. The patient reported that most of the vaccine leaked down from their arm from the needle and felt like they didn't get the whole dose.  On 18-May-2021, Reportedly, the clinicians could not confirm more than half of the dose was administered and it was also reported that the patient returned for additional 2nd dose on 16-Apr-2021.  No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up was received on 18-May-2021. Added patient demographics. Added vaccine facility information. Updated anatomical location and description of the event.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Soreness in the arms; Nausea; Headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arms), NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in the arms), NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Soreness in the arms), NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was having nausea, headache, fever, chills, and soreness in their arms.  No Concomitant product use was reported. No treatment information was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia oral, Swollen tongue
Clinical narrative: swollen lips; swollen tongue; numb lips; numb tongue; This spontaneous case was reported by a nurse and describes the occurrence of LIP SWELLING (swollen lips), SWOLLEN TONGUE (swollen tongue), HYPOAESTHESIA ORAL (numb lips) and PARAESTHESIA ORAL (numb tongue) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for an unknown indication.     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) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced LIP SWELLING (swollen lips), SWOLLEN TONGUE (swollen tongue), HYPOAESTHESIA ORAL (numb lips) and PARAESTHESIA ORAL (numb tongue). At the time of the report, LIP SWELLING (swollen lips), SWOLLEN TONGUE (swollen tongue), HYPOAESTHESIA ORAL (numb lips) and PARAESTHESIA ORAL (numb tongue) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow up received on 14-APR-2021Included Reporter details , Age
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Started having nose bleeds; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Started having nose bleeds) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A.) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced EPISTAXIS (Started having nose bleeds). At the time of the report, EPISTAXIS (Started having nose bleeds) had not resolved.            On 05-Apr-2021, the patient received their second dose of the Moderna COVID-19 vaccine. On the next day, the patient began to have nose bleeds on the right side of their nose and reported that the patient never had nose bleeds before in their life. The patient also reported that the symptom was still ongoing.   Reportedly, the patient visited a physician who referred the patient to an ENT.   Concomitant medication reported included medication for blood pressure.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Explosive diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Explosive diarrhea) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced DIARRHOEA (Explosive diarrhea). At the time of the report, DIARRHOEA (Explosive diarrhea) had resolved.            No concomitant medication was reported.  The treatment information was unknown.  Patient took second dose but had no adverse event.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Outcome of the event and narrative was updated.