chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Syringe issue, Wrong technique in device usage process
Clinical narrative: A spontaneous report was received  from a other health care professional  concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced to receive her 1st dose but she states that immediately the vaccine and syringe broke and the liquid splashed all over her arm, she didn't feel nothing, didn't feel any puncture and she claims she didn't receive any vaccine at all. As provided by the reporter the patient does not have medical history. No concomitant medication reported. On 18 MAR 2021 , the patient received their first of first planned doses of mRNA-1273 (Lot number: 045A21A) was administered intramuscularly via unknown site for prophylaxis of COVID-19 infection. On  18 MAR 2021, After  receiving mRNA-1273, the patient experienced to receive her first dose but she states that immediately the vaccine and syringe broke and the liquid splashed all over her arm, she didn't feel nothing, didn't feel any puncture and she claims she didn't receive any vaccine at all.  Action taken with mRNA-1273 in response to the events was not reported. The event(s) immediately the vaccine and syringe broke and the liquid splashed all over her arm, she didn't feel nothing, didn't feel any puncture and she claims she didn't receive any vaccine at all were resolved on 18 Mar 2021.; Reporter's Comments: This report refers to a case of Accidental underdose, Syringe issue, Wrong technique in device usage process for mRNA-1273, lot # 045A21A  with no associated Adverse Events.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Nausea
Clinical narrative: gastro-enteric problem; slight nausea upon waking up; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (gastro-enteric problem) and NAUSEA (slight nausea upon waking up) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 022M20A) 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) (unknown route) 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 13-Mar-2021, the patient experienced GASTROINTESTINAL DISORDER (gastro-enteric problem) and NAUSEA (slight nausea upon waking up). At the time of the report, GASTROINTESTINAL DISORDER (gastro-enteric problem) and NAUSEA (slight nausea upon waking up) outcome was unknown.            No concomitant information was reported.  No treatment information was reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Throughout the week, itching and redness is spreading around the arm; Throughout the week, itching and redness is spreading around the arm; After 8 days, her arm started itching, swollen, hard at injection site.; After 8 days, her arm started itching, swollen, hard at injection site.; After 8 days, her arm started itching, swollen, hard at injection site.; Next day, her arm was sore and she was fine next day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Next day, her arm was sore and she was fine next day), ERYTHEMA (Throughout the week, itching and redness is spreading around the arm), PRURITUS (Throughout the week, itching and redness is spreading around the arm), VACCINATION SITE INDURATION (After 8 days, her arm started itching, swollen, hard at injection site.) and VACCINATION SITE PRURITUS (After 8 days, her arm started itching, swollen, hard at injection site.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Next day, her arm was sore and she was fine next day). On 15-Mar-2021, the patient experienced VACCINATION SITE INDURATION (After 8 days, her arm started itching, swollen, hard at injection site.), VACCINATION SITE PRURITUS (After 8 days, her arm started itching, swollen, hard at injection site.) and VACCINATION SITE SWELLING (After 8 days, her arm started itching, swollen, hard at injection site.). On 19-Mar-2021, the patient experienced ERYTHEMA (Throughout the week, itching and redness is spreading around the arm) and PRURITUS (Throughout the week, itching and redness is spreading around the arm). On 09-Mar-2021, PAIN IN EXTREMITY (Next day, her arm was sore and she was fine next day) had resolved. At the time of the report, ERYTHEMA (Throughout the week, itching and redness is spreading around the arm), PRURITUS (Throughout the week, itching and redness is spreading around the arm), VACCINATION SITE INDURATION (After 8 days, her arm started itching, swollen, hard at injection site.), VACCINATION SITE PRURITUS (After 8 days, her arm started itching, swollen, hard at injection site.) and VACCINATION SITE SWELLING (After 8 days, her arm started itching, swollen, hard at injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included High blood pressure medicines. Treatment medication included Anti-itching cream.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Throughout the week, itching and redness is spreading around the arm; Throughout the week, itching and redness is spreading around the arm; After 8 days, her arm started itching, swollen, hard at injection site.; After 8 days, her arm started itching, swollen, hard at injection site.; After 8 days, her arm started itching, swollen, hard at injection site.; Next day, her arm was sore and she was fine next day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Next day, her arm was sore and she was fine next day), ERYTHEMA (Throughout the week, itching and redness is spreading around the arm), PRURITUS (Throughout the week, itching and redness is spreading around the arm), VACCINATION SITE INDURATION (After 8 days, her arm started itching, swollen, hard at injection site.) and VACCINATION SITE PRURITUS (After 8 days, her arm started itching, swollen, hard at injection site.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Next day, her arm was sore and she was fine next day). On 15-Mar-2021, the patient experienced VACCINATION SITE INDURATION (After 8 days, her arm started itching, swollen, hard at injection site.), VACCINATION SITE PRURITUS (After 8 days, her arm started itching, swollen, hard at injection site.) and VACCINATION SITE SWELLING (After 8 days, her arm started itching, swollen, hard at injection site.). On 19-Mar-2021, the patient experienced ERYTHEMA (Throughout the week, itching and redness is spreading around the arm) and PRURITUS (Throughout the week, itching and redness is spreading around the arm). On 09-Mar-2021, PAIN IN EXTREMITY (Next day, her arm was sore and she was fine next day) had resolved. At the time of the report, ERYTHEMA (Throughout the week, itching and redness is spreading around the arm), PRURITUS (Throughout the week, itching and redness is spreading around the arm), VACCINATION SITE INDURATION (After 8 days, her arm started itching, swollen, hard at injection site.), VACCINATION SITE PRURITUS (After 8 days, her arm started itching, swollen, hard at injection site.) and VACCINATION SITE SWELLING (After 8 days, her arm started itching, swollen, hard at injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included High blood pressure medicines. Treatment medication included Anti-itching cream.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Derealisation, Eye pain, Head discomfort, Headache
Clinical narrative: looks like a freak; lips have blown up; outside around her eyes (face) are tender; head was in a vice grip; all of the common side effects; couldn't move her left arm; headache; shooting pain headaches; painful left arm; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful left arm), LIP SWELLING (lips have blown up), MOBILITY DECREASED (couldn't move her left arm), DEREALISATION (looks like a freak) and ASTHENIA (all of the common side effects) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Asthma. Concomitant products included LIOTHYRONINE SODIUM (CYTOMEL) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left arm). On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (painful left arm). On 10-Feb-2021, the patient experienced MOBILITY DECREASED (couldn't move her left arm), HEADACHE (headache) and HEADACHE (shooting pain headaches). On 10-Feb-2021 at 10:00 PM, the patient experienced ASTHENIA (all of the common side effects) and HEAD DISCOMFORT (head was in a vice grip). On 11-Feb-2021, the patient experienced LIP SWELLING (lips have blown up) and EYE PAIN (outside around her eyes (face) are tender). On an unknown date, the patient experienced DEREALISATION (looks like a freak). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Fever, at a dose of 1 dosage form. On 16-Jan-2021, VACCINATION SITE PAIN (sore left arm) had resolved. On 11-Feb-2021, PAIN IN EXTREMITY (painful left arm) and MOBILITY DECREASED (couldn't move her left arm) had resolved. At the time of the report, LIP SWELLING (lips have blown up), DEREALISATION (looks like a freak), ASTHENIA (all of the common side effects), EYE PAIN (outside around her eyes (face) are tender), HEAD DISCOMFORT (head was in a vice grip), HEADACHE (headache) and HEADACHE (shooting pain headaches) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Non-significant Follow up Appended - Reporter mail address updated
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Mobility decreased, Pain in extremity, Vaccination site pain
Clinical narrative: looks like a freak; lips have blown up; outside around her eyes (face) are tender; head was in a vice grip; all of the common side effects; couldn't move her left arm; headache; shooting pain headaches; painful left arm; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful left arm), LIP SWELLING (lips have blown up), MOBILITY DECREASED (couldn't move her left arm), DEREALISATION (looks like a freak) and ASTHENIA (all of the common side effects) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Asthma. Concomitant products included LIOTHYRONINE SODIUM (CYTOMEL) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left arm). On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (painful left arm). On 10-Feb-2021, the patient experienced MOBILITY DECREASED (couldn't move her left arm), HEADACHE (headache) and HEADACHE (shooting pain headaches). On 10-Feb-2021 at 10:00 PM, the patient experienced ASTHENIA (all of the common side effects) and HEAD DISCOMFORT (head was in a vice grip). On 11-Feb-2021, the patient experienced LIP SWELLING (lips have blown up) and EYE PAIN (outside around her eyes (face) are tender). On an unknown date, the patient experienced DEREALISATION (looks like a freak). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Fever, at a dose of 1 dosage form. On 16-Jan-2021, VACCINATION SITE PAIN (sore left arm) had resolved. On 11-Feb-2021, PAIN IN EXTREMITY (painful left arm) and MOBILITY DECREASED (couldn't move her left arm) had resolved. At the time of the report, LIP SWELLING (lips have blown up), DEREALISATION (looks like a freak), ASTHENIA (all of the common side effects), EYE PAIN (outside around her eyes (face) are tender), HEAD DISCOMFORT (head was in a vice grip), HEADACHE (headache) and HEADACHE (shooting pain headaches) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Non-significant Follow up Appended - Reporter mail address updated
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Severe Itching over rash sites; Rash over scalp,neck and ears; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Severe Itching over rash sites) and RASH (Rash over scalp,neck and ears) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023V20A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced RASH PRURITIC (Severe Itching over rash sites) and RASH (Rash over scalp,neck and ears). At the time of the report, RASH PRURITIC (Severe Itching over rash sites) and RASH (Rash over scalp,neck and ears) outcome was unknown.            Treatment information not provided. No concomitant information was reported.   This case was linked to MOD-2021-103111 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Fatigue; Headache; Fever; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Fever) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020 and Fatigue (Experienced for 2 weeks and thought that he might have been infected) in March 2020.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN (Soreness). On 17-Jan-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Fever). On 18-Jan-2021, PAIN (Soreness), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 antibody test: positive (Positive) Positive.         No concomitant and treatment medications were reported.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-020728 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up information received on 22-JUN-2021 contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Swelling
Clinical narrative: Headache; Mild pain; Fever; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN (Mild pain), PYREXIA (Fever) and SWELLING (Swelling) 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 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (Headache), PAIN (Mild pain), PYREXIA (Fever) and SWELLING (Swelling). At the time of the report, HEADACHE (Headache), PAIN (Mild pain), PYREXIA (Fever) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: Diarrhea 2 weeks after second dose; Headache after second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea 2 weeks after second dose) and HEADACHE (Headache after second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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 DIARRHOEA (Diarrhea 2 weeks after second dose) and HEADACHE (Headache after second dose). At the time of the report, DIARRHOEA (Diarrhea 2 weeks after second dose) and HEADACHE (Headache after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information provided. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up does not contain any new information.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness postural, Feeling of body temperature change, Musculoskeletal discomfort, Myalgia
Clinical narrative: hot/cold sensation; back is bothering her; dizzy when getting up from a chair; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (hot/cold sensation), MUSCULOSKELETAL DISCOMFORT (back is bothering her), DIZZINESS POSTURAL (dizzy when getting up from a chair), MYALGIA (body aches) and CHILLS (chills) in a 78-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 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (hot/cold sensation), MUSCULOSKELETAL DISCOMFORT (back is bothering her), DIZZINESS POSTURAL (dizzy when getting up from a chair), MYALGIA (body aches) and CHILLS (chills). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (hot/cold sensation), MUSCULOSKELETAL DISCOMFORT (back is bothering her), DIZZINESS POSTURAL (dizzy when getting up from a chair), MYALGIA (body aches) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.  Benadryl is used as treatment medication.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient) in a 42-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Cramp (Light cramping during this pregnancy) and Spotting vaginal (Spotting during this pregnancy). Concurrent medical conditions included Drug allergy (The patient is sensitive to codeine.). Concomitant products included FISH OIL and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 28-Jan-2021 and the estimated date of delivery was 04-Nov-2021. On 24-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 24-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood test: normal (normal) Everything was normal. On an unknown date, Ultrasound scan: normal (normal) Everything looked normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  The estimated date of conception was on 10-Feb-2021.  Pregnancy history:  Pregnancy date: 02-Aug-2019, Outcome: Live birth. Pregnancy date: 30-Sep-2020, Outcome: Miscarriage.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16-year-old received vaccine; A spontaneous report was received from a  nurse concerning a 16-year-old male patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was congenital disorder. Concomitant history was not provided by the reporter.   On 09 Mar 2021, The patient received their first of two planned doses of mRNA-1273 (Lot number: 030A21A) intramuscularly in left deltoid  for prophylaxis of COVID-19 infection .  On 09 Mar 2021, a 16-year-old, received the Moderna COVID-19 vaccine.   The treatment history was not provided.  The Action taken with the first dose of mRNA-1273 in response to the event was not applicable.  The outcome of event, 16-year-old received vaccine/inappropriate age of vaccine administration, was considered resolved on 09 Mar 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old male) for mRNA-1273 (lot number 030A21A) with no associated AEs reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Injection site erythema, Injection site swelling
Clinical narrative: Both eyes blew up swollen; Slight Swelling at the injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Both eyes blew up swollen), INJECTION SITE SWELLING (Slight Swelling at the injection site) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy, Allergy to nuts (Patient is allergic to peanuts,), Drug allergy (Patient is allergic to sulfite.) and Latex allergy (Patient is allergic to latex.). Concomitant products included AMLODIPINE, METOPROLOL TARTRATE (METOPROLOL - 1 A PHARMA), CLOPIDOGREL, ROSUVASTATIN and RANOLAZINE (RANOLAZINE EXTENDED RELEASE) for an unknown indication.   On 08-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021 at 10:30 AM, 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 EYE SWELLING (Both eyes blew up swollen), INJECTION SITE SWELLING (Slight Swelling at the injection site) and INJECTION SITE ERYTHEMA (Redness at injection site). The patient was treated with OMEPRAZOLE ongoing since an unknown date at a dose of 40 mg; NITROGLYCERIN ongoing since an unknown date at a dose of 0.4 mg and OLOPATADINE ongoing since an unknown date at a dose of 0.2 %. At the time of the report, EYE SWELLING (Both eyes blew up swollen) had resolved and INJECTION SITE SWELLING (Slight Swelling at the injection site) and INJECTION SITE ERYTHEMA (Redness at injection site) outcome was unknown.            Concomitant medicines include Amlodipine, Metoprolol, Clopidogrel, Ranolazadine, Rosuvastatin.  Treatment information were olopatadine 0.2 %  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: ADR Form- Updated contact information , moderna vaccine information , treatment medication , event tab changes was done .
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Oral herpes
Clinical narrative: Cold sore on left lip; Low grade temperature; Chills; Fatigue; Headache; Dizziness/ Light headedness/ Woozy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade temperature), DIZZINESS (Dizziness/ Light headedness/ Woozy), HEADACHE (Headache), ORAL HERPES (Cold sore on left lip) and CHILLS (Chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (Dizziness/ Light headedness/ Woozy) and HEADACHE (Headache). On 07-Mar-2021, the patient experienced PYREXIA (Low grade temperature), CHILLS (Chills) and FATIGUE (Fatigue). On 13-Mar-2021, the patient experienced ORAL HERPES (Cold sore on left lip). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (Low grade temperature), DIZZINESS (Dizziness/ Light headedness/ Woozy), HEADACHE (Headache), ORAL HERPES (Cold sore on left lip), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Cold sore on left lip; Low grade temperature; Chills; Fatigue; Headache; Dizziness/ Light headedness/ Woozy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade temperature), DIZZINESS (Dizziness/ Light headedness/ Woozy), HEADACHE (Headache), ORAL HERPES (Cold sore on left lip) and CHILLS (Chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (Dizziness/ Light headedness/ Woozy) and HEADACHE (Headache). On 07-Mar-2021, the patient experienced PYREXIA (Low grade temperature), CHILLS (Chills) and FATIGUE (Fatigue). On 13-Mar-2021, the patient experienced ORAL HERPES (Cold sore on left lip). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (Low grade temperature), DIZZINESS (Dizziness/ Light headedness/ Woozy), HEADACHE (Headache), ORAL HERPES (Cold sore on left lip), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided by the reporter.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Rash erythematous
Clinical narrative: 5 Swollen red spots in the armpit; Pain and swelling at injection site; Pain and swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (5 Swollen red spots in the armpit), INJECTION SITE SWELLING (Pain and swelling at injection site) and INJECTION SITE PAIN (Pain and swelling at injection site) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 18-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 RASH ERYTHEMATOUS (5 Swollen red spots in the armpit), INJECTION SITE SWELLING (Pain and swelling at injection site) and INJECTION SITE PAIN (Pain and swelling at injection site). At the time of the report, RASH ERYTHEMATOUS (5 Swollen red spots in the armpit), INJECTION SITE SWELLING (Pain and swelling at injection site) and INJECTION SITE PAIN (Pain and swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included migraine prevention medicine once a month.  No treatment details were provided
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: tested positive for covid; temp; chills; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid), PYREXIA (temp), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced COVID-19 (tested positive for covid), PYREXIA (temp), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, COVID-19 (tested positive for covid), PYREXIA (temp), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive for covid; temp; chills; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid), PYREXIA (temp), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced COVID-19 (tested positive for covid), PYREXIA (temp), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, COVID-19 (tested positive for covid), PYREXIA (temp), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Vomiting
Clinical narrative: Dizziness; Weakness; Diarrhea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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 DIZZINESS (Dizziness), ASTHENIA (Weakness), DIARRHOEA (Diarrhea) and VOMITING (Vomiting). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dyspnoea, Fatigue, Illness
Clinical narrative: felt sick; tired; wheezing in her chest; feels weak; has to catch her breath; a little bit of a cough; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick), FATIGUE (tired), WHEEZING (wheezing in her chest), ASTHENIA (feels weak) and DYSPNOEA (has to catch her breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ILLNESS (felt sick), FATIGUE (tired), WHEEZING (wheezing in her chest), ASTHENIA (feels weak), DYSPNOEA (has to catch her breath) and COUGH (a little bit of a cough). At the time of the report, ILLNESS (felt sick), FATIGUE (tired), ASTHENIA (feels weak), DYSPNOEA (has to catch her breath) and COUGH (a little bit of a cough) outcome was unknown and WHEEZING (wheezing in her chest) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: felt sick; tired; wheezing in her chest; feels weak; has to catch her breath; a little bit of a cough; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick), FATIGUE (tired), WHEEZING (wheezing in her chest), ASTHENIA (feels weak) and DYSPNOEA (has to catch her breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ILLNESS (felt sick), FATIGUE (tired), WHEEZING (wheezing in her chest), ASTHENIA (feels weak), DYSPNOEA (has to catch her breath) and COUGH (a little bit of a cough). At the time of the report, ILLNESS (felt sick), FATIGUE (tired), ASTHENIA (feels weak), DYSPNOEA (has to catch her breath) and COUGH (a little bit of a cough) outcome was unknown and WHEEZING (wheezing in her chest) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: lump in my arm that wont go down; lump kept growing and growing at the site of injection; Hard; Big, round like base ball; Red; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump in my arm that wont go down), VACCINATION SITE MASS (lump kept growing and growing at the site of injection), VACCINATION SITE INDURATION (Hard), VACCINATION SITE SWELLING (Big, round like base ball) and VACCINATION SITE ERYTHEMA (Red) in a 44-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 09-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 VACCINATION SITE MASS (lump in my arm that wont go down), VACCINATION SITE MASS (lump kept growing and growing at the site of injection), VACCINATION SITE INDURATION (Hard), VACCINATION SITE SWELLING (Big, round like base ball), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, VACCINATION SITE MASS (lump in my arm that wont go down), VACCINATION SITE MASS (lump kept growing and growing at the site of injection), VACCINATION SITE INDURATION (Hard), VACCINATION SITE SWELLING (Big, round like base ball), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PRURITUS (Itchy) 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 details was reported. No treatment medication details was reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back ache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back ache) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M201A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced BACK PAIN (back ache). At the time of the report, BACK PAIN (back ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. Treatment details included chronic back ache.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Gastrointestinal sounds abnormal, Nausea, Vomiting
Clinical narrative: Convolution below stomach; Diarrhea; Vomiting; Queasy feelings; Rumbles in Tummy; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL SOUNDS ABNORMAL (Rumbles in Tummy), ABDOMINAL DISCOMFORT (Convolution below stomach), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and NAUSEA (Queasy feelings) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced GASTROINTESTINAL SOUNDS ABNORMAL (Rumbles in Tummy) and DIARRHOEA (Diarrhea). 18-Mar-2021, the patient experienced VOMITING (Vomiting) and NAUSEA (Queasy feelings). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Convolution below stomach). At the time of the report, GASTROINTESTINAL SOUNDS ABNORMAL (Rumbles in Tummy), ABDOMINAL DISCOMFORT (Convolution below stomach), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and NAUSEA (Queasy feelings) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported  No treatment medication was reported  In the second follow up it was reported that all the symptoms had settled within one day and patient  had the second dose of vaccine  without any issues   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Event added, event intensity updated On 03-Jun-2021: Second dose details provided, outcome of the event updated
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dizziness, Fatigue
Clinical narrative: fatigue; loss of appetite; headache; diarrhea; nausea; vomiting; dizziness; muscle pain; tingling in hands and feet; fever; fast heartrate; hot; cold; tremors; weakness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DECREASED APPETITE (loss of appetite), HEADACHE (headache), DIARRHOEA (diarrhea) and NAUSEA (nausea) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (fatigue), DECREASED APPETITE (loss of appetite), HEADACHE (headache), DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting), DIZZINESS (dizziness), MYALGIA (muscle pain), PARAESTHESIA (tingling in hands and feet), PYREXIA (fever), TACHYCARDIA (fast heartrate), FEELING HOT (hot), NASOPHARYNGITIS (cold), TREMOR (tremors) and ASTHENIA (weakness). At the time of the report, FATIGUE (fatigue), DECREASED APPETITE (loss of appetite), HEADACHE (headache), DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting), DIZZINESS (dizziness), MYALGIA (muscle pain), PARAESTHESIA (tingling in hands and feet), PYREXIA (fever), TACHYCARDIA (fast heartrate), FEELING HOT (hot), NASOPHARYNGITIS (cold), TREMOR (tremors) and ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Myalgia, Nasopharyngitis, Nausea
Clinical narrative: fatigue; loss of appetite; headache; diarrhea; nausea; vomiting; dizziness; muscle pain; tingling in hands and feet; fever; fast heartrate; hot; cold; tremors; weakness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DECREASED APPETITE (loss of appetite), HEADACHE (headache), DIARRHOEA (diarrhea) and NAUSEA (nausea) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (fatigue), DECREASED APPETITE (loss of appetite), HEADACHE (headache), DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting), DIZZINESS (dizziness), MYALGIA (muscle pain), PARAESTHESIA (tingling in hands and feet), PYREXIA (fever), TACHYCARDIA (fast heartrate), FEELING HOT (hot), NASOPHARYNGITIS (cold), TREMOR (tremors) and ASTHENIA (weakness). At the time of the report, FATIGUE (fatigue), DECREASED APPETITE (loss of appetite), HEADACHE (headache), DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting), DIZZINESS (dizziness), MYALGIA (muscle pain), PARAESTHESIA (tingling in hands and feet), PYREXIA (fever), TACHYCARDIA (fast heartrate), FEELING HOT (hot), NASOPHARYNGITIS (cold), TREMOR (tremors) and ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Tachycardia, Tremor, Vomiting
Clinical narrative: fatigue; loss of appetite; headache; diarrhea; nausea; vomiting; dizziness; muscle pain; tingling in hands and feet; fever; fast heartrate; hot; cold; tremors; weakness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DECREASED APPETITE (loss of appetite), HEADACHE (headache), DIARRHOEA (diarrhea) and NAUSEA (nausea) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (fatigue), DECREASED APPETITE (loss of appetite), HEADACHE (headache), DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting), DIZZINESS (dizziness), MYALGIA (muscle pain), PARAESTHESIA (tingling in hands and feet), PYREXIA (fever), TACHYCARDIA (fast heartrate), FEELING HOT (hot), NASOPHARYNGITIS (cold), TREMOR (tremors) and ASTHENIA (weakness). At the time of the report, FATIGUE (fatigue), DECREASED APPETITE (loss of appetite), HEADACHE (headache), DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting), DIZZINESS (dizziness), MYALGIA (muscle pain), PARAESTHESIA (tingling in hands and feet), PYREXIA (fever), TACHYCARDIA (fast heartrate), FEELING HOT (hot), NASOPHARYNGITIS (cold), TREMOR (tremors) and ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.