chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site itchy; injection site swelling; injection site sore to touch; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (injection site sore to touch) and VACCINATION SITE ERYTHEMA (injection site red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for COPD, LISINOPRIL, AMLODIPINE, ATENOLOL, ROSUVASTATIN, WARFARIN and ALPRAZOLAM for an unknown indication, SALBUTAMOL (VENTOLIN [SALBUTAMOL]).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (injection site sore to touch) and VACCINATION SITE ERYTHEMA (injection site red). At the time of the report, VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PAIN (injection site sore to touch) and VACCINATION SITE ERYTHEMA (injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Non-significant FU added.Fax Number Updated
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site nodule, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccination site gota nod; Injection site itching real bad; injection site swelled back up; Hot injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE NODULE (Vaccination site gota nod), VACCINATION SITE PRURITUS (Injection site itching real bad) and VACCINATION SITE SWELLING (injection site swelled back up) 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 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Injection site itching real bad) and VACCINATION SITE SWELLING (injection site swelled back up). On an unknown date, the patient experienced VACCINATION SITE NODULE (Vaccination site gota nod). At the time of the report, VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE NODULE (Vaccination site gota nod), VACCINATION SITE PRURITUS (Injection site itching real bad) and VACCINATION SITE SWELLING (injection site swelled back up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red around the injection site/spreading and getting bigger, but lighter in color; Swollen around the injection site/swelling is flattening; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red around the injection site/spreading and getting bigger, but lighter in color) and INJECTION SITE SWELLING (Swollen around the injection site/swelling is flattening) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Red around the injection site/spreading and getting bigger, but lighter in color) and INJECTION SITE SWELLING (Swollen around the injection site/swelling is flattening). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10 milligram once a day; HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at an unspecified dose and frequency; Steroid Pack (STEROIDS) at an unspecified dose and frequency and DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE [DOXYCYCLINE MONOHYDRATE]) for Infection, at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (Red around the injection site/spreading and getting bigger, but lighter in color) and INJECTION SITE SWELLING (Swollen around the injection site/swelling is flattening) outcome was unknown. 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.   Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: dizziness; tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FATIGUE (tired) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (tired) and HEADACHE (headache). On 28-Jan-2021, DIZZINESS (dizziness) and HEADACHE (headache) had resolved. At the time of the report, FATIGUE (tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Declined to provide information
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pyrexia
Clinical narrative: fever (102F); terrible chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever (102F)) and CHILLS (terrible chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Feb-2021, the patient experienced PYREXIA (fever (102F)) and CHILLS (terrible chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever (102F)) and CHILLS (terrible chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature increased: 102 (High) Patient had 102F fever..   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal discomfort
Clinical narrative: Sores inside nose; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (Sores inside nose) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergy to the flu vaccine).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced NASAL DISCOMFORT (Sores inside nose). At the time of the report, NASAL DISCOMFORT (Sores inside nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: NNI
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Heart rate, Heart rate increased
Clinical narrative: muscle weakness in her legs; pain in her legs; blood pressure shot up; pulse was high; queezy; dizziness; 4 inch diameter red rash; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), INJECTION SITE RASH (4 inch diameter red rash), MUSCULAR WEAKNESS (muscle weakness in her legs), PAIN IN EXTREMITY (pain in her legs) and BLOOD PRESSURE INCREASED (blood pressure shot up) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE, FENOFIBRATE and FEXOFENADINE for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE RASH (4 inch diameter red rash). On 29-Jan-2021, the patient experienced DIZZINESS (dizziness), MUSCULAR WEAKNESS (muscle weakness in her legs), PAIN IN EXTREMITY (pain in her legs), BLOOD PRESSURE INCREASED (blood pressure shot up), HEART RATE INCREASED (pulse was high) and NAUSEA (queezy). At the time of the report, DIZZINESS (dizziness), MUSCULAR WEAKNESS (muscle weakness in her legs), PAIN IN EXTREMITY (pain in her legs), BLOOD PRESSURE INCREASED (blood pressure shot up), HEART RATE INCREASED (pulse was high) and NAUSEA (queezy) outcome was unknown and INJECTION SITE RASH (4 inch diameter red rash) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Blood pressure measurement: 100/60 (High) Patient's blood pressure is around 100/60.. On 29-Jan-2021, Heart rate: 80 (High) Patient's pulse rate was around 80..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Muscular weakness, Nausea, Pain in extremity
Clinical narrative: muscle weakness in her legs; pain in her legs; blood pressure shot up; pulse was high; queezy; dizziness; 4 inch diameter red rash; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), INJECTION SITE RASH (4 inch diameter red rash), MUSCULAR WEAKNESS (muscle weakness in her legs), PAIN IN EXTREMITY (pain in her legs) and BLOOD PRESSURE INCREASED (blood pressure shot up) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE, FENOFIBRATE and FEXOFENADINE for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE RASH (4 inch diameter red rash). On 29-Jan-2021, the patient experienced DIZZINESS (dizziness), MUSCULAR WEAKNESS (muscle weakness in her legs), PAIN IN EXTREMITY (pain in her legs), BLOOD PRESSURE INCREASED (blood pressure shot up), HEART RATE INCREASED (pulse was high) and NAUSEA (queezy). At the time of the report, DIZZINESS (dizziness), MUSCULAR WEAKNESS (muscle weakness in her legs), PAIN IN EXTREMITY (pain in her legs), BLOOD PRESSURE INCREASED (blood pressure shot up), HEART RATE INCREASED (pulse was high) and NAUSEA (queezy) outcome was unknown and INJECTION SITE RASH (4 inch diameter red rash) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Blood pressure measurement: 100/60 (High) Patient's blood pressure is around 100/60.. On 29-Jan-2021, Heart rate: 80 (High) Patient's pulse rate was around 80..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: felt really tired; felt with no energy; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt really tired) and ASTHENIA (felt with no energy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FATIGUE (felt really tired). In February 2021, the patient experienced ASTHENIA (felt with no energy). On 06-Feb-2021, FATIGUE (felt really tired) had resolved. At the time of the report, ASTHENIA (felt with no energy) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Drug interaction
Clinical narrative: interactions between the vaccine and NSSRIs; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (interactions between the vaccine and NSSRIs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRUG INTERACTION (interactions between the vaccine and NSSRIs). At the time of the report, DRUG INTERACTION (interactions between the vaccine and NSSRIs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; Body pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and MYALGIA (Body pain) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Body pain). At the time of the report, PYREXIA (Fever) and MYALGIA (Body pain) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   It is reported that patient takes high blood pressure medication. Concomitant product use was not provided by the reporter.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Pain in the arm).   At the time of the report, VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Pain in the arm) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Really bad reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Really bad reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 VACCINATION COMPLICATION (Really bad reaction). At the time of the report, VACCINATION COMPLICATION (Really bad reaction) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Side effect NOS; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effect NOS) 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 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Feb-2021, the patient experienced ADVERSE EVENT (Side effect NOS).   At the time of the report, ADVERSE EVENT (Side effect NOS) outcome was unknown. Not Provided    Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: nausea; dizziness; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), DIZZINESS (dizziness) and VOMITING (vomiting) 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 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced NAUSEA (nausea), DIZZINESS (dizziness) and VOMITING (vomiting). At the time of the report, NAUSEA (nausea), DIZZINESS (dizziness) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; 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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rhinorrhoea, Sneezing
Clinical narrative: reports sneezing; runny nose; little tired; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (reports sneezing), RHINORRHOEA (runny nose) and FATIGUE (little tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced SNEEZING (reports sneezing), RHINORRHOEA (runny nose) and FATIGUE (little tired). At the time of the report, SNEEZING (reports sneezing), RHINORRHOEA (runny nose) and FATIGUE (little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided. It is reported that patient does not think events are related to the vaccine because her daughter who lives with her has a sinus infection and believes this is the problem.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: nausea; vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 09-Feb-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever).   At the time of the report, NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash around the injection site). At the time of the report, VACCINATION SITE RASH (Rash around the injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact  Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: NNI
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swollen (area at the injection site); Vccination site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen (area at the injection site)) and VACCINATION SITE ERYTHEMA (Vccination site red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 06-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swollen (area at the injection site)) and VACCINATION SITE ERYTHEMA (Vccination site red). The patient was treated with PARACETAMOL (PANADOL) at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE SWELLING (swollen (area at the injection site)) and VACCINATION SITE ERYTHEMA (Vccination site red) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Dysgeusia, Paraesthesia
Clinical narrative: Possible tingling on the side of my tongue; Dizzy; An extremely dry mouth with significant taste of metal; Significant taste of metal; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Possible tingling on the side of my tongue), DIZZINESS (Dizzy), DRY MOUTH (An extremely dry mouth with significant taste of metal) and DYSGEUSIA (Significant taste of metal) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Possible tingling on the side of my tongue), DIZZINESS (Dizzy), DRY MOUTH (An extremely dry mouth with significant taste of metal) and DYSGEUSIA (Significant taste of metal). At the time of the report, PARAESTHESIA (Possible tingling on the side of my tongue), DIZZINESS (Dizzy), DRY MOUTH (An extremely dry mouth with significant taste of metal) and DYSGEUSIA (Significant taste of metal) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No treatment medication were provided.  No concomitant medication information was provided.   This case was linked to MOD-2021-244897 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up information received on 02-Jul-2021 contains second dose administration details.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: body aches; felt woozy; Headaches/headache is worse; diarrhea; vomiting; chills; body aches; Headaches; nauseated; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), the second episode of PAIN (body aches), the first episode of PAIN (body aches), DIZZINESS (felt woozy) and AXILLARY PAIN (sore arm) 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.     The patient's past medical history included Lymphoma in 2008, Lymphoma in 2012 and Stem cell transplant (Patient had stem cell transplant of her own cells.) on 29-Nov-2012.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced AXILLARY PAIN (sore arm). On 29-Jan-2021, the patient experienced NAUSEA (nauseated). On 30-Jan-2021, the patient experienced the first episode of PAIN (body aches), CHILLS (chills) and HEADACHE (Headaches). On 30-Jan-2021 at 2:30 AM, the patient experienced DIARRHOEA (diarrhea) and VOMITING (vomiting). On 31-Jan-2021, the patient experienced the second episode of PAIN (body aches), DIZZINESS (felt woozy) and HEADACHE (Headaches/headache is worse). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at an unspecified dose and frequency; KAOLIN, NEOMYCIN SULFATE, PECTIN (KAOPECTATE [KAOLIN;NEOMYCIN SULFATE;PECTIN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Jan-2021 at 6:30 AM, DIARRHOEA (diarrhea) and VOMITING (vomiting) had resolved. At the time of the report, last episode of PAIN (body aches), AXILLARY PAIN (sore arm), NAUSEA (nauseated), CHILLS (chills), HEADACHE (Headaches/headache is worse) and HEADACHE (Headaches) was resolving and DIZZINESS (felt woozy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-027499 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: body aches; felt woozy; Headaches/headache is worse; diarrhea; vomiting; chills; body aches; Headaches; nauseated; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), the second episode of PAIN (body aches), the first episode of PAIN (body aches), DIZZINESS (felt woozy) and AXILLARY PAIN (sore arm) 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.     The patient's past medical history included Lymphoma in 2008, Lymphoma in 2012 and Stem cell transplant (Patient had stem cell transplant of her own cells.) on 29-Nov-2012.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced AXILLARY PAIN (sore arm). On 29-Jan-2021, the patient experienced NAUSEA (nauseated). On 30-Jan-2021, the patient experienced the first episode of PAIN (body aches), CHILLS (chills) and HEADACHE (Headaches). On 30-Jan-2021 at 2:30 AM, the patient experienced DIARRHOEA (diarrhea) and VOMITING (vomiting). On 31-Jan-2021, the patient experienced the second episode of PAIN (body aches), DIZZINESS (felt woozy) and HEADACHE (Headaches/headache is worse). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at an unspecified dose and frequency; KAOLIN, NEOMYCIN SULFATE, PECTIN (KAOPECTATE [KAOLIN;NEOMYCIN SULFATE;PECTIN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Jan-2021 at 6:30 AM, DIARRHOEA (diarrhea) and VOMITING (vomiting) had resolved. At the time of the report, last episode of PAIN (body aches), AXILLARY PAIN (sore arm), NAUSEA (nauseated), CHILLS (chills), HEADACHE (Headaches/headache is worse) and HEADACHE (Headaches) was resolving and DIZZINESS (felt woozy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-027499 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching; Headache; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Redness) 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PRURITUS (Itching), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Redness). On 01-Feb-2021, VACCINATION SITE PRURITUS (Itching), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Redness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.   Reporter did not allow further contact; 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.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, Urticaria
Clinical narrative: Itchy and uncomfortable; Raised hives on the stomach, arms, and eyelids; Elbows felt itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Elbows felt itchy), FEELING ABNORMAL (Itchy and uncomfortable) and URTICARIA (Raised hives on the stomach, arms, and eyelids) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 31-Jan-2021, the patient experienced PRURITUS (Elbows felt itchy).   On 01-Feb-2021, the patient experienced FEELING ABNORMAL (Itchy and uncomfortable) and URTICARIA (Raised hives on the stomach, arms, and eyelids). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency.   On 02-Feb-2021, PRURITUS (Elbows felt itchy), FEELING ABNORMAL (Itchy and uncomfortable) and URTICARIA (Raised hives on the stomach, arms, and eyelids) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Side effects that I had after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects that I had after the first shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On an unknown date, the patient experienced ADVERSE EVENT (Side effects that I had after the first shot).   At the time of the report, ADVERSE EVENT (Side effects that I had after the first shot) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction
Clinical narrative: it says detected, which means positive, on the nasal swab; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (it says detected, which means positive, on the nasal swab) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced COVID-19 (it says detected, which means positive, on the nasal swab). At the time of the report, COVID-19 (it says detected, which means positive, on the nasal swab) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Polymerase chain reaction: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Fever; Nausea; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Bad headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 09-Feb-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Bad headache).   At the time of the report, PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Bad headache) outcome was unknown. Not Provided    Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (sore arm) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 28-Jan-2021, the patient experienced AXILLARY PAIN (sore arm). At the time of the report, AXILLARY PAIN (sore arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-027492 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced COVID-19 (Tested positive). At the time of the report, COVID-19 (Tested positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Very limited information regarding this event has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Problems from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Problems from the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION COMPLICATION (Problems from the vaccine).   At the time of the report, VACCINATION COMPLICATION (Problems from the vaccine) had resolved.      Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 77.0
Sex: M
Vaccine: UNK
Symptoms: Dysarthria, Nausea, Somnolence
Clinical narrative: Slept a lot; Slurring when he spoke; Felt nauseated; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept a lot), DYSARTHRIA (Slurring when he spoke) and NAUSEA (Felt nauseated) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease. Concomitant products included AMANTADINE, PREGABALIN, AMITRIPTYLINE, CARBIDOPA and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced SOMNOLENCE (Slept a lot), DYSARTHRIA (Slurring when he spoke) and NAUSEA (Felt nauseated). On 05-May-2021, SOMNOLENCE (Slept a lot), DYSARTHRIA (Slurring when he spoke) and NAUSEA (Felt nauseated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: TCR : Outcome of event resolved.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: injection site got red and was about size of a hand print; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site got red and was about size of a hand print) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included TESTOSTERONE, ATORVASTATIN CALCIUM (LIPITOR), LEUPRORELIN ACETATE (LUPRON), BICALUTAMIDE (CASODEX), RIVAROXABAN (XARELTO) and FINASTERIDE (PROSCAR) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site got red and was about size of a hand print). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Jan-2021, INJECTION SITE ERYTHEMA (injection site got red and was about size of a hand print) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Non significant follow up
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Nasal congestion
Clinical narrative: Could not sleep secondary to Headaches; Terrible Headaches mostly on the back of the head close to the left ear; a little congested; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep secondary to Headaches), HEADACHE (Terrible Headaches mostly on the back of the head close to the left ear) and NASAL CONGESTION (a little congested) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 28-Jan-2021, the patient experienced INSOMNIA (Could not sleep secondary to Headaches), HEADACHE (Terrible Headaches mostly on the back of the head close to the left ear) and NASAL CONGESTION (a little congested). The patient was treated with MUSCLE RELAXANTS for Sleep problem, at an unspecified dose and frequency; IBUPROFEN for Headache, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Nasal congestion, at an unspecified dose and frequency.   At the time of the report, INSOMNIA (Could not sleep secondary to Headaches), HEADACHE (Terrible Headaches mostly on the back of the head close to the left ear) and NASAL CONGESTION (a little congested) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Hardness on the area of the injection; Swelling on the area of injection; Redness (around 2 inches in diameter); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness on the area of the injection), VACCINATION SITE SWELLING (Swelling on the area of injection) and VACCINATION SITE ERYTHEMA (Redness (around 2 inches in diameter)) 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 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On an unknown date, the patient experienced VACCINATION SITE INDURATION (Hardness on the area of the injection), VACCINATION SITE SWELLING (Swelling on the area of injection) and VACCINATION SITE ERYTHEMA (Redness (around 2 inches in diameter)).   At the time of the report, VACCINATION SITE INDURATION (Hardness on the area of the injection), VACCINATION SITE SWELLING (Swelling on the area of injection) and VACCINATION SITE ERYTHEMA (Redness (around 2 inches in diameter)) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Flushing, Headache
Clinical narrative: Fever; Feeling warm; Flushed; Headache; Chills; Swelling at the injection site; Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling warm), FLUSHING (Flushed), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Glaucoma, Asthma and Allergy.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced FEELING HOT (Feeling warm), FLUSHING (Flushed), HEADACHE (Headache), CHILLS (Chills), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at injection site). On 09-Feb-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) from 08-Feb-2021 to 09-Feb-2021 for Headache and Fever, at a dose of 1 dosage form. On 10-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, FEELING HOT (Feeling warm), FLUSHING (Flushed), HEADACHE (Headache) and CHILLS (Chills) was resolving and VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 100.8 (Inconclusive) 100.8F. On 09-Feb-2021, Body temperature: 100.1 (Inconclusive) 100.1F.         The concomitant medication included blood pressure medication, glaucoma eye drops, asthma medication and allergy medication. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: Patient history were added. The concomitant medication details added.The product first dose details was added. The event outcome of feeling hot, flushing, headache and chills were updated to resolving and the treatment information updated.