chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: Sore left arm; Rash on belly below breast; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on belly below breast) and VACCINATION SITE PAIN (Sore left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced RASH (Rash on belly below breast). On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). At the time of the report, RASH (Rash on belly below breast) and VACCINATION SITE PAIN (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information include medication for thyroid and anxiety Treatment information not provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: red rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (red rash at injection site) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (red rash at injection site). At the time of the report, VACCINATION SITE RASH (red rash at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dysphonia, Fatigue, Headache
Clinical narrative: felt lightheaded; shoulders ache; hoarse throat; tired; headache; nausea; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt lightheaded), ARTHRALGIA (shoulders ache), DYSPHONIA (hoarse throat), FATIGUE (tired) and HEADACHE (headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (erythromycin) and Penicillin allergy.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (headache), NAUSEA (nausea) and PAIN (body aches). On an unknown date, the patient experienced DIZZINESS (felt lightheaded), ARTHRALGIA (shoulders ache), DYSPHONIA (hoarse throat) and FATIGUE (tired). At the time of the report, DIZZINESS (felt lightheaded), ARTHRALGIA (shoulders ache), DYSPHONIA (hoarse throat), FATIGUE (tired), HEADACHE (headache), NAUSEA (nausea) and PAIN (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative.   Action taken with mRNA-1273 in response to the events was not applicable     No concomitant medication provided no treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: FU received on 08-May-2021. Updated the alternate phone number  of the  patient
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, SARS-CoV-2 test
Clinical narrative: felt lightheaded; shoulders ache; hoarse throat; tired; headache; nausea; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt lightheaded), ARTHRALGIA (shoulders ache), DYSPHONIA (hoarse throat), FATIGUE (tired) and HEADACHE (headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (erythromycin) and Penicillin allergy.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (headache), NAUSEA (nausea) and PAIN (body aches). On an unknown date, the patient experienced DIZZINESS (felt lightheaded), ARTHRALGIA (shoulders ache), DYSPHONIA (hoarse throat) and FATIGUE (tired). At the time of the report, DIZZINESS (felt lightheaded), ARTHRALGIA (shoulders ache), DYSPHONIA (hoarse throat), FATIGUE (tired), HEADACHE (headache), NAUSEA (nausea) and PAIN (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative.   Action taken with mRNA-1273 in response to the events was not applicable     No concomitant medication provided no treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: FU received on 08-May-2021. Updated the alternate phone number  of the  patient
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Complication associated with device
Clinical narrative: Felt a boom in his chest; pacemaker adverse event; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Felt a boom in his chest) and COMPLICATION ASSOCIATED WITH DEVICE (pacemaker adverse event) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pacemaker insertion (cardiac).    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 CHEST PAIN (Felt a boom in his chest) and COMPLICATION ASSOCIATED WITH DEVICE (pacemaker adverse event). At the time of the report, CHEST PAIN (Felt a boom in his chest) and COMPLICATION ASSOCIATED WITH DEVICE (pacemaker adverse event) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant medications were not reported. Treatment information were not provided.   This case was linked to MOD-2021-059062 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: New event pacemaker adverse event was added
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (receiving the vaccine she has not been hungry) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DECREASED APPETITE (receiving the vaccine she has not been hungry). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (receiving the vaccine she has not been hungry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Limb discomfort, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Flushed; Heaviness of arms and legs; Injection site itching; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushed), LIMB DISCOMFORT (Heaviness of arms and legs), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site swelling) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FLUSHING (Flushed), LIMB DISCOMFORT (Heaviness of arms and legs), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, FLUSHING (Flushed), LIMB DISCOMFORT (Heaviness of arms and legs), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was mentioned. No laboratory details was given. No treatment information was mentioned.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood pressure measurement, Body temperature, Chills, Erythema
Clinical narrative: skin redness; chills; fever; vomiting; intractable nausea; headache; left arm soreness; abdominal pain/cramping; fatigue; deltoid rash; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (intractable nausea), VOMITING (vomiting), ABDOMINAL PAIN (abdominal pain/cramping) and PYREXIA (fever) 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 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 HEADACHE (headache), NAUSEA (intractable nausea), VOMITING (vomiting), ABDOMINAL PAIN (abdominal pain/cramping), PYREXIA (fever) and CHILLS (chills). At the time of the report, HEADACHE (headache), NAUSEA (intractable nausea), VOMITING (vomiting), ABDOMINAL PAIN (abdominal pain/cramping), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Nausea, Oxygen saturation
Clinical narrative: skin redness; chills; fever; vomiting; intractable nausea; headache; left arm soreness; abdominal pain/cramping; fatigue; deltoid rash; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (intractable nausea), VOMITING (vomiting), ABDOMINAL PAIN (abdominal pain/cramping) and PYREXIA (fever) 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 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 HEADACHE (headache), NAUSEA (intractable nausea), VOMITING (vomiting), ABDOMINAL PAIN (abdominal pain/cramping), PYREXIA (fever) and CHILLS (chills). At the time of the report, HEADACHE (headache), NAUSEA (intractable nausea), VOMITING (vomiting), ABDOMINAL PAIN (abdominal pain/cramping), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site rash, Vomiting
Clinical narrative: skin redness; chills; fever; vomiting; intractable nausea; headache; left arm soreness; abdominal pain/cramping; fatigue; deltoid rash; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (intractable nausea), VOMITING (vomiting), ABDOMINAL PAIN (abdominal pain/cramping) and PYREXIA (fever) 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 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 HEADACHE (headache), NAUSEA (intractable nausea), VOMITING (vomiting), ABDOMINAL PAIN (abdominal pain/cramping), PYREXIA (fever) and CHILLS (chills). At the time of the report, HEADACHE (headache), NAUSEA (intractable nausea), VOMITING (vomiting), ABDOMINAL PAIN (abdominal pain/cramping), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Pyrexia, Vaccination site rash
Clinical narrative: Body is itching; Vaccination site rash; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Body is itching), VACCINATION SITE RASH (Vaccination site rash), PYREXIA (Fever) and FATIGUE (Fatigue) in a 70-year-old female patient 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. On 04-Mar-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash), PYREXIA (Fever) and FATIGUE (Fatigue). On 25-Mar-2021, the patient experienced PRURITUS (Body is itching). At the time of the report, PRURITUS (Body is itching), VACCINATION SITE RASH (Vaccination site rash), PYREXIA (Fever) and FATIGUE (Fatigue) 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Mild dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Mild dizziness) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (Mild dizziness). At the time of the report, DIZZINESS (Mild dizziness) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Rash on stomach; Fever; Chills; Felt achy; Felt fatigued; Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt achy), PAIN IN EXTREMITY (Sore arm), RASH (Rash on stomach), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM, TAMOXIFEN and PROBIOTICS NOS for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2010, the patient experienced HEADACHE (Headache). On 22-Mar-2020, the patient experienced PAIN IN EXTREMITY (Sore arm). On 24-Mar-2020, the patient experienced FATIGUE (Felt fatigued). On 22-Mar-2021, the patient experienced PAIN (Felt achy), PYREXIA (Fever) and CHILLS (Chills). On 24-Mar-2021, the patient experienced RASH (Rash on stomach). At the time of the report, PAIN (Felt achy), PAIN IN EXTREMITY (Sore arm), RASH (Rash on stomach), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Felt fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were  provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: TCR form received - Patient Declined to provide additional contact information.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on stomach; Fever; Chills; Felt achy; Felt fatigued; Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt achy), PAIN IN EXTREMITY (Sore arm), RASH (Rash on stomach), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM, TAMOXIFEN and PROBIOTICS NOS for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2010, the patient experienced HEADACHE (Headache). On 22-Mar-2020, the patient experienced PAIN IN EXTREMITY (Sore arm). On 24-Mar-2020, the patient experienced FATIGUE (Felt fatigued). On 22-Mar-2021, the patient experienced PAIN (Felt achy), PYREXIA (Fever) and CHILLS (Chills). On 24-Mar-2021, the patient experienced RASH (Rash on stomach). At the time of the report, PAIN (Felt achy), PAIN IN EXTREMITY (Sore arm), RASH (Rash on stomach), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Felt fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were  provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: TCR form received - Patient Declined to provide additional contact information.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site vesicles, Pain in extremity
Clinical narrative: Developed a blister at the injection site; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE VESICLES (Developed a blister at the injection site) and PAIN IN EXTREMITY (Arm pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INJECTION SITE VESICLES (Developed a blister at the injection site) and PAIN IN EXTREMITY (Arm pain). At the time of the report, INJECTION SITE VESICLES (Developed a blister at the injection site) and PAIN IN EXTREMITY (Arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment was provided.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Exposure to SARS-CoV-2, Fatigue, Headache
Clinical narrative: local irritation in my left arm; little headache; Body aches; fatigue; sore throat; give mouth-to-mouth resuscitation to a person who was covid positive 48 hrs ago; dizzy; off-balanced; low-grade fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE IRRITATION (local irritation in my left arm), DIZZINESS (dizzy), BALANCE DISORDER (off-balanced), OROPHARYNGEAL PAIN (sore throat) and EXPOSURE TO SARS-COV-2 (give mouth-to-mouth resuscitation to a person who was covid positive 48 hrs ago) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 041M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced DIZZINESS (dizzy), BALANCE DISORDER (off-balanced) and PYREXIA (low-grade fever). In March 2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and EXPOSURE TO SARS-COV-2 (give mouth-to-mouth resuscitation to a person who was covid positive 48 hrs ago). On an unknown date, the patient experienced VACCINATION SITE IRRITATION (local irritation in my left arm), HEADACHE (little headache), MYALGIA (Body aches) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE IRRITATION (local irritation in my left arm), DIZZINESS (dizzy), BALANCE DISORDER (off-balanced), OROPHARYNGEAL PAIN (sore throat), EXPOSURE TO SARS-COV-2 (give mouth-to-mouth resuscitation to a person who was covid positive 48 hrs ago), HEADACHE (little headache), PYREXIA (low-grade fever), MYALGIA (Body aches) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 09 Mar 2021 patient had to give mouth-to-mouth resuscitation to a person who was covid positive.  The action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, Vaccination site irritation
Clinical narrative: local irritation in my left arm; little headache; Body aches; fatigue; sore throat; give mouth-to-mouth resuscitation to a person who was covid positive 48 hrs ago; dizzy; off-balanced; low-grade fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE IRRITATION (local irritation in my left arm), DIZZINESS (dizzy), BALANCE DISORDER (off-balanced), OROPHARYNGEAL PAIN (sore throat) and EXPOSURE TO SARS-COV-2 (give mouth-to-mouth resuscitation to a person who was covid positive 48 hrs ago) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 041M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced DIZZINESS (dizzy), BALANCE DISORDER (off-balanced) and PYREXIA (low-grade fever). In March 2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and EXPOSURE TO SARS-COV-2 (give mouth-to-mouth resuscitation to a person who was covid positive 48 hrs ago). On an unknown date, the patient experienced VACCINATION SITE IRRITATION (local irritation in my left arm), HEADACHE (little headache), MYALGIA (Body aches) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE IRRITATION (local irritation in my left arm), DIZZINESS (dizzy), BALANCE DISORDER (off-balanced), OROPHARYNGEAL PAIN (sore throat), EXPOSURE TO SARS-COV-2 (give mouth-to-mouth resuscitation to a person who was covid positive 48 hrs ago), HEADACHE (little headache), PYREXIA (low-grade fever), MYALGIA (Body aches) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 09 Mar 2021 patient had to give mouth-to-mouth resuscitation to a person who was covid positive.  The action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Ear pain, Inappropriate schedule of product administration, Nasopharyngitis, Rhinorrhoea
Clinical narrative: nasal discharge (ridiculous), draining badly; dull taste, no taste at all; Ear pain; sinusitis for more than a month now; Bad colds; 2nd dose received on 1 Feb 2021; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SINUSITIS (sinusitis for more than a month now), NASOPHARYNGITIS (Bad colds), RHINORRHOEA (nasal discharge (ridiculous), draining badly), AGEUSIA (dull taste, no taste at all) and EAR PAIN (Ear pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 1 Feb 2021). On 22-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SINUSITIS (sinusitis for more than a month now) and NASOPHARYNGITIS (Bad colds). On an unknown date, the patient experienced RHINORRHOEA (nasal discharge (ridiculous), draining badly), AGEUSIA (dull taste, no taste at all) and EAR PAIN (Ear pain). On 01-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 1 Feb 2021) had resolved. At the time of the report, SINUSITIS (sinusitis for more than a month now), NASOPHARYNGITIS (Bad colds), RHINORRHOEA (nasal discharge (ridiculous), draining badly), AGEUSIA (dull taste, no taste at all) and EAR PAIN (Ear pain) outcome was unknown. Not Provided          No concomitant medications were reported. Treatment included paracetamol and unspecified steroids. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: nasal discharge (ridiculous), draining badly; dull taste, no taste at all; Ear pain; sinusitis for more than a month now; Bad colds; 2nd dose received on 1 Feb 2021; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SINUSITIS (sinusitis for more than a month now), NASOPHARYNGITIS (Bad colds), RHINORRHOEA (nasal discharge (ridiculous), draining badly), AGEUSIA (dull taste, no taste at all) and EAR PAIN (Ear pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 1 Feb 2021). On 22-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SINUSITIS (sinusitis for more than a month now) and NASOPHARYNGITIS (Bad colds). On an unknown date, the patient experienced RHINORRHOEA (nasal discharge (ridiculous), draining badly), AGEUSIA (dull taste, no taste at all) and EAR PAIN (Ear pain). On 01-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received on 1 Feb 2021) had resolved. At the time of the report, SINUSITIS (sinusitis for more than a month now), NASOPHARYNGITIS (Bad colds), RHINORRHOEA (nasal discharge (ridiculous), draining badly), AGEUSIA (dull taste, no taste at all) and EAR PAIN (Ear pain) outcome was unknown. Not Provided          No concomitant medications were reported. Treatment included paracetamol and unspecified steroids. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Eye disorder, Glossodynia, Pain
Clinical narrative: tongue stinging; face stinging; back arms stinging; bottom stinging; back stinging; seeing black dots in her right eye; legs itiching; dizzy; burning sensation felt like she fell into a beehive; stinging sensation felt like she fell into a bee hive; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation felt like she fell into a beehive), PAIN (stinging sensation felt like she fell into a bee hive), GLOSSODYNIA (tongue stinging), PAIN (face stinging) and PAIN (back arms stinging) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acid reflux (oesophageal), Respiratory abnormality, unspecified since an unknown date, Thyroid disorder since an unknown date and Asthma. Concomitant products included LOSARTAN, PRAVASTATIN and FAMOTIDINE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced BURNING SENSATION (burning sensation felt like she fell into a beehive) and PAIN (stinging sensation felt like she fell into a bee hive). On 19-Mar-2021, the patient experienced EYE DISORDER (seeing black dots in her right eye), PRURITUS (legs itiching) and DIZZINESS (dizzy). On an unknown date, the patient experienced GLOSSODYNIA (tongue stinging), PAIN (face stinging), PAIN (back arms stinging), PAIN (bottom stinging) and PAIN (back stinging). At the time of the report, BURNING SENSATION (burning sensation felt like she fell into a beehive) and PAIN (stinging sensation felt like she fell into a bee hive) had not resolved and GLOSSODYNIA (tongue stinging), PAIN (face stinging), PAIN (back arms stinging), PAIN (bottom stinging), PAIN (back stinging), EYE DISORDER (seeing black dots in her right eye), PRURITUS (legs itiching) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reportedly, on 19-Mar-2021, patient's blood pressure went up (details not provided) and she had to increase her blood pressure medicine.   Treatment  information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: tongue stinging; face stinging; back arms stinging; bottom stinging; back stinging; seeing black dots in her right eye; legs itiching; dizzy; burning sensation felt like she fell into a beehive; stinging sensation felt like she fell into a bee hive; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation felt like she fell into a beehive), PAIN (stinging sensation felt like she fell into a bee hive), GLOSSODYNIA (tongue stinging), PAIN (face stinging) and PAIN (back arms stinging) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acid reflux (oesophageal), Respiratory abnormality, unspecified since an unknown date, Thyroid disorder since an unknown date and Asthma. Concomitant products included LOSARTAN, PRAVASTATIN and FAMOTIDINE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced BURNING SENSATION (burning sensation felt like she fell into a beehive) and PAIN (stinging sensation felt like she fell into a bee hive). On 19-Mar-2021, the patient experienced EYE DISORDER (seeing black dots in her right eye), PRURITUS (legs itiching) and DIZZINESS (dizzy). On an unknown date, the patient experienced GLOSSODYNIA (tongue stinging), PAIN (face stinging), PAIN (back arms stinging), PAIN (bottom stinging) and PAIN (back stinging). At the time of the report, BURNING SENSATION (burning sensation felt like she fell into a beehive) and PAIN (stinging sensation felt like she fell into a bee hive) had not resolved and GLOSSODYNIA (tongue stinging), PAIN (face stinging), PAIN (back arms stinging), PAIN (bottom stinging), PAIN (back stinging), EYE DISORDER (seeing black dots in her right eye), PRURITUS (legs itiching) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reportedly, on 19-Mar-2021, patient's blood pressure went up (details not provided) and she had to increase her blood pressure medicine.   Treatment  information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Lump and redness at injection site; Red mark and lump at injection site growing; joint pain everywhere; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Red mark and lump at injection site growing), INJECTION SITE PAIN (Soreness in arm), ARTHRALGIA (joint pain everywhere) and INJECTION SITE ERYTHEMA (Lump and redness at injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 030L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and METHOTREXATE for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 22-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness in arm). On 23-Feb-2021, the patient experienced ARTHRALGIA (joint pain everywhere). On 24-Feb-2021, the patient experienced INJECTION SITE MASS (Red mark and lump at injection site growing). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Lump and redness at injection site). At the time of the report, INJECTION SITE MASS (Red mark and lump at injection site growing), INJECTION SITE PAIN (Soreness in arm), ARTHRALGIA (joint pain everywhere) and INJECTION SITE ERYTHEMA (Lump and redness at injection site) had not resolved.            Treatment information includes Dose 1 - ice, Tylenol Dose 2 - Benadryl cream, anti inflammatory gel   This case was linked to MOD-2021-024360 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Oropharyngeal pain, Pain, Swelling face
Clinical narrative: Body pain at the moment of injection; Numb mouth; Lips inflamed; Cheeks inflamed; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body pain at the moment of injection), HYPOAESTHESIA ORAL (Numb mouth), LIP SWELLING (Lips inflamed), SWELLING FACE (Cheeks inflamed) and OROPHARYNGEAL PAIN (Sore throat) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy (Patient was under treatment for 3 years until 3 months ago.).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (Body pain at the moment of injection), HYPOAESTHESIA ORAL (Numb mouth), LIP SWELLING (Lips inflamed), SWELLING FACE (Cheeks inflamed) and OROPHARYNGEAL PAIN (Sore throat). The patient was treated with PARACETAMOL (TYLENOL) on 24-Mar-2021 for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, PAIN (Body pain at the moment of injection), HYPOAESTHESIA ORAL (Numb mouth), LIP SWELLING (Lips inflamed), SWELLING FACE (Cheeks inflamed) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Headache, Myalgia, Nausea
Clinical narrative: Every bone in her body aches; Nausea; Severe headaches; Achiness all over her body; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Every bone in her body aches), NAUSEA (Nausea), HEADACHE (Severe headaches) and MYALGIA (Achiness all over her body) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012m20a and 029a21a) for COVID-19 vaccination.     No reported medical history.  Concomitant products included METFORMIN, SIMVASTATIN, AMITRIPTYLINE, CLONIDINE and METOPROLOL for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BONE PAIN (Every bone in her body aches), NAUSEA (Nausea), HEADACHE (Severe headaches) and MYALGIA (Achiness all over her body). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, BONE PAIN (Every bone in her body aches), NAUSEA (Nausea), HEADACHE (Severe headaches) and MYALGIA (Achiness all over her body) outcome was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pin marks all over her body, shoulder, legs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma and Heartburn. Concomitant products included LATANOPROST for Glaucoma, OMEPRAZOLE for Heartburn, APIXABAN (ELIQUIS) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PARAESTHESIA (Pin marks all over her body, shoulder, legs). On 16-Jan-2021, PARAESTHESIA (Pin marks all over her body, shoulder, legs) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-044828 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: NNI were not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Right arm hurting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm hurting) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination.     No reported medical history.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), HYDROXYZINE and PARACETAMOL (TYLENOL) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm hurting) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Right arm hurting) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included: sleeping pill.  No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: Rapid heart rate; Loss of appetite; fever 101 Fahrenheit; Muscle pain/body ache; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart rate), DECREASED APPETITE (Loss of appetite), PYREXIA (fever 101 Fahrenheit), MYALGIA (Muscle pain/body ache) and FATIGUE (Feeling tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Also had covid-19 in june 2020) in May 2020. Concurrent medical conditions included Hypertension and Cholesterol.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced HEART RATE INCREASED (Rapid heart rate), DECREASED APPETITE (Loss of appetite), PYREXIA (fever 101 Fahrenheit), MYALGIA (Muscle pain/body ache) and FATIGUE (Feeling tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Rapid heart rate), DECREASED APPETITE (Loss of appetite), PYREXIA (fever 101 Fahrenheit), MYALGIA (Muscle pain/body ache) and FATIGUE (Feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were provided as blood pressure pills, cholesterol pills, blood thinner medicine.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: experienced pain in left arm; shoulder  pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (experienced pain in left arm) and ARTHRALGIA (  shoulder  pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 004m20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MELOXICAM (MOBIC), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), ESTRADIOL (ESTROGEN), VITAMIN D NOS, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), FISH OIL and CENTRUM SILVER +50 for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 31-Jan-2021, the patient experienced ARTHRALGIA (  shoulder  pain). On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (experienced pain in left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (experienced pain in left arm) and ARTHRALGIA (  shoulder  pain) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Feeling abnormal, Headache
Clinical narrative: down for 48 hours; really bad; headache; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (down for 48 hours), FEELING ABNORMAL (really bad) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (down for 48 hours), FEELING ABNORMAL (really bad) and HEADACHE (headache). At the time of the report, DEPRESSED MOOD (down for 48 hours), FEELING ABNORMAL (really bad) and HEADACHE (headache) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD21-062901, US-MODERNATX, INC.-MOD-2021-082277 (E2B Linked Report).; Sender's Comments:  MOD21-062901: US-MODERNATX, INC.-MOD-2021-082277:Dose 1 events
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Injection site erythema, Injection site warmth
Clinical narrative: swelling arm; warm on injection site; lost appetite; red spot on injection site; chills; felt tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swelling arm), INJECTION SITE WARMTH (warm on injection site), DECREASED APPETITE (lost appetite), INJECTION SITE ERYTHEMA (red spot on injection site) and CHILLS (chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A. and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE BESILATE (NORVASC) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling arm), INJECTION SITE WARMTH (warm on injection site), DECREASED APPETITE (lost appetite), INJECTION SITE ERYTHEMA (red spot on injection site), CHILLS (chills) and FATIGUE (felt tired). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of UNK dosage form. At the time of the report, PERIPHERAL SWELLING (swelling arm), INJECTION SITE WARMTH (warm on injection site), DECREASED APPETITE (lost appetite), INJECTION SITE ERYTHEMA (red spot on injection site), CHILLS (chills) and FATIGUE (felt tired) outcome was unknown. Not Provided