chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: Chills; fatigue; headache; nausea; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (fatigue), HEADACHE (headache), NAUSEA (nausea) and VACCINATION SITE PAIN (sore arm) 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 03-Feb-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 CHILLS (Chills), FATIGUE (fatigue), HEADACHE (headache), NAUSEA (nausea) and VACCINATION SITE PAIN (sore arm). At the time of the report, CHILLS (Chills), FATIGUE (fatigue), HEADACHE (headache), NAUSEA (nausea) and VACCINATION SITE PAIN (sore arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Arm was warm; Big sized circle reaction around the injection site; Arm was itchy; Redness; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (Arm was warm), VACCINATION SITE REACTION (Big sized circle reaction around the injection site), VACCINATION SITE PRURITUS (Arm was itchy) and VACCINATION SITE ERYTHEMA (Redness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included Knee pain (Left and right) on 24-Nov-2020. Concomitant products included HYDROCORTISONE (CORTIZONE 10) and HYALURONATE SODIUM (EUFLEXXA) for Knee pain, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ), ROSUVASTATIN CALCIUM (CRESTOR), DULOXETINE HYDROCHLORIDE (CYMBALTA), LORAZEPAM (ATIVAN), MELOXICAM (MOBIC), CENTRUM SILVER +50 and HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Arm was warm), VACCINATION SITE REACTION (Big sized circle reaction around the injection site), VACCINATION SITE PRURITUS (Arm was itchy) and VACCINATION SITE ERYTHEMA (Redness). On 08-Feb-2021, VACCINATION SITE WARMTH (Arm was warm), VACCINATION SITE REACTION (Big sized circle reaction around the injection site), VACCINATION SITE PRURITUS (Arm was itchy) and VACCINATION SITE ERYTHEMA (Redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include Benadryl, non drowsy antihistamine   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Added HCP details, vaccine facility information,patient demographic details, other relevant history , concomitant medication, second dose information,event stop date, event outcome.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Headache, SARS-CoV-2 test negative
Clinical narrative: Lost taste and smell; Lost taste and smell; A bad headache; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost taste and smell), ANOSMIA (Lost taste and smell) and HEADACHE (A bad headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (A bad headache). On 11-Feb-2021, the patient experienced AGEUSIA (Lost taste and smell) and ANOSMIA (Lost taste and smell). On 11-Feb-2021, HEADACHE (A bad headache) had resolved. At the time of the report, AGEUSIA (Lost taste and smell) and ANOSMIA (Lost taste and smell) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, SARS-CoV-2 test negative: Negative.   No relevant concomitant medications were reported.  No treatment.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: slight red rash around the injection site; slightly itchy rash around the injection site; Rash 2 inches in diameter around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (slight red rash around the injection site), VACCINATION SITE PRURITUS (slightly itchy rash around the injection site) and VACCINATION SITE RASH (Rash 2 inches in diameter around the injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (slight red rash around the injection site), VACCINATION SITE PRURITUS (slightly itchy rash around the injection site) and VACCINATION SITE RASH (Rash 2 inches in diameter around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (slight red rash around the injection site), VACCINATION SITE PRURITUS (slightly itchy rash around the injection site) and VACCINATION SITE RASH (Rash 2 inches in diameter around the injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment details included for the symptoms: cortisone cream. Other: Blood thinner and Simvastatin.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Pain
Clinical narrative: chills; a lot of fatigue; body ache; loss of appetite; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (chills), FATIGUE (a lot of fatigue), PAIN (body ache) and DECREASED APPETITE (loss of appetite) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (chills), FATIGUE (a lot of fatigue), PAIN (body ache) and DECREASED APPETITE (loss of appetite). On 12-Feb-2021, CHILLS (chills), FATIGUE (a lot of fatigue), PAIN (body ache) and DECREASED APPETITE (loss of appetite) had resolved. Not Provided     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 65-year-old male 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) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site erythema
Clinical narrative: itchy rash at the injection site; red rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash at the injection site) and VACCINATION SITE ERYTHEMA (red rash at the injection site) in a 72-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 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced RASH PRURITIC (itchy rash at the injection site) and VACCINATION SITE ERYTHEMA (red rash at the injection site). In February 2021, RASH PRURITIC (itchy rash at the injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red rash at the injection site) outcome was unknown. Not Provided          No concomitant and treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Outcome, duration and stop date of the event 'itchy rash at the injection site' was updated. Action taken was corrected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Musculoskeletal stiffness, Skin warm, Swelling
Clinical narrative: bump; redness; feels warm; hard; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (bump), ERYTHEMA (redness), SKIN WARM (feels warm) and MUSCULOSKELETAL STIFFNESS (hard) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN and INSULIN for Diabetes mellitus, LISINOPRIL for Hypertension.    On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced SWELLING (bump), ERYTHEMA (redness), SKIN WARM (feels warm) and MUSCULOSKELETAL STIFFNESS (hard). At the time of the report, SWELLING (bump), ERYTHEMA (redness), SKIN WARM (feels warm) and MUSCULOSKELETAL STIFFNESS (hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  treatment to the events not provide.
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction from the Moderna vaccine; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an adverse reaction from the Moderna vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the event, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced an adverse reaction from the Moderna vaccine.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, an adverse reaction from the Moderna vaccine was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Chills, Pyrexia, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PRURITUS (itching), VACCINATION SITE RASH (rash at injection site grew to 2 inches), VACCINATION SITE ERYTHEMA (redness at injection site) and PYREXIA (fever of 100.7 F) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE RASH (rash at injection site grew to 2 inches), VACCINATION SITE ERYTHEMA (redness at injection site), PYREXIA (fever of 100.7 F) and CHILLS (chills). On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching) and AXILLARY PAIN (armpit pain). At the time of the report, VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PRURITUS (itching), VACCINATION SITE RASH (rash at injection site grew to 2 inches), VACCINATION SITE ERYTHEMA (redness at injection site), PYREXIA (fever of 100.7 F), CHILLS (chills) and AXILLARY PAIN (armpit pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 100.7 (Inconclusive) 100.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  On 04-FEB-2021, the patient had experienced Rash at the injection site that was red and warm to the touch, Patient had a fever of 100.7 F. and chills. The next day the rash grew to 2". Then the rash disappeared on 12-Feb-2021. Rash had returned that was red and warm again, it itches and there was armpit pain.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received on 23APR2021, No new information received denied the call
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PRURITUS (itching), VACCINATION SITE RASH (rash at injection site grew to 2 inches), VACCINATION SITE ERYTHEMA (redness at injection site) and PYREXIA (fever of 100.7 F) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE RASH (rash at injection site grew to 2 inches), VACCINATION SITE ERYTHEMA (redness at injection site), PYREXIA (fever of 100.7 F) and CHILLS (chills). On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching) and AXILLARY PAIN (armpit pain). At the time of the report, VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PRURITUS (itching), VACCINATION SITE RASH (rash at injection site grew to 2 inches), VACCINATION SITE ERYTHEMA (redness at injection site), PYREXIA (fever of 100.7 F), CHILLS (chills) and AXILLARY PAIN (armpit pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 100.7 (Inconclusive) 100.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  On 04-FEB-2021, the patient had experienced Rash at the injection site that was red and warm to the touch, Patient had a fever of 100.7 F. and chills. The next day the rash grew to 2". Then the rash disappeared on 12-Feb-2021. Rash had returned that was red and warm again, it itches and there was armpit pain.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received on 23APR2021, No new information received denied the call
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Erythema, Headache
Clinical narrative: back red; breast red; sharp pain from under the arm to the breast; headache; horrible back ache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (horrible back ache), BREAST PAIN (sharp pain from under the arm to the breast), HEADACHE (headache), ERYTHEMA (back red) and ERYTHEMA (breast red) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012420A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and LISINOPRIL for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced BACK PAIN (horrible back ache). On 05-Feb-2021, the patient experienced BREAST PAIN (sharp pain from under the arm to the breast) and HEADACHE (headache). On 07-Feb-2021, the patient experienced ERYTHEMA (back red) and ERYTHEMA (breast red). At the time of the report, BACK PAIN (horrible back ache), BREAST PAIN (sharp pain from under the arm to the breast), HEADACHE (headache), ERYTHEMA (back red) and ERYTHEMA (breast red) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment: No.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever of 99.6; Sore Arm like someone sucker punched her; Body Aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 99.6), PAIN IN EXTREMITY (Sore Arm like someone sucker punched her), MYALGIA (Body Aches) and HEADACHE (Headaches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PYREXIA (Fever of 99.6), PAIN IN EXTREMITY (Sore Arm like someone sucker punched her), MYALGIA (Body Aches) and HEADACHE (Headaches). At the time of the report, PYREXIA (Fever of 99.6), PAIN IN EXTREMITY (Sore Arm like someone sucker punched her), MYALGIA (Body Aches) and HEADACHE (Headaches) outcome was unknown.      No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Diarrhoea, Fatigue, Hypersomnia
Clinical narrative: Diarrhea; Cough; Loss appetite/no hungry; Sleep a lot; Tired; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), DECREASED APPETITE (Loss appetite/no hungry), HYPERSOMNIA (Sleep a lot), DIARRHOEA (Diarrhea) and FATIGUE (Tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced DECREASED APPETITE (Loss appetite/no hungry), HYPERSOMNIA (Sleep a lot) and FATIGUE (Tired). On 07-Feb-2021, the patient experienced COUGH (Cough). On 08-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (Cough), DECREASED APPETITE (Loss appetite/no hungry), HYPERSOMNIA (Sleep a lot), DIARRHOEA (Diarrhea) and FATIGUE (Tired) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication included Tylenol and Rubinstein.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received on 26APR2021, updated reporter details and 2nd dose details
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: shoulder to neck on left site like joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder to neck on left site like joint pain) and MYALGIA (muscle pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included LISINOPRIL for Blood pressure.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ARTHRALGIA (shoulder to neck on left site like joint pain) and MYALGIA (muscle pain). At the time of the report, ARTHRALGIA (shoulder to neck on left site like joint pain) and MYALGIA (muscle pain) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Additional concomitant medications included cholesterol medicine.  Treatment details included one lied and cream.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Product dose omission issue, Pyrexia
Clinical narrative: never got second dose; Excessive perspiration; Horrible Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (never got second dose), HYPERHIDROSIS (Excessive perspiration), PYREXIA (Horrible Fever) and CHILLS (Chills) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HYPERHIDROSIS (Excessive perspiration), PYREXIA (Horrible Fever) and CHILLS (Chills). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never got second dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (never got second dose), HYPERHIDROSIS (Excessive perspiration), PYREXIA (Horrible Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up information received on 10-JUN-2021 contains significant information. Patient contact details and event details has been updated.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse reaction nos; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse reaction 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 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 ADVERSE EVENT (Adverse reaction nos). At the time of the report, ADVERSE EVENT (Adverse reaction nos) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were reported.  No treatments were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye swelling, Illness, Lip swelling, Vaccination site pain
Clinical narrative: Swollen Lips; Swollen eyes; Sicker than a dog; Rash around the injection site; Chills; Sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen Lips), EYE SWELLING (Swollen eyes), ILLNESS (Sicker than a dog), VACCINATION SITE RASH (Rash around the injection site) and CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ILLNESS (Sicker than a dog), VACCINATION SITE RASH (Rash around the injection site), CHILLS (Chills) and VACCINATION SITE PAIN (Sore at injection site). On 12-Feb-2021, the patient experienced LIP SWELLING (Swollen Lips) and EYE SWELLING (Swollen eyes). On 11-Feb-2021, ILLNESS (Sicker than a dog), VACCINATION SITE RASH (Rash around the injection site) and CHILLS (Chills) had resolved. At the time of the report, LIP SWELLING (Swollen Lips), EYE SWELLING (Swollen eyes) and VACCINATION SITE PAIN (Sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Swollen Lips; Swollen eyes; Sicker than a dog; Rash around the injection site; Chills; Sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen Lips), EYE SWELLING (Swollen eyes), ILLNESS (Sicker than a dog), VACCINATION SITE RASH (Rash around the injection site) and CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ILLNESS (Sicker than a dog), VACCINATION SITE RASH (Rash around the injection site), CHILLS (Chills) and VACCINATION SITE PAIN (Sore at injection site). On 12-Feb-2021, the patient experienced LIP SWELLING (Swollen Lips) and EYE SWELLING (Swollen eyes). On 11-Feb-2021, ILLNESS (Sicker than a dog), VACCINATION SITE RASH (Rash around the injection site) and CHILLS (Chills) had resolved. At the time of the report, LIP SWELLING (Swollen Lips), EYE SWELLING (Swollen eyes) and VACCINATION SITE PAIN (Sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Sinus disorder
Clinical narrative: sinus issues and fever; sinus issues and fever; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (sinus issues and fever) and PYREXIA (sinus issues and fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UL12L20A) 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 an unknown date, the patient experienced SINUS DISORDER (sinus issues and fever) and PYREXIA (sinus issues and fever). At the time of the report, SINUS DISORDER (sinus issues and fever) and PYREXIA (sinus issues and fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. On 04-Feb-2021, SARS-CoV-2 test: (Negative) Negative.   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: Erythema, Pain, Vaccination site erythema
Clinical narrative: redness is spreading in area around; little bit sore; redness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness is spreading in area around), PAIN (little bit sore) and VACCINATION SITE ERYTHEMA (redness at the site of injection) 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 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced ERYTHEMA (redness is spreading in area around), PAIN (little bit sore) and VACCINATION SITE ERYTHEMA (redness at the site of injection). At the time of the report, ERYTHEMA (redness is spreading in area around), PAIN (little bit sore) and VACCINATION SITE ERYTHEMA (redness at the site of injection) outcome was unknown.            no concomitant medications are provided. treatment to the events not provided.  Action taken with mRNA-1273 in response to the event was not applicable
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Hypersomnia
Clinical narrative: Diarrhea; tired; Loose appetite/No hungry; sleeps a lot; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loose appetite/No hungry), HYPERSOMNIA (sleeps a lot), DIARRHOEA (Diarrhea) and FATIGUE (tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DECREASED APPETITE (Loose appetite/No hungry), HYPERSOMNIA (sleeps a lot) and FATIGUE (tired). On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DECREASED APPETITE (Loose appetite/No hungry), HYPERSOMNIA (sleeps a lot), DIARRHOEA (Diarrhea) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection; A spontaneous report was received from a consumer concerning a 86-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, prior to the onset of the events the patient received the second of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced urinary tract infection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of urinary tract infection was unknown.; Reporter'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.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Vaccination site discolouration, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: injection site was pink and faded; injection site was itching; injection site was red; red welt on her arm, welt on her chest; red welt on her arm that was itching, chest was itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (red welt on her arm, welt on her chest), PRURITUS (red welt on her arm that was itching, chest was itching), VACCINATION SITE DISCOLOURATION (injection site was pink and faded), VACCINATION SITE PRURITUS (injection site was itching) and VACCINATION SITE ERYTHEMA (injection site was red) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (niacin), Penicillin allergy, Drug allergy (Erythromycin) and Latex allergy.    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 URTICARIA (red welt on her arm, welt on her chest) and PRURITUS (red welt on her arm that was itching, chest was itching). On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site was itching) and VACCINATION SITE ERYTHEMA (injection site was red). On 15-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (injection site was pink and faded). The patient was treated with CORTISONE for Erythema urticarial and Itching, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching and Welts, at an unspecified dose and frequency. At the time of the report, URTICARIA (red welt on her arm, welt on her chest), PRURITUS (red welt on her arm that was itching, chest was itching), VACCINATION SITE DISCOLOURATION (injection site was pink and faded), VACCINATION SITE PRURITUS (injection site was itching) and VACCINATION SITE ERYTHEMA (injection site was red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that injection site was about the size of a 1/2-dollar. Concomitant medications were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Event outcomes were updated. Permissions for further follow up was updated.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Vaccination site pain
Clinical narrative: Extremely sore arm at site of injection; body ache and pain; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Extremely sore arm at site of injection), MYALGIA (body ache and pain) and CHILLS (chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Extremely sore arm at site of injection), MYALGIA (body ache and pain) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 11-Feb-2021, MYALGIA (body ache and pain) and CHILLS (chills) had resolved. At the time of the report, VACCINATION SITE PAIN (Extremely sore arm at site of injection) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, COVID-19: positive Positive. On 06-Feb-2021, COVID-19: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: he patient reported that no symptoms occurred and tested negative for COVId-19 on 06-FEB-2021. The patient reported that she believes it was a false positive.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dry throat, Oropharyngeal pain, Paraesthesia, Pharyngeal swelling
Clinical narrative: sore throat; tingling in her arm which migrate to shoulder and back.; difficult to swollow; extremely dry mouth; throat was swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (tingling in her arm which migrate to shoulder and back.), DRY THROAT (difficult to swollow), DRY MOUTH (extremely dry mouth), PHARYNGEAL SWELLING (throat was swollen) and OROPHARYNGEAL PAIN (sore throat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PARAESTHESIA (tingling in her arm which migrate to shoulder and back.), DRY THROAT (difficult to swollow), DRY MOUTH (extremely dry mouth) and PHARYNGEAL SWELLING (throat was swollen). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, PARAESTHESIA (tingling in her arm which migrate to shoulder and back.), DRY THROAT (difficult to swollow) and PHARYNGEAL SWELLING (throat was swollen) outcome was unknown and DRY MOUTH (extremely dry mouth) and OROPHARYNGEAL PAIN (sore throat) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient did not took the Second Dose as suggested by her Physician. No Treatment Medicines were Included. No Concomitant Medicines were included.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up was received on 23-APR-2021 Patient demographics were updated.Added new Event Oropharyngeal Pain. Patient did not take the second dose. The action taken with the Drug was updated from Unknown to Withdrawn.  Updated Outcome of the Event Dry mouth from Unknown to Not Recovered.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Peripheral swelling, Pruritus, Skin burning sensation, Swelling face
Clinical narrative: eyes swollen shut; swelling face; body itching; Hives; skin feels like it is on fire; Puffiness/swelling of various limbs- right hand,arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (body itching), URTICARIA (Hives), SKIN BURNING SENSATION (skin feels like it is on fire), PERIPHERAL SWELLING (Puffiness/swelling of various limbs- right hand,arm) and EYE SWELLING (eyes swollen shut) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PRURITUS (body itching), URTICARIA (Hives), SKIN BURNING SENSATION (skin feels like it is on fire), PERIPHERAL SWELLING (Puffiness/swelling of various limbs- right hand,arm) and SWELLING FACE (swelling face). On an unknown date, the patient experienced EYE SWELLING (eyes swollen shut). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (body itching), URTICARIA (Hives) and PERIPHERAL SWELLING (Puffiness/swelling of various limbs- right hand,arm) had not resolved and SKIN BURNING SENSATION (skin feels like it is on fire), EYE SWELLING (eyes swollen shut) and SWELLING FACE (swelling face) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: eyes swollen shut; swelling face; body itching; Hives; skin feels like it is on fire; Puffiness/swelling of various limbs- right hand,arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (body itching), URTICARIA (Hives), SKIN BURNING SENSATION (skin feels like it is on fire), PERIPHERAL SWELLING (Puffiness/swelling of various limbs- right hand,arm) and EYE SWELLING (eyes swollen shut) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PRURITUS (body itching), URTICARIA (Hives), SKIN BURNING SENSATION (skin feels like it is on fire), PERIPHERAL SWELLING (Puffiness/swelling of various limbs- right hand,arm) and SWELLING FACE (swelling face). On an unknown date, the patient experienced EYE SWELLING (eyes swollen shut). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (body itching), URTICARIA (Hives) and PERIPHERAL SWELLING (Puffiness/swelling of various limbs- right hand,arm) had not resolved and SKIN BURNING SENSATION (skin feels like it is on fire), EYE SWELLING (eyes swollen shut) and SWELLING FACE (swelling face) outcome was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Headache/severe headache; Soreness of arm; Tiredness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Feb-2021 and was forwarded to Moderna on 16-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm), FATIGUE (Tiredness) and HEADACHE (Headache/severe headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   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 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Tiredness). On 14-Feb-2021, the patient experienced HEADACHE (Headache/severe headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 13-Feb-2021, PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Tiredness) had resolved. On 18-Feb-2021, HEADACHE (Headache/severe headache) had resolved.            No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up received on 27-APR-2021. Contact information updated. First dose details were reported. Event outcome and end date added to case. On 29-Jun-2021: Non-Significant followup appended.