chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body hurts) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body hurts). At the time of the report, MYALGIA (Body hurts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up document received on 26-MAY-2021 contains non significant information
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm; Achy; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (Achy) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (Achy) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (Achy) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were provided   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non-Significant follow up received and contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Headache, Visual impairment
Clinical narrative: Earache; Vision abnormal; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Earache), VISUAL IMPAIRMENT (Vision abnormal) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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 EAR PAIN (Earache), VISUAL IMPAIRMENT (Vision abnormal) and HEADACHE (Headache). At the time of the report, EAR PAIN (Earache), VISUAL IMPAIRMENT (Vision abnormal) and HEADACHE (Headache) 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.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received. No new information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: On and off nauseous after the 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (On and off nauseous after the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (On and off nauseous after the 2nd dose). At the time of the report, NAUSEA (On and off nauseous after the 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported , No treatment medication was report   This case was linked to MOD-2021-169978 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant followup appended
Sex: U
Vaccine: COVID19
Symptoms: Body temperature decreased
Clinical narrative: run a low temp 2 days after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (run a low temp 2 days after 2nd shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) 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) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE DECREASED (run a low temp 2 days after 2nd shot). At the time of the report, BODY TEMPERATURE DECREASED (run a low temp 2 days after 2nd shot) outcome was unknown. Not Provided          No concomitant medication was provided.  No treatment details were provided.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non-significant follow-up appended to AER
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Product storage error, Pyrexia
Clinical narrative: Vomited; Tired; Fever; arm is sore; Lightheaded; pre-filled syringe that had been at room temperature/improper storage of dose given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (pre-filled syringe that had been at room temperature/improper storage of dose given to patient), DIZZINESS (Lightheaded), VOMITING (Vomited), FATIGUE (Tired) and PYREXIA (Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-May-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced PRODUCT STORAGE ERROR (pre-filled syringe that had been at room temperature/improper storage of dose given to patient). On 22-May-2021, the patient experienced DIZZINESS (Lightheaded), FATIGUE (Tired), PYREXIA (Fever) and MYALGIA (arm is sore). On 22-May-2021 at 1:00 AM, the patient experienced VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) on 23-May-2021 for Adverse event, at an unspecified dose and frequency. On 21-May-2021, PRODUCT STORAGE ERROR (pre-filled syringe that had been at room temperature/improper storage of dose given to patient) had resolved. At the time of the report, DIZZINESS (Lightheaded), VOMITING (Vomited), FATIGUE (Tired), PYREXIA (Fever) and MYALGIA (arm is sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   On 23-May-2021, the patient's arm was sore and so they used a cold compress.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Newevents added.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomited; Tired; Fever; arm is sore; Lightheaded; pre-filled syringe that had been at room temperature/improper storage of dose given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (pre-filled syringe that had been at room temperature/improper storage of dose given to patient), DIZZINESS (Lightheaded), VOMITING (Vomited), FATIGUE (Tired) and PYREXIA (Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-May-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced PRODUCT STORAGE ERROR (pre-filled syringe that had been at room temperature/improper storage of dose given to patient). On 22-May-2021, the patient experienced DIZZINESS (Lightheaded), FATIGUE (Tired), PYREXIA (Fever) and MYALGIA (arm is sore). On 22-May-2021 at 1:00 AM, the patient experienced VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) on 23-May-2021 for Adverse event, at an unspecified dose and frequency. On 21-May-2021, PRODUCT STORAGE ERROR (pre-filled syringe that had been at room temperature/improper storage of dose given to patient) had resolved. At the time of the report, DIZZINESS (Lightheaded), VOMITING (Vomited), FATIGUE (Tired), PYREXIA (Fever) and MYALGIA (arm is sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   On 23-May-2021, the patient's arm was sore and so they used a cold compress.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Newevents added.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dysgeusia (metallic taste after shots) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's medical history not reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced dysgeusia (metallic  taste after shots). At the time of the report, dysgeusia (metallic taste after shots) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: teeth hurt; bad headache; chills; tired; achy; temperature 103F; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (teeth hurt), HEADACHE (bad headache), CHILLS (chills), FATIGUE (tired) and MYALGIA (achy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was reported.  Concomitant products included PAROXETINE for Depression, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3), VITAMIN D3, BIOTIN, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]), FISH OIL and CALCIUM for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced TOOTHACHE (teeth hurt), HEADACHE (bad headache), CHILLS (chills), FATIGUE (tired), MYALGIA (achy) and PYREXIA (temperature 103F). The patient was treated with IBUPROFEN at a dose of 200 mg. At the time of the report, TOOTHACHE (teeth hurt), HEADACHE (bad headache), CHILLS (chills), FATIGUE (tired), MYALGIA (achy) and PYREXIA (temperature 103F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103 High.         Concomitant medications - Vitamin calcium D3 zinc magnesium, Vitamin D3, Biotin, Probiotic are taken as supplements by the patient. It was reported that patient height was 5'5.   This case was linked to MOD-2021-170043 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up document received on 08-JULY-2021 contain information of added concomitant products. And patient demographics were added.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Toothache
Clinical narrative: teeth hurt; bad headache; chills; tired; achy; temperature 103F; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (teeth hurt), HEADACHE (bad headache), CHILLS (chills), FATIGUE (tired) and MYALGIA (achy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was reported.  Concomitant products included PAROXETINE for Depression, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3), VITAMIN D3, BIOTIN, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]), FISH OIL and CALCIUM for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced TOOTHACHE (teeth hurt), HEADACHE (bad headache), CHILLS (chills), FATIGUE (tired), MYALGIA (achy) and PYREXIA (temperature 103F). The patient was treated with IBUPROFEN at a dose of 200 mg. At the time of the report, TOOTHACHE (teeth hurt), HEADACHE (bad headache), CHILLS (chills), FATIGUE (tired), MYALGIA (achy) and PYREXIA (temperature 103F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103 High.         Concomitant medications - Vitamin calcium D3 zinc magnesium, Vitamin D3, Biotin, Probiotic are taken as supplements by the patient. It was reported that patient height was 5'5.   This case was linked to MOD-2021-170043 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up document received on 08-JULY-2021 contain information of added concomitant products. And patient demographics were added.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a patient of an unknown age and gender 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 INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Depression, Myalgia, Pain in extremity
Clinical narrative: vitiligo rapidly spread everywhere/developed vitiligo skin condition; sore arm; look terrible; achy; chills; fever; I am in pain with burning skin most of the time; It is mentally, emotionally, and psychologically depressing; This spontaneous case was reported by a consumer and describes the occurrence of VITILIGO (vitiligo rapidly spread everywhere/developed vitiligo skin condition), PAIN IN EXTREMITY (sore arm), BURNING SENSATION (I am in pain with burning skin most of the time), DEPRESSION (It is mentally, emotionally, and psychologically depressing) and UNEVALUABLE EVENT (look terrible) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Vitiligo (20 plus year old vitiligo condition) since 2001.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced BURNING SENSATION (I am in pain with burning skin most of the time) and DEPRESSION (It is mentally, emotionally, and psychologically depressing). On an unknown date, the patient experienced VITILIGO (vitiligo rapidly spread everywhere/developed vitiligo skin condition), PAIN IN EXTREMITY (sore arm), UNEVALUABLE EVENT (look terrible), MYALGIA (achy), CHILLS (chills) and PYREXIA (fever). At the time of the report, VITILIGO (vitiligo rapidly spread everywhere/developed vitiligo skin condition), PAIN IN EXTREMITY (sore arm), BURNING SENSATION (I am in pain with burning skin most of the time), DEPRESSION (It is mentally, emotionally, and psychologically depressing), UNEVALUABLE EVENT (look terrible), MYALGIA (achy), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up information received contains added events - Myalgia, Burning sensation, Depression, Pain, Chills, Pyrexia,  and Lot No. - 002A21A On 10-Aug-2021: Follow-up information received contains no new Information.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Unevaluable event, Vitiligo
Clinical narrative: vitiligo rapidly spread everywhere/developed vitiligo skin condition; sore arm; look terrible; achy; chills; fever; I am in pain with burning skin most of the time; It is mentally, emotionally, and psychologically depressing; This spontaneous case was reported by a consumer and describes the occurrence of VITILIGO (vitiligo rapidly spread everywhere/developed vitiligo skin condition), PAIN IN EXTREMITY (sore arm), BURNING SENSATION (I am in pain with burning skin most of the time), DEPRESSION (It is mentally, emotionally, and psychologically depressing) and UNEVALUABLE EVENT (look terrible) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Vitiligo (20 plus year old vitiligo condition) since 2001.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced BURNING SENSATION (I am in pain with burning skin most of the time) and DEPRESSION (It is mentally, emotionally, and psychologically depressing). On an unknown date, the patient experienced VITILIGO (vitiligo rapidly spread everywhere/developed vitiligo skin condition), PAIN IN EXTREMITY (sore arm), UNEVALUABLE EVENT (look terrible), MYALGIA (achy), CHILLS (chills) and PYREXIA (fever). At the time of the report, VITILIGO (vitiligo rapidly spread everywhere/developed vitiligo skin condition), PAIN IN EXTREMITY (sore arm), BURNING SENSATION (I am in pain with burning skin most of the time), DEPRESSION (It is mentally, emotionally, and psychologically depressing), UNEVALUABLE EVENT (look terrible), MYALGIA (achy), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up information received contains added events - Myalgia, Burning sensation, Depression, Pain, Chills, Pyrexia,  and Lot No. - 002A21A On 10-Aug-2021: Follow-up information received contains no new Information.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feel fatigue after one week; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feel fatigue after one week) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (feel fatigue after one week). At the time of the report, FATIGUE (feel fatigue after one week) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Macule
Clinical narrative: red bumps on chest and neck; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MACULE (red bumps on chest and neck) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MACULE (red bumps on chest and neck). At the time of the report, MACULE (red bumps on chest and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported by reporter. No treatment details was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: This follow-up was received on 26-MAY-2021 which did not update any new information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Glycosylated haemoglobin increased, Somnolence
Clinical narrative: fell asleep while standing; fall; A1C high; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (fell asleep while standing), FALL (fall) and GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C high) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (fell asleep while standing) and FALL (fall). an unknown date, the patient experienced GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C high). At the time of the report, SOMNOLENCE (fell asleep while standing) and FALL (fall) had resolved and GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C high) outcome was unknown.            No concomitant or treatment medications were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-033738, MOD-2021-170199 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore Injection Site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Sore 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore Injection Site). At the time of the report, VACCINATION SITE PAIN (Sore 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 concomitant medications were reported. Treatment medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: loss of taste; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) outcome was unknown. Not Provided          no concomitant  medications are provided. treatment to the events not reported. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up information received on 25-may-2021, it does not contain any new information.
Sex: U
Vaccine: COVID19
Symptoms: Mental disorder
Clinical narrative: going insane and couldn't tell if I was really at work or not; This spontaneous case was reported by an other and describes the occurrence of MENTAL DISORDER (going insane and couldn't tell if I was really at work or not) in a patient of an unknown age and gender 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 MENTAL DISORDER (going insane and couldn't tell if I was really at work or not). At the time of the report, MENTAL DISORDER (going insane and couldn't tell if I was really at work or not) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter.  Patient experienced the symptom three days after receiving the first dose of the Moderna COVID-19 vaccine.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular menstruation; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUATION IRREGULAR (Irregular menstruation) 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 MENSTRUATION IRREGULAR (Irregular menstruation). At the time of the report, MENSTRUATION IRREGULAR (Irregular menstruation) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (side effects). At the time of the report, UNEVALUABLE EVENT (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was provided. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: My face got a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (My face got a rash) in a patient of an unknown age and gender 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) at an unspecified dose. On an unknown date, the patient experienced RASH (My face got a rash). At the time of the report, RASH (My face got a rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Injection site mass, Swelling
Clinical narrative: she developed hard lumps to both Nasolabial folds; swelling that lasted 3 days; This spontaneous case was reported by a non-health professional and describes the occurrence of SWELLING (swelling that lasted 3 days) and INJECTION SITE MASS (she developed hard lumps to both Nasolabial folds) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE DEFYNE) injection for an unknown indication, BOTULINUM TOXIN TYPE A HAEMAGGLUTININ COMPLEX (DYSPORT) for an unknown indication and HYALURONIC ACID (JUVEDERM) for an unknown indication.    The patient's past medical history included Dermal filler injection (.). Previously administered products included for an unreported indication: BOTOX and RESTYLANE. Concurrent medical conditions included Fibromyalgia.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient started HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE DEFYNE) (unknown route) 2 ml. On 10-May-2021, the patient started HYALURONIC ACID (JUVEDERM) (unknown route) dosage form. On an unknown date, the patient started BOTULINUM TOXIN TYPE A HAEMAGGLUTININ COMPLEX (DYSPORT) (unknown route) dosage form. On 11-Mar-2021, the patient experienced SWELLING (swelling that lasted 3 days). On an unknown date, the patient experienced INJECTION SITE MASS (she developed hard lumps to both Nasolabial folds). On 14-Mar-2021, SWELLING (swelling that lasted 3 days) had resolved. At the time of the report, INJECTION SITE MASS (she developed hard lumps to both Nasolabial folds) outcome was unknown. Not Provided          Patient reported a history of unknown filler in the tear trough that became swollen in August 2020 and required 8 months of treatments with antibiotics.  Concomitant medication history not provided.   Treatment information was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Peripheral swelling
Clinical narrative: Swollen finger; Redness on stomach; Tiredness,fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen finger), ERYTHEMA (Redness on stomach), FATIGUE (Tiredness,fatigue) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was provided.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 PERIPHERAL SWELLING (Swollen finger), ERYTHEMA (Redness on stomach), FATIGUE (Tiredness,fatigue) and HEADACHE (Headache). The patient was treated with OXYCODONE for Pain, at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Swollen finger), ERYTHEMA (Redness on stomach), FATIGUE (Tiredness,fatigue) and HEADACHE (Headache) outcome was unknown.            Concomitant drugs include thyroid medication , and Hormone cream.  Treatment medications include ANTI NAUSEA medication.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: arm rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (arm rash) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (arm rash). At the time of the report, RASH (arm rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  No treatment information was reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Received different vaccine doses; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received different vaccine doses) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received different vaccine doses). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received different vaccine doses) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that she received Pfizer vaccine for the second dose mistakenly.  Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-MAY-2021, contains non-significant information (updated patient initials).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Achy; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) from 30-Mar-2021 to an unknown date for Antacid therapy, ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +) for Nutritional supplementation, VITAMIN D [VITAMIN D NOS] for Vitamin D deficiency.    On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MYALGIA (Achy), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Achy), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 102 (High) 102. In April 2021, Body temperature: 99.9 (High) 99.9.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-059800 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I took the first shot March 14th Didn't get the second shot yet; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I took the first shot March 14th Didn't get the second shot yet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I took the first shot March 14th Didn't get the second shot yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I took the first shot March 14th Didn't get the second shot yet) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received including Non-Significant follow up appended to AER. IRMS document attached.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Oropharyngeal pain, Pain in extremity, Sensation of foreign body
Clinical narrative: sore arm; lump on arm; sore throat; feel like a large lump on the left side of throat and underneath the inside of the throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), SENSATION OF FOREIGN BODY (feel like a large lump on the left side of throat and underneath the inside of the throat), PAIN IN EXTREMITY (sore arm) and MASS (lump on arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Fragrance sensitivity (chemical sensitivity to fragrances, especially citrus perfumes), Drug allergy (Allergic to levofloxacin) and Asthma (No major incidents since 2015) since 2005. Concomitant products included BECLOMETASONE DIPROPIONATE (QVAR) from an unknown date to 05-Apr-2021 for Asthma, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Seasonal allergy, UBIDECARENONE (COQ10 [UBIDECARENONE]), VITAMIN B COMPLEX (VITAMIN B COMP [VITAMIN B COMPLEX]), POTASSIUM, IODINE, RIBES NIGRUM SEED OIL (BLACK CURRANT OIL [RIBES NIGRUM SEED OIL]) and PLANTAGO OVATA SEED HUSK (PSYLLIUM HUSKS) for an unknown indication.    On 24-Feb-2021 at 4:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced SENSATION OF FOREIGN BODY (feel like a large lump on the left side of throat and underneath the inside of the throat). On 26-Feb-2021 at 4:00 AM, the patient experienced OROPHARYNGEAL PAIN (sore throat). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and MASS (lump on arm). The patient was treated with BENZOCAINE, MENTHOL (CHLORASEPTIC SORE THROAT [BENZOCAINE;MENTHOL]) (topical) on 26-Feb-2021 for Sore throat, at a dose of 1 dosage form. On 07-Mar-2021, OROPHARYNGEAL PAIN (sore throat) and SENSATION OF FOREIGN BODY (feel like a large lump on the left side of throat and underneath the inside of the throat) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and MASS (lump on arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient also reported taking an unspecified 24 hour antihistamine concomitantly.   This case was linked to MOD-2021-117024 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Completed ADR Form attached: Concomitant medication added
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: asthmatic with side effects; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (asthmatic with side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHMA (asthmatic with side effects). At the time of the report, ASTHMA (asthmatic with side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Haematoma, Haematuria
Clinical narrative: hematoma after 2nd dose; hematuria after 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOMA (hematoma after 2nd dose) and HAEMATURIA (hematuria after 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMATOMA (hematoma after 2nd dose) and HAEMATURIA (hematuria after 2nd dose). At the time of the report, HAEMATOMA (hematoma after 2nd dose) and HAEMATURIA (hematuria after 2nd dose) outcome was unknown. Not Provided          No concomitant and treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Nonsignificant Follow-up appended
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felling of sickness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Felling of sickness) 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 MALAISE (Felling of sickness). At the time of the report, MALAISE (Felling of sickness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant product use was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Product dose omission issue
Clinical narrative: Sore arm after the 1st dose; Headache after the 1st dose; Patient missed her 2nd dose, more than 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed her 2nd dose, more than 42 days), PAIN IN EXTREMITY (Sore arm after the 1st dose) and HEADACHE (Headache after the 1st dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0372A1B) for COVID-19 vaccination.     No medical history reported by the patient.  Concurrent medical conditions included Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO) for Atrial fibrillation, ATENOLOL, PRAVASTATIN and VITAMINS NOS for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed her 2nd dose, more than 42 days). On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after the 1st dose) and HEADACHE (Headache after the 1st dose). On 14-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Patient missed her 2nd dose, more than 42 days) had resolved. On 16-Apr-2021, PAIN IN EXTREMITY (Sore arm after the 1st dose) and HEADACHE (Headache after the 1st dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient didn't get any treatment medications.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain, Vomiting
Clinical narrative: sore arm; fatigue; chills; vomitng; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue), CHILLS (chills) and VOMITING (vomitng) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 immunization.     Concurrent medical conditions included Drug allergy and Food allergy. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, ARIPIPRAZOLE (ABILIFY) for Depression, ESTRADIOL (ESTRACE) for In vitro fertilization.    On 13-May-2021 at 1:45 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue), CHILLS (chills) and VOMITING (vomitng). At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue), CHILLS (chills) and VOMITING (vomitng) had resolved.            Treatment medication for these events were not reported by the reporter.   This case was linked to MOD-2021-083767 (Patient Link).