chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Pain, Vaccination site pain
Clinical narrative: He also has abdominal cramping along with diarrhea; He also started with diarrhea that started next day/He still has diarrhea; The pain was going up and down on the left side of the body for about a day & half; He had soreness in the injected left arm on that day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (The pain was going up and down on the left side of the body for about a day & half), DIARRHOEA (He also started with diarrhea that started next day/He still has diarrhea), ABDOMINAL PAIN (He also has abdominal cramping along with diarrhea) and VACCINATION SITE PAIN (He had soreness in the injected left arm on that day) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced PAIN (The pain was going up and down on the left side of the body for about a day & half) and VACCINATION SITE PAIN (He had soreness in the injected left arm on that day). On 07-Aug-2021, the patient experienced DIARRHOEA (He also started with diarrhea that started next day/He still has diarrhea). On an unknown date, the patient experienced ABDOMINAL PAIN (He also has abdominal cramping along with diarrhea). At the time of the report, PAIN (The pain was going up and down on the left side of the body for about a day & half) and VACCINATION SITE PAIN (He had soreness in the injected left arm on that day) outcome was unknown and DIARRHOEA (He also started with diarrhea that started next day/He still has diarrhea) and ABDOMINAL PAIN (He also has abdominal cramping along with diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Nausea, Pain in extremity, Product dose omission issue
Clinical narrative: Felt wheezy; Arm hurt; Big knot at the site of injection that is the size of ping pong/ Noticed the knot; Site of injection feels hot to touch; Worried; Red patch at the site of injection that is 2by2 inches/ patch after she received the vaccine; Injection site burns; She will not be getting the 2nd dose of the vaccine; It was much bigger; Throwing up; Under her ribs in her stomach area she felt nauseous/Really nauseous; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Felt wheezy), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE NODULE (Big knot at the site of injection that is the size of ping pong/ Noticed the knot), VACCINATION SITE WARMTH (Site of injection feels hot to touch) and CONDITION AGGRAVATED (It was much bigger) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced NAUSEA (Under her ribs in her stomach area she felt nauseous/Really nauseous). On 31-Jul-2021, the patient experienced VOMITING (Throwing up). On 08-Aug-2021, the patient experienced CONDITION AGGRAVATED (It was much bigger). On an unknown date, the patient experienced WHEEZING (Felt wheezy), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE NODULE (Big knot at the site of injection that is the size of ping pong/ Noticed the knot), VACCINATION SITE WARMTH (Site of injection feels hot to touch), ANXIETY (Worried), VACCINATION SITE ERYTHEMA (Red patch at the site of injection that is 2by2 inches/ patch after she received the vaccine), VACCINATION SITE PAIN (Injection site burns) and PRODUCT DOSE OMISSION ISSUE (She will not be getting the 2nd dose of the vaccine). The patient was treated with PREDNISOLONE at a dose of 1 dosage form. At the time of the report, WHEEZING (Felt wheezy), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE NODULE (Big knot at the site of injection that is the size of ping pong/ Noticed the knot), VACCINATION SITE WARMTH (Site of injection feels hot to touch), CONDITION AGGRAVATED (It was much bigger), ANXIETY (Worried), NAUSEA (Under her ribs in her stomach area she felt nauseous/Really nauseous), VOMITING (Throwing up), VACCINATION SITE ERYTHEMA (Red patch at the site of injection that is 2by2 inches/ patch after she received the vaccine) and VACCINATION SITE PAIN (Injection site burns) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She will not be getting the 2nd dose of the vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The patient stated that she would not receive second dose of vaccine.  Concomitant medication was not provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site nodule, Vaccination site pain, Vaccination site warmth, Vomiting
Clinical narrative: Felt wheezy; Arm hurt; Big knot at the site of injection that is the size of ping pong/ Noticed the knot; Site of injection feels hot to touch; Worried; Red patch at the site of injection that is 2by2 inches/ patch after she received the vaccine; Injection site burns; She will not be getting the 2nd dose of the vaccine; It was much bigger; Throwing up; Under her ribs in her stomach area she felt nauseous/Really nauseous; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Felt wheezy), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE NODULE (Big knot at the site of injection that is the size of ping pong/ Noticed the knot), VACCINATION SITE WARMTH (Site of injection feels hot to touch) and CONDITION AGGRAVATED (It was much bigger) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced NAUSEA (Under her ribs in her stomach area she felt nauseous/Really nauseous). On 31-Jul-2021, the patient experienced VOMITING (Throwing up). On 08-Aug-2021, the patient experienced CONDITION AGGRAVATED (It was much bigger). On an unknown date, the patient experienced WHEEZING (Felt wheezy), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE NODULE (Big knot at the site of injection that is the size of ping pong/ Noticed the knot), VACCINATION SITE WARMTH (Site of injection feels hot to touch), ANXIETY (Worried), VACCINATION SITE ERYTHEMA (Red patch at the site of injection that is 2by2 inches/ patch after she received the vaccine), VACCINATION SITE PAIN (Injection site burns) and PRODUCT DOSE OMISSION ISSUE (She will not be getting the 2nd dose of the vaccine). The patient was treated with PREDNISOLONE at a dose of 1 dosage form. At the time of the report, WHEEZING (Felt wheezy), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE NODULE (Big knot at the site of injection that is the size of ping pong/ Noticed the knot), VACCINATION SITE WARMTH (Site of injection feels hot to touch), CONDITION AGGRAVATED (It was much bigger), ANXIETY (Worried), NAUSEA (Under her ribs in her stomach area she felt nauseous/Really nauseous), VOMITING (Throwing up), VACCINATION SITE ERYTHEMA (Red patch at the site of injection that is 2by2 inches/ patch after she received the vaccine) and VACCINATION SITE PAIN (Injection site burns) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She will not be getting the 2nd dose of the vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The patient stated that she would not receive second dose of vaccine.  Concomitant medication was not provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Felt wheezy; Arm hurt; Big knot at the site of injection that is the size of ping pong/ Noticed the knot; Site of injection feels hot to touch; Worried; Red patch at the site of injection that is 2by2 inches/ patch after she received the vaccine; Injection site burns; She will not be getting the 2nd dose of the vaccine; It was much bigger; Throwing up; Under her ribs in her stomach area she felt nauseous/Really nauseous; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Felt wheezy), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE NODULE (Big knot at the site of injection that is the size of ping pong/ Noticed the knot), VACCINATION SITE WARMTH (Site of injection feels hot to touch) and CONDITION AGGRAVATED (It was much bigger) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced NAUSEA (Under her ribs in her stomach area she felt nauseous/Really nauseous). On 31-Jul-2021, the patient experienced VOMITING (Throwing up). On 08-Aug-2021, the patient experienced CONDITION AGGRAVATED (It was much bigger). On an unknown date, the patient experienced WHEEZING (Felt wheezy), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE NODULE (Big knot at the site of injection that is the size of ping pong/ Noticed the knot), VACCINATION SITE WARMTH (Site of injection feels hot to touch), ANXIETY (Worried), VACCINATION SITE ERYTHEMA (Red patch at the site of injection that is 2by2 inches/ patch after she received the vaccine), VACCINATION SITE PAIN (Injection site burns) and PRODUCT DOSE OMISSION ISSUE (She will not be getting the 2nd dose of the vaccine). The patient was treated with PREDNISOLONE at a dose of 1 dosage form. At the time of the report, WHEEZING (Felt wheezy), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE NODULE (Big knot at the site of injection that is the size of ping pong/ Noticed the knot), VACCINATION SITE WARMTH (Site of injection feels hot to touch), CONDITION AGGRAVATED (It was much bigger), ANXIETY (Worried), NAUSEA (Under her ribs in her stomach area she felt nauseous/Really nauseous), VOMITING (Throwing up), VACCINATION SITE ERYTHEMA (Red patch at the site of injection that is 2by2 inches/ patch after she received the vaccine) and VACCINATION SITE PAIN (Injection site burns) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She will not be getting the 2nd dose of the vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The patient stated that she would not receive second dose of vaccine.  Concomitant medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Myalgia, Vomiting
Clinical narrative: Sick to my stomach; Having some chills; Muscle Pain; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick to my stomach), CHILLS (Having some chills), MYALGIA (Muscle Pain) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 007D21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.   On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021 at 9:30 AM, the patient experienced ABDOMINAL DISCOMFORT (Sick to my stomach), CHILLS (Having some chills), MYALGIA (Muscle Pain) and VOMITING (vomiting). At the time of the report, ABDOMINAL DISCOMFORT (Sick to my stomach), CHILLS (Having some chills), MYALGIA (Muscle Pain) and VOMITING (vomiting) outcome was unknown.            No relevant concomitant medications were reported.  It was reported that patient was concerned that she may have potentially exposed to COVID. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: report my side effects from my vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (report my side effects from my vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (report my side effects from my vaccine). At the time of the report, VACCINATION COMPLICATION (report my side effects from my vaccine) outcome was unknown.            No Concomitant medication information was reported. No Treatment medications were provided.   Reporter did not allow further contact
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual period was off and crazy for 3 months after vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of MENSTRUAL DISORDER (Menstrual period was off and crazy for 3 months after vaccination) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (Menstrual period was off and crazy for 3 months after vaccination). At the time of the report, MENSTRUAL DISORDER (Menstrual period was off and crazy for 3 months after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow up received contain no new information.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Thirst
Clinical narrative: extreme thirst; feeling lightheaded; feeling strange with the thirst; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (extreme thirst), DIZZINESS (feeling lightheaded) and FEELING ABNORMAL (feeling strange with the thirst) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced THIRST (extreme thirst), DIZZINESS (feeling lightheaded) and FEELING ABNORMAL (feeling strange with the thirst). At the time of the report, THIRST (extreme thirst), DIZZINESS (feeling lightheaded) and FEELING ABNORMAL (feeling strange with the thirst) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was not provided by the reporter. Concomitant product was centrum. patient had taken Shingrix Vaccine in July & Oct of 2020,   This case was linked to MOD-2021-282754 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up received and contains non significant information.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna covid vaccine found to be out of date after administration on 8/APR/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/APR/21) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/APR/21). On 08-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/APR/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash, Urticaria
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of BLISTER (Breakout in rash and blisters), URTICARIA (Hives) and RASH (Breakout in rash and blisters,rash all over body) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced BLISTER (Breakout in rash and blisters), URTICARIA (Hives) and RASH (Breakout in rash and blisters,rash all over body). The patient was treated with PREDNISONE ongoing since an unknown date for Rash and Hives, at an unspecified dose and frequency. At the time of the report, BLISTER (Breakout in rash and blisters) and RASH (Breakout in rash and blisters,rash all over body) had not resolved and URTICARIA (Hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Followup reiceived :Live Follow Up Appended- patient info updated.Primary reporter type updated as per recent data received.Lot no.updated,treatment drug added.Event onset date updated
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired product administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired product administered) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered). On 04-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired product administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported. The treatment information was not provided.; Sender's Comments: This report refers to a case of medication error, administration of expired Covid 19/mRNA-1273 vaccine with lot number/batch number 015M20A with no known associated adverse event.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID vaccine found to be out of date after administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine found to be out of date after administration ) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine found to be out of date after administration ). On 04-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine found to be out of date after administration ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided. It was reported that the individual was notified and opted not to repeat the vaccine. No adverse events were reported as a result of the event.; Sender's Comments: This report refers to a case of Medication error, administration of expired Covid 19/ mRNA-1273 vaccine with lot number/batch number 015M20A with no known associated adverse event.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna covid vaccine found to be out of date after administration on 8/APR/2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/APR/2021) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/APR/2021). On 08-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Moderna covid vaccine found to be out of date after administration on 8/APR/2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided. The patient was notified and opted not to repeat the vaccine.  No adverse events were reported as a result of the event.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose > 35 days ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago). On 26-Mar-2021, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product were reported  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Unspecific adverse event.; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Unspecific adverse event.) 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 ADVERSE EVENT (Unspecific adverse event.). At the time of the report, ADVERSE EVENT (Unspecific adverse event.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nosebleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nosebleed) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EPISTAXIS (nosebleed). At the time of the report, EPISTAXIS (nosebleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: Sick from covid; Sick from covid; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick from covid) and COVID-19 (Sick from covid) in a 24-year-old female patient 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 02-Aug-2021, the patient experienced ILLNESS (Sick from covid). On 04-Aug-2021, the patient experienced COVID-19 (Sick from covid). At the time of the report, ILLNESS (Sick from covid) and COVID-19 (Sick from covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had symptoms on 02-Aug-2021 prior to being tested positive for COVID on 04-Aug-2021.  Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Non-Significant follow up appended
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I would like to report a side effect; 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 VACCINATION COMPLICATION (I would like to report a side effect) 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 VACCINATION COMPLICATION (I would like to report a side effect). At the time of the report, VACCINATION COMPLICATION (I would like to report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications reported.  No treatment medications reported.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Confusional state, Fatigue, Feeling abnormal, Loss of personal independence in daily activities
Clinical narrative: heart palpitations; feel confusion/ Patient "doesn't know what to do"; sometimes it is like my brain has no thoughts like it is not working / brain couldn't process information and was not thinking as he used to; have good days and bad days; still having side effects; fogginess; affecting his job performance; very fatigued/ tiredness/ chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), CONFUSIONAL STATE (feel confusion/ Patient "doesn't know what to do"), THINKING ABNORMAL (sometimes it is like my brain has no thoughts like it is not working / brain couldn't process information and was not thinking as he used to), MALAISE (have good days and bad days) and ADVERSE REACTION (still having side effects) in a 45-year-old male 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.  Concomitant products included LISINOPRIL, VARENICLINE TARTRATE (CHAMPIX), CLONAZEPAM and CITALOPRAM for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 PALPITATIONS (heart palpitations), CONFUSIONAL STATE (feel confusion/ Patient "doesn't know what to do"), THINKING ABNORMAL (sometimes it is like my brain has no thoughts like it is not working / brain couldn't process information and was not thinking as he used to), MALAISE (have good days and bad days), ADVERSE REACTION (still having side effects), FEELING ABNORMAL (fogginess), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (affecting his job performance) and FATIGUE (very fatigued/ tiredness/ chronic fatigue). At the time of the report, PALPITATIONS (heart palpitations), CONFUSIONAL STATE (feel confusion/ Patient "doesn't know what to do"), THINKING ABNORMAL (sometimes it is like my brain has no thoughts like it is not working / brain couldn't process information and was not thinking as he used to), MALAISE (have good days and bad days), ADVERSE REACTION (still having side effects) and FATIGUE (very fatigued/ tiredness/ chronic fatigue) had not resolved and FEELING ABNORMAL (fogginess) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (affecting his job performance) outcome was unknown.            Concomitant medication also included accumarol No treatment medications were reported. Patient visited his regular physician and was told patients who had COVID19 were experiencing those symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received and added vaccination details,concomitant medications and events fogginess, affect job performance. Also updated reporter and patient details.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Palpitations, Thinking abnormal
Clinical narrative: heart palpitations; feel confusion/ Patient "doesn't know what to do"; sometimes it is like my brain has no thoughts like it is not working / brain couldn't process information and was not thinking as he used to; have good days and bad days; still having side effects; fogginess; affecting his job performance; very fatigued/ tiredness/ chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), CONFUSIONAL STATE (feel confusion/ Patient "doesn't know what to do"), THINKING ABNORMAL (sometimes it is like my brain has no thoughts like it is not working / brain couldn't process information and was not thinking as he used to), MALAISE (have good days and bad days) and ADVERSE REACTION (still having side effects) in a 45-year-old male 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.  Concomitant products included LISINOPRIL, VARENICLINE TARTRATE (CHAMPIX), CLONAZEPAM and CITALOPRAM for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 PALPITATIONS (heart palpitations), CONFUSIONAL STATE (feel confusion/ Patient "doesn't know what to do"), THINKING ABNORMAL (sometimes it is like my brain has no thoughts like it is not working / brain couldn't process information and was not thinking as he used to), MALAISE (have good days and bad days), ADVERSE REACTION (still having side effects), FEELING ABNORMAL (fogginess), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (affecting his job performance) and FATIGUE (very fatigued/ tiredness/ chronic fatigue). At the time of the report, PALPITATIONS (heart palpitations), CONFUSIONAL STATE (feel confusion/ Patient "doesn't know what to do"), THINKING ABNORMAL (sometimes it is like my brain has no thoughts like it is not working / brain couldn't process information and was not thinking as he used to), MALAISE (have good days and bad days), ADVERSE REACTION (still having side effects) and FATIGUE (very fatigued/ tiredness/ chronic fatigue) had not resolved and FEELING ABNORMAL (fogginess) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (affecting his job performance) outcome was unknown.            Concomitant medication also included accumarol No treatment medications were reported. Patient visited his regular physician and was told patients who had COVID19 were experiencing those symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received and added vaccination details,concomitant medications and events fogginess, affect job performance. Also updated reporter and patient details.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Genital warts  gone; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Genital warts  gone) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 036B21A) for COVID-19 vaccination.     The patient's past medical history included Genital warts (had genital warts for over 20 years). Concurrent medical conditions included Diabetes (Patient is diabetic). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), ENALAPRIL, PHENOBARBITAL, GLIPIZIDE, INSULIN LISPRO (HUMALOG), HYDROCHLOROTHIAZIDE, INSULIN GLARGINE (LANTUS), METFORMIN, METOPROLOL and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Genital warts  gone). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Genital warts  gone) had resolved.            No treatment medication reported. No adverse event reported. Patient provided consent for Safety to follow up, but no contact details provided.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) 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 DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug information was provided by reporter.  No treatment medication was provided by reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose in January 2021 and wanted to know if I need to start over; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose in January 2021 and wanted to know if I need to start over) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose in January 2021 and wanted to know if I need to start over). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose in January 2021 and wanted to know if I need to start over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Got his 1  st dose of the Moderna COVID-19 Vaccine, 5 months ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got his 1  st dose of the Moderna COVID-19 Vaccine, 5 months ago) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got his 1  st dose of the Moderna COVID-19 Vaccine, 5 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got his 1  st dose of the Moderna COVID-19 Vaccine, 5 months ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: patient received 2 different manufactured covid19 vacine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient received 2 different manufactured covid19 vacine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication.    No Medical History information was reported.   In 2021, the patient received dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient received 2 different manufactured covid19 vacine). On 04-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (patient received 2 different manufactured covid19 vacine) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pharmacist reported that the patient administered 1 dose of the moderna vaccine to three patients. Pharmacist reports that all three patients received a dose of the astrazeneca vaccine last month overseas  No concomitant medication was reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow-up information included race and ethnicity was added
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Muscle discomfort, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of impaired work ability (muscular problems kept him from working), muscle discomfort (muscular problems) and pyrexia (high fever) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced impaired work ability (muscular problems kept him from working), muscle discomfort (muscular problems) and pyrexia (high fever). At the time of the report, impaired work ability (muscular problems kept him from working): resolved; muscle discomfort (muscular problems) and pyrexia (high fever) outcome: unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-283049 (patient link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of product dose omission issue (patient got the first dose of the Moderna vaccine on Mar 3, 2021 and has not received the second one yet) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 036A21A) for COVID-19 immunization. No medical history reported. On Mar 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced product dose omission issue (patient got the first dose of the Moderna vaccine on Mar 3, 2021 and has not received the second one yet). At the time of the report, product dose omission issue (patient got the first dose of the Moderna vaccine on Mar 3, 2021 and has not received the second one yet): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular): unknown. Concomitant medications included systemic steroids. The reporter did not provide any causality assessments or treatment information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased
Clinical narrative: Low Heart Rate (52 and 58); This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE DECREASED (Low Heart Rate (52 and 58)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Overweight and Type 2 diabetes mellitus.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced HEART RATE DECREASED (Low Heart Rate (52 and 58)). At the time of the report, HEART RATE DECREASED (Low Heart Rate (52 and 58)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2021, Heart rate: 52-58 (Low) normally is about 70.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include a sugar pill for diabetes and blood pressure medication. Treatment information not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Dyspnoea, Malaise, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Began feeling ill; Nose is so stuffy; Breathing out of mouth; Sounds like a mouse; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Began feeling ill), NASAL CONGESTION (Nose is so stuffy), DYSPNOEA (Breathing out of mouth) and DYSPHONIA (Sounds like a mouse) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Began feeling ill), NASAL CONGESTION (Nose is so stuffy), DYSPNOEA (Breathing out of mouth) and DYSPHONIA (Sounds like a mouse). On 08-Aug-2021, MALAISE (Began feeling ill), NASAL CONGESTION (Nose is so stuffy), DYSPNOEA (Breathing out of mouth) and DYSPHONIA (Sounds like a mouse) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, SARS-CoV-2 test: positive (Positive) tested positive for Covid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information not reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (did not receive the 2nd dose between 25-35 days of the 1st dose) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 048B21A) for COVID-19 immunization. No medical history reported. On Jun 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced product dose omission issue (did not receive the 2nd dose between 25-35 days of the 1st dose). At the time of the report, product dose omission issue (did not receive the 2nd dose between 25-35 days of the 1st dose) had resolved.  The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported. Sender's comments: This is a case of medication error. Dose omission for 2nd dose of COVID-19 (mRNA-1273) vaccine. Causality for medication error not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1 dose of expired Moderna COVID 19 vaccine was administered to 1 patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of expired Moderna COVID 19 vaccine was administered to 1 patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of expired Moderna COVID 19 vaccine was administered to 1 patient). On 04-Aug-2021, EXPIRED PRODUCT ADMINISTERED (1 dose of expired Moderna COVID 19 vaccine was administered to 1 patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment information provided.