chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Primary 1 on 11FEB2021 and Primary 2 on 4MAR2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1 on 11FEB2021 and Primary 2 on 4MAR2021) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1 on 11FEB2021 and Primary 2 on 4MAR2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1 on 11FEB2021 and Primary 2 on 4MAR2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1 on 11FEB2021 and Primary 2 on 4MAR2021). No concomitant medications were reported. The lot number and the expiration date for both the primary doses were unknown. No treatment information was provided by the reporter.   This case was linked to MOD-2022-631139 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013B22A) for COVID-19 prophylaxis. No Medical History information was reported. On 12-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Aug-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered doses of the Moderna COVID-19 vaccine after a potential temperature excursion). Concomitant medications details were not reported by the reporter. It was reported that there were 2 incidents of potential temperature excursions. The vaccines were stored in a frozen condition. On 26-Jul-2022 for a few minutes, temperature dropped while other things were being (Unknown duration on 29-Jul-2022). Maximum or minimum temperatures reached, as applicable was reported as 9.3 degrees Fahrenheit, 33.2 degrees Fahrenheit. The Vials were returned into refrigerators with some administrations. There was no visual changes, appeared frozen for both. Proposed desired date for administration was this afternoon. Total 8 vials were impacted and 3 vials were administered unknown number of patients. No symptoms reported. Patient did not received any additional doses medications or treatments.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (injected arm was minimally sore especially when reaching over her head), VACCINATION SITE PAIN (injected arm was minimally sore especially when reaching over her head) and COVID-19 (got Covid in April of 2022) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 044A21A and 006M20A) 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) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (got Covid in April of 2022). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (injected arm was minimally sore especially when reaching over her head) and VACCINATION SITE PAIN (injected arm was minimally sore especially when reaching over her head). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (injected arm was minimally sore especially when reaching over her head), VACCINATION SITE PAIN (injected arm was minimally sore especially when reaching over her head) and COVID-19 (got Covid in April of 2022) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. Company comment: This is a spontaneous case concerning a 71 years old female, with no medical history, who experienced unexpected non serious AESI events of covid-19, which occurred approximately 5 months after third dose of mRNA-1273 vaccine. SARS-CoV-2 test Positive approximately 5 months after third dose of mRNA-1273 vaccine. At the time of report outcome of the events is unknown. Current ongoing pandemia remains as confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-630782, MOD-2022-630787 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 71 years old female, with no medical history, who experienced unexpected non serious AESI events of covid-19, which occurred approximately 5 months after third dose of mRNA-1273 vaccine. SARS-CoV-2 test Positive approximately 5 months after third dose of mRNA-1273 vaccine. At the time of report outcome of the events is unknown. Current ongoing pandemia remains as confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by an other caregiver and describes the occurrence of COVID-19 (COVID-19) in a 57-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for an unknown indication. The patient does not have any known allergies. Concomitant products included LEVOTHYROXINE, FOLIC ACID, CALCIUM, CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) and COLECALCIFEROL, FISH OIL (FISH OIL + VITAMIN D3) for an unknown indication. In 2021, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) 11 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. It was reported that the patients husband stated that the patient had COVID-19 at the end of July and stopped medication for 1 to 2 weeks. The husband also stated that the prescribing doctor was not aware of this but primary doctor was. The husband stated that wife was doing well now. The patient husband also stated that patient was no longer taking the medication. Company comment: This spontaneous case was reported by an other caregiver and describes the occurrence of COVID-19 (COVID-19) in a 57-year-old female patient in the context of a dose of mRNA-1273 vaccine. Co-suspect product included non-company product TOFACITINIB. Very limited information is available in source document regarding data of the event, diagnostic work-up to support the current diagnosis and treatment received. Temporal association cannot be assessed due to lack of information on onset date of the events  and vaccination date. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. Treatment information was not provided. Reporter did not allow further contact. Sender's Comments: This spontaneous case was reported by an other caregiver and describes the occurrence of COVID-19 (COVID-19) in a 57-year-old female patient in the context of a dose of mRNA-1273 vaccine. Co-suspect product included non-company product TOFACITINIB. Very limited information is available in source document regarding data of the event, diagnostic work-up to support the current diagnosis and treatment received. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination date. The benefit -risk relationship of mRNA -1273 (Moderna Covid-19 Vaccine) is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            Concomitant medication list was not provided.  Treatment information was not provided.  Company Comment: This spontaneous case concerns an unknown-years-old male patient, with no medical history reported who experienced the unexpected AESI of Covid-19 unknown days after 3rd. dose of mRNA-1273 vaccine. The patient received three doses of moderna vaccine. At the time of the report, COVID-19 (COVID-19) was resolving.    The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns an unknown-years-old male patient, with no medical history reported who experienced the unexpected AESI of Covid-19 unknown days after 3rd. dose of mRNA-1273 vaccine. The patient received three doses of moderna vaccine. At the time of the report, COVID-19 (COVID-19) was resolving.    The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: Potential lack of efficacy; This spontaneous case was reported by an other health care professional and describes the occurrence of DRUG INEFFECTIVE (Potential lack of efficacy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. 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 DRUG INEFFECTIVE (Potential lack of efficacy). At the time of the report, DRUG INEFFECTIVE (Potential lack of efficacy) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.  Company Comment- This spontaneous case concerns a patient of unknown age and gender with no medical history reported, who reported non serious unexpected event of potential lack of efficacy (reported as I don't feel like the doses I have received have been optimal in protecting me) unspecified days after receiving the first Booster dose of mRNA vaccine. Details of first 2 doses and first booster dose are not provided. There is no information if the patient experienced any symptoms specifying lack of effect. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no medical history reported, who reported non serious unexpected event of potential lack of efficacy (reported as I don't feel like the doses I have received have been optimal in protecting me) unspecified days after receiving the first Booster dose of mRNA vaccine. Details of first 2 doses and first booster dose are not provided. There is no information if the patient experienced any symptoms specifying lack of effect. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Chills, Dysmenorrhoea, Heavy menstrual bleeding, Myalgia
Clinical narrative: heart rhythm changes/ resting rate changes; excess bleeding; excruciating cramps; shaking; high fevers (105-106); chills; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of ARRHYTHMIA (heart rhythm changes/ resting rate changes) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (3 times patient had COVID (2 prior to getting vaccinated and once while pregnant).).    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (heart rhythm changes/ resting rate changes) (seriousness criterion medically significant), HEAVY MENSTRUAL BLEEDING (excess bleeding), DYSMENORRHOEA (excruciating cramps), TREMOR (shaking), PYREXIA (high fevers (105-106)), CHILLS (chills) and MYALGIA (body aches). At the time of the report, ARRHYTHMIA (heart rhythm changes/ resting rate changes), HEAVY MENSTRUAL BLEEDING (excess bleeding), DYSMENORRHOEA (excruciating cramps), TREMOR (shaking), PYREXIA (high fevers (105-106)), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided.  Company Comment: This spontaneous case concerns a female patient of unknown age, with no relevant medical history, who experienced unexpected, serious (medically significant) AESI arrhythmia with other non-serious events, after receiving a second dose of mRNA-1273 on an unknown date.  She reported heart rhythm changes and resting rate changes shortly after vaccination.  Clinical course, diagnostic evaluation, concomitant medications, and treatment details not reported.  Outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no relevant medical history, who experienced unexpected, serious (medically significant) AESI arrhythmia with other non-serious events, after receiving a second dose of mRNA-1273 on an unknown date.  She reported heart rhythm changes and resting rate changes shortly after vaccination.  Clinical course, diagnostic evaluation, concomitant medications, and treatment details not reported.  Outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: heart rhythm changes/ resting rate changes; excess bleeding; excruciating cramps; shaking; high fevers (105-106); chills; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of ARRHYTHMIA (heart rhythm changes/ resting rate changes) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (3 times patient had COVID (2 prior to getting vaccinated and once while pregnant).).    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (heart rhythm changes/ resting rate changes) (seriousness criterion medically significant), HEAVY MENSTRUAL BLEEDING (excess bleeding), DYSMENORRHOEA (excruciating cramps), TREMOR (shaking), PYREXIA (high fevers (105-106)), CHILLS (chills) and MYALGIA (body aches). At the time of the report, ARRHYTHMIA (heart rhythm changes/ resting rate changes), HEAVY MENSTRUAL BLEEDING (excess bleeding), DYSMENORRHOEA (excruciating cramps), TREMOR (shaking), PYREXIA (high fevers (105-106)), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided.  Company Comment: This spontaneous case concerns a female patient of unknown age, with no relevant medical history, who experienced unexpected, serious (medically significant) AESI arrhythmia with other non-serious events, after receiving a second dose of mRNA-1273 on an unknown date.  She reported heart rhythm changes and resting rate changes shortly after vaccination.  Clinical course, diagnostic evaluation, concomitant medications, and treatment details not reported.  Outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no relevant medical history, who experienced unexpected, serious (medically significant) AESI arrhythmia with other non-serious events, after receiving a second dose of mRNA-1273 on an unknown date.  She reported heart rhythm changes and resting rate changes shortly after vaccination.  Clinical course, diagnostic evaluation, concomitant medications, and treatment details not reported.  Outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Primary 1: 22JAN2021,Primary 2: 27FEB2021; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1: 22JAN2021,Primary 2: 27FEB2021) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1: 22JAN2021,Primary 2: 27FEB2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1: 22JAN2021,Primary 2: 27FEB2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Primary 1: 22JAN2021,Primary 2: 27FEB2021).    No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-630784 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient had side effects and still had side effect; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient had side effects and still had side effect) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient had side effects and still had side effect). At the time of the report, IMMUNISATION REACTION (Patient had side effects and still had side effect) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant products were not reported. Treatment medications were not reported. Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Musculoskeletal discomfort
Clinical narrative: Neck problems/neck cracking/every time he moves his neck he feelsa pinch/sore movement; Never felt good since vaccination; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Neck problems/neck cracking/every time he moves his neck he feelsa pinch/sore movement) and IMMUNISATION REACTION (Never felt good since vaccination) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 06B21A and 012A21A) for COVID-19 vaccination.     Patient did not had any allergies. It was reported that patient has never been diagnosed/tested positive for COVID-19.  The patient's past medical history included Tooth lost (Teeth fell out).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Neck problems/neck cracking/every time he moves his neck he feels a pinch/sore movement) and IMMUNISATION REACTION (Never felt good since vaccination). The patient was treated with Manual therapy (Heating pads) for Musculoskeletal discomfort. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Neck problems/neck cracking/every time he moves his neck he feelsa pinch/sore movement) and IMMUNISATION REACTION (Never felt good since vaccination) had not resolved. Patient was not taking any concomitant medication.  Patient had received all the vaccines doses in deltoid muscle. It was reported that the patient never had any back problems. No other vaccine was received within 1 month prior to COVID-19 vaccine. Adverse event did not cause patient to cause seek medical care. Patient never experienced similar event in the past. Patient had received the treatment of complex sodium cream with no improvement and heating pads which stopped cracking.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013B22A) for COVID-19 prophylaxis. No Medical History information was reported. On 05-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 19-Aug-2022, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2022, SARS-CoV-2 test: (Positive) Positive. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medication information provided. It was reported that patient did not had any allergies. Patient did not had any Acute and Chronic illnesses at the time of vaccination. Patient did not had other vaccines within 1 month prior to Moderna COVID-19 vaccine. Reporter stated that at her work they asked her to get tested for Covid-19 every week. She had never tested positive before. She would like to know if the vaccine could compromise the result of the test, and if she should keep on getting tested now that she received the vaccine. Patient did not experienced any similar event in the past. No treatment information provided. Company Comment:  This spontaneous case was reported by a patient concerning a 48 year old female patient with no medical history reported , who experienced non-serious , unexpected , of Covid 19 which occurred 14 days post vaccination with the dose 1 of mRNA-1273 vaccine.  This patient tested positive for SARS COV 2 test last 19-08-2022.   Reporter stated that at her work they asked her to get tested for Covid-19 every week. She had never tested positive before. Treatment information  results of other laboratories/diagnostic procedures were not  reported. There was no information if this patient made any  medical consultation. Outcome of the event  is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. Sender's Comments: This spontaneous case was reported by a patient concerning a 48 year old female patient with no medical history reported , who experienced non-serious , unexpected ,of Covid 19 which occurred 14 days post vaccination with the dose 1 of mRNA-1273 vaccine.  This patient tested positive for SARS COV 2 test last 19-08-2022.   Reporter stated that at her work they asked her to get tested for Covid-19 every week. She had never tested positive before. Treatment information  results of other laboratories/diagnostic procedures were not  reported. There was no information if this patient made any  medical consultation. Outcome of the event  is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Arrhythmia, Back pain, Diarrhoea, Headache
Clinical narrative: Arrhythmia; Arrhythmia that cause Angina; Backache; Serious Diarrhea; Headache; This spontaneous case was reported by a patient and describes the occurrence of ARRHYTHMIA (Arrhythmia) and ANGINA PECTORIS (Arrhythmia that cause Angina) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant), ANGINA PECTORIS (Arrhythmia that cause Angina) (seriousness criterion medically significant), BACK PAIN (Backache), DIARRHOEA (Serious Diarrhea) and HEADACHE (Headache). At the time of the report, ARRHYTHMIA (Arrhythmia), ANGINA PECTORIS (Arrhythmia that cause Angina), BACK PAIN (Backache), DIARRHOEA (Serious Diarrhea) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported. Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI of Arrhythmia and unexpected, serious (Medically significant) event of Angina pectoris. The exact date of administration of third dose of mRNA-1273 and onset of the events was not specified, hence latency could not be assessed. There was no information provided regarding the initial two doses. Details of concomitant medications, medical history, clinical course and treatment were not provided. The outcome of the events was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI of Arrhythmia and unexpected, serious (Medically significant) event of Angina pectoris. The exact date of administration of third dose of mRNA-1273 and onset of the events was not specified, hence latency could not be assessed. There was no information provided regarding the initial two doses. Details of concomitant medications, medical history, clinical course and treatment were not provided. The outcome of the events was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Dysstasia, Headache, Muscle spasms
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COUGH (Slight cough), DYSSTASIA (Stared for two hours because she can't hardly stand up for a minute of two /Cried for two hours because she can't hardly stand up for a minute of two), DECREASED APPETITE (Have not eaten for three days), MUSCLE SPASMS (Cramps) and PARAESTHESIA (Right hand tingles a little) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient current condition included IVS unspecified. Concurrent medical conditions included Excessive eye blinking, Asthma, Chronic bronchitis, Type 2 diabetes mellitus, Migraine, Obesity, Brain tumor, Fibromyalgia and Neuropathy. On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Slight cough), DYSSTASIA (Stared for two hours because she can't hardly stand up for a minute of two /Cried for two hours because she can't hardly stand up for a minute of two), DECREASED APPETITE (Have not eaten for three days), MUSCLE SPASMS (Cramps), PARAESTHESIA (Right hand tingles a little), PAIN IN EXTREMITY (Severe pain in legs / Severe pain in arms), HEADACHE (Headache), VACCINATION SITE PAIN (Pain and soreness at the injection site) and MYALGIA (All over body pain and ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, COUGH (Slight cough), DYSSTASIA (Stared for two hours because she can't hardly stand up for a minute of two /Cried for two hours because she can't hardly stand up for a minute of two), DECREASED APPETITE (Have not eaten for three days), MUSCLE SPASMS (Cramps), PARAESTHESIA (Right hand tingles a little), PAIN IN EXTREMITY (Severe pain in legs / Severe pain in arms), HEADACHE (Headache), VACCINATION SITE PAIN (Pain and soreness at the injection site) and MYALGIA (All over body pain and ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Patient tested herself negative. No concomitant medications were reported. Patient did not experience any side effects in her first and second Moderna shots. Patient did not experience similar events in the past. Patient called her HCP and the pharmacy where she got her booster dose for events.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Paraesthesia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COUGH (Slight cough), DYSSTASIA (Stared for two hours because she can't hardly stand up for a minute of two /Cried for two hours because she can't hardly stand up for a minute of two), DECREASED APPETITE (Have not eaten for three days), MUSCLE SPASMS (Cramps) and PARAESTHESIA (Right hand tingles a little) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient current condition included IVS unspecified. Concurrent medical conditions included Excessive eye blinking, Asthma, Chronic bronchitis, Type 2 diabetes mellitus, Migraine, Obesity, Brain tumor, Fibromyalgia and Neuropathy. On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Slight cough), DYSSTASIA (Stared for two hours because she can't hardly stand up for a minute of two /Cried for two hours because she can't hardly stand up for a minute of two), DECREASED APPETITE (Have not eaten for three days), MUSCLE SPASMS (Cramps), PARAESTHESIA (Right hand tingles a little), PAIN IN EXTREMITY (Severe pain in legs / Severe pain in arms), HEADACHE (Headache), VACCINATION SITE PAIN (Pain and soreness at the injection site) and MYALGIA (All over body pain and ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, COUGH (Slight cough), DYSSTASIA (Stared for two hours because she can't hardly stand up for a minute of two /Cried for two hours because she can't hardly stand up for a minute of two), DECREASED APPETITE (Have not eaten for three days), MUSCLE SPASMS (Cramps), PARAESTHESIA (Right hand tingles a little), PAIN IN EXTREMITY (Severe pain in legs / Severe pain in arms), HEADACHE (Headache), VACCINATION SITE PAIN (Pain and soreness at the injection site) and MYALGIA (All over body pain and ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Patient tested herself negative. No concomitant medications were reported. Patient did not experience any side effects in her first and second Moderna shots. Patient did not experience similar events in the past. Patient called her HCP and the pharmacy where she got her booster dose for events.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 19-Aug-2022; No adverse event; Received expired 2nd booster dose after 30 day beyond use expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose after 30 day beyond use expiry date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 19-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose after 30 day beyond use expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 19-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose after 30 day beyond use expiry date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 19-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose after 30 day beyond use expiry date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 19-Aug-2022).    Concomitant medications details were not reported by the reporter. Patient received the second booster dose. Reportedly 4 doses and 3 vials were initially stored in the refrigerator on 15-Jul-2022. Two patients received Moderna COVID-19 Vaccine on 19-AUG-2022. The vials had not undergone any temperature excursions. Treatment details were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-631699 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-631699:Adult patient 1
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose after 30 day beyond use expiry date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 20-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051B22A) for COVID-19 vaccination. No Medical History information was reported. On 20-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose after 30 day beyond use expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 20-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose after 30 day beyond use expiry date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 20-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster dose after 30 day beyond use expiry date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 15-Jul-2022 and administered on 20-Aug-2022). No concomitant medication was reported.  The vial was initially stored in the refrigerator on 15-Jul-2022. The vial did not undergo any temperature excursions. No treatment information was reported. This case was linked to MODERNATX, INC.-MOD-2022-631699, MODERNATX, INC.-MOD-2022-631701 (E2B Linked Report). Sender's Comments: MODERNATX, INC.-MOD-2022-631699:Adult patient 1; MODERNATX, INC.-MOD-2022-631701:Adult patient 2
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Someone had an adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (Someone had an adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 ADVERSE EVENT (Someone had an adverse event) (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (Someone had an adverse event) 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 were reported. It was reported that the clinical trial researcher wanted to know if someone had an adverse event and had financial problem would Moderna reimburse them. It was tried to gather the information about the adverse event, and they refused to give the information, until they got a guarantee that Moderna would reimburse them for the ambulance ride, and hospitalization of the pediatric under 16 years of agefamily member. No treatment medications were reported.  Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious, event of Adverse Event NOS which led to the hospitalization of the patient and occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious, event of Adverse Event NOS which led to the hospitalization of the patient and occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine experienced excursion in the refrigerator), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine experienced excursion in the refrigerator on 21-Aug-2022 and dose was adminitered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 vaccination. No Medical History information was reported. On 22-Aug-2022 at 9:30 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine experienced excursion in the refrigerator on 21-Aug-2022 and dose was administered on 22-Aug-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine experienced excursion in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine experienced excursion in the refrigerator), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine experienced excursion in the refrigerator on 21-Aug-2022 and dose was administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine experienced excursion in the refrigerator) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine experienced excursion in the refrigerator on 21-Aug-2022 and dose was administered on 22-Aug-2022). Patient received 2nd booster dose. No concomitant medications were reported. Vaccine experienced excursion in the refrigerator on 21-AUG-2022. Vaccine was refrigerated at the time of excursion. Maximum or minimum  temperatures reached was reported as Maximum 54 Fahrenheit. Excursion duration was 12 hours. Vial was moved from  freezer to refrigerator on 21-AUG-2022. Visual inspection noting any vaccine state change was reported as normal. Total 12 Unpunctured vials experienced excursion. No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Keratoacanthoma
Clinical narrative: KERATOACANTHOMA SKIN CANCER.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Second dose of the Moderna Covid 19 vaccine was administered 5 days before the recommended interval; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the Moderna Covid 19 vaccine was administered 5 days before the recommended interval) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the Moderna Covid 19 vaccine was administered 5 days before the recommended interval). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the Moderna Covid 19 vaccine was administered 5 days before the recommended interval) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the Moderna Covid 19 vaccine was administered 5 days before the recommended interval).    No concomitant medication was reported.  The patient did not ever tested positive for Covid 19.  No treatment medication was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Tinnitis and decreased hearing in L ear.