chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) 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 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 (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 an unknown date, SARS-CoV-2 test: positive (Positive) positive.         Concomitant products were not provided. Treatment medications were not reported  Company comment: This is a spontaneous case concerning a  patient of an unknown age and gender with no medical history reported; who experienced unexpected event of COVID-19 (AESI). The event occurred on an unknown date after the administration of mRNA-1273 vaccine. Caller mentions they know that 1 senator from the state of Massachusetts tested positive for COVID-19 even after getting 2 shots and the booster form one COVID-19 vaccine. Clinical course and treatment details were not provided. Caller does not provided consent for follow up. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.     Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a  patient of an unknown age and gender with no medical history reported; who experienced unexpected event of COVID-10 (AESI). The event occurred on an unknown date after the administration of mRNA-1273 vaccine. Caller mentions they know that 1 senator from the state of Massachusetts tested positive for COVID-19 even after getting 2 shots and the booster form one COVID-19 vaccine. Clinical course and treatment details were not provided. Caller does not provided consent for follow up. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: they contracted COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (they contracted COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 COVID-19 (they contracted COVID-19). At the time of the report, COVID-19 (they contracted COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company Comment: This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected AESI event of COVID-19. The event occurred on an unknown date after a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected AESI event of COVID-19. The event occurred on an unknown date after a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19 after Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 after Moderna shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 COVID-19 (Covid-19 after Moderna shot). At the time of the report, COVID-19 (Covid-19 after Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.  This case concerns a male patient of an unknown age with no medical history, who experienced the AESI COVID-19. The event occurred on an unknown date after receiving an unspecified and undated dose of mRNA-1273. The rechallenge was is not applicable since no vaccination dates or dosage was given. No clinical or treatment details were disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no medical history, who experienced the AESI COVID-19. The event occurred on an unknown date after receiving an unspecified and undated dose of mRNA-1273. The rechallenge was is not applicable since no vaccination dates or dosage was given. No clinical or treatment details were disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during breast feeding, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: tested positive for covid in a PCR test after her booster; Now she is nursing; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid in a PCR test after her booster) and MATERNAL EXPOSURE DURING BREAST FEEDING (Now she is nursing) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Concurrent medical conditions included Breast feeding.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced COVID-19 (tested positive for covid in a PCR test after her booster) and MATERNAL EXPOSURE DURING BREAST FEEDING (Now she is nursing). On 20-Dec-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Now she is nursing) had resolved. At the time of the report, COVID-19 (tested positive for covid in a PCR test after her booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Dec-2021, SARS-CoV-2 test: negative covid-19 test (Negative) negative Covid-19 test. On 20-Dec-2021, SARS-CoV-2 antibody test: negative covid-19 test (Negative) negative Covid-19 test. On 20-Dec-2021, SARS-CoV-2 test: positive pcr test (Positive) Positive PCR test.         No concomitant medication was reported.  No treatment medication was reported.  Patient was not pregnant now but was pregnant during the first 2 shots of the vaccine. Now the patient was nursing.  This is a spontaneous case concerning  a  35-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of Maternal exposure during breastfeeding and Covid-19 as an added event. The events occurred approximately on the same day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The event covid-19 outcome as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  35-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of Maternal exposure during breastfeeding and Covid-19 as an added event. The events occurred approximately on the same day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The event covid-19 outcome as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Myalgia, Pyrexia
Clinical narrative: Passed out after first shot for 24 hours; Headache after first shot for 24 hours; Extreme body ache after first shot for 24 hours; Fever after first shot for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out after first shot for 24 hours), HEADACHE (Headache after first shot for 24 hours), MYALGIA (Extreme body ache after first shot for 24 hours) and PYREXIA (Fever after first shot for 24 hours) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020. Concurrent medical conditions included Allergy NOS.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out after first shot for 24 hours), HEADACHE (Headache after first shot for 24 hours), MYALGIA (Extreme body ache after first shot for 24 hours) and PYREXIA (Fever after first shot for 24 hours). In February 2021, LOSS OF CONSCIOUSNESS (Passed out after first shot for 24 hours), HEADACHE (Headache after first shot for 24 hours), MYALGIA (Extreme body ache after first shot for 24 hours) and PYREXIA (Fever after first shot for 24 hours) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medication was reported.    No treatment medications were reported.  It was reported that the symptoms got recovered after 24 hours.   This case was linked to MOD-2021-422844 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Urticaria
Clinical narrative: Anaphylactic reaction; Pink hives of full body; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0U9C21A, 013F21A and D39A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced URTICARIA (Pink hives of full body). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criteria medically significant and life threatening). The patient was treated with LORATADINE (CLARITINE) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Anaphylactic reaction, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) and URTICARIA (Pink hives of full body) outcome was unknown.            No concomitant medications were reported.  Company Comment: This is a spontaneous case concerning a 31-year-old, male patient with no medical history, who experienced the expected serious event of Anaphylactic reaction and non-serious event Utricaria. The event Anaphylactic reaction occurred on an unknown day and event utricaria occurred 17 days after the second dose of mRNA-1273 vaccine. Patient was treated with Claritine, Benadryl, solumedrol, prednisone and Medrol. The event utricaria was resolved in three weeks. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-422932 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 31-year-old, male patient with no medical history, who experienced the expected serious event of Anaphylactic reaction and non-serious event Utricaria. The event Anaphylactic reaction occurred on an unknown day and event utricaria occurred 17 days after the second dose of mRNA-1273 vaccine. Patient was treated with Claritine, Benadryl, solumedrol, prednisone and Medrol. The event utricaria was resolved in three weeks. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: she got the covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (she got the covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced COVID-19 (she got the covid). At the time of the report, COVID-19 (she got the covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  It was reported that the patient participated in the pediatric COVID 19 vaccine trial. Upon unblinding, it was confirmed that she got the vaccine, not placebo.  Company comment: This case concerns a female patient of unknown age with no medical history reported, who experienced the adverse events of special interest COVID-19. The event occurred an unknown time after the most recent dose of mRNA-1273. Information regarding medical evaluation and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no medical history reported, who experienced the adverse events of special interest COVID-19. The event occurred an unknown time after the most recent dose of mRNA-1273. Information regarding medical evaluation and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 after getting Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after getting Moderna booster) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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 (Tested positive for COVID-19 after getting Moderna booster). At the time of the report, COVID-19 (Tested positive for COVID-19 after getting Moderna booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.         No concomitant medications were reported. No treatment medications were reported. Company Comment: This case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non-serious AESI COVID-19, as he tested positive for COVID-19. The event occurred at an unknown after the booster dose of mRNA-1273 vaccine (reporter states that the patient had completed his vaccination series). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non-serious AESI COVID-19, as he tested positive for COVID-19. The event occurred at an unknown after the booster dose of mRNA-1273 vaccine (reporter states that the patient had completed his vaccination series). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Had a seizure that lasted for 30 minutes; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Had a seizure that lasted for 30 minutes) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     The patient's past medical history included Seizures (He does have a history of seizures but had not had one in a while.). Previously administered products included for COVID-19 vaccination: Johnson and Johnson (J&J) COVID-19 vaccine (first vaccination was the Johnson and Johnson (J&J) COVID-19 vaccine and batch number 203A21A) on 19-May-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson (J&J) COVID-19 vaccine. Concurrent medical conditions included Autism spectrum disorder (under the care of a physician for autism spectrum disorder). Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE), GUANFACINE and SERTRALINE for an unknown indication.    On 21-Dec-2021 at 6:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021 at 11:30 PM, the patient experienced SEIZURE (Had a seizure that lasted for 30 minutes) (seriousness criterion medically significant). On 22-Dec-2021, SEIZURE (Had a seizure that lasted for 30 minutes) had resolved.            No treatment information was provided by the reporter.  Mother who was a caretaker for her son reported that patient received the Moderna COVID-19 booster vaccine and had a seizure that lasted for 30 minutes. No temperature. It was tremors with his eyes rolling. Patient does have a history of seizures but had not had one in a while. Patient was under the care of a physician for autism spectrum disorder.  Company comment: This is a  spontaneous case concerning a  19-year-old male  patient with concurrent medical condition of Autism spectrum disorder and medical history of seizures; who experienced unexpected event of seizure. The event occurred approximately 5 hours after the third dose of mRNA-1273 vaccine. It was reported that seizure lasted for 30 minutes. No temperature. It was tremors with his eyes rolling. Treatment details were not provided. Concurrent medical condition of Autism spectrum disorder and medical history of seizures remain confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a  spontaneous case concerning a  19-year-old male  patient with concurrent medical condition of Autism spectrum disorder and medical history of seizures; who experienced unexpected event of seizure. The event occurred approximately 5 hours after the third dose of mRNA-1273 vaccine. It was reported that seizure lasted for 30 minutes. No temperature. It was tremors with his eyes rolling. Treatment details were not provided. Concurrent medical condition of Autism spectrum disorder and medical history of seizures remain confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Persistent headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Persistent headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced HEADACHE (Persistent headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Persistent headache, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Persistent headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Persistent headache) had not resolved.            No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: thought it was cellulitis; 3 days after 2nd dose left ankle swelled up; was out of work for 4 months after 2nd Moderna dose; was in so much pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (thought it was cellulitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CELLULITIS (thought it was cellulitis) (seriousness criterion medically significant), JOINT SWELLING (3 days after 2nd dose left ankle swelled up), PAIN (was in so much pain) and ARTHRALGIA (Joint pain). an unknown date, the patient experienced IMPAIRED WORK ABILITY (was out of work for 4 months after 2nd Moderna dose). At the time of the report, CELLULITIS (thought it was cellulitis), JOINT SWELLING (3 days after 2nd dose left ankle swelled up), IMPAIRED WORK ABILITY (was out of work for 4 months after 2nd Moderna dose), PAIN (was in so much pain) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) bloodwork out of whack, nothing in range.         No concomitant medication were reported.  Treatment medication included Antibiotics. The patient was out of work for 4 months after second Moderna dose. Patient stated that three days after second dose left ankle swelled up, doctors thought it was cellulitis, was in so much pain. The blood work was out of whack, nothing in range. Patient also experienced joint pain which was a side effect always experienced.  Company Comment: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected events of Cellulitis, Joint swelling, Impaired work ability, Pain and the expected event of Arthralgia. The events occurred approximately 3 days after the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected events of Cellulitis, Joint swelling, Impaired work ability, Pain and the expected event of Arthralgia. The events occurred approximately 3 days after the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 antibody test
Clinical narrative: not able to receive the second dose of the vaccine as the Moderna COVID19 vaccine; COVID19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Dec-2021 and was forwarded to Moderna on 23-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID19) and PRODUCT DOSE OMISSION ISSUE (not able to receive the second dose of the vaccine as the Moderna COVID19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced COVID-19 (COVID19). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not able to receive the second dose of the vaccine as the Moderna COVID19 vaccine). At the time of the report, COVID-19 (COVID19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not able to receive the second dose of the vaccine as the Moderna COVID19 vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 antibody test: positive (Positive) had COVID-19 in March.         No concomitant medication was given.  No treatment medication was given. Patient had COVID19 in March and because of that she had to wait for her second dose.  Company comment This is a regulatory case concerning a female patient of an unknown age with no medical history reported, who experienced the non-serious AESI event of COVID-19. PRODUCT DOSE OMISSION ISSUE was considered as an additional event. The event occurred on an unknown date in March 2021, after the first dose of mRNA-1273 (administered in December 2020). The rechallenge was assessed as not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report. COVID-19 is diagnosed after receiving only first dose, the second dose has not been administered, so lack of efficacy situation cannot be properly assessed.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Follow up contains no new information.; Sender's Comments: This is a regulatory case concerning a female patient of an unknown age with no medical history reported, who experienced the non-serious AESI event of COVID-19. PRODUCT DOSE OMISSION ISSUE was considered as an additional event. The event occurred on an unknown date in March 2021, after the first dose of mRNA-1273 (administered in December 2020). The rechallenge was assessed as not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report. COVID-19 is diagnosed after receiving only first dose, the second dose has not been administered, so lack of efficacy situation cannot be properly assessed.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: got a mild case of Covid 12 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (got a mild case of Covid 12 days ago) in a 78-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (got a mild case of Covid 12 days ago). At the time of the report, COVID-19 (got a mild case of Covid 12 days ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 antibody test: positive (Positive) mild case of COVID 12 days ago..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.  Patient had a mild case of COVID 12 days ago and had no symptoms in the last 5 days.  Company comment This is a spontaneous case concerning a 78-year-old male patient with no medical history reported, who experienced the non-serious AESI event of COVID-19. The event occurred in December 2021, after the second dose of mRNA-1273 (vaccination dates are unknown). The rechallenge was assessed as not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report. Although referred that COVID-19 is diagnosed being fully vaccinated, the information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a 78-year-old male patient with no medical history reported, who experienced the non-serious AESI event of COVID-19. The event occurred in December 2021, after the second dose of mRNA-1273 (vaccination dates are unknown). The rechallenge was assessed as not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report. Although referred that COVID-19 is diagnosed being fully vaccinated, the information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Neuralgia, Pericarditis
Clinical narrative: Had inflammation around his heart; Had bad nerve pain from head to toes; Felt terrible from head to toes; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Dec-2021 and was forwarded to Moderna on 23-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Had inflammation around his heart) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 PERICARDITIS (Had inflammation around his heart) (seriousness criterion medically significant), NEURALGIA (Had bad nerve pain from head to toes) and FEELING ABNORMAL (Felt terrible from head to toes). At the time of the report, PERICARDITIS (Had inflammation around his heart), NEURALGIA (Had bad nerve pain from head to toes) and FEELING ABNORMAL (Felt terrible from head to toes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided.  It was reported that the patient was a pharmacist and experienced side effects that were really bad. Treatment information was not provided.  Company Comment This case concerns a patient of an unknown age with no previous relevant medical history reported. The event occurred on an unknown date after a dose of COVID-19 Vaccine Moderna (mRNA-1273). Very limited information regarding this event has been provided at this time. Clinical course with diagnostic workup and treatment details were not provided. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age with no previous relevant medical history reported. The event occurred on an unknown date after a dose of COVID-19 Vaccine Moderna (mRNA-1273). Very limited information regarding this event has been provided at this time. Clinical course with diagnostic workup and treatment details were not provided. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Lost sense of smell; Lost sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Lost sense of smell) and AGEUSIA (Lost sense of taste) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 ANOSMIA (Lost sense of smell) and AGEUSIA (Lost sense of taste). At the time of the report, ANOSMIA (Lost sense of smell) and AGEUSIA (Lost sense of taste) outcome was unknown.            No concomitant medication were reported. No treatment medication were reported.  Company comment: This case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non serious  events of anosmia and ageusia. The events occurred after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non serious events of anosmia and ageusia. The events occurred after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: booster shot after having a breakthrough case of covid and you were fully vaccinated with the first 2 moderna shots; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (booster shot after having a breakthrough case of covid and you were fully vaccinated with the first 2 moderna shots) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 COVID-19 (booster shot after having a breakthrough case of covid and you were fully vaccinated with the first 2 moderna shots). At the time of the report, COVID-19 (booster shot after having a breakthrough case of covid and you were fully vaccinated with the first 2 moderna shots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was fully vaccinated with the first 2 Moderna shots.  No relevant medical history provided. No relevant concomitant medication information provided. No relevant treatment medication information provided.  Company comment: This case concerns a patient of unknown age and gender, with no medical history,  who experienced the unexpected events of COVID 19. The events occurred approximately 1 day after the third dose of mRNA-1273.As reported, a patient had a breakthrough case of covid and was fully vaccinated with the first 2 moderna shots. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender, with no medical history,  who experienced the unexpected events of COVID 19. The events occurred approximately 1 day after the third dose of mRNA-1273.As reported, a patient had a breakthrough case of covid and was fully vaccinated with the first 2 moderna shots. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of SYNCOPE (Fainting) 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 SYNCOPE (Fainting). At the time of the report, SYNCOPE (Fainting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Pruritus, Vaccination complication
Clinical narrative: When she is itching, her body begins to bleed; When she is itching, her body begins to bleed; Took the booster about 1 month ago and she is still having side effects; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (When she is itching, her body begins to bleed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-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 HAEMORRHAGE (When she is itching, her body begins to bleed) (seriousness criterion medically significant), PRURITUS (When she is itching, her body begins to bleed) and VACCINATION COMPLICATION (Took the booster about 1 month ago and she is still having side effects). At the time of the report, HAEMORRHAGE (When she is itching, her body begins to bleed), PRURITUS (When she is itching, her body begins to bleed) and VACCINATION COMPLICATION (Took the booster about 1 month ago and she is still having side effects) had not resolved.            Concomitant products were not provided. Treatment medications were not reported.  Company Comment : This spontaneous case concerns a female patient with unknown age , with no medical history reported , vaccinated for two doses , primary series using mRNA-1273 vaccine ,  who experienced Serious ( Medically significant ) , unexpected event of hemorrhage and other non-serious, unexpected events of pruritus and vaccination complication. These events occurred on Dec. 2021 after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the events had not resolved and the events occurred after the 3rd dose and no additional doses will be given. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient with unknown age , with no medical history reported , vaccinated for two doses , primary series using mRNA-1273 vaccine ,  who experienced Serious ( Medically significant ) , unexpected event of hemorrhage and other non-serious, unexpected events of pruritus and vaccination complication. These events occurred on Dec. 2021 after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the events had not resolved and the events occurred after the 3rd dose and no additional doses will be given. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High temperature of 105; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High temperature of 105) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Multiple sclerosis, Asthma, Seasonal allergy, Allergic to dogs, Allergic to cats, Hay fever and Allergy (Oak tree allergy). Concomitant products included OCRELIZUMAB (OCREVUS), ALBUTEROL [SALBUTAMOL], FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), VALPROATE SEMISODIUM (DEPAKOTE) and VITAMIN D NOS for an unknown indication.    In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (High temperature of 105) (seriousness criterion hospitalization). At the time of the report, PYREXIA (High temperature of 105) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.  Company comment: This spontaneous case concerns a 52-year-old female patient with a relevant medical history of Multiple sclerosis undergoing treatment with Ocrelizumab, who experienced the unexpected serious (hospitalization) event of Pyrexia after mRNA- 1273 vaccine. The event occurred on an unknown date after the dose of mRNA- 1273 vaccine, dose number unknown. Pyrexia is consistent with the known safety profile of the vaccine, but since it had a serious outcome it is considered unexpected. Very limited information is available regarding hospitalization and diagnostic work-up. At the time of the report, the event had resolved. Concomitant medication Ocrelizumab might be a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2021: Follow-up information received on 27-DEC-2021 contains no new information.; Sender's Comments: This spontaneous case concerns a 52-year-old female patient with a relevant medical history of Multiple sclerosis undergoing treatment with Ocrelizumab, who experienced the unexpected serious (hospitalization) event of Pyrexia after mRNA- 1273 vaccine. The event occurred on an unknown date after the dose of mRNA- 1273 vaccine, dose number unknown. Pyrexia is consistent with the known safety profile of the vaccine, but since it had a serious outcome it is considered unexpected. Very limited information is available regarding hospitalization and diagnostic work-up. At the time of the report, the event had resolved. Concomitant medication Ocrelizumab might be a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Appendicitis; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A, 007B21A and 039F21A) for COVID-19 vaccination.     Concomitant products included HYDROXYCHLOROQUINE and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criterion hospitalization). The patient was hospitalized from 22-Nov-2021 to 23-Nov-2021 due to APPENDICITIS. The patient was treated with ZOLPIDEM TARTRATE (AMBIEN) for Appendicitis, at a dose of 1 dosage form and Surgery for Appendicitis. At the time of the report, APPENDICITIS (Appendicitis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   she had appendicitis and her appendectomy was on 22 Nov 2021. she was hospitalized for a day for the surgery and was in the hospital overnight for the surgery.  This is a regulatory authority case concerning  a  23-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of appendicitis. The events occurred approximately 6 months after the second dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2021: Significant Live Follow up : hospitalization added as seriousness; Sender's Comments: This is a regulatory authority case concerning  a  23-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of appendicitis. The events occurred approximately 6 months after the second dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.