chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Illness, Inappropriate schedule of product administration, Paraesthesia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (After second shot, ill/ so sick/ In bed the whole day), FEELING ABNORMAL (it was awful), PARAESTHESIA (tingling in arms/tingling in hands/Breaking things because fingers tingly), HYPOAESTHESIA (numbness in hands and arms/has been going on for over a year) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose < 24 days after 1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 026A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced ILLNESS (After second shot, ill/ so sick/ In bed the whole day), PARAESTHESIA (tingling in arms/tingling in hands/Breaking things because fingers tingly), HYPOAESTHESIA (numbness in hands and arms/has been going on for over a year) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose < 24 days after 1st dose). 09-Apr-2021, the patient experienced FEELING ABNORMAL (it was awful). At the time of the report, ILLNESS (After second shot, ill/ so sick/ In bed the whole day), FEELING ABNORMAL (it was awful), PARAESTHESIA (tingling in arms/tingling in hands/Breaking things because fingers tingly) and HYPOAESTHESIA (numbness in hands and arms/has been going on for over a year) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose < 24 days after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: Neck X-ray, Result in the middle, little bit of closing, but nothing to be concerned about..         No concomitant medication was reported. Patient was very healthy. Patient did not have COVID test or diagnosis. Patient reported that the events has been going on for over a year. Patient had been visited to local orthopedic specialist group and to physical therapy and they thought It was because of the shot. Had to be something to do with the shot and thought it was carpel tunnel, but not carpel tunnel. Caller stated she wanted the MRI but had to get physical therapy first. Patient was referred to physical therapy and had dry needling on hand and that was not working. Patient reported that putting earrings on was difficult. Treatment information reported as, patient was referred to physical therapy and had dry needling on hand and that was not working   This case was linked to MOD-2022-609318 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (After second shot, ill/ so sick/ In bed the whole day), FEELING ABNORMAL (it was awful), PARAESTHESIA (tingling in arms/tingling in hands/Breaking things because fingers tingly), HYPOAESTHESIA (numbness in hands and arms/has been going on for over a year) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose < 24 days after 1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 026A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced ILLNESS (After second shot, ill/ so sick/ In bed the whole day), PARAESTHESIA (tingling in arms/tingling in hands/Breaking things because fingers tingly), HYPOAESTHESIA (numbness in hands and arms/has been going on for over a year) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose < 24 days after 1st dose). 09-Apr-2021, the patient experienced FEELING ABNORMAL (it was awful). At the time of the report, ILLNESS (After second shot, ill/ so sick/ In bed the whole day), FEELING ABNORMAL (it was awful), PARAESTHESIA (tingling in arms/tingling in hands/Breaking things because fingers tingly) and HYPOAESTHESIA (numbness in hands and arms/has been going on for over a year) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose < 24 days after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: Neck X-ray, Result in the middle, little bit of closing, but nothing to be concerned about..         No concomitant medication was reported. Patient was very healthy. Patient did not have COVID test or diagnosis. Patient reported that the events has been going on for over a year. Patient had been visited to local orthopedic specialist group and to physical therapy and they thought It was because of the shot. Had to be something to do with the shot and thought it was carpel tunnel, but not carpel tunnel. Caller stated she wanted the MRI but had to get physical therapy first. Patient was referred to physical therapy and had dry needling on hand and that was not working. Patient reported that putting earrings on was difficult. Treatment information reported as, patient was referred to physical therapy and had dry needling on hand and that was not working   This case was linked to MOD-2022-609318 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza
Clinical narrative: He had just gotten over the COVID-19 virus; He had a" flu" case; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (He had a" flu" case) and COVID-19 (He had just gotten over the COVID-19 virus) in an adult male patient 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) (Intramuscular) 1 dosage form. On 27-Jun-2022, the patient experienced COVID-19 (He had just gotten over the COVID-19 virus). On an unknown date, the patient experienced INFLUENZA (He had a" flu" case). At the time of the report, INFLUENZA (He had a" flu" case) and COVID-19 (He had just gotten over the COVID-19 virus) had resolved.            No concomitant medications were provided. No treatment information was reported.  Lot number and expiration dates not provided. The dates of administration for patient's other Moderna vaccines was not provided.  Company Comment:  This spontaneous case concerns an adult male patient of unspecified age, with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (reported as He had just gotten over the COVID-19 virus) on an unknown interval (date of vaccination unknown) after receiving a dose of mRNA-1273 vaccine.  Information on treatment or SARS-CoV-2 test was not provided.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-609254 (Patient Link).; Sender's Comments: This spontaneous case concerns an adult male patient of unspecified age, with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 (reported as He had just gotten over the COVID-19 virus) on an unknown interval (date of vaccination unknown) after receiving a dose of mRNA-1273 vaccine.  Information on treatment or SARS-CoV-2 test was not provided.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient received a moderna vaccine and later had COVID.; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Patient received a moderna vaccine and later had COVID.) in an adult male patient 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 COVID-19 (Patient received a moderna vaccine and later had COVID.). At the time of the report, COVID-19 (Patient received a moderna vaccine and later had COVID.) outcome was unknown.  The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.  Patient's age was reported between 35 to 45 years. No concomitant medications were reported. No treatment medication were reported.  Company comment: This spontaneous case concerns an adult male patient of unknown age with no reported medical history, who experienced an unexpected, non-serious AESI COVID-19 after receiving a dose of mRNA-1273 vaccine. Exact latency of the event relative to vaccination cannot be determined with an unknown event's onset date and vaccine administration date. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case concerns an adult male patient of unknown age with no reported medical history, who experienced an unexpected, non-serious AESI COVID-19 after receiving a dose of mRNA-1273 vaccine. Exact latency of the event relative to vaccination cannot be determined with an unknown event's onset date and vaccine administration date. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed per medical judgement.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: Blood clots in her lungs; blood clots in legs; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY THROMBOSIS (Blood clots in her lungs) and THROMBOSIS (blood clots in legs) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 042B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-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 PULMONARY THROMBOSIS (Blood clots in her lungs) (seriousness criteria hospitalization and medically significant) and THROMBOSIS (blood clots in legs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in December 2021 due to PULMONARY THROMBOSIS and THROMBOSIS. The patient was treated with RIVAROXABAN (XARELTO) at an unspecified dose and frequency. At the time of the report, PULMONARY THROMBOSIS (Blood clots in her lungs) and THROMBOSIS (blood clots in legs) outcome was unknown.            No concomitant medications were reported.  Company comment- This is a spontaneous case concerning a 74-year-old female patient with no medical history reported who experienced the serious (hospitalization and medically significant) and unexpected AESI thrombosis and pulmonary thrombosis 2 weeks after a booster dose of mRNA-1273 vaccine was administered. Patient was in the hospital with blood clots in her lungs and legs and was treated with Rivaroxaban. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 74-year-old female patient with no medical history reported who experienced the serious (hospitalization and medically significant) and unexpected AESI thrombosis and pulmonary thrombosis 2 weeks after a booster dose of mRNA-1273 vaccine was administered. Patient was in the hospital with blood clots in her lungs and legs and was treated with Rivaroxaban. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After the second dose patient had a very intense leg pain for seven day, had to sit under and electric blanket for a week.; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (After the second dose patient had a very intense leg pain for seven day, had to sit under and electric blanket for a week.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 040a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure, Drug allergy (47 medicines), Latex allergy, Drug allergy (sulfa drugs), Polyethylene glycol allergy (polyethylene glycol) and Liver disorder. Concomitant products included ATENOLOL for Blood pressure.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-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 PAIN IN EXTREMITY (After the second dose patient had a very intense leg pain for seven day, had to sit under and electric blanket for a week.). At the time of the report, PAIN IN EXTREMITY (After the second dose patient had a very intense leg pain for seven day, had to sit under and electric blanket for a week.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported the patient had to sit under a electric blanket for a week. No treatment drug details was reported. There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The AE did not cause patient to seek medical care. The patient did not experienced a similar event in the past.   This case was linked to MOD-2022-609287 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysphonia, Heart rate, Immunisation reaction, Pyrexia
Clinical narrative: running a fever of 101F; in bed the whole day; voice was very, very hoarse but throat was not hurting; This spontaneous case was reported by a patient and describes the occurrence of DYSPHONIA (voice was very, very hoarse but throat was not hurting), IMMUNISATION REACTION (in bed the whole day) and PYREXIA (running a fever of 101F) 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 15-Jul-2022 at 3:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2022, the patient experienced DYSPHONIA (voice was very, very hoarse but throat was not hurting). On 17-Jul-2022, the patient experienced IMMUNISATION REACTION (in bed the whole day). On 18-Jul-2022, the patient experienced PYREXIA (running a fever of 101F). At the time of the report, DYSPHONIA (voice was very, very hoarse but throat was not hurting), IMMUNISATION REACTION (in bed the whole day) and PYREXIA (running a fever of 101F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101F. On an unknown date, Heart rate: little elevated.         No concomitant medications were reported. Treatment information was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccinated with a lot number that just expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. The patient was vaccinated with a booster dose with a lot number that just expired 2 days ago. Number of doses or vials included 7 doses. On 09-JUL-2022 the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medication details was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Lichen planus
Clinical narrative: lichen planus/itching; This spontaneous case was reported by a patient and describes the occurrence of LICHEN PLANUS (lichen planus/itching) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 018B21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID-19 - Jan2022, no hospitalization) in January 2022. Previously administered products included for Product used for unknown indication: FLU VACCINE VII in 2021. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concurrent medical conditions included Seasonal asthma.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced LICHEN PLANUS (lichen planus/itching). The patient was treated with HYDROXYZINE for Itching, at a dose of 2-3 tabs at night; LORATADINE at a dose of Once at night; DOXYCYCLINE at a dose of Once in the morning for 30 days but will need a refill and CLOBETASOL PROPIONATE (IMPOYZ) at an unspecified dose and frequency. At the time of the report, LICHEN PLANUS (lichen planus/itching) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, Biopsy: Diagnosed with Lichen Planus.         No concomitant medication was reported.  Patient had not experienced similar events in the past. It was reported that the events on some parts of the body were improving but breaking out on some. Treatment also include Fernico spray.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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 COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication was not provided.  It was reported that in a treatment program, one of the other participants who had the Moderna Covid-19 Vaccine tested positive for COVID 19. Everyone in the program was sent to dorm quarantine.  Treatment information was not provided.  Company comment-This spontaneous case concerns a patient of unknown gender and age with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. COVID -19 test was positive on an unknown date. No further details on clinical course, other lab test and treatment received were reported. Outcome of the event Covid 19 was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unknown gender and age with no medical history reported, who experienced the unexpected non serious AESI of Covid 19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. COVID -19 test was positive on an unknown date. No further details on clinical course, other lab test and treatment received were reported. Outcome of the event Covid 19 was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: After the first booster had a flush experience and was pretty red.; This spontaneous case was reported by an other health care professional and describes the occurrence of FLUSHING (After the first booster had a flush experience and was pretty red.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 025B21A and 040a21a) for COVID-19 prophylaxis.     Patient did not tested positive for Covid-19.  There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Surgery (A major surgery this year.) in 2022. Concurrent medical conditions included Drug allergy (47 medicines), Latex allergy (Latex allergy), Drug allergy (Sulfa drug allergy), Polyethylene glycol allergy (Polyethylene glycol alergy), Blood pressure abnormal, Liver disorder (Has a liver issue.) and Allergy to vaccine (Allergic to a ingredient that is in the Moderna vaccine.). Concomitant products included ATENOLOL for Blood pressure.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced FLUSHING (After the first booster had a flush experience and was pretty red.). In November 2021, FLUSHING (After the first booster had a flush experience and was pretty red.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received first booster.   The patient had not experienced any similar event in the past.  The adverse event did not cause patient to seek medical care.  No treatment drug details was reported.   This case was linked to MOD-2022-609280 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Liver function test increased
Clinical narrative: Had blood work on 15Jul2022 which showed elevated liver function tests, specifically the AST & ALT levels; Had blood work on 15Jul2022 which showed elevated liver function tests, specifically the AST & ALT levels; Had blood work on 15Jul2022 which showed elevated liver function tests, specifically the AST & ALT levels; This spontaneous case was reported by a patient and describes the occurrence of LIVER FUNCTION TEST INCREASED (Had blood work on 15Jul2022 which showed elevated liver function tests, specifically the AST & ALT levels), ASPARTATE AMINOTRANSFERASE INCREASED (Had blood work on 15Jul2022 which showed elevated liver function tests, specifically the AST & ALT levels) and ALANINE AMINOTRANSFERASE INCREASED (Had blood work on 15Jul2022 which showed elevated liver function tests, specifically the AST & ALT levels) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051B22A, 014F21A, 007C21A and 020B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jul-2022, the patient experienced LIVER FUNCTION TEST INCREASED (Had blood work on 15Jul2022 which showed elevated liver function tests, specifically the AST & ALT levels), ASPARTATE AMINOTRANSFERASE INCREASED (Had blood work on 15Jul2022 which showed elevated liver function tests, specifically the AST & ALT levels) and ALANINE AMINOTRANSFERASE INCREASED (Had blood work on 15Jul2022 which showed elevated liver function tests, specifically the AST & ALT levels). At the time of the report, LIVER FUNCTION TEST INCREASED (Had blood work on 15Jul2022 which showed elevated liver function tests, specifically the AST & ALT levels), ASPARTATE AMINOTRANSFERASE INCREASED (Had blood work on 15Jul2022 which showed elevated liver function tests, specifically the AST & ALT levels) and ALANINE AMINOTRANSFERASE INCREASED (Had blood work on 15Jul2022 which showed elevated liver function tests, specifically the AST & ALT levels) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2022, Alanine aminotransferase: increased. On 15-Jul-2022, Aspartate aminotransferase: increased.         No Concomitant medications were reported.  No Treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccinated with a lot number that just expired 2 days ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired 2 days ago) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired 2 days ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired 2 days ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Number of doses/vials: 7 doses.  Date the vial was initially stored in the refrigerator 09-Jul-2022. The vial did not undergone any temperature excursions.  No treatment medication was reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccinated with a lot number that just expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. Number of doses or vials included 7 doses. On 09-JUL-2022 the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medication details was reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccinated with a lot number that just expired 2 days ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired 2 days ago) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired 2 days ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired 2 days ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that the patient was vaccinated with booster dose with a lot number that just expired 2 days ago. The date the vial initially stored in the refrigerator was reported as 09-Jul-2022. Reportedly, the vial didn't undergo any temperature excursions.  No treatment information was provided by the reporter.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccinated with a lot number that just expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The vial was initially stored in the refrigerator on 09-Jul-2022. The vial did not underwent any temperature excursions.  Treatment information was not provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccinated with a lot number that just expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter.  Date of  vial  initially stored in the refrigerator was 09-Jul-2022. It was reported that patient was vaccinated with a booster dose lot number that just expired 2 days ago from the day of reporting.  The vial did not undergo any temperature excursions.  No treatment medication was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated with a lot number that just expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with a lot number that just expired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with a lot number that just expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with a lot number that just expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. No treatment drug was reported.  On 09-Jul-2022, the vial was initially stored in the refrigerator.  The patient was vaccinated a booster dose with a lot number that just expired 2 days ago.  The vial did not undergo temperature excursions.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient had a mild fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Patient had a mild fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040X21A and 031L20A) 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 16-Mar-2021, the patient experienced PYREXIA (Patient had a mild fever). At the time of the report, PYREXIA (Patient had a mild fever) had resolved.            No concomitant drug reported.  The patient had a mild fever and stayed home after 1st dose and had a fever and stayed in bed all day after 2nd dose.   No treatment information was provided by the reporter.   This case was linked to MOD-2022-609311 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: gave 4 doses that were expired; vial was initially stored in the refrigerator on 12Jul2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave 4 doses that were expired) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 12Jul2022) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 12Jul2022). On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 4 doses that were expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave 4 doses that were expired) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 12Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.              The patient was administered with booster dose. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry,expired vial was punctured and used on a patient; Second booster dose administered to 45 year old patient; Second booster dose administered to 45 year old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry,expired vial was punctured and used on a patient), EXTRA DOSE ADMINISTERED (Second booster dose administered to 45 year old patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Second booster dose administered to 45 year old patient) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A and 045L21A) for COVID-19 vaccination.     It was reported that patient had no allergies. It was reported that patient never had COVID positive test or diagnosis. It was also reported that patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 18-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry,expired vial was punctured and used on a patient), EXTRA DOSE ADMINISTERED (Second booster dose administered to 45 year old patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Second booster dose administered to 45 year old patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry,expired vial was punctured and used on a patient), EXTRA DOSE ADMINISTERED (Second booster dose administered to 45 year old patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Second booster dose administered to 45 year old patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient received first booster and second booster dose of Moderna COVID-19 vaccine. It was reported that the vial did not undergo any temperature excursions. No concomitant medications were reported. No treatment medications were reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses were expired 06 Jul 2022, Date the vial was initially stored in the refrigerator was on 12 Jul 2022; Gave 4 doses that were expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave 4 doses that were expired) and PRODUCT STORAGE ERROR (Doses were expired 06 Jul 2022, Date the vial was initially stored in the refrigerator was on 12 Jul 2022) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave 4 doses that were expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses were expired 06 Jul 2022, Date the vial was initially stored in the refrigerator was on 12 Jul 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave 4 doses that were expired) and PRODUCT STORAGE ERROR (Doses were expired 06 Jul 2022, Date the vial was initially stored in the refrigerator was on 12 Jul 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.     Date the vial was initially stored in the refrigerator was on 12-Jul-2022. The vial did not undergo any temperature excursions. Patient was administered with booster dose. (Not specified first or second booster dose)  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-609299, US-MODERNATX, INC.-MOD-2022-609300, US-MODERNATX, INC.-MOD-2022-609296 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-609299: US-MODERNATX, INC.-MOD-2022-609300: US-MODERNATX, INC.-MOD-2022-609296:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses were expired 06Jul2022, Date the vial was initially stored in the refrigerator was on 12Jul2022; Gave 4 doses that were expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave 4 doses that were expired) and PRODUCT STORAGE ERROR (Doses were expired 06Jul2022, Date the vial was initially stored in the refrigerator was on 12Jul2022) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave 4 doses that were expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses were expired 06Jul2022, Date the vial was initially stored in the refrigerator was on 12Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave 4 doses that were expired) and PRODUCT STORAGE ERROR (Doses were expired 06Jul2022, Date the vial was initially stored in the refrigerator was on 12Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Reporter was wondering what will be the process because last week they had a clinic, and they realized the doses were expired on 06-Jul-2022 and on 12-Jul-2022, the vials were initially stored in the refrigerator. On 13Jul2022, they gave 4 booster doses that were expired, and reporter was confused about the expiration date. The vial did not undergone any temperature excursions. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-609300, US-MODERNATX, INC.-MOD-2022-609296, US-MODERNATX, INC.-MOD-2022-609298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-609300:Same reporter case US-MODERNATX, INC.-MOD-2022-609296:Same reporter case US-MODERNATX, INC.-MOD-2022-609298:Same reporter case
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: gave 4 doses that were expired; vial was initially stored in the refrigerator on 12-Jul-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave 4 doses that were expired) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 12-Jul-2022) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 12-Jul-2022). On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 4 doses that were expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave 4 doses that were expired) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No temperature excursions was reported.  The vial was initially stored in the refrigerator on 12-Jul-2022.  No treatment medication was reported.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy, COVID-19, Guttate psoriasis, SARS-CoV-2 test
Clinical narrative: Red blotches initially on his shin,  another outbreak of red blotches on the hips; This spontaneous case was reported by a patient and describes the occurrence of RASH MACULAR (Red blotches initially on his shin,  another outbreak of red blotches on the hips) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 025B21A and 010A21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: INFLUENZA in September 2021. Past adverse reactions to the above products included No adverse event with INFLUENZA.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced RASH MACULAR (Red blotches initially on his shin,  another outbreak of red blotches on the hips). At the time of the report, RASH MACULAR (Red blotches initially on his shin,  another outbreak of red blotches on the hips) had not resolved.            Patient medical history information included no allergies or medical conditions (both acute and chronic illness). No concomitant medications were reported. Patient was initially given a steroid cream which did nothing as treatment.   This case was linked to MOD-2022-609301 (Patient Link).