chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Erythema, Pruritus
Clinical narrative: Red spots on back and front/I have red round spots on my arm can i be elergic to the vaccine of moderna; Itchy; Feeling shut down; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red spots on back and front/I have red round spots on my arm can i be elergic to the vaccine of moderna), PRURITUS (Itchy) and DEPRESSED MOOD (Feeling shut down) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05821A and 023621A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red spots on back and front/I have red round spots on my arm can i be elergic to the vaccine of moderna), PRURITUS (Itchy) and DEPRESSED MOOD (Feeling shut down). At the time of the report, ERYTHEMA (Red spots on back and front/I have red round spots on my arm can i be elergic to the vaccine of moderna), PRURITUS (Itchy) and DEPRESSED MOOD (Feeling shut down) outcome was unknown.            No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter  patient reports diarrhea and stomach pain from the first dose which was resolved.   This case was linked to MOD-2021-320714 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: The verbatim added to event erythema.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose is February/2nd dose in August/ One of the empolyees was vaccinated 6 months apart; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose is February/2nd dose in August/ One of the empolyees was vaccinated 6 months apart) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose is February/2nd dose in August/ One of the empolyees was vaccinated 6 months apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose is February/2nd dose in August/ One of the empolyees was vaccinated 6 months apart) had resolved.            Treatment information was not provided. List of concomitant medication were not given.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration
Clinical narrative: that he decided not to take the second dose/ second dose administered more than 35 days after first dose; shoulder hurts; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (that he decided not to take the second dose/ second dose administered more than 35 days after first dose) and ARTHRALGIA (shoulder hurts) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.    On 14-Sep-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (that he decided not to take the second dose/ second dose administered more than 35 days after first dose) and ARTHRALGIA (shoulder hurts). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (that he decided not to take the second dose/ second dose administered more than 35 days after first dose) had resolved and ARTHRALGIA (shoulder hurts) outcome was unknown.            Concomitant and treatment medications were not provided.   This case was linked to MOD-2021-320758 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: he had so many side effects after that dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (he had so many side effects after that dose) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (he had so many side effects after that dose). At the time of the report, VACCINATION COMPLICATION (he had so many side effects after that dose) 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.   This case was linked to MOD-2021-320740 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Electrical seizures; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of SEIZURE (Electrical seizures) 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 SEIZURE (Electrical seizures) (seriousness criterion medically significant). At the time of the report, SEIZURE (Electrical seizures) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.  Company Comment: This case concerns a patient of unknown age and gender, who experienced the unexpected  events of Seizure. The event occurred an unknown number of days after the most recent dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender, who experienced the unexpected  events of Seizure. The event occurred an unknown number of days after the most recent dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient received her 1st dose on Jul 27th 2021, Patient was scheduled to receive her 2nd dose on Aug 21st 2021 but she missed her appointment; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received her 1st dose on Jul 27th 2021, Patient was scheduled to receive her 2nd dose on Aug 21st 2021 but she missed her appointment) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received her 1st dose on Jul 27th 2021, Patient was scheduled to receive her 2nd dose on Aug 21st 2021 but she missed her appointment). On 21-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Patient received her 1st dose on Jul 27th 2021, Patient was scheduled to receive her 2nd dose on Aug 21st 2021 but she missed her appointment) had resolved.            concomitant medicines was not reported by reporter Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: consumer answered yes when asked if they experienced any side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects). At the time of the report, VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment medication were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysphonia, Erythema, Oral discomfort, Pruritus
Clinical narrative: redness/again it appear in other parts of her; burning sensation on the lips and tip of the tongue/strangest thing was in her mouth; voice is hoarse, it's not normal; burning sensation on the lips and tip of the tongue; itchy; rashes on her body skin; high fever; rashes on her legs; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness/again it appear in other parts of her), ORAL DISCOMFORT (burning sensation on the lips and tip of the tongue/strangest thing was in her mouth), DYSPHONIA (voice is hoarse, it's not normal), TONGUE DISCOMFORT (burning sensation on the lips and tip of the tongue) and PRURITUS (itchy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0MBF21A, 013M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, VITAMIN 15 for Sleep disturbance.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness/again it appear in other parts of her), ORAL DISCOMFORT (burning sensation on the lips and tip of the tongue/strangest thing was in her mouth), DYSPHONIA (voice is hoarse, it's not normal), TONGUE DISCOMFORT (burning sensation on the lips and tip of the tongue), PRURITUS (itchy), RASH (rashes on her body skin), PYREXIA (high fever) and RASH (rashes on her legs). The patient was treated with ACETAMINOPHEN for Fever, at a dose of 500 and LORATADINE (CLARITIN [LORATADINE]) for Rash, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness/again it appear in other parts of her) had not resolved, ORAL DISCOMFORT (burning sensation on the lips and tip of the tongue/strangest thing was in her mouth), DYSPHONIA (voice is hoarse, it's not normal), TONGUE DISCOMFORT (burning sensation on the lips and tip of the tongue), PRURITUS (itchy) and PYREXIA (high fever) outcome was unknown and RASH (rashes on her body skin) and RASH (rashes on her legs) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) High.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took claritin and it got better but the redness was still there for the next day and again it appear in other parts of her body; first day was itchy but then it wasn't, the strangest thing was in her mouth, she had a burning sensation on the lips and tip of the tongue.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Tongue discomfort
Clinical narrative: redness/again it appear in other parts of her; burning sensation on the lips and tip of the tongue/strangest thing was in her mouth; voice is hoarse, it's not normal; burning sensation on the lips and tip of the tongue; itchy; rashes on her body skin; high fever; rashes on her legs; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness/again it appear in other parts of her), ORAL DISCOMFORT (burning sensation on the lips and tip of the tongue/strangest thing was in her mouth), DYSPHONIA (voice is hoarse, it's not normal), TONGUE DISCOMFORT (burning sensation on the lips and tip of the tongue) and PRURITUS (itchy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0MBF21A, 013M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, VITAMIN 15 for Sleep disturbance.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness/again it appear in other parts of her), ORAL DISCOMFORT (burning sensation on the lips and tip of the tongue/strangest thing was in her mouth), DYSPHONIA (voice is hoarse, it's not normal), TONGUE DISCOMFORT (burning sensation on the lips and tip of the tongue), PRURITUS (itchy), RASH (rashes on her body skin), PYREXIA (high fever) and RASH (rashes on her legs). The patient was treated with ACETAMINOPHEN for Fever, at a dose of 500 and LORATADINE (CLARITIN [LORATADINE]) for Rash, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness/again it appear in other parts of her) had not resolved, ORAL DISCOMFORT (burning sensation on the lips and tip of the tongue/strangest thing was in her mouth), DYSPHONIA (voice is hoarse, it's not normal), TONGUE DISCOMFORT (burning sensation on the lips and tip of the tongue), PRURITUS (itchy) and PYREXIA (high fever) outcome was unknown and RASH (rashes on her body skin) and RASH (rashes on her legs) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) High.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took claritin and it got better but the redness was still there for the next day and again it appear in other parts of her body; first day was itchy but then it wasn't, the strangest thing was in her mouth, she had a burning sensation on the lips and tip of the tongue.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pancreatitis acute, Product dose omission issue
Clinical narrative: 1st dose on 12Mar2021 & has not gotten his 2nd dose; acute pancreatitis; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS ACUTE (acute pancreatitis) and PRODUCT DOSE OMISSION ISSUE (1st dose on 12Mar2021 & has not gotten his 2nd dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PANCREATITIS ACUTE (acute pancreatitis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose on 12Mar2021 & has not gotten his 2nd dose) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 31-Mar-2021 to sometime in April 2021 due to PANCREATITIS ACUTE. At the time of the report, PANCREATITIS ACUTE (acute pancreatitis) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (1st dose on 12Mar2021 & has not gotten his 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.No treatment medications reported.  Patient was hospitalized for 4 or 5 days with acute pancreatitis. They couldn't find a cause for the pancreatitis. patient has no prior history of pancreas problems. The patient  has not gotten the 2nd dose.  This is a spontaneous report of serious unexpected pancreatitis (AESI) that required hospitalization in a 56 year-old male, whose medical history and concomitant medication were not provided. The event occurred approximately 20 days after the first dose of the product. Rechallenge was not done as per the patient did not receive the second dose (the event Dose omission was added).  The event was considered related to the product per the reporter's assessment.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested for completing the causality assessment.; Sender's Comments: This is a spontaneous report of serious unexpected pancreatitis (AESI) that required hospitalization in a 56 year-old male, whose medical history and concomitant medication were not provided. The event occurred approximately 20 days after the first dose of the product. Rechallenge was not done as per the patient did not receive the second dose (the event Dose omission was added).  The event was considered related to the product per the reporter's assessment.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested for completing the causality assessment.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The arm hurt after each shot a little bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The arm hurt after each shot a little bit) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included OMEPRAZOLE, LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (OLMESARTAN HCTZ), DILTIAZEM, PREDNISOLONE ACETATE, OFLOXACIN from an unknown date to 13-Sep-2021 and BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (The arm hurt after each shot a little bit). At the time of the report, VACCINATION SITE PAIN (The arm hurt after each shot a little bit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication information was provided.   This case was linked to MOD-2021-320932, MOD-2021-320954 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The arm hurt a little bit after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The arm hurt a little bit after 1st shot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Combigan (once a day). Concomitant products included OMEPRAZOLE, LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (OLMESARTAN HCTZ), DILTIAZEM, PREDNISOLONE ACETATE and OFLOXACIN from an unknown date to 13-Sep-2021 for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (The arm hurt a little bit after 1st shot). At the time of the report, PAIN IN EXTREMITY (The arm hurt a little bit after 1st shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.   This case was linked to MOD-2021-320953, MOD-2021-320932 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: positive side effect; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (positive side effect) 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 THERAPEUTIC RESPONSE UNEXPECTED (positive side effect). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (positive side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient got the shot from the vial that has been thawed more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got the shot from the vial that has been thawed more than 30 days) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038821A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got the shot from the vial that has been thawed more than 30 days). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient got the shot from the vial that has been thawed more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was administered with a vial that was thawed from the freezer more than 30 days ago and the expiration of vaccine is  on 25-sep-21 and the administration was done on 15-sep-21 .However the vials were removed from the freezer to refrigerator storage on 08-april-21.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 104.1 after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 104.1 after the first dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 063A21A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 104.1 after the first dose). At the time of the report, PYREXIA (Fever of 104.1 after the first dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia (97.6-99.6): high (High) 104.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-320993 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Hyperpyrexia
Clinical narrative: high fever of 107.9; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (high fever of 107.9) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 063A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERPYREXIA (high fever of 107.9) (seriousness criterion medically significant). At the time of the report, HYPERPYREXIA (high fever of 107.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 107.9 (High) after the second dose.         Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient states he took a cold shower and went to the emergency room after his fever was 107.9. The patient states he had reactions to both of the Moderna shots. He wants to know if he should get the booster. He would hate to go through the same adverse reaction that he had from the first two shots.  Company Comment: This report concerns a 52 year old male patient with past medical history of COVID-19 who experienced a serious unexpected event of high fever of 107.9 (hyperpyrexia). The event occurred unknown duration after vaccination with second dose of mRNA-1273. The patient reports having high fever of 104.1 unknown duration after the first dose of mRNA-1273 too. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-320983 (Patient Link).; Sender's Comments: This report concerns a 52 year old male patient with past medical history of COVID-19 who experienced a serious unexpected event of high fever of 107.9 (hyperpyrexia). The event occurred unknown duration after vaccination with second dose of mRNA-1273. The patient reports having high fever of 104.1 unknown duration after the first dose of mRNA-1273 too. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Product administered to patient of inappropriate age
Clinical narrative: 15 year old accidentally received Moderna vaccine; Regular chills; Body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (Regular chills), MYALGIA (Body aches) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old accidentally received Moderna vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced CHILLS (Regular chills) and MYALGIA (Body aches). On 17-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old accidentally received Moderna vaccine). On 17-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old accidentally received Moderna vaccine) had resolved. At the time of the report, CHILLS (Regular chills) and MYALGIA (Body aches) 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 product use was not provided.   Treatment information was not provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: some soreness in his left arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (some soreness in his left arm at injection site) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced VACCINATION SITE PAIN (some soreness in his left arm at injection site). At the time of the report, VACCINATION SITE PAIN (some soreness in his left arm at injection site) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication were reported. No treatment information was reported.   This case was linked to MOD-2021-320997 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: Off label use- started to give half doses of Moderna as boosters to staff; -started to give half doses of Moderna as boosters to staff; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Off label use- started to give half doses of Moderna as boosters to staff) and UNDERDOSE (-started to give half doses of Moderna as boosters to staff) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Off label use- started to give half doses of Moderna as boosters to staff) and UNDERDOSE (-started to give half doses of Moderna as boosters to staff). At the time of the report, OFF LABEL USE (Off label use- started to give half doses of Moderna as boosters to staff) and UNDERDOSE (-started to give half doses of Moderna as boosters to staff) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis reactive
Clinical narrative: Diagnosed with reactive arthritis; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS REACTIVE (Diagnosed with reactive arthritis) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced ARTHRITIS REACTIVE (Diagnosed with reactive arthritis) (seriousness criterion medically significant). At the time of the report, ARTHRITIS REACTIVE (Diagnosed with reactive arthritis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated he suffered from severe swelling and pain in both right and left thigh, knee, leg, foot and ankle. Patient visited ER twice, and was later diagnosed with reactive arthritis and was under the care of a rheumatologist.  Concomitant medications were not reported. Treatment information in response to events was not provided.  This case concerns a  62 year old male patient with no relevant medical history, who experienced the unexpected event of arthritis reactive. The event approximately 36 days after the second dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The event is considered related to the product per the reporter's assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a  62 year old male patient with no relevant medical history, who experienced the unexpected event of arthritis reactive. The event approximately 36 days after the second dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The event is considered related to the product per the reporter's assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of the Moderna COVID-19 vacinne is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Myalgia
Clinical narrative: losing her hair,almost completely lost all her hair,still loosing her hair; it is a little depressing; it spread down to lymph nodes and breast and across shoulder; arm was very sore for days; it spread down to lymph nodes and breast and across shoulder; tired; it spread down to lymph nodes and breast and across shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (losing her hair,almost completely lost all her hair,still loosing her hair) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement in March 2020. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) from 2021 to an unknown date and SUCRALFATE (CARAFATE) from 2021 to an unknown date for Peptic ulcer.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (losing her hair,almost completely lost all her hair,still loosing her hair) (seriousness criterion medically significant), DEPRESSION (it is a little depressing), BREAST PAIN (it spread down to lymph nodes and breast and across shoulder), MYALGIA (arm was very sore for days), LYMPH NODE PAIN (it spread down to lymph nodes and breast and across shoulder), FATIGUE (tired) and ARTHRALGIA (it spread down to lymph nodes and breast and across shoulder). The patient was treated with CORTISONE ACETATE ongoing since an unknown date for Alopecia, at an unspecified dose and frequency. At the time of the report, ALOPECIA (losing her hair,almost completely lost all her hair,still loosing her hair) had not resolved, DEPRESSION (it is a little depressing) outcome was unknown and BREAST PAIN (it spread down to lymph nodes and breast and across shoulder), MYALGIA (arm was very sore for days), LYMPH NODE PAIN (it spread down to lymph nodes and breast and across shoulder), FATIGUE (tired) and ARTHRALGIA (it spread down to lymph nodes and breast and across shoulder) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case concerns a 66-year-old, female patient with no relevant medical history, who experienced the unexpected event of Alopecia. The events occurred a couple of weeks after the second dose. The rechallenge is not applicable. The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns a 66-year-old, female patient with no relevant medical history, who experienced the unexpected event of Alopecia. The events occurred a couple of weeks after the second dose. The rechallenge is not applicable. The benefit-risk relationship of Spikevax in not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter  Treatment information was not provided.  It was reported that patient was asking if she can take Tylenol to treat a Headache after the third dose of her Moderna Covid-19 vaccine.   This case was linked to MOD-2021-321418, MOD-2021-321402 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: all the arm hurt and was very sore; injection site pain; body ache; their body was painful like getting the flu.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (all the arm hurt and was very sore), VACCINATION SITE PAIN (injection site pain), MYALGIA (body ache) and MYALGIA (their body was painful like getting the flu.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer in remission (Patient was going through cancer remission and their immune system is very low.).    On 14-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (all the arm hurt and was very sore), VACCINATION SITE PAIN (injection site pain), MYALGIA (body ache) and MYALGIA (their body was painful like getting the flu.). At the time of the report, PAIN IN EXTREMITY (all the arm hurt and was very sore), VACCINATION SITE PAIN (injection site pain), MYALGIA (body ache) and MYALGIA (their body was painful like getting the flu.) outcome was unknown.            Concomitant medications was not provided by the reporter Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Pruritus
Clinical narrative: itching was in the arms, head, legs, everywhere; allergic vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching was in the arms, head, legs, everywhere) and ALLERGY TO VACCINE (allergic vaccine) 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 PRURITUS (itching was in the arms, head, legs, everywhere) and ALLERGY TO VACCINE (allergic vaccine). The patient was treated with HYDROCORTISONE, OXYTETRACYCLINE (HYDROCYCLIN) for Adverse event, at a dose of 25 mg every four hours. At the time of the report, PRURITUS (itching was in the arms, head, legs, everywhere) and ALLERGY TO VACCINE (allergic vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications were reported.   This case was linked to MOD-2021-322809 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Fungal infection, Pyrexia, Vaccination site pain
Clinical narrative: minor nuisance; yeast infection; injection site is itching like crazy /  probably asecondary skin reaction at injection site 7 days after the shot; pain at the injections site; swelling at the injections site/injection site has swollen back up; low grade fever around 100.2°F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (minor nuisance), FUNGAL INFECTION (yeast infection), VACCINATION SITE PRURITUS (injection site is itching like crazy /  probably asecondary skin reaction at injection site 7 days after the shot), VACCINATION SITE PAIN (pain at the injections site) and VACCINATION SITE SWELLING (swelling at the injections site/injection site has swollen back up) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GLUCOSAMINE for Joint disorder, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (minor nuisance), FUNGAL INFECTION (yeast infection), VACCINATION SITE PRURITUS (injection site is itching like crazy /  probably asecondary skin reaction at injection site 7 days after the shot), VACCINATION SITE PAIN (pain at the injections site), VACCINATION SITE SWELLING (swelling at the injections site/injection site has swollen back up) and PYREXIA (low grade fever around 100.2°F). At the time of the report, FEELING ABNORMAL (minor nuisance), FUNGAL INFECTION (yeast infection) and VACCINATION SITE PRURITUS (injection site is itching like crazy /  probably asecondary skin reaction at injection site 7 days after the shot) outcome was unknown, VACCINATION SITE PAIN (pain at the injections site) and PYREXIA (low grade fever around 100.2°F) had resolved and VACCINATION SITE SWELLING (swelling at the injections site/injection site has swollen back up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2°f (Low) low grade fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other medication included herbal supplements and turmeric. Treatment information was not provided. Patient  scheduled for  second dose on 08-Oct-2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: minor nuisance; yeast infection; injection site is itching like crazy /  probably asecondary skin reaction at injection site 7 days after the shot; pain at the injections site; swelling at the injections site/injection site has swollen back up; low grade fever around 100.2°F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (minor nuisance), FUNGAL INFECTION (yeast infection), VACCINATION SITE PRURITUS (injection site is itching like crazy /  probably asecondary skin reaction at injection site 7 days after the shot), VACCINATION SITE PAIN (pain at the injections site) and VACCINATION SITE SWELLING (swelling at the injections site/injection site has swollen back up) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GLUCOSAMINE for Joint disorder, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (minor nuisance), FUNGAL INFECTION (yeast infection), VACCINATION SITE PRURITUS (injection site is itching like crazy /  probably asecondary skin reaction at injection site 7 days after the shot), VACCINATION SITE PAIN (pain at the injections site), VACCINATION SITE SWELLING (swelling at the injections site/injection site has swollen back up) and PYREXIA (low grade fever around 100.2°F). At the time of the report, FEELING ABNORMAL (minor nuisance), FUNGAL INFECTION (yeast infection) and VACCINATION SITE PRURITUS (injection site is itching like crazy /  probably asecondary skin reaction at injection site 7 days after the shot) outcome was unknown, VACCINATION SITE PAIN (pain at the injections site) and PYREXIA (low grade fever around 100.2°F) had resolved and VACCINATION SITE SWELLING (swelling at the injections site/injection site has swollen back up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2°f (Low) low grade fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other medication included herbal supplements and turmeric. Treatment information was not provided. Patient  scheduled for  second dose on 08-Oct-2021.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: isn't immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (isn't immunocompromised) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Penicillin allergy.    On 16-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (isn't immunocompromised). At the time of the report, OFF LABEL USE (isn't immunocompromised) outcome was unknown.            Caller reported that her husband takes lot of medications , but she doesn't know the names of them.