chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: I had inflammation under my arm.; This spontaneous case was reported by another health care professional and describes the occurrence of INFLAMMATION (I had inflammation under my arm.) 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 February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INFLAMMATION (I had inflammation under my arm.). At the time of the report, INFLAMMATION (I had inflammation under my arm.) outcome 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 information was reported.   This case was linked to MOD-2021-403270, MOD-2021-403277 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: booster doses administered after expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date). In November 2021, EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) had resolved.        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. All booster doses were injected intramuscularly in deltoid muscle.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Pain in extremity, Somnolence
Clinical narrative: funny feeling; fell asleep could not get up from the sofa.; ittle bit of nausea; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (funny feeling), SOMNOLENCE (fell asleep could not get up from the sofa.) and NAUSEA (ittle bit of nausea) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012HZ113) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and NAUSEA (ittle bit of nausea). On an unknown date, the patient experienced FEELING ABNORMAL (funny feeling) and SOMNOLENCE (fell asleep could not get up from the sofa.). The patient was treated with ACETYLSALICYLIC ACID (ALKA SELTZER [ACETYLSALICYLIC ACID]) for Nausea, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (funny feeling), SOMNOLENCE (fell asleep could not get up from the sofa.) and NAUSEA (ittle bit of nausea) outcome was unknown.            No concomitant medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: booster doses administered after expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. List of concomitant medication were not given.  Vaccine were given on 8, 9, 10, 11, 12, 15, 16, 17, 18, 19 and 22 of November. HCP did not have # of doses given each day but said that on average, 6-7 doses were given per day; "it is possible we had used 2 vials in the same day", HCP added. All booster doses were injected intramuscularly in deltoid muscle.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: booster doses administered after expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator less than 72 hours before vials were used (administration date).  No concomitant medications were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: booster doses administered after expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: booster doses administered after expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   injected intramuscularly in deltoid muscle. No concomitant medication details was provided. No treatment medication details was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 doses administered more than 12 hours after 1st puncture of the vials; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021 at 9:54 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021 at 9:54 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials). On 20-Sep-2021 at 9:54 AM, EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial was stored in refrigerator on 09-Sep-2021 and initially punctured on 16-Sep-2021 11:45 AM. Vial was stored in fridge after used in room temperature at 8 to 25 degree Celsius. and vial did not undergo any temperature excursion.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment drugs were reported .
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: booster doses administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A.) for COVID-19 vaccination.     No medical history was provided.     On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. No treatment drug information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with the vaccine beyond to 30 day use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. These were a mix of 1st and 2nd doses. HCP not sure if there were booster or 3rd doses included. There were 2 lot numbers (053E21A,032F21A) from where the doses which was beyond the 30 day use were administered to patients.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with the vaccine beyond to 30 day use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with the vaccine beyond to 30 day use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond to 30 day use date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with the vaccine from vial which has been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from vial which has been punctured for more than 12 hours) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from vial which has been punctured for more than 12 hours). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from vial which has been punctured for more than 12 hours) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided. Patient reported no adverse reactions
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: they administered the Moderna Covid-19 vaccine from a vial which has been punctured for more than 12 hours to 12 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved. Not Provided      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 reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment mediations were reported.  Patient reported of no adverse event.   This case was linked to MOD-2021-390578 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided Patient reported of no adverse event.   This case was linked to MOD-2021-390578 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with the vaccine from vial which has been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021 at 9:11 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No other adverse reaction is reported. No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-390578 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with the vaccine from vial which has been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from vial which has been punctured for more than 12 hours) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from vial which has been punctured for more than 12 hours). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from vial which has been punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. The booster dose was given on 11-Nov-2021 between 09:00 AM to 11:00 AM. The pharmacist reported there were no reported adverse reaction.   This case was linked to MOD-2021-390578 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with the vaccine from vial which has been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The booster dose was given on 11-Nov-2021 between 09:00 AM to 11:00 AM. The pharmacist reported there were no reported adverse reaction.  Treatment information was not reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021 at 9:11 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   NO concomitant medication details were reported. No treatment medication details were reported.   This case was linked to MOD-2021-390578 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Administered booster dose instead of full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administered booster dose instead of full dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Administered booster dose instead of full dose). On 26-Nov-2021, ACCIDENTAL UNDERDOSE (Administered booster dose instead of full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient is on steroid medication everyday. Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Injury
Clinical narrative: Injury; Back pain; This spontaneous case was reported by an other health care professional and describes the occurrence of INJURY (Injury) and BACK PAIN (Back pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 INJURY (Injury) and BACK PAIN (Back pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Back pain, at a dose of 300 mg and IBUPROFEN for Back pain, at an unspecified dose and frequency. At the time of the report, INJURY (Injury) and BACK PAIN (Back pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BACK PAIN (Back pain) to be not related. No further causality assessment was provided for INJURY (Injury).    No concomitant medications were provided.  The patient mentioned the back pain she had was because of an injury and unrelated to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: High fever; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever) and VOMITING (Throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Respiratory disorder NOS (she is on oxygen 24 hours per day.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (High fever) and VOMITING (Throwing up). At the time of the report, PYREXIA (High fever) and VOMITING (Throwing up) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-403374 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site discolouration
Clinical narrative: Stain on her injection site from first shot; Mild reaction to the first shot; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE DISCOLOURATION (Stain on her injection site from first shot) and VACCINATION COMPLICATION (Mild reaction to the first shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (Patient disclosed that Flu vaccine a few years ago gave worse reactions.). Past adverse reactions to the above products included Adverse reaction with Flu vaccine. Concurrent medical conditions included Asthma. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), DICLOFENAC (VOLTAREN [DICLOFENAC]) and HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Stain on her injection site from first shot) and VACCINATION COMPLICATION (Mild reaction to the first shot). At the time of the report, VACCINATION SITE DISCOLOURATION (Stain on her injection site from first shot) had not resolved and VACCINATION COMPLICATION (Mild reaction to the first shot) outcome was unknown.        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.   Patient weigh 200. No treatment information was provided.   This case was linked to MOD-2021-403381 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Barely any reaction to the second shot; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Barely any reaction to the second shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0474B21A and 031A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), DICLOFENAC SODIUM (VOLTAREN ACTIGO [DICLOFENAC SODIUM]) and HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced VACCINATION COMPLICATION (Barely any reaction to the second shot). At the time of the report, VACCINATION COMPLICATION (Barely any reaction to the second shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. Patient's weight was reported as 200.   This case was linked to MOD-2021-403378, MOD-2021-403383 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: have a very sore arm; This spontaneous case was reported by another health care professional and describes the occurrence of VACCINATION SITE PAIN (have a very sore arm) 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 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced VACCINATION SITE PAIN (have a very sore arm). At the time of the report, VACCINATION SITE PAIN (have a very sore arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Upper-airway cough syndrome
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of UPPER-AIRWAY COUGH SYNDROME (Post nasal drip) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Postnasal drip.   In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-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 UPPER-AIRWAY COUGH SYNDROME (Post nasal drip) and FATIGUE (Tiredness). The patient was treated with AZELASTINE for Adverse event, at an unspecified dose and frequency and SALINE [SODIUM CHLORIDE] for Adverse event, at an unspecified dose and frequency. At the time of the report, UPPER-AIRWAY COUGH SYNDROME (Post nasal drip) had not resolved and FATIGUE (Tiredness) outcome was unknown.            Treatment -Air purifier  No concomitant product information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 100.1 the morning of 12/2; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100.1 the morning of 12/2) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced PYREXIA (fever of 100.1 the morning of 12/2). At the time of the report, PYREXIA (fever of 100.1 the morning of 12/2) outcome was unknown. Not Provided.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 02-Dec-2021, Body temperature 100.1 (High).         No concomitant medications were reported.  No treatment information was reported.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Inappropriate schedule of product administration, Malaise, Product storage error
Clinical narrative: I was notified within a few days that the batch had been left out of the cooler too long; feeling kind of cruddy; chills; sore arm; Extra dose administered; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), PRODUCT STORAGE ERROR (I was notified within a few days that the batch had been left out of the cooler too long), EXTRA DOSE ADMINISTERED (Extra dose administered), MALAISE (feeling kind of cruddy) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A, 046A21A and 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (I was notified within a few days that the batch had been left out of the cooler too long), MALAISE (feeling kind of cruddy), CHILLS (chills) and VACCINATION SITE PAIN (sore arm). On 22-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PRODUCT STORAGE ERROR (I was notified within a few days that the batch had been left out of the cooler too long) and EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved and MALAISE (feeling kind of cruddy), CHILLS (chills) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  No Treatment informations were reported.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I was notified within a few days that the batch had been left out of the cooler too long; feeling kind of cruddy; chills; sore arm; Extra dose administered; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), PRODUCT STORAGE ERROR (I was notified within a few days that the batch had been left out of the cooler too long), EXTRA DOSE ADMINISTERED (Extra dose administered), MALAISE (feeling kind of cruddy) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A, 046A21A and 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (I was notified within a few days that the batch had been left out of the cooler too long), MALAISE (feeling kind of cruddy), CHILLS (chills) and VACCINATION SITE PAIN (sore arm). On 22-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PRODUCT STORAGE ERROR (I was notified within a few days that the batch had been left out of the cooler too long) and EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved and MALAISE (feeling kind of cruddy), CHILLS (chills) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  No Treatment informations were reported.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: My shoulder hurt; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (My shoulder hurt) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0016210 and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced ARTHRALGIA (My shoulder hurt). At the time of the report, ARTHRALGIA (My shoulder hurt) outcome was unknown.            No Concomitant medications were provided No treatment medications were provided.  Patient reported after second dose of Moderna Vaccine he didn't have any side effects
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Gave a booster to someone who was there to get a third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Gave a booster to someone who was there to get a third dose) 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 Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Gave a booster to someone who was there to get a third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Gave a booster to someone who was there to get a third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that an immunocompromised patient was given a wrong dose of 0.25ml.    No concomitant medications were reported.  No treatment information was reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nasal congestion, Off label use, Oropharyngeal pain
Clinical narrative: stuffy nose; sore throat; fever/burning with 101.8 fever; chills; dose given was the low dose per advise by their physician; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy nose), OROPHARYNGEAL PAIN (sore throat), PYREXIA (fever/burning with 101.8 fever), CHILLS (chills) and OFF LABEL USE (dose given was the low dose per advise by their physician) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 012M20A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Stroke in January 2021.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced PYREXIA (fever/burning with 101.8 fever), CHILLS (chills) and OFF LABEL USE (dose given was the low dose per advise by their physician). On 02-Dec-2021, the patient experienced NASAL CONGESTION (stuffy nose) and OROPHARYNGEAL PAIN (sore throat). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) from 01-Dec-2021 to 02-Dec-2021 for Adverse event, at an unspecified dose and frequency. On 01-Dec-2021, OFF LABEL USE (dose given was the low dose per advise by their physician) had resolved. At the time of the report, NASAL CONGESTION (stuffy nose), OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills) outcome was unknown and PYREXIA (fever/burning with 101.8 fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, Body temperature: 101.8 (High) 101.8 fever.         No relevant concomitant medications were reported.   This case was linked to MOD-2021-403617 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: stuffy nose; sore throat; fever/burning with 101.8 fever; chills; dose given was the low dose per advise by their physician; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy nose), OROPHARYNGEAL PAIN (sore throat), PYREXIA (fever/burning with 101.8 fever), CHILLS (chills) and OFF LABEL USE (dose given was the low dose per advise by their physician) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 012M20A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Stroke in January 2021.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced PYREXIA (fever/burning with 101.8 fever), CHILLS (chills) and OFF LABEL USE (dose given was the low dose per advise by their physician). On 02-Dec-2021, the patient experienced NASAL CONGESTION (stuffy nose) and OROPHARYNGEAL PAIN (sore throat). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) from 01-Dec-2021 to 02-Dec-2021 for Adverse event, at an unspecified dose and frequency. On 01-Dec-2021, OFF LABEL USE (dose given was the low dose per advise by their physician) had resolved. At the time of the report, NASAL CONGESTION (stuffy nose), OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills) outcome was unknown and PYREXIA (fever/burning with 101.8 fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, Body temperature: 101.8 (High) 101.8 fever.         No relevant concomitant medications were reported.   This case was linked to MOD-2021-403617 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth
Clinical narrative: tooth cold; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA TEETH in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Disorder tooth.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced HYPERAESTHESIA TEETH. At the time of the report, HYPERAESTHESIA TEETH outcome was unknown.            No relevant concomitant medications were reported. Patient stated that they were going to give her novacaine to the area where the tooth was getting pulled.