chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: mild symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (mild symptoms) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (mild symptoms). At the time of the report, VACCINATION COMPLICATION (mild symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pneumonia
Clinical narrative: Pneumonia; was a little bit dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C212, 037AC1B and 030A214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included COPD.   On 31-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 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced DIZZINESS (was a little bit dizzy). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia) and DIZZINESS (was a little bit dizzy) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Has COPD and taken medications for that. Recently she had to go to the hospital because of pneumonia.  No treatment drug was reported.  Patient felt good, but when patient had the dose, felt it, it was something like sudden. Patient felt that it was something different in her system, and was a little bit dizzy.  Company Comment - This case concerns a 63 year-old female patient with a history of chronic obstructive pulmonary disease who experienced the unexpected serious event of pneumonia. The event occurred on an unknown date relative to vaccination with first, second and booster third dose of mRNA-1273. The rechallenge was unknown as the date of the event was not provided. The medical history of chronic obstructive pulmonary disease remains a confounder for pneumonia. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per reporting, however there was no information in the source document supporting that the events were of a medically serious nature.; Sender's Comments: This case concerns a 63 year-old female patient with a history of chronic obstructive pulmonary disease who experienced the unexpected serious event of pneumonia. The event occurred on an unknown date relative to vaccination with first, second and booster third dose of mRNA-1273. The rechallenge was unknown as the date of the event was not provided. The medical history of chronic obstructive pulmonary disease remains a confounder for pneumonia. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per reporting, however there was no information in the source document supporting that the events were of a medically serious nature
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and medication information provided.  No treatment information provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of efficacy; break through COVID; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (break through COVID) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (break through COVID). At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (break through COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, SARS-CoV-2 test: positive (Positive) positive for COVID-19.         No concomitant medications were taken by the patient.  No treatment medications were taken by the patient.  The patient had to undergo a surgery for the shoulder.  The patient had undergone rapid COVID test and the patient was not sick at all and has self-quarantined rom the family members.  This is a case of drug ineffective of this 59-year-old, male patient, with no known medical history, who experienced the non-serious, unexpected, AESI event of Covid-19. The event occurred  7 months after second dose of Moderna vaccine. The rechallenge is not applicable as there is no information regarding a third dose. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This is a case of drug ineffective of this 59-year-old, male patient, with no known medical history, who experienced the non-serious, unexpected, AESI event of Covid-19. The event occurred  7 months after second dose of Moderna vaccine. The rechallenge is not applicable as there is no information regarding a third dose. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dementia Alzheimer's type, Fatigue, Headache, Malaise
Clinical narrative: Beginning of Alzheimer; Not feeling well / just not been feeling well; Fatigue; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (Beginning of Alzheimer) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), LOSARTAN, LEVOFLOXACIN (LEVOXIN), DONEPEZIL HYDROCHLORIDE (ARICEPT), PRIMIDONE and VITAMINS NOS for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced MALAISE (Not feeling well / just not been feeling well), FATIGUE (Fatigue) and HEADACHE (Head ache). On an unknown date, the patient experienced DEMENTIA ALZHEIMER'S TYPE (Beginning of Alzheimer) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, DEMENTIA ALZHEIMER'S TYPE (Beginning of Alzheimer), MALAISE (Not feeling well / just not been feeling well), FATIGUE (Fatigue) and HEADACHE (Head ache) outcome was unknown.     The patient received the booster dose and was not feeling well. The patient just not been feeling well, just the fatigue with the headache. The patient had beginning of Alzheimer.  Company Comment - This case concerns a 79-year-old female patient with no relevant medical history, who experienced the unexpected event of Dementia Alzheimer's Type. The event occurred on approximately around the same month when the third dose of mRNA-1273 (Moderna COVID-19 Vaccine) was given. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 79-year-old female patient with no relevant medical history, who experienced the unexpected event of Dementia Alzheimer's Type. The event occurred on approximately around the same month when the third dose of mRNA-1273 (Moderna COVID-19 Vaccine) was given. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died right after the shot; 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 DEATH (Died right after the shot) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.      Concomitant Medication use information was not provided by reporter.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.  Treatment  Medication use information was not provided by reporter.  This case concerns a patient (demographics unknown) with no relevant medical history, who experienced the unexpected event of Death. The event occurred at an unknown interval after a dose of mRNA-1273 (Moderna Covid-19 vaccine); it's unclear if it was the first or second dose. The rechallenge was not applicable as event resulted in the death. Limited information provided precludes a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   This case was linked to MOD-2021-365068 (Patient Link).; Sender's Comments: This case concerns a patient (demographics unknown) with no relevant medical history, who experienced the unexpected event of Death. The event occurred at an unknown interval after a dose of mRNA-1273 (Moderna Covid-19 vaccine); it's unclear if it was the first or second dose. The rechallenge was not applicable as event resulted in the death. Limited information provided precludes a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired dose as a booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose as a booster dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose as a booster dose). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not reported.    This case was linked to MOD-2021-365005 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Death
Clinical narrative: Death; Covid-19 after vaccine; 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 DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and COVID-19 (Covid-19 after vaccine). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, COVID-19 (Covid-19 after vaccine) outcome was unknown.            Patient reported that  25-30 people who had the Moderna vaccination that either had COVID-19 or died.  Company Comment : This case concerns a patient(s) with no relevant medical history, who experienced the unexpected events of Covid-19 and Death  The events occurred at unspecified interval after a dose of mRNA-1273 (Moderna Covid-19 vaccine); it's unclear from the source document whether this was first or second dose. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a patient(s) with no relevant medical history, who experienced the unexpected events of Covid-19 and Death  The events occurred at unspecified interval after a dose of mRNA-1273 (Moderna Covid-19 vaccine); it's unclear from the source document whether this was first or second dose. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Painful arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Abdominal disorder (taking rifaximin antibiotic for abdominal issues). Concomitant products included RIFAXIMIN (XIFAXAN) for Abdominal discomfort.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced PAIN IN EXTREMITY (Painful arm). At the time of the report, PAIN IN EXTREMITY (Painful arm) outcome was unknown.            Treatment details was not reported by the reporter. The patient was taking 500 mg of Rifaximin twice daily for 2 weeks.   Most recent FOLLOW-UP information incorporated above includes: On 30-Oct-2021: follow up : Dose detail of suspect vaccine updated and Event coding updated
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date) had resolved.      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. Date of refrigeration was 07-May-2021.   This case was linked to MOD-2021-365154 (Patient Link).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-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 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter. Treatment medication was reported.  Date of refrigeration 7 May 2021.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received dose from vials beyond 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30 day use by date) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30 day use by date). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30 day use by date) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  The date of refrigeration was reported to be on 07-May-2021.  Treatment information was not provided.   This case was linked to MOD-2021-365165 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from vials beyond 30-day use by 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 information was provided  Date of Refrigeration was 07-MAY-2021  This case was linked to MOD-2021-365177 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Heart rate, Sensitive skin
Clinical narrative: Sensitivity of the skin; feeling not so hot; Very tired; Had a headache; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Sensitivity of the skin), FEELING ABNORMAL (feeling not so hot), FATIGUE (Very tired) and HEADACHE (Had a headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061F21A, 039K20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced FATIGUE (Very tired) and HEADACHE (Had a headache). On an unknown date, the patient experienced SENSITIVE SKIN (Sensitivity of the skin) and FEELING ABNORMAL (feeling not so hot). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, SENSITIVE SKIN (Sensitivity of the skin), FEELING ABNORMAL (feeling not so hot), FATIGUE (Very tired) and HEADACHE (Had a headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2021, Heart rate: 104-105-106 (High) 104-105-106 and 114 (High) pulse being 104-105-106, and as they talked, she said it went to 114.Patient said it is usually around 70. She noticed it in the morning, when it was around 95, and then it kept increasing..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.   This case was linked to MOD-2021-365171 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jun 30, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 30, 2021, patient administered expired product (318 patients received dose from vials beyond 30-day use by date). On Jun 30, 2021, administered expired product (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of refrigeration: May 7, 2021.
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Exceeded the 20 puncture limit on a vial of Moderna Covid-19 Vaccine for booster doses for 1 or 2 patients with 1 vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Exceeded the 20 puncture limit on a vial of Moderna Covid-19 Vaccine for booster doses for 1 or 2 patients with 1 vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Exceeded the 20 puncture limit on a vial of Moderna Covid-19 Vaccine for booster doses for 1 or 2 patients with 1 vial). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Exceeded the 20 puncture limit on a vial of Moderna Covid-19 Vaccine for booster doses for 1 or 2 patients with 1 vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned.  No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: 20 patients total who received the shot outside of temperature range; expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients total who received the shot outside of temperature range) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients total who received the shot outside of temperature range). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (20 patients total who received the shot outside of temperature range) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided. Maximum or minimum temperatures reached, is min -59C; max -75C and Excursion duration is of  6 days.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered dose past 12-hour mark; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose past 12-hour mark) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose past 12-hour mark). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered dose past 12-hour mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications, Lab data details and Treatment information were not provided.   This case was linked to MOD-2021-363303, MOD-2021-365214, MOD-2021-365212, MOD-2021-364190, MOD-2021-365032, MOD-2021-365214 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Non- significant follow-up appended:  e-mail ID added.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Somnolence, Suicidal ideation
Clinical narrative: Having ideation (suicidal) thoughts; Had no energy; Kept falling asleep at work, and almost fell asleep while driving to and from work; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (Having ideation (suicidal) thoughts) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Thyroid disorder.   On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced SUICIDAL IDEATION (Having ideation (suicidal) thoughts) (seriousness criterion medically significant). 23-Oct-2021, the patient experienced ASTHENIA (Had no energy) and SOMNOLENCE (Kept falling asleep at work, and almost fell asleep while driving to and from work). At the time of the report, SUICIDAL IDEATION (Having ideation (suicidal) thoughts), ASTHENIA (Had no energy) and SOMNOLENCE (Kept falling asleep at work, and almost fell asleep while driving to and from work) outcome was unknown.            Patient stated that she saw her therapist on 25-Oct-2021 as she was having ideation (suicidal) thoughts. Patient stated that her physician knows about her adverse events. Concomitant medications include unspecified blood pressure and unspecified thyroid medications.  No treatment medications were reported.  Company Comment: This case concerns a  62-year-old, female patient with no relevant medical history, who experienced the unexpected event of Suicidal Ideation). The event occurred approximately 1 day after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   This case was linked to MOD-2021-365227 (Patient Link).; Sender's Comments: This case concerns a  62-year-old, female patient with no relevant medical history, who experienced the unexpected event of Suicidal Ideation). The event occurred approximately 1 day after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: hearing loss; tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (hearing loss) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (hearing loss) (seriousness criterion medically significant) and TINNITUS (tinnitus). At the time of the report, DEAFNESS (hearing loss) and TINNITUS (tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication was reported by patient.  The patient was reporting own side effects. Patient also reported that he saw that people were reporting tinnitus and hearing loss as a side effect of Moderna. It was becoming more and more frequent. patient found that CDC literature stated this could be a potentially severe side effect. Patient stated these have been reported over the last 6-7 months.  Company Comment: This case concerns a male patient of unknown age with no relevant medical history, who experienced the unexpected event of Deafness. The event occurred approximately 6 days on an unknown date after receiving an unknown dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as there's no information available about the dose number. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a male patient of unknown age with no relevant medical history, who experienced the unexpected event of Deafness. The event occurred approximately 6 days on an unknown date after receiving an unknown dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as there's no information available about the dose number. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This is worse than second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (This is worse than second dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 007M204) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac valve disease.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (This is worse than second dose). At the time of the report, VACCINATION COMPLICATION (This is worse than second dose) outcome was unknown.            No Concomitant  informations were reported.  No Treatment informations were reported.   This case was linked to MOD-2021-365408 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival disorder, Gingival swelling
Clinical narrative: Inflammation in the gums, white spots, deep red inflammation/swelling; Inflammation in the gums, white spots, deep red inflammation/swelling; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL SWELLING (Inflammation in the gums, white spots, deep red inflammation/swelling) and GINGIVAL DISORDER (Inflammation in the gums, white spots, deep red inflammation/swelling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Leukemia. Concomitant products included LOSARTAN, LEVOTHYROXINE and ANASTROZOLE (ANASTRAZOLE DENK) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GINGIVAL SWELLING (Inflammation in the gums, white spots, deep red inflammation/swelling) and GINGIVAL DISORDER (Inflammation in the gums, white spots, deep red inflammation/swelling). At the time of the report, GINGIVAL SWELLING (Inflammation in the gums, white spots, deep red inflammation/swelling) and GINGIVAL DISORDER (Inflammation in the gums, white spots, deep red inflammation/swelling) had not resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had seen 3-4 doctors and a biopsy on gums to rule out lupus, oral surgeon could not diagnose. The symptoms are still ongoing, The treatment medication included Antibiotics (unspecified).   This case was linked to MOD-2021-366461 (Patient Link).
Age: 64.0
Sex: M
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 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Sep-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 medication information was not reported  Treatment information was not reported
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (expired vaccine used) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 031B21A) for COVID-19  immunization. No medical history reported. On Sep 24, 2021, at 14:21, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 24, 2021, at 14:21, patient administered expired product (expired vaccine used). On Sep 24, 2021, at 14:21, administered expired product (expired vaccine used) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The patient did not have any adverse event and did not require any medical attention.
Age: 48.0
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 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Sep-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 and treatment medications are provided by the reporter. The patient did not receive any adverse events and did not required any medical attention.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: got the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (got the vaccine while pregnant) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 20-Feb-2022. On 27-Oct-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (got the vaccine while pregnant). On 27-Oct-2021, MATERNAL EXPOSURE DURING PREGNANCY (got the vaccine while pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  It was reported that the second shot was scheduled on 24-Nov-2021. Company comment: This is a case of Maternal exposure during pregnancy for this 41-year-old female patient. Reportedly, the patient received the first dose of Moderna COVID-19 Vaccine during pregnancy. The patient's last menstrual period was not provided, and as per the estimated date of delivery, the patient received this first dose approximately during the sixth month of pregnancy (however, this information will be confirmed during follow up). No adverse events were reported at the time of this report. The company causality for the event of Maternal exposure during pregnancy is not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of Maternal exposure during pregnancy for this 41-year-old female patient. Reportedly, the patient received the first dose of Moderna COVID-19 Vaccine during pregnancy. The patient's last menstrual period was not provided, and as per the estimated date of delivery, the patient received this first dose approximately during the sixth month of pregnancy (however, this information will be confirmed during follow up). No adverse events were reported at the time of this report. The company causality for the event of Maternal exposure during pregnancy is not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Myalgia, Taste disorder
Clinical narrative: little bit tired in the arm; tongue was numb; glass of water felt peppery/couldn't taste the candy; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (tongue was numb), TASTE DISORDER (glass of water felt peppery/couldn't taste the candy) and MYALGIA (little bit tired in the arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021 at 5:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced HYPOAESTHESIA ORAL (tongue was numb) and TASTE DISORDER (glass of water felt peppery/couldn't taste the candy). On an unknown date, the patient experienced MYALGIA (little bit tired in the arm). At the time of the report, HYPOAESTHESIA ORAL (tongue was numb), TASTE DISORDER (glass of water felt peppery/couldn't taste the candy) and MYALGIA (little bit tired in the arm) outcome was unknown.            no concomitant and treatment medications are provided by the reporter. After the booster shot, everything was fine right away,Consent denied for Safety to contact HCP.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Got Moderna booster of 2.5 ml; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Got Moderna booster of 2.5 ml) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Got Moderna booster of 2.5 ml). On 23-Oct-2021, INCORRECT DOSE ADMINISTERED (Got Moderna booster of 2.5 ml) had resolved.            No concomitant and treatment medications are provided by the reporter.  Patient got her Moderna booster on Saturday and it was 2.5 ml. This is a case of inappropriate dose of vaccine administered for this female patient of unknown age with no relevant medical history. No adverse event was reported after administration of the third (booster) dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This is a case of inappropriate dose of vaccine administered for this female patient of unknown age with no relevant medical history. No adverse event was reported after administration of the third (booster) dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature abnormal, Diarrhoea, Dysgeusia
Clinical narrative: osteoarthritis flare is severe pain, generalized in joints and soft tissue.; brain fog to date; dry sinuses; Joint pain; immediate sharp pain down left arm to wrist and across clavicle into lymph node with immediate swelling of node.; immediate sharp pain down left arm to wrist and across clavicle into lymph node with immediate swelling of node.; immediate sharp pain down left arm to wrist and across clavicle into lymph node with immediate swelling of node.; immediate sharp pain down left arm to wrist and across clavicle into lymph node with immediate swelling of node.; Taste the chemical ingratiates; 100 temp/temp 99.9; muscles/body aches; muscles/body aches; diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: ER8736) via an unspecified route of administration, administered in Arm Left on 02Aug2021 at 10:30 (age at vaccination was 53 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included osteoarthritis (OA) and allergies: several. The concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications was received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Aug2021, the patient experienced immediate sharp pain down left arm to wrist and across clavicle into lymph node with immediate swelling of node, taste the chemical ingratiates, 100 temp/temp 99.9, muscles/body aches and diarrhea. On 03Aug2021, the patient experienced brain fog to date, dry sinuses, joint pain and increasing (L) lymph node swelling and pain. On 04Aug2021, the patient experienced osteoarthritis flare is severe pain, generalized in joints and soft tissue. The events resulted in doctor or other healthcare professional office/clinic visit on an unspecified date. The patient underwent lab tests and procedures which included temperature was 100 on 02Aug2021 and 99.9 on 03Aug2021. Therapeutic measures were taken as a result of events Voltaren for 5 days, Tylenol fore fever, penetrex for muscles aches, an unspecified supplements and pushed fluids 8/7 at outstanding SEs: for brain fog and (L) lymph node swelling. PCP was notified. Forced to call out from work. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.