chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Had some fatigue after her 1st booster dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 017B21A and 010A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-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 FATIGUE (Had some fatigue after her 1st booster dose). At the time of the report, FATIGUE (Had some fatigue after her 1st booster dose) outcome was unknown. No concomitant medications were provided. Patient had received the first booster dose. No treatment medications were reported. This case was linked to MOD-2022-537773, MOD-2022-537798 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours previously; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours previously) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen COVID-19 vaccine in March 2021 and Pfizer COVID-19 vaccine in October 2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 07-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours previously). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours previously) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Medical history was not provided by the reporter.  Patient was not on any concomitant medications.  Reporter stated that, a patient received the first booster dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours previously on 06-Apr-2022. The patient had not reported any adverse reactions at this time. No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 17-Feb-2022 at 10:00 am, expired on 1-Apr-2022 and administered on 06-Apr-2022; 21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022 at 10:00 am, expired on 1-Apr-2022 and administered on 06-Apr-2022) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022 at 10:00 am, expired on 1-Apr-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022 at 10:00 am, expired on 1-Apr-2022 and administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  It was reported that 21 vials were initially stored in refrigerator on 17-Feb-2022 at 10:00 am and doses were administered 30 day use by date or after manufacturer date of expiry.  The vials did not undergo any temperature excursions.  It was reported that the vials likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  No adverse events were reported.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up document contains no new information
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expiration date 25Mar2022/vial was taken from freezer and placed in refrigerator on 7 April/ administered on 7 April; Administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Expiration date 25Mar2022/vial was taken from freezer and placed in refrigerator on 7 April/ administered on 7 April) and EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date 25Mar2022/vial was taken from freezer and placed in refrigerator on 7 April/ administered on 7 April). At the time of the report, PRODUCT STORAGE ERROR (Expiration date 25Mar2022/vial was taken from freezer and placed in refrigerator on 7 April/ administered on 7 April) and EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications was reported.  Patient was administered with booster dose. The vial was taken from the freezer on the morning of 07-Apr-2022 and placed in the refrigerator for use on 07-Apr-2022. Vial had not undergone any temperature excursions.   This case was linked to MOD-2022-537851 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 05-Apr-2022; administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 05-Apr-2022) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 05-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  It was reported that 21 vials were initially stored in refrigerator on 17-Feb-2022 and doses were administered 30 day use by date or after manufacturer date of expiry.  The vials did not undergo any temperature excursions.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up document contains no additional information.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 25-Mar-2022 and was stored in freezer till 07-Apr-2022; Patient administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 25-Mar-2022 and was stored in freezer till 07-Apr-2022) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 25-Mar-2022 and was stored in freezer till 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 25-Mar-2022 and was stored in freezer till 07-Apr-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The pharmacist reported that they inadvertently administered an expired vaccine to the patient. The vial was taken from the freezer on the morning of 07-Apr-2022 and placed in the refrigerator for use on the same day.  The vial did not undergo any temperature excursions.  No treatment details were reported.   This case was linked to MOD-2022-537781, MOD-2022-537834, MOD-2022-537863 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine was stored and then administered; Administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered) and EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.  No Medical History information was reported. On 07-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered). At the time of the report, PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered) and EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The patient was administered with booster dose. The vial was taken from the freezer on the morning of 07-Apr-2022 and placed in the refrigerator for use on 07-Apr-2022. The vial did not undergo any temperature excursions.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Extra dose administered
Clinical narrative: Received 0.5ml dose instead of 0.25mL for their 2nd booster dose (4th dose); 42 years old non-immunocompromised patient received 2nd booster.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5ml dose instead of 0.25mL for their 2nd booster dose (4th dose)) and EXTRA DOSE ADMINISTERED (42 years old non-immunocompromised patient received 2nd booster.) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 939903, 01451A and 040121A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Diabetes type 1).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 10-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Apr-2022, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5ml dose instead of 0.25mL for their 2nd booster dose (4th dose)) and EXTRA DOSE ADMINISTERED (42 years old non-immunocompromised patient received 2nd booster.). At the time of the report, ACCIDENTAL OVERDOSE (Received 0.5ml dose instead of 0.25mL for their 2nd booster dose (4th dose)) and EXTRA DOSE ADMINISTERED (42 years old non-immunocompromised patient received 2nd booster.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  The Reporter stated that a 0.5mL dose from a red cap and a label with a light border was administered as patient 2nd booster dose (4th dose) instead of 0.25mL.The patient was not immunocompromised.  Treatment information was not provided.   This case was linked to MOD-2022-537620 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Some of the vaccine leaked out while administering the vaccine to a patient; Patient felt some of the medication was dripping / Some medication did not get into the arm / Most of the medication was dripping; This spontaneous case was reported by a physician and describes the occurrence of DEVICE CONNECTION ISSUE (Some of the vaccine leaked out while administering the vaccine to a patient) and UNDERDOSE (Patient felt some of the medication was dripping / Some medication did not get into the arm / Most of the medication was dripping) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Some of the vaccine leaked out while administering the vaccine to a patient) and UNDERDOSE (Patient felt some of the medication was dripping / Some medication did not get into the arm / Most of the medication was dripping). At the time of the report, DEVICE CONNECTION ISSUE (Some of the vaccine leaked out while administering the vaccine to a patient) and UNDERDOSE (Patient felt some of the medication was dripping / Some medication did not get into the arm / Most of the medication was dripping) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was administered with the 2nd booster of the Moderna COVID-19 vaccine. From the patient point of view most of the medication was dripped out.  No concomitant medication was reported.    No treatment information was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was placed in refrigerator on 17-Feb-2022, expired product date on 01-Apr- 2022, administration date on 05-Apr-2022.; 21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 17-Feb-2022, expired product date on 01-Apr- 2022, administration date on 05-Apr-2022.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 17-Feb-2022, expired product date on 01-Apr- 2022, administration date on 05-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 17-Feb-2022, expired product date on 01-Apr- 2022, administration date on 05-Apr-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on  17-Feb-2022. The vial did not undergo any temperature excursions.  It was reported that no patients had come out with adverse events.  The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received contains non significant information.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tremor
Clinical narrative: Has tremors but that they got worst; Feeling faint; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Has tremors but that they got worst) and DIZZINESS (Feeling faint) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M23A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Johnson (Patient took first dose of Johnson and Johnson vaccine.). Past adverse reactions to the above products included No adverse event with Johnson and Johnson. Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 10-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Has tremors but that they got worst) and DIZZINESS (Feeling faint). At the time of the report, TREMOR (Has tremors but that they got worst) had not resolved and DIZZINESS (Feeling faint) outcome was unknown.            No treatment details were reported.   This case was linked to MOD-2022-538041 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Acute disseminated encephalomyelitis; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE DISSEMINATED ENCEPHALOMYELITIS (Acute disseminated encephalomyelitis) in an 81-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.   LITERATURE REFERENCE:      No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE DISSEMINATED ENCEPHALOMYELITIS (Acute disseminated encephalomyelitis) (seriousness criteria death and medically significant). The reported cause of death was Acute disseminated encephalomyelitis. It is unknown if an autopsy was performed.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered ACUTE DISSEMINATED ENCEPHALOMYELITIS (Acute disseminated encephalomyelitis) to be related.    No concomitant and treatment medications were reported.  Company Comment This Literature Non study case report, concerns a 81-year-old male patient with no medical history reported, who experienced the unexpected serious fatal (Medically significant, Death) event of Acute Disseminated Encephalomyelitis unknown days after the first dose of mRNA-1273 vaccine administration. The event had a fatal outcome. The reported cause of death was Acute disseminated encephalomyelitis. It is unknown if an autopsy was performed. Very limited information was available in the report. No details of symptoms, clinical course, risk factors, labs, diagnostic procedures and treatment details were provided. The reporter considered the event to be related to mRNA-1273 vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per regulatory authority's report.   This case was linked to MOD-2022-537972, MOD-2022-537973 (Patient Link).; Sender's Comments: This Literature Non study case report, concerns a 81-year-old male patient with no medical history reported, who experienced the unexpected serious fatal (Medically significant, Death) event of Acute Disseminated Encephalomyelitis unknown days after the first dose of mRNA-1273 vaccine administration. The event had a fatal outcome. The reported cause of death was Acute disseminated encephalomyelitis. It is unknown if an autopsy was performed. Very limited information was available in the report. No details of symptoms, clinical course, risk factors, labs, diagnostic procedures and treatment details were provided. The reporter considered the event to be related to mRNA-1273 vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per regulatory authority's report.; Reported Cause(s) of Death: Acute disseminated encephalomyelitis
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Prior to the second booster dose of the vaccine he had only experienced a little arm soreness.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Prior to the second booster dose of the vaccine he had only experienced a little arm soreness.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 027A21A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Prior to the second booster dose of the vaccine he had only experienced a little arm soreness.). At the time of the report, PAIN IN EXTREMITY (Prior to the second booster dose of the vaccine he had only experienced a little arm soreness.) outcome was unknown.            No concomitant drug details were reported. On 05-Nov-2021 patient received first booster dose of Moderna vaccine. No treatment information was provided.   This case was linked to MOD-2022-538035 (Patient Link).   Reporter did not allow further contact
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Fatigue, Malaise, Rash papular, Vaccination site pain
Clinical narrative: Prior to the second booster dose of the vaccine he had only experienced a little arm soreness.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Prior to the second booster dose of the vaccine he had only experienced a little arm soreness.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 027A21A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Prior to the second booster dose of the vaccine he had only experienced a little arm soreness.). At the time of the report, PAIN IN EXTREMITY (Prior to the second booster dose of the vaccine he had only experienced a little arm soreness.) outcome was unknown.            No concomitant drug details were reported. On 05-Nov-2021 patient received first booster dose of Moderna vaccine. No treatment information was provided.   This case was linked to MOD-2022-538035 (Patient Link).   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: he noticed little rashes or bumps below his navel, under his right arm, on his back, and on his thigh; his arm where the injection occurred was very sore; little fatigued; not been feeling good; tightness in his chest for the past couple days; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (he noticed little rashes or bumps below his navel, under his right arm, on his back, and on his thigh), MALAISE (not been feeling good), CHEST DISCOMFORT (tightness in his chest for the past couple days), VACCINATION SITE PAIN (his arm where the injection occurred was very sore) and FATIGUE (little fatigued) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 029K20A, 027A21A and 033F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (his arm where the injection occurred was very sore). On 09-Apr-2022, the patient experienced RASH PAPULAR (he noticed little rashes or bumps below his navel, under his right arm, on his back, and on his thigh). In April 2022, the patient experienced MALAISE (not been feeling good), CHEST DISCOMFORT (tightness in his chest for the past couple days) and FATIGUE (little fatigued). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, RASH PAPULAR (he noticed little rashes or bumps below his navel, under his right arm, on his back, and on his thigh), MALAISE (not been feeling good), CHEST DISCOMFORT (tightness in his chest for the past couple days), VACCINATION SITE PAIN (his arm where the injection occurred was very sore) and FATIGUE (little fatigued) outcome was unknown.      Concomitant medication was not provided.  Prior to the second booster dose of the vaccine patient had only experienced a little arm soreness.  The patient received 2 booster doses of the Moderna vaccine by intramuscular injection on 05-Nov-2021 (Lot: 033F21A and expiry date unknown) and 06-Apr-2022 (Lot: 045L21A and expiry date unknown) respectively.   This case was linked to MOD-2022-537938 (Patient Link).   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Fatigue, Malaise, Rash papular, Vaccination site pain
Clinical narrative: he noticed little rashes or bumps below his navel, under his right arm, on his back, and on his thigh; his arm where the injection occurred was very sore; little fatigued; not been feeling good; tightness in his chest for the past couple days; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (he noticed little rashes or bumps below his navel, under his right arm, on his back, and on his thigh), MALAISE (not been feeling good), CHEST DISCOMFORT (tightness in his chest for the past couple days), VACCINATION SITE PAIN (his arm where the injection occurred was very sore) and FATIGUE (little fatigued) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 029K20A, 027A21A and 033F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (his arm where the injection occurred was very sore). On 09-Apr-2022, the patient experienced RASH PAPULAR (he noticed little rashes or bumps below his navel, under his right arm, on his back, and on his thigh). In April 2022, the patient experienced MALAISE (not been feeling good), CHEST DISCOMFORT (tightness in his chest for the past couple days) and FATIGUE (little fatigued). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, RASH PAPULAR (he noticed little rashes or bumps below his navel, under his right arm, on his back, and on his thigh), MALAISE (not been feeling good), CHEST DISCOMFORT (tightness in his chest for the past couple days), VACCINATION SITE PAIN (his arm where the injection occurred was very sore) and FATIGUE (little fatigued) outcome was unknown.      Concomitant medication was not provided.  Prior to the second booster dose of the vaccine patient had only experienced a little arm soreness.  The patient received 2 booster doses of the Moderna vaccine by intramuscular injection on 05-Nov-2021 (Lot: 033F21A and expiry date unknown) and 06-Apr-2022 (Lot: 045L21A and expiry date unknown) respectively.   This case was linked to MOD-2022-537938 (Patient Link).   Reporter did not allow further contact
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1: Administration Date: 01-Nov-2021 and Dose 2: Administration Date: 21-Nov-2021; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: Administration Date: 01-Nov-2021 and Dose 2: Administration Date: 21-Nov-2021) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: Administration Date: 01-Nov-2021 and Dose 2: Administration Date: 21-Nov-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: Administration Date: 01-Nov-2021 and Dose 2: Administration Date: 21-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-537607 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Neuromyelitis optica spectrum disorder
Clinical narrative: New-onset Neuromyelitis Optica Spectrum Disorder; This literature-non-study case was reported in a literature article and describes the occurrence of NEUROMYELITIS OPTICA SPECTRUM DISORDER (New-onset Neuromyelitis Optica Spectrum Disorder) in a 54-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROMYELITIS OPTICA SPECTRUM DISORDER (New-onset Neuromyelitis Optica Spectrum Disorder) (seriousness criterion medically significant). At the time of the report, NEUROMYELITIS OPTICA SPECTRUM DISORDER (New-onset Neuromyelitis Optica Spectrum Disorder) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NEUROMYELITIS OPTICA SPECTRUM DISORDER (New-onset Neuromyelitis Optica Spectrum Disorder) to be related.    No concomitant and treatment medication were reported.  Company Comment: This is a Literature-Non-Study case concerning a 54-year-old female patient, with no medical history reported, who experienced the serious unexpected adverse event of Neuromyelitis optica spectrum disorder (serious criteria Medically Significant), in an unknown date, after receiving the second dose of the mRNA-1273 vaccine. Very limited information is available regarding clinical course and diagnostic work-up. It is stated in this case that there is a new-Onset of Neuromyelitis Optica Spectrum Disorder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-537932, MOD-2022-537973.; Sender's Comments: This is a Literature-Non-Study case concerning a 54-year-old female patient, with no medical history reported, who experienced the serious unexpected adverse event of Neuromyelitis optica spectrum disorder (serious criteria Medically Significant), in an unknown date, after receiving the second dose of the mRNA-1273 vaccine. Very limited information is available regarding clinical course and diagnostic work-up. It is stated in this case that there is a new-Onset of Neuromyelitis Optica Spectrum Disorder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Demyelination
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of DEMYELINATION (Fulminant onset of inflammatory demyelinating disease) in a 49-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. LITERATURE REFERENCE: A single-health system case series of new-onset CNS Inflammatory disorders temporally associated with mRNA-based SARS-CoV-2 vaccines. Front Neurol;13:796882. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, after starting mRNA-1273 (Spikevax), the patient experienced DEMYELINATION (Fulminant onset of inflammatory demyelinating disease)  (seriousness criterion medically significant). At the time of the report, DEMYELINATION (Fulminant onset of inflammatory demyelinating disease) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered DEMYELINATION (Fulminant onset of inflammatory demyelinating disease) to be related. Concomitant and treatment medications were not reported. Company comment: This literature non-study case concerns a 49  year  old, male patient with no medical history reported, who experienced the unexpected, serious medically significant event of demyelination. The event occurred within two weeks after the administration of an unspecified dose number of mRNA-1273 vaccine. The report stated that the patient experienced a fulminant onset of inflammatory demyelinating disease. No further details such as blood tests, lumbar puncture tests, nerve conduction studies, electromyography, imaging study diagnosis tests or hospitalization dates were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-537972, MOD-2022-537932 (Patient Link). Sender's Comments: This literature non-study case concerns a 49  year  old, male patient with no medical history reported, who experienced the unexpected, serious medically significant event of demyelination. The event occurred within two weeks after the administration of an unspecified dose number of mRNA-1273 vaccine. The report stated that the patient experienced a fulminant onset of inflammatory demyelinating disease. No further details such as blood tests, lumbar puncture tests, nerve conduction studies, electromyography, imaging study diagnosis tests or hospitalization dates were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The product was placed in refrigerator on 17-Feb-2022, expired on 01-Apr-2022 and administered on 06-Apr-2022; 21 patients administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (The product was placed in refrigerator on 17-Feb-2022, expired on 01-Apr-2022 and administered on 06-Apr-2022) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The product was placed in refrigerator on 17-Feb-2022, expired on 01-Apr-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (The product was placed in refrigerator on 17-Feb-2022, expired on 01-Apr-2022 and administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that 21 vials were initially stored in refrigerator on 17-Feb-2022 and doses were administered 30 day use by date or after manufacturer date of expiry.  The vials did not undergo any temperature excursions. No adverse events were reported.  It was reported that the vials likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up received and confirmed that the vials did not maintain the activity to protect against COVID-19.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 06-Apr-2022; Patient administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 06-Apr-2022) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The vial was initially stored in refrigerator on 17 Feb 2022 10:00 am. The vials did not undergo any temperature excursions. It was reported that  no patients have come out with adverse events.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up document contains no new information.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 17-FEB-2022, expired on 01-APR-2022 and administered on 06-APR-2022; Patients administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients administered with expired vaccine) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-FEB-2022, expired on 01-APR-2022 and administered on 06-APR-2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-FEB-2022, expired on 01-APR-2022 and administered on 06-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients administered with expired vaccine) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-FEB-2022, expired on 01-APR-2022 and administered on 06-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  Date the vial was initially stored in refrigerator was on 17-Feb-2022 at 10 AM. Vial did not undergo any temperature excursion. Patient did not had adverse events.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up contains Non-Significant information
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Breast cancer surgery; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Breast surgery) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21B, 031L20A and 029L20A) for COVID-19 vaccination.     It was reported that Patient was not allergic, never tested positive for Covid-19.  Concomitant products included THYROID (ARMOUR THYROID) 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 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced VACCINATION COMPLICATION (Breast surgery). At the time of the report, VACCINATION COMPLICATION (Breast surgery) outcome was unknown.            Reportedly, patient was not an Anti-Vaccine. Patient did not have any reaction on previous doses of the Moderna COVID-19 Vaccine and didn't have any vaccine in between 1 month near booster.  Patient took 1st Booster on 23Aug2021 and had breast cancer surgery.  No treatment information was reported.   This case was linked to MOD-2022-538004 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: she took The Johnson and Johnson for the first  dose, the Moderna covid19 vaccine for the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she took The Johnson and Johnson for the first  dose, the Moderna covid19 vaccine for the second dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039T20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for Product used for unknown indication: Johnson and Johnson (The patient took  Johnson and Johnson as the first dose.). Past adverse reactions to the above products included No adverse event with Johnson and Johnson. Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 06-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she took The Johnson and Johnson for the first  dose, the Moderna covid19 vaccine for the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she took The Johnson and Johnson for the first  dose, the Moderna covid19 vaccine for the second dose) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2022-537899 (Patient Link).