chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired moderna vaccine administered to patient; The vial was initially stored in the refrigerator on 05-Apr-2022, expired on 01-Apr-2022, administered on 06-Apr-2022 to 09-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-Apr-2022, expired on 01-Apr-2022, administered on 06-Apr-2022 to 09-Apr-2022) in a 50-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-Apr-2022, expired on 01-Apr-2022, administered on 06-Apr-2022 to 09-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-Apr-2022, expired on 01-Apr-2022, administered on 06-Apr-2022 to 09-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. It was reported that the administration of vaccine occurred from 06-Apr-2022 to 09-Apr-2022. Patients did not report any adverse reaction after the vaccination. The manufacturing date of the vial was 01-Dec-2021 Vial was initially placed in refrigerator on 05-Apr-2022. The product didn't undergo any temperature excursion issue. Reporter wants to know if the patients need to be re-vaccinated. No treatment drug information was reported.   This case was linked to MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Moderna vaccine administered to patients; vials were initially stored in the refrigerator on 05-Apr-2022 and then administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (vials were initially stored in the refrigerator on 05-Apr-2022 and then administered) in a 64-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (vials were initially stored in the refrigerator on 05-Apr-2022 and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (vials were initially stored in the refrigerator on 05-Apr-2022 and then administered) 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.  Reportedly, 20 doses were initially stored in the refrigerator on 05-Apr-2022. Manufacturing date was reported as 01-Dec-2021.  Patients had not reported any adverse reactions.  Doses were administered after 30-day Use By Date or after manufacturer date of expiry. Vaccines were administered in between 06-Apr-2022 to 09-Apr-2022.  The vials did not undergo any temperature excursions.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689, MOD-2022-538701, MOD-2022-538672 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Moderna vaccine administered to patients; Vaccine was expired on 01 Apr 2022 and stored in refrigerator on 05 Apr 2022 and administered between 06-Apr-2022 to 09-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01 Apr 2022 and stored in refrigerator on 05 Apr 2022 and administered between 06-Apr-2022 to 09-Apr-2022) in a 73-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01 Apr 2022 and stored in refrigerator on 05 Apr 2022 and administered between 06-Apr-2022 to 09-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01 Apr 2022 and stored in refrigerator on 05 Apr 2022 and administered between 06-Apr-2022 to 09-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.  The administration occurred from 06-Apr-2022 to 09-Apr-2022.  The vial did not undergo any temperature excursion. Patients did not reported any adverse reactions.  No treatment medications were reported.   This case was linked to MOD-2022-538692 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Moderna vaccine administered to patients; The vial was initially stored in the refrigerator on 5-Apr-2022, Administered between 6-Apr-2022 to 9-Apr-2022, which was expired on 1-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 5-Apr-2022, Administered between 6-Apr-2022 to 9-Apr-2022, which was expired on 1-Apr-2022) in a 78-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 5-Apr-2022, Administered between 6-Apr-2022 to 9-Apr-2022, which was expired on 1-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 5-Apr-2022, Administered between 6-Apr-2022 to 9-Apr-2022, which was expired on 1-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that the administration occurred from 6-Apr-2022 to 9-Apr-2022. The vial was initially stored in the refrigerator on 5-Apr-2022 The vial had not undergone any temperature excursions.  It was also reported that patients had not reported any adverse reactions No treatment medication information was given.   This case was linked to MOD-2022-538688, MOD-2022-538614 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Endocrine ophthalmopathy, Thyroid function test
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of ENDOCRINE OPHTHALMOPATHY (TED reactivation) in a 66-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. LITERATURE REFERENCE: Thyroid eye disease reactivation associated with COVID-19 vaccination. The patient's past medical history included Thyroid eye disease. 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 ENDOCRINE OPHTHALMOPATHY (seriousness criterion medically significant). At the time of the report, ENDOCRINE OPHTHALMOPATHY was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid function test: stable (normal) Stable. For mRNA-1273 (Spikevax) (Unknown), the reporter considered ENDOCRINE OPHTHALMOPATHY to be related. Three female patients over 18 years of age (range 4566 years) received either the Moderna or Pfizer COVID-19 vaccine presented with symptoms of thyroid eye disease within 24 h to 21 days of receiving their first or second dose. None of the patients had previous infections with severe acute respiratory syndrome coronavirus 2. All three patients presented with proptosis. In two of three patients, periorbital edema, eyelid retraction, and diplopia were present. None were current smokers. One had prior facial hyaluronic acid filler injections. Symptoms in all patients were improving at 4 to 8 months. Concomitant medication and treatment information were not reported by the reporter. Company comment: This literature non-study case concerns a 66-year-old female patient with medical history of Thyroid eye disease, who experienced the serious, due to medically significant, unexpected event of Endocrine Ophthalmopathy, which occurred 3 weeks after the 2nd dose of mRNA-1273 vaccine. No further information regarding the clinical course and treatment of the events were provided. The mentioned medical history remains as confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-538891 (Patient Link). Sender's Comments: This literature non-study case concerns a 66-year-old female patient with medical history of Thyroid eye disease, who experienced the serious, due to medically significant, unexpected event of Endocrine Ophthalmopathy, which occurred 3 weeks after the 2nd dose of mRNA-1273 vaccine. No further information regarding the clinical course and treatment of the events were provided. The mentioned medical history remains as confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm with the other couple doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm with the other couple doses) in a female patient of an unknown age 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 PAIN IN EXTREMITY (sore arm with the other couple doses). At the time of the report, PAIN IN EXTREMITY (sore arm with the other couple doses) outcome was unknown.            Concomitant medications was not provided by the reporter. Patient  had a sore arm with the other couple doses. She got the full hundred ccs dose with the booster. Treatment information was not provided.    This case was linked to MOD-2022-538679, MOD-2022-538686 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm with the other couple doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm with the other couple doses) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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 PAIN IN EXTREMITY (Sore arm with the other couple doses). At the time of the report, PAIN IN EXTREMITY (Sore arm with the other couple doses) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-538679, MOD-2022-538687, MOD-2022-538684 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (vaccine expired on 1 Apr 2022, Date the vial was initially stored in the refrigerator on 05 Apr 2022) in a 79-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (vaccine expired on 1 Apr 2022, Date the vial was initially stored in the refrigerator on 05 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (vaccine expired on 1 Apr 2022, Date the vial was initially stored in the refrigerator 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 drug information was provided. Reporter reported that the administration of vaccine occurred from 6 Apr 2022 to 9 Apr 2022. Patient had not reported any adverse reaction after the vaccination. The manufacturing date of the vial was 1 Dec 2021. Vial was initially placed in refrigerator on 5 Apr 2022. The product did not undergo any temperature excursion issue. No treatment drug information was reported. This case was linked to MOD-2022-537580, MOD-2022-538672, MOD-2022-538673, MOD-2022-538675, MOD-2022-538676, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538689, MOD-2022-538691, MOD-2022-538692, MOD-2022-538693, MOD-2022-538696, MOD-2022-538697, MOD-2022-538698, MOD-2022-538701, MOD-2022-538702, MOD-2022-538698, MOD-2022-538689 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Moderna vaccine administered to patient; Vaccine expired on 1 Apr 2022, Vial was initially stored in the refrigerator on 05 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 1 Apr 2022, Vial was initially stored in the refrigerator on 05 Apr 2022) in a 79-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 1 Apr 2022, Vial was initially stored in the refrigerator on 05 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 1 Apr 2022, Vial was initially stored in the refrigerator 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 provided.  Reporter reported that the administration of vaccine occurred from 6 Apr 2022 to 9 Apr 2022. Patient had no adverse reaction after the vaccination. The manufacturing date of the vial was 1 Dec 2021. Vial was initially placed in refrigerator on 5 Apr 2022. The product did not undergo any temperature excursion issue.  No treatment medication was reported.   This case was linked to MOD-2022-537580, MOD-2022-538614, MOD-2022-538672, MOD-2022-538673, MOD-2022-538675, MOD-2022-538676, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538688, MOD-2022-538691, MOD-2022-538692, MOD-2022-538693, MOD-2022-538696, MOD-2022-538697, MOD-2022-538698, MOD-2022-538701, MOD-2022-538702, MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538676 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired Moderna vaccine administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) in a 55-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) 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 medications were reported. Reporter reported that the administration of vaccine occurred from 06-Apr-2022 to 09-Apr-2022. Date the vial was initially stored in the refrigerator*: 05-Apr-2022 Patients have not reported any adverse reaction after the vaccination.   This case was linked to MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Moderna vaccine administered to patients; Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022) in a 56-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-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. No treatment medications were reported. Reporter reported that the administration of vaccine occurred from  6-Apr-2022 to 9-Apr-2022. Patient had not reported any adverse reaction after the vaccination. The manufacturing date of the vial was 1-Dec-2021. Vial was initially placed in refrigerator on 5-Apr-2022. The product did not undergo any temperature excursion issue. Reporter wanted to know if patient need to be re-vaccinated.   This case was linked to MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689, MOD-2022-538701, MOD-2022-538672, MOD-2022-538676, MOD-2022-538696, MOD-2022-537580, MOD-2022-538673, MOD-2022-538675, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538691, MOD-2022-538697, MOD-2022-538702 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Patient details were added. Updated reporter information. Added suspect drug dose details.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Moderna vaccine administered to patients; Vials were initially stored in the refrigerator on 05-Apr-2022 and then administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Vials were initially stored in the refrigerator on 05-Apr-2022 and then administered) in a 70-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Vials were initially stored in the refrigerator on 05-Apr-2022 and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Vials were initially stored in the refrigerator on 05-Apr-2022 and then administered) 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.  Reportedly, 20 doses were initially stored in the refrigerator on 05-Apr-2022. Manufacturing date was reported as 01-Dec-2021.  Patients had not reported any adverse reactions.  Doses were administered after 30-day Use By Date or after manufacturer date of expiry. Vaccines were administered in between 06-Apr-2022 to 09-Apr-2022.  The vials did not undergo any temperature excursions.  Treatment details were not reported by the reporter.    .   This case was linked to MOD-2022-537580, MOD-2022-538675 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired Moderna vaccine administered to patients; The vial was initially stored in the refrigerator on 5-Apr-2022, Administered between 6-Apr-2022 to 9-Apr-2022, which was expired on 1-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 5-Apr-2022, Administered between 6-Apr-2022 to 9-Apr-2022, which was expired on 1-Apr-2022) in a 64-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 5-Apr-2022, Administered between 6-Apr-2022 to 9-Apr-2022, which was expired on 1-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 5-Apr-2022, Administered between 6-Apr-2022 to 9-Apr-2022, which was expired on 1-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial was initially stored in the refrigerator on 5-Apr-2022. It was reported that the administration occurred from 6-Apr-2022 to 9-Apr-2022.  The vial had not undergone any temperature excursions. Patients had not reported any adverse reaction No treatment medication information was given.   This case was linked to MOD-2022-537580, MOD-2022-538673, MOD-2022-538675, MOD-2022-538676, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538691, MOD-2022-538692, MOD-2022-538693, MOD-2022-538697, MOD-2022-538702, MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689, MOD-2022-538701, MOD-2022-538672, MOD-2022-538676 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired dose of the Moderna COVID-19 vaccine was administered; expired vaccine was stored in refrigerator (vaccine expired on 01-Apr-2022 and stored in refrigerator on 05-Apr-2022); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose of the Moderna COVID-19 vaccine was administered) and PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator (vaccine expired on 01-Apr-2022 and stored in refrigerator on 05-Apr-2022)) in a 69-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose of the Moderna COVID-19 vaccine was administered) and PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator (vaccine expired on 01-Apr-2022 and stored in refrigerator on 05-Apr-2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose of the Moderna COVID-19 vaccine was administered) and PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator (vaccine expired on 01-Apr-2022 and stored in refrigerator on 05-Apr-2022)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that they received Moderna COVID-19 vaccine vials with a manufacturing date of 01-Dec-2021 and an expiration date of 01-Apr-2022 (Lot: 026L21B). The reporter used Moderna's online expiration tool to confirm the expiration date.  The reporter reported that unknowingly, expired doses of the Moderna COVID-19 vaccine were administered to 20 patients from lot 026L21B. The administration occurred from 06-Apr-2022 to 09-Apr-2022. The vials were initially stored in the refrigerator was on 05-Apr-2022 and the vials did not undergo any temperature excursions.  The patient did not report any adverse reactions.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-537580 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Moderna vaccine administered to patients; Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022) in a 65-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  No of dose vials used 20 doses.  Patients were received Moderna COVID-19 vaccine vials with a manufacturing date of 1Dec2021 and an expiration date of 1Apr2022 (Lot: 026L21B). Also received Moderna vaccine vials with a manufacturing date of 10Dec2021 with an expiration date of JUL2022 (Lot: 001M21A). It was reported that the administration of vaccine occurred from 6-Apr-2022 to 9-Apr-2022. Patients not had adverse reaction after the vaccination. The manufacturing date of the vial was 1-Dec-2021 Vial was initially placed in refrigerator on 5-Apr-2022. The product didn't undergo any temperature excursion issue. Reporter wants to know if the patients need to be re-vaccinated. No treatment drug information was reported.   This case was linked to MOD-2022-538688, MOD-2022-538614, MOD-2022-537580, MOD-2022-538672, MOD-2022-538673, MOD-2022-538675, MOD-2022-538675, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538688, MOD-2022-538689, MOD-2022-538691, MOD-2022-538692, MOD-2022-538693, MOD-2022-538696, MOD-2022-538697, MOD-2022-538701, MOD-2022-538702, MOD-2022-538689, MOD-2022-538672, MOD-2022-538676 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Patient Identifier added.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Moderna vaccine administered to patient; Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator on 05-APR-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator on 05-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator on 05-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator 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 drug reported.  Reporter reported that the administration of vaccine occurred from 6-Apr-2022 to 9-Apr-2022. Patients have not reported any adverse reaction after the vaccination. The manufacturing date of the vial was 1-Dec-2021. Vial was initially placed in refrigerator on 5-Apr-2022. The product didn't undergo any temperature excursion issue.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-537580, MOD-2022-538672, MOD-2022-538673, MOD-2022-538676, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538691, MOD-2022-538692, MOD-2022-538696, MOD-2022-538701, MOD-2022-538702, MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689, MOD-2022-538701, MOD-2022-538672, MOD-2022-538676.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Moderna vaccine administered to patients; Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022) in a 71-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patients) and PRODUCT STORAGE ERROR (Date the vial was expired on 01-APR-2022 and initially stored in the refrigerator: 05-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that they received the Moderna vaccine vials with a manufacturing date of 1-Dec-2021 and an expiration date of 1-Apr-2022 Lot-026L21B. They also received Moderna vaccine vials with a manufacturing date of10-Dec-2021 with an expiration date of Jul-2022 Lot-001M21A.   It was reported that expired doses of the Moderna COVID-19 vaccine was administered to 20 patients from lot-026L21B on 06-Apr-2022 to 09-Apr-2022. The reporter stated that the vial was stored in the refrigerator on 05-Apr-2022. Also, mentioned that the vial did not undergo any temperature excursion. Patient did not experienced any adverse reaction at the time of reporting.  Treatment medications were not reported.   This case was linked to MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689, MOD-2022-538701, MOD-2022-538672, MOD-2022-538676, MOD-2022-538696, MOD-2022-538692 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 client given doses from vial after temp excursion(s)) and PRODUCT TEMPERATURE EXCURSION ISSUE (1 client given doses from vial after temp excursion(s)) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 066K21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 client given doses from vial after temp excursion(s)). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (1 client given doses from vial after temp excursion(s)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 client given doses from vial after temp excursion(s)) and PRODUCT TEMPERATURE EXCURSION ISSUE (1 client given doses from vial after temp excursion(s)) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Reporter stated that vials removed from Freezer on 22-Mar-2022 at 05:00 PM and placed into refrigeration. Before use by date of vaccine was 21-Apr-2022. Reported data of out of Range and freeze/thaw was as follows: On 26-Mar-2022, minimum temp reached was 34.7 degree Fahrenheit for a total of 1 hr. and 15 minutes. On 27-Mar-2022, minimum temp reached was 34.8 degree Fahrenheit for a total of 1 hr. On 28-Mar-2022, minimum temp reached was 34.8 degree Fahrenheit for 1 hr. On 29-Mar-2022, minimum temperature reached was 34.3 degree Fahrenheit for 1 hr. and 45 minutes. No treatment medications were reported. This case was linked to MOD-2022-538685, MOD-2022-538852, MOD-2022-538849, MOD-2022-538851, MOD-2022-538848, MOD-2022-538850, MOD-2022-538850 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears after 2nd dose after moderna vaccine/Tinnitus in the ears after 2nd dose of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ears after 2nd dose after moderna vaccine/Tinnitus in the ears after 2nd dose of moderna vaccine) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     It was reported that patient did not had Covid test.  Concurrent medical conditions included Sulfonamide allergy (Sulfa).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ringing in the ears after 2nd dose after moderna vaccine/Tinnitus in the ears after 2nd dose of moderna vaccine). At the time of the report, TINNITUS (Ringing in the ears after 2nd dose after moderna vaccine/Tinnitus in the ears after 2nd dose of moderna vaccine) outcome was unknown.            No concomitant drug was reported. It was reported that patient received 1st and 2nd dose 1 month apart and stated that patient received all 3 doses in the recommended time frame. It was also reported that the patient stated that she had read a bit online regarding the side effect of ringing in the ears but never had this before but after the 2nd dose of moderna vaccine, she had rang in the ears and tinnitus in the ears. No Treatment medications were reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Endocrine ophthalmopathy, Thyroid function test
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of ENDOCRINE OPHTHALMOPATHY (TED reactivation) in a 45-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. LITERATURE REFERENCE: Concurrent medical conditions included Thyroid eye disease (Patient had stable disease for 5 years). On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced ENDOCRINE OPHTHALMOPATHY (TED reactivation) (seriousness criterion medically significant). At the time of the report, ENDOCRINE OPHTHALMOPATHY (TED reactivation) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid function test: stable Stable. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered ENDOCRINE OPHTHALMOPATHY (TED reactivation) to be related. No treatment and concomitant medication reported. Three female patients over 18 years of age (range 4566 years) received either the Moderna or Pfizer COVID-19 vaccine presented with symptoms of thyroid eye disease (TED) within 24 h to 21 days of receiving their first or second dose. None of the patients had previous infections with severe acute respiratory syndrome coronavirus 2. Patient presented with proptosis. And was not a current smoker. Symptoms in patient was improving at 4 to 8 months. Company Comment: This literature case concerns a 45-year-old female patient with Concurrent medical conditions of Thyroid eye disease (Patient had stable disease for 5 years), who experienced the unexpected serious event of Endocrine Ophthalmopathy (TED reactivation) (seriousness criterion medically significant) which occurred 3 weeks after receiving the first dose of mRNA-1273 vaccine. Patients with Concurrent medical conditions of Thyroid eye disease could be confounder for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case was linked to MOD-2022-538683 (Patient Link). Sender's Comments: This literature case concerns a 45-year-old female patient with Concurrent medical conditions of Thyroid eye disease (Patient had stable disease for 5 years), who experienced the unexpected serious event of Endocrine Ophthalmopathy (TED reactivation) (seriousness criterion medically significant) which occurred 3 weeks after receiving the first dose of mRNA-1273 vaccine. Patients with Concurrent medical conditions of Thyroid eye disease could be confounder for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: rash at the injection site.; itching at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash at the injection site.) and INJECTION SITE PRURITUS (itching at the injection site.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (rash at the injection site.) and INJECTION SITE PRURITUS (itching at the injection site.). At the time of the report, INJECTION SITE RASH (rash at the injection site.) and INJECTION SITE PRURITUS (itching at the injection site.) outcome was unknown.            It was reported that patient had 4th Moderna shot on  Apr-2022. No concomitant medication were provided. No treatment medication were provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 07-Mar-2022, expired on 06-Apr-2022 and the dose was administered on 08-Apr-2022; Patient potentially administered with expired vaccine (beyond 30 days use by date)/Expired booster vaccine dose administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient potentially administered with expired vaccine (beyond 30 days use by date)/Expired booster vaccine dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Mar-2022, expired on 06-Apr-2022 and the dose was administered on 08-Apr-2022) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient potentially administered with expired vaccine (beyond 30 days use by date)/Expired booster vaccine dose administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Mar-2022, expired on 06-Apr-2022 and the dose was administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient potentially administered with expired vaccine (beyond 30 days use by date)/Expired booster vaccine dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Mar-2022, expired on 06-Apr-2022 and the dose was administered on 08-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 by health care professional that there was an error in documentation that occurred in their facility. The 30 days use by date was written inadvertently as 16-Apr and they found out that it was supposed to be 06-Apr-2022. Some patients were potentially given these vaccines on 07-Apr-2022 to 08-Apr-2022. The vial was initially stored in the refrigerator on 07-Mar-2022. The vial had not undergone any temperature excursions. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2022: Follow up received includes significant information: suspect vaccine information was added. On 12-Apr-2022: Follow up received includes significant information: Live FU received, significant checkbox ticked because the case was valid in FU 2 version (received patient details). Added patient details and historical condition.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Patient felt dizzy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Kidney cancer. Concurrent medical conditions included Immunocompromised (Immunocompromised patient due to kidney cancer).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (Patient felt dizzy). At the time of the report, DIZZINESS (Patient felt dizzy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant product use was reported.  It was reported that the immunocompromised patient due to kidney cancer received their 1st dose of Moderna COVID-19 Vaccine and after 1st dose the patient felt dizzy.  The patient's height was unknown and any allergies to medications, food and other products was unknown. It was unknown whether any recent change occurred in status such as improvement or worsening of medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. It was also unknown if the patient was given any other vaccines within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose number.  Reportedly, it was unknown if the patient had experienced a similar event in the past.  The patient's weight was reported as 142.  No treatment information was provided.   This case was linked to MOD-2022-538919, MOD-2022-538920 (Patient Link).