chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: We are in constant pain; arm is in constant pain,our arms both hurt so bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (We are in constant pain) and PAIN IN EXTREMITY (arm is in constant pain,our arms both hurt so bad) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 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 PAIN (We are in constant pain) and PAIN IN EXTREMITY (arm is in constant pain,our arms both hurt so bad). At the time of the report, PAIN (We are in constant pain) and PAIN IN EXTREMITY (arm is in constant pain,our arms both hurt so bad) had not resolved.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna Covid-19 vaccine was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was administered) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was administered) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported.  Patient received the booster dose of Moderna vaccine (Expiry date: 17-Apr-2022). The vial was initially stored in the refrigerator on 29-Apr-2022. Vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator: 29Apr2022 and Date of expiry date 17Apr2022.; Expired Moderna Covid-19 vaccine were administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine were administered to patient) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 29Apr2022 and Date of expiry date 17Apr2022.) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine were administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 29Apr2022 and Date of expiry date 17Apr2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine were administered to patient) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 29Apr2022 and Date of expiry date 17Apr2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Date the vial was initially stored in the refrigerator was 29Apr2022 & 04May2022. The vial did not undergone any temperature excursions.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: wiped out sense of smell; wiped out sense of taste; This spontaneous case was reported by a non-health professional and describes the occurrence of ANOSMIA (wiped out sense of smell) and AGEUSIA (wiped out sense of taste) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANOSMIA (wiped out sense of smell) and AGEUSIA (wiped out sense of taste). At the time of the report, ANOSMIA (wiped out sense of smell) and AGEUSIA (wiped out sense of taste) outcome was unknown.            Concomitant medication of the patient was not reported.  The patient had the first two shots starting in January 2021 and this year the patient received two booster shots.  No treatment information was provided by the reporter.  The patient needed information on how to get the smell and taste and back.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender with no medical history reported, who experienced the unexpected non-serious ADR of Anosmia and Ageusia unspecified days after receiving the third (first booster) dose of mRNA-1273 vaccine. Its reported that patient had two shots starting in Jan2021 and this year received two booster shots, but the first shot wiped out sense of smell and taste. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no medical history reported, who experienced the unexpected non-serious ADR of Anosmia and Ageusia unspecified days after receiving the third (first booster) dose of mRNA-1273 vaccine. Its reported that patient had two shots starting in Jan2021 and this year received two booster shots, but the first shot wiped out sense of smell and taste. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 25 doses of expired Moderna COVID-19 vaccine were administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna COVID-19 vaccine were administered to patients.) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna COVID-19 vaccine were administered to patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna COVID-19 vaccine were administered to patients.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vial did not undergo any temperature excursion. The vial was stored in refrigerator on 29-Apr-2022.  No treatment medications was reported.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 25 doses of expired Moderna Covid-19 vaccine were administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient received Moderna Covid-19 vaccine as booster dose. The vial was initially stored in the refrigerator on 29 Apr 2022 and 04 May 2022. Vial did not undergo any temperature excursions.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: pain in my muscles; pain in my joints; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in my muscles) and ARTHRALGIA (pain in my joints) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-May-2022, the patient experienced MYALGIA (pain in my muscles) and ARTHRALGIA (pain in my joints). At the time of the report, MYALGIA (pain in my muscles) and ARTHRALGIA (pain in my joints) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Skin exfoliation
Clinical narrative: noticed his fingers and toes turning red; itchy; peeling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (noticed his fingers and toes turning red), PRURITUS (itchy) and SKIN EXFOLIATION (peeling) 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (noticed his fingers and toes turning red), PRURITUS (itchy) and SKIN EXFOLIATION (peeling). At the time of the report, ERYTHEMA (noticed his fingers and toes turning red), PRURITUS (itchy) and SKIN EXFOLIATION (peeling) had resolved.            No concomitant medication information provided.  It was reported after the first dose everything was fine and the adverse events resulted from the second dose got cleared up within 6 months.  No treatment information provided.   This case was linked to MOD-2022-568088 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Onychoclasis, Pruritus, Skin exfoliation
Clinical narrative: noticed his fingers and toes turning red; itchy; peeling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (noticed his fingers and toes turning red), PRURITUS (itchy) and SKIN EXFOLIATION (peeling) 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (noticed his fingers and toes turning red), PRURITUS (itchy) and SKIN EXFOLIATION (peeling). At the time of the report, ERYTHEMA (noticed his fingers and toes turning red), PRURITUS (itchy) and SKIN EXFOLIATION (peeling) had resolved.            No concomitant medication information provided.  It was reported after the first dose everything was fine and the adverse events resulted from the second dose got cleared up within 6 months.  No treatment information provided.   This case was linked to MOD-2022-568088 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Skin exfoliation
Clinical narrative: noticed his fingers and toes turning red; itchy/ nails are ready to peel off and are itchy; peeling; my nails are ready to peel off; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (noticed his fingers and toes turning red), PRURITUS (itchy/ nails are ready to peel off and are itchy), SKIN EXFOLIATION (peeling) and ONYCHOCLASIS (my nails are ready to peel off) 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-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 ERYTHEMA (noticed his fingers and toes turning red), PRURITUS (itchy/ nails are ready to peel off and are itchy), SKIN EXFOLIATION (peeling) and ONYCHOCLASIS (my nails are ready to peel off). At the time of the report, ERYTHEMA (noticed his fingers and toes turning red), PRURITUS (itchy/ nails are ready to peel off and are itchy), SKIN EXFOLIATION (peeling) and ONYCHOCLASIS (my nails are ready to peel off) had not resolved.            Concomitant product information was not provided. It was reported that after receiving 1st dose everything was fine. Treatment information was not provided.   This case was linked to MOD-2022-568005 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Onychoclasis, Pruritus, Skin exfoliation
Clinical narrative: noticed his fingers and toes turning red; itchy/ nails are ready to peel off and are itchy; peeling; my nails are ready to peel off; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (noticed his fingers and toes turning red), PRURITUS (itchy/ nails are ready to peel off and are itchy), SKIN EXFOLIATION (peeling) and ONYCHOCLASIS (my nails are ready to peel off) 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-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 ERYTHEMA (noticed his fingers and toes turning red), PRURITUS (itchy/ nails are ready to peel off and are itchy), SKIN EXFOLIATION (peeling) and ONYCHOCLASIS (my nails are ready to peel off). At the time of the report, ERYTHEMA (noticed his fingers and toes turning red), PRURITUS (itchy/ nails are ready to peel off and are itchy), SKIN EXFOLIATION (peeling) and ONYCHOCLASIS (my nails are ready to peel off) had not resolved.            Concomitant product information was not provided. It was reported that after receiving 1st dose everything was fine. Treatment information was not provided.   This case was linked to MOD-2022-568005 (Patient Link).
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 25 doses of expired Moderna Covid-19 vaccine were administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient received Moderna Covid-19 vaccine as booster dose The vial was initially stored in the refrigerator on 29-Apr-2022 and 04-May-2022. Treatment information was not provided.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022 was administered on 29-Apr-2022) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination. No Medical History information was reported. On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022 was administered on 29-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022 was administered on 29-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 patient received booster dose. Date the vial was initially stored in the refrigerator on 29-Apr-2022. The vial did not undergo any temperature excursion. No treatment medications were provided.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 25 doses of expired Moderna Covid-19 vaccine were administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were 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 provided. No treatment medications were provided. It was reported that vial was initially stored in the refrigerator on 29 Apr 2022, 04 May 2022 and did not undergo temperature excursions.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 25 doses of expired Moderna Covid-19 vaccine were administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patient) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medication were provided.  The vial was initially stored in the refrigerator on 29 Apr 2022 and 04 May 2022. The vial  does not undergo any temperature excursions.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 17-Apr-2022 but was initially stored in the refrigerator on 29-Apr-2022; Patient received the vaccine on 29-Apr-2022, which had expired on 17-Apr-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 29-Apr-2022, which had expired on 17-Apr-2022.) and PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 but was initially stored in the refrigerator on 29-Apr-2022) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 29-Apr-2022, which had expired on 17-Apr-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 but was initially stored in the refrigerator on 29-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 29-Apr-2022, which had expired on 17-Apr-2022.) and PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 but was initially stored in the refrigerator on 29-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine expired on 17-Apr-2022 but was initially stored in the refrigerator on 29-Apr-2022.  Concomitant drugs were not reported.  Treatment details were not given.  The vial did not undergo any temperature excursions
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator 29Apr2022 & 04May2022; 25 doses of expired Moderna Covid-19 vaccine were administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 29Apr2022 & 04May2022) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 29Apr2022 & 04May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 29Apr2022 & 04May2022) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drug was reported. The vial was initially stored in the refrigerator on 29-Apr-2022. The vial did not undergo any temperature excursions. The patient received third full dose. No treatment drug was reported.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine expired on 17-Apr-2022, was administered on 04-May-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022, was administered on 04-May-2022.) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022, was administered on 04-May-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022, was administered on 04-May-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.  The patient received booster dose. The vial did not undergo any temperature excursion. The vial was stored in refrigerator on 04-May-2022.   No treatment medications was reported.
Age: 85.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial expired on 17-Apr-2022, initially stored in the refrigerator on 04-May-2022 and administered on the same day; 25 doses of expired Moderna Covid-19 vaccine were administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients) and PRODUCT STORAGE ERROR (the vial expired on 17-Apr-2022, initially stored in the refrigerator on 04-May-2022 and administered on the same day) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial expired on 17-Apr-2022, initially stored in the refrigerator on 04-May-2022 and administered on the same day). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients) and PRODUCT STORAGE ERROR (the vial expired on 17-Apr-2022, initially stored in the refrigerator on 04-May-2022 and administered on the same day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not reported.  The vial did not undergo any temperature excursions.  On 04-May-2022, the patient received full dose of Moderna COVID-19 vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received greater than 36 days from 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received greater than 36 days from 1st dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 028L20A) for COVID-19 vaccination.     The patient did not have any allergy. The patient had not tested positive covid test or diagnosis. .    On 28-Aug-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received greater than 36 days from 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received greater than 36 days from 1st dose) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2022-568025 (Patient Link).
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine expired on 17-Apr-2022 was administered on 04-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022 was administered on 04-May-2022) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022 was administered on 04-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022 was administered on 04-May-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 patient received booster dose. Date the vial was initially stored in the refrigerator was on 04-May-2022. The vial did not undergo any temperature excursion.  No treatment medications were provided.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine expired on 17-Apr-2022 was administered on 04-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022 was administered on 04-May-2022) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported. On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022 was administered on 04-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022 was administered on 04-May-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.  The patient received booster dose. The vial did not undergo any temperature excursion. The vial was stored in refrigerator on 04-May-2022.   Treatment details was not reported by the reporter.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Gastric infection, Injection site bruising
Clinical narrative: Anxiety; Gastric infection / Stomach bug; Injection site bruising; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), GASTRIC INFECTION (Gastric infection / Stomach bug) and INJECTION SITE BRUISING (Injection site bruising) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ANXIETY (Anxiety), GASTRIC INFECTION (Gastric infection / Stomach bug) and INJECTION SITE BRUISING (Injection site bruising). At the time of the report, ANXIETY (Anxiety) outcome was unknown, GASTRIC INFECTION (Gastric infection / Stomach bug) was resolving and INJECTION SITE BRUISING (Injection site bruising) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no reported medical history.  On an unknown date, the patient had event of anxiety about upcoming colonoscopy and small bruise at injection site.  On an unknown date in 2022, the patient had stomach bug.  The causality for the events of anxiety, gastric infection / stomach bug and Injection site bruising was reasonable possibility with humira.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator 29Apr2022 & 04May2022; 25 doses of expired Moderna Covid-19 vaccine were administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 29Apr2022 & 04May2022) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 29Apr2022 & 04May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 29Apr2022 & 04May2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided by the reporter. The vial was initially stored in refrigerator on 4may2022. The patient received third full dose. The vial did not undergo any temperature  excursion .
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination. No Medical History information was reported. On 04-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. The vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 04-May-2022. No treatment information was provided by the reporter.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 17-Apr-2022 and date moved to refrigeration on 29-Apr-2022 and 04-may2022 vaccine was administered; Expired Moderna Covid-19 vaccine was administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 and date moved to refrigeration on 29-Apr-2022 and 04-may2022 vaccine was administered) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 and date moved to refrigeration on 29-Apr-2022 and 04-may2022 vaccine was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 and date moved to refrigeration on 29-Apr-2022 and 04-may2022 vaccine was administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. The vial was initially stored in the refrigerator on 29-Apr-2022 and 04-May-2022. The vial did not undergo any temperature excursions. No treatment medications was reported.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 25 doses of expired Moderna Covid-19 vaccine were administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient received Moderna Covid-19 vaccine as booster dose The vaccine was expired on 17-Apr-2022 .The vial was initially stored in the refrigerator on 29-Apr-2022 and 04-May-2022.  Treatment information was not provided.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 17-Apr-2022 and on 04-May-2022 moved to refrigeration and was administered on same day; 25 doses of expired Moderna Covid-19 vaccine were administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) and PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 and on 04-May-2022 moved to refrigeration and was administered on same day) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 and on 04-May-2022 moved to refrigeration and was administered on same day). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) and PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 and on 04-May-2022 moved to refrigeration and was administered on same day) 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 vial was initially stored in refrigerator on 04-May-2022. The vial didn't undergone any temperature excursion. No treatment medications were reported.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine was stored in the refrigerator; Expired Moderna COVID-19 vaccine was administered to the patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID-19 vaccine was administered to the patient) and PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID-19 vaccine was administered to the patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID-19 vaccine was administered to the patient) and PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator) 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 patient received the booster dose. It was reported that the vials were initially stored in the refrigerator was on 29-Apr-2022 and on 04-May-2022. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 25 doses of expired Moderna COVID-19 vaccine were administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna COVID-19 vaccine were administered to patients.) in an 86-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna COVID-19 vaccine were administered to patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna COVID-19 vaccine were administered to patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vial was initially stored in refrigerator on 04-May-2022. The vial didn't undergone any temperature excursion.  No treatment medications was reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: soreness in his right arm injection site; tired/may have felt tired because he was very busy at the time.; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (soreness in his right arm injection site) and FATIGUE (tired/may have felt tired because he was very busy at the time.) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in his right arm injection site) and FATIGUE (tired/may have felt tired because he was very busy at the time.). At the time of the report, VACCINATION SITE PAIN (soreness in his right arm injection site) and FATIGUE (tired/may have felt tired because he was very busy at the time.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medication were provided.   This case was linked to MOD-2022-568134 (Patient Link).