chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 14-Apr-2023; No adverse event; Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD), PRODUCT STORAGE ERROR (The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 14-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 14-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 14-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD), PRODUCT STORAGE ERROR (The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 14-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 9 doses of the bivalent vaccines to patients from 5 vials which were beyond the BUD) and PRODUCT STORAGE ERROR (The date when the vial was stored in the fridge was 14-Mar-2023 and the date of administration was 14-Apr-2023).    Concomitant medication information was not provided.  No adverse event had been reported and a dose of the Moderna bivalent vaccine was administered beyond the use by date of 13-Apr-2023.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-721275 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721275:Master case
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Expired product administered, Interchange of vaccine products, No adverse event
Clinical narrative: No adverse event; 1 patient recieved the Monovalent Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient recieved the Monovalent Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 01-Feb-2023, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 27-Mar-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient recieved the Monovalent Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient recieved the Monovalent Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (1 patient recieved the Monovalent Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine).    No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 07-FEB-2023. The vial did not undergo any temperature excursions. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-722188 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722188:
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The BUD was 13-APR-2023 and the vaccine was given on 14-APR-2023; No adverse event; Dose of moderna vaccine given beyond use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose of moderna vaccine given beyond use by date), PRODUCT STORAGE ERROR (The BUD was 13-APR-2023 and the vaccine was given on 14-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 14-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose of moderna vaccine given beyond use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The BUD was 13-APR-2023 and the vaccine was given on 14-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose of moderna vaccine given beyond use by date), PRODUCT STORAGE ERROR (The BUD was 13-APR-2023 and the vaccine was given on 14-APR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose of moderna vaccine given beyond use by date) and PRODUCT STORAGE ERROR (The BUD was 13-APR-2023 and the vaccine was given on 14-APR-2023).    Concomitant medications were not reported. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-721275 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721275:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient received Moderna COVID-19 Vaccine, Monovalent, lot number 015B22A, as a booster dose on 27Jan2023 instead of Moderna COVID Vaccine, Bivalent; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received Moderna COVID-19 Vaccine, Monovalent, lot number 015B22A, as a booster dose on 27Jan2023 instead of Moderna COVID Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (patient received Moderna COVID-19 Vaccine, Monovalent, lot number 015B22A, as a booster dose on 27Jan2023 instead of Moderna COVID Vaccine, Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received Moderna COVID-19 Vaccine, Monovalent, lot number 015B22A, as a booster dose on 27Jan2023 instead of Moderna COVID Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder developmental
Clinical narrative: Born during Covid have not spoken a word at this time/ the only word they say is "da-da"; This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER DEVELOPMENTAL (Born during Covid have not spoken a word at this time/ the only word they say is "da-da") in an infant male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Ear infection (ear infection twice already but still not labelled as chronic), Maternal exposure during pregnancy and Exposure via semen.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. On an unknown date, 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 SPEECH DISORDER DEVELOPMENTAL (Born during Covid have not spoken a word at this time/ the only word they say is "da-da"). At the time of the report, SPEECH DISORDER DEVELOPMENTAL (Born during Covid have not spoken a word at this time/ the only word they say is "da-da") outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental), the reporter did not provide any causality assessments.   This case was considered for the first grandson.  No concomitant and treatment medications were reported.  Caller finds it odd that both of the grandsons who were born during Covid have not spoken a word at this time, the only word they hear is "da-da".  Caller stated that they were unsure if the grandsons were given Moderna Covid-19 vaccines already. Caller stated that this could also be natural but they wanted to know if there's been research regarding the possibility of this condition being caused by the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-722092 (E2B Linked Report). This case was linked to MOD-2023-722090 (Parent-Child Link).   See case MOD-2023-722090 for details regarding the child case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722092:Case for Mother of 1st grandson
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Speech disorder developmental
Clinical narrative: Born during Covid have not spoken a word at this time/ the only word they say is "da-da"; This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER DEVELOPMENTAL (Born during Covid have not spoken a word at this time/ the only word they say is "da-da") in an infant male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    The patient's past medical history included Exposure via semen and Maternal exposure during pregnancy.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Transplacental) 1 dosage form. On an unknown date, the patient experienced SPEECH DISORDER DEVELOPMENTAL (Born during Covid have not spoken a word at this time/ the only word they say is "da-da"). At the time of the report, SPEECH DISORDER DEVELOPMENTAL (Born during Covid have not spoken a word at this time/ the only word they say is "da-da") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental), the reporter did not provide any causality assessments.   This case was considered for the second grandson.  No concomitant and treatment medications were reported.  Caller finds it odd that both of the grandsons who were born during Covid have not spoken a word at this time, the only word they hear is "da-da".  Caller stated that they were unsure if the grandsons were given Moderna Covid-19 vaccines already. Caller stated that this could also be natural but they wanted to know if there's been research regarding the possibility of this condition being caused by the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-722093 (E2B Linked Report). This case was linked to MOD-2023-722091, MOD-2023-722091 (Parent-Child Link).   See case MOD-2023-722091,MOD-2023-722091 for details regarding the child case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722093:Case for Mother of 2nd grandson
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired 11 days before patient got the vaccine shot; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired 11 days before patient got the vaccine shot) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired 11 days before patient got the vaccine shot) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired 11 days before patient got the vaccine shot) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine expired 11 days before patient got the vaccine shot).    No concomitant medication was reported.  Caller stated that his wife took the vaccine and he checked the LOT number online and it expired 11 days before his wife got the vaccine shot.  No treatment information was reported.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling
Clinical narrative: Patient had some swelling of her arm; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Patient had some swelling of her arm) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Kidney disorder (Patient had for 17 plus years but under control).    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Patient had some swelling of her arm). At the time of the report, PERIPHERAL SWELLING (Patient had some swelling of her arm) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Age: 2.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; More than 35 days in between the first two doses of the Moderna Covid-19 primary series vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between the first two doses of the Moderna Covid-19 primary series vaccine.) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1416B and AR9236B) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 21-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between the first two doses of the Moderna Covid-19 primary series vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between the first two doses of the Moderna Covid-19 primary series vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between the first two doses of the Moderna Covid-19 primary series vaccine.).    Concomitant drugs were not reported. It was reported that it was not known if patient had any adverse reactions after dose 1 and dose 2. Treatment medications were not provided.   This case was linked to MOD-2023-722155 (Patient Link).
Age: 2.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: No adverse event; More than 35 days in between the first two doses of the Moderna Covid-19 primary series vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between the first two doses of the Moderna Covid-19 primary series vaccine.) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1416B and AR9236B) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 21-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between the first two doses of the Moderna Covid-19 primary series vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between the first two doses of the Moderna Covid-19 primary series vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between the first two doses of the Moderna Covid-19 primary series vaccine.).    Concomitant drugs were not reported. It was reported that it was not known if patient had any adverse reactions after dose 1 and dose 2. Treatment medications were not provided.   This case was linked to MOD-2023-722155 (Patient Link).
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: It is not believed that the freezer had not gone out of range during this time however it was also not known if the if the freezer went out of range during this time.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (It is not believed that the freezer had not gone out of range during this time however it was also not known if the if the freezer went out of range during this time.) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (lot number AS1416B, received in left thigh) on 21-Jul-2022, Moderna COVID-19 Vaccine (lot number AR9236B and received in right thigh) on 27-Oct-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and Moderna COVID-19 Vaccine.    On 28-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (It is not believed that the freezer had not gone out of range during this time however it was also not known if the if the freezer went out of range during this time.) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (It is not believed that the freezer had not gone out of range during this time however it was also not known if the if the freezer went out of range during this time.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (It is not believed that the freezer had not gone out of range during this time however it was also not known if the if the freezer went out of range during this time.).    No concomitant information was reported. Suspect product dosage text was reported as initial booster. It was reported that patient received Moderna Covid-19 vaccine from a freezer where the temperature had not been checked each day since 13-Apr-2023. The freezer does have an alarm on it that had not gone off since 13-Apr-2023. No other adverse reactions reported. No treatment information was provided.   This case was linked to MOD-2023-722152 (Patient Link).
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: It is not believed that the freezer had not gone out of range during this time however it was also not known if the if the freezer went out of range during this time.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (It is not believed that the freezer had not gone out of range during this time however it was also not known if the if the freezer went out of range during this time.) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (lot number AS1416B, received in left thigh) on 21-Jul-2022, Moderna COVID-19 Vaccine (lot number AR9236B and received in right thigh) on 27-Oct-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and Moderna COVID-19 Vaccine.    On 28-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (It is not believed that the freezer had not gone out of range during this time however it was also not known if the if the freezer went out of range during this time.) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (It is not believed that the freezer had not gone out of range during this time however it was also not known if the if the freezer went out of range during this time.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (It is not believed that the freezer had not gone out of range during this time however it was also not known if the if the freezer went out of range during this time.).    No concomitant information was reported. Suspect product dosage text was reported as initial booster. It was reported that patient received Moderna Covid-19 vaccine from a freezer where the temperature had not been checked each day since 13-Apr-2023. The freezer does have an alarm on it that had not gone off since 13-Apr-2023. No other adverse reactions reported. No treatment information was provided.   This case was linked to MOD-2023-722152 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 07-Feb-2023; No adverse event; she has few Moderna vaccines administered after the 30-day beyond use date. This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (she has few Moderna vaccines administered after the 30-day beyond use date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (she has few Moderna vaccines administered after the 30-day beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (she has few Moderna vaccines administered after the 30-day beyond use date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (she has few Moderna vaccines administered after the 30-day beyond use date.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Feb-2023).    Concomitant medication was not provided.  It was reported that the vial was individual vial and size was 2.5 ml. The vial did not undergo any temperature excursion. Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2023-722319 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722319:
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; I've only taken one type of covid shot, Moderna vaccines. She has taken 2 doses on 17SEP2021 and 8DEC2022. This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I've only taken one type of covid shot, Moderna vaccines. She has taken 2 doses on 17SEP2021 and 8DEC2022.) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Dec-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I've only taken one type of covid shot, Moderna vaccines. She has taken 2 doses on 17SEP2021 and 8DEC2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I've only taken one type of covid shot, Moderna vaccines. She has taken 2 doses on 17SEP2021 and 8DEC2022.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I've only taken one type of covid shot, Moderna vaccines. She has taken 2 doses on 17SEP2021 and 8DEC2022.).    No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Androgen deficiency, Arthralgia, Blood testosterone, Carpal tunnel syndrome, Peripheral swelling
Clinical narrative: testosterone plummeted; They said his testosterone plummeted and had no B12; right hand is swollen severely and could barely make a fist.; suspected carpa tunnel.; he has been very sick with his joints, severely hurting, not able to get out of bed; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANDROGEN DEFICIENCY (testosterone plummeted), VITAMIN B12 DEFICIENCY (They said his testosterone plummeted and had no B12), PERIPHERAL SWELLING (right hand is swollen severely and could barely make a fist.), CARPAL TUNNEL SYNDROME (suspected carpa tunnel.) and ARTHRALGIA (he has been very sick with his joints, severely hurting, not able to get out of bed) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57145B) for COVID-19 prophylaxis.     The patient had no known allergies and no covid diagnose.  Concurrent medical conditions included Blood pressure high (since teenager).    On 13-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In February 2023, the patient experienced ANDROGEN DEFICIENCY (testosterone plummeted), VITAMIN B12 DEFICIENCY (They said his testosterone plummeted and had no B12), PERIPHERAL SWELLING (right hand is swollen severely and could barely make a fist.), CARPAL TUNNEL SYNDROME (suspected carpa tunnel.) and ARTHRALGIA (he has been very sick with his joints, severely hurting, not able to get out of bed). At the time of the report, ANDROGEN DEFICIENCY (testosterone plummeted), VITAMIN B12 DEFICIENCY (They said his testosterone plummeted and had no B12) and ARTHRALGIA (he has been very sick with his joints, severely hurting, not able to get out of bed) had not resolved and PERIPHERAL SWELLING (right hand is swollen severely and could barely make a fist.) and CARPAL TUNNEL SYNDROME (suspected carpa tunnel.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2023, Blood testosterone: plummeted. In February 2023, Vitamin B12: no B12 in blood.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The last dose was given at store to the patient.  No concomitant medications were reported.  The patient received two times booster vaccine.  The doctor started him on testosterone and B12 injections. They were 12 weeks in. Caller reports her husband's right hand is swollen severely and could barely make a fist. They went to an orthopedic doctor and suspected carpatunnel. Now his joints were extremely painful and they did not know if it was an autoimmune disorder. Today the patient was suppose to get his fourth testosterone injection. Doctor told him not to get anymore covid vaccines.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vitamin B12, Vitamin B12 deficiency
Clinical narrative: testosterone plummeted; They said his testosterone plummeted and had no B12; right hand is swollen severely and could barely make a fist.; suspected carpa tunnel.; he has been very sick with his joints, severely hurting, not able to get out of bed; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANDROGEN DEFICIENCY (testosterone plummeted), VITAMIN B12 DEFICIENCY (They said his testosterone plummeted and had no B12), PERIPHERAL SWELLING (right hand is swollen severely and could barely make a fist.), CARPAL TUNNEL SYNDROME (suspected carpa tunnel.) and ARTHRALGIA (he has been very sick with his joints, severely hurting, not able to get out of bed) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57145B) for COVID-19 prophylaxis.     The patient had no known allergies and no covid diagnose.  Concurrent medical conditions included Blood pressure high (since teenager).    On 13-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In February 2023, the patient experienced ANDROGEN DEFICIENCY (testosterone plummeted), VITAMIN B12 DEFICIENCY (They said his testosterone plummeted and had no B12), PERIPHERAL SWELLING (right hand is swollen severely and could barely make a fist.), CARPAL TUNNEL SYNDROME (suspected carpa tunnel.) and ARTHRALGIA (he has been very sick with his joints, severely hurting, not able to get out of bed). At the time of the report, ANDROGEN DEFICIENCY (testosterone plummeted), VITAMIN B12 DEFICIENCY (They said his testosterone plummeted and had no B12) and ARTHRALGIA (he has been very sick with his joints, severely hurting, not able to get out of bed) had not resolved and PERIPHERAL SWELLING (right hand is swollen severely and could barely make a fist.) and CARPAL TUNNEL SYNDROME (suspected carpa tunnel.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2023, Blood testosterone: plummeted. In February 2023, Vitamin B12: no B12 in blood.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The last dose was given at store to the patient.  No concomitant medications were reported.  The patient received two times booster vaccine.  The doctor started him on testosterone and B12 injections. They were 12 weeks in. Caller reports her husband's right hand is swollen severely and could barely make a fist. They went to an orthopedic doctor and suspected carpatunnel. Now his joints were extremely painful and they did not know if it was an autoimmune disorder. Today the patient was suppose to get his fourth testosterone injection. Doctor told him not to get anymore covid vaccines.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 18Oct2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Chronic fatigue syndrome following EBV" (unspecified if ongoing); "Chronic fatigue syndrome following EBV" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Never stopped testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had received Paxlovid from 22Apr2023 to 26Apr2023 as COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175986 same reporter/patient, different drug/event;
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single, in left arm and on 07Apr2021 as dose 2, single at the age of 44 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Statin. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid for treatment of COVID-19 from 17Apr2023 to 22Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175926 same patient, different event/ drug;
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Mar2023 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Apr2023, outcome "recovered with sequelae" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2023) Tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175732 same reporter/patient, different drug/event;
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 25Nov2022 at 18:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 17Apr2023 to 21Apr2023. The patient has no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175738 same reporter/patient, different drug/event;
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 69 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN5318), in right arm, on 23Feb2021 as dose 2, single (Lot number: EN6200), in right arm, on 05Oct2021 as dose 3 (booster), single (Lot number: FD8448), in right arm and on 20May2022 as dose 4 (booster), single (Lot number: FM7553), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arterial sclerosis" (unspecified if ongoing); "Have two arterial stents" (not ongoing); "Hydrocodone allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering"; COVID-19 (medically significant), outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Test was very faint, barely visible; Positive, notes: Test was boldly positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: On day 10 after initial onset of Covid, patinet had essentially no symptoms, but still tested positive. However, the positive (home antigen) test was very faint, barely visible. Then after symptoms resumed (day 13), the test was boldly positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175662 Same patient/reporter, different drug/AE (Paxlovid);
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 17:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Axial spondyloarthritis" (unspecified if ongoing); "ulcerative proctitis" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE, start date: 06Jun2020, stop date: 08Apr2023; ORAL CONTRACEPTIVE NOS, start date: 01Sep2020, stop date: 08Apr2023; LEUCOVORIN [CALCIUM FOLINATE], start date: 06Sep2020, stop date: 09Apr2023; HUMIRA, start date: 26Jan2021, stop date: 29Mar2023. Past drug history included: Topical salicylic acid, reaction(s): "DRUG ALLERGY"; Cyclobenzaprine, reaction(s): "drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events,Linked Report(s) : US-PFIZER INC-202300175644 same  patient/reporter, different drug/AE;