chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 / Excursion took place 15Dec2022 through 27Dec2022/Maximum temperature reached: 46.5F; Excursion took place 15Dec2022 through 27Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022), POOR QUALITY PRODUCT ADMINISTERED (HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 / Excursion took place 15Dec2022 through 27Dec2022/Maximum temperature reached: 46.5F) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-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. On 15-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022). On 19-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 / Excursion took place 15Dec2022 through 27Dec2022/Maximum temperature reached: 46.5F). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022), POOR QUALITY PRODUCT ADMINISTERED (HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 / Excursion took place 15Dec2022 through 27Dec2022/Maximum temperature reached: 46.5F) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022) and POOR QUALITY PRODUCT ADMINISTERED (HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 / Excursion took place 15Dec2022 through 27Dec2022/Maximum temperature reached: 46.5F).    No concomitant medication was reported.    It was reported that first time excursion started on 15-Dec-2022. It was unknown that patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine and also no reports of side effects had been reported to them. All patients received vaccines at pharmacy. No treatment information was reported.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; HCP reported that patient received the vaccines on 17-Dec-2022 and then following that the vaccines were marked not to use.; Excursion cumulative duration19.3 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion cumulative duration19.3 hours), POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccines on 17-Dec-2022 and then following that the vaccines were marked not to use.) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Dec-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. On 15-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion cumulative duration19.3 hours). On 17-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccines on 17-Dec-2022 and then following that the vaccines were marked not to use.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion cumulative duration19.3 hours), POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccines on 17-Dec-2022 and then following that the vaccines were marked not to use.) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion cumulative duration19.3 hours) and POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccines on 17-Dec-2022 and then following that the vaccines were marked not to use.).    No concomitant information was reported. It was reported that first time excursion started on 15-Dec-2022. It was unknown that patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine and also no reports of side effects had been reported to them. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: First time excursion started on 15Dec2022; 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (First time excursion started on 15Dec2022), POOR QUALITY PRODUCT ADMINISTERED (16 doses of the vaccines between the 15Dec2022 and the 21Dec2022) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Dec-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. On 17-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (First time excursion started on 15Dec2022), POOR QUALITY PRODUCT ADMINISTERED (16 doses of the vaccines between the 15Dec2022 and the 21Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (First time excursion started on 15Dec2022), POOR QUALITY PRODUCT ADMINISTERED (16 doses of the vaccines between the 15Dec2022 and the 21Dec2022) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (First time excursion started on 15Dec2022) and POOR QUALITY PRODUCT ADMINISTERED (16 doses of the vaccines between the 15Dec2022 and the 21Dec2022).    No concomitant medication details was reported. Date and Time of Last Administration was reported as 17-Dec-2022 for Moderna COVID-19 vaccine bivalent. It was unknown that patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine and also no reports of side effects had been reported to them. No treatment medication details was reported.  It was reported that Excursion took place 15Dec2022 through 27Dec2022. Maximum temperature reached was 46.5F. Excursion cumulative duration was 19.3 hours. First time excursion started on 15Dec2022.
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a  patient of an unknown age and gender 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 IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.            No concomitant products reported.  Patient wanted to know if the event was life threatening.  No treatment products reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date vial was initially stored in the refrigerator: 13Jan2023 and administered on 16Feb2023; No adverse event; a bivalent dose was administered which was beyond the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a bivalent dose was administered which was beyond the 30 day BUD), PRODUCT STORAGE ERROR (Date vial was initially stored in the refrigerator: 13Jan2023 and administered on 16Feb2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender 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 16-Feb-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 16-Feb-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 (a bivalent dose was administered which was beyond the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vial was initially stored in the refrigerator: 13Jan2023 and administered on 16Feb2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a bivalent dose was administered which was beyond the 30 day BUD), PRODUCT STORAGE ERROR (Date vial was initially stored in the refrigerator: 13Jan2023 and administered on 16Feb2023) 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 (a bivalent dose was administered which was beyond the 30 day BUD) and PRODUCT STORAGE ERROR (Date vial was initially stored in the refrigerator: 13Jan2023 and administered on 16Feb2023).    No concomitant medications were reported. Date vial was initially stored in the refrigerator: 13-Jan-2023 No treatment medications were reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Allergy to vaccine, Chillblains, Lichenoid keratosis
Clinical narrative: Lichenoid dermatitis; Allergic to the mRNA (Moderna); This spontaneous case was reported by a consumer and describes the occurrence of CHILLBLAINS (Chilblains), LICHENOID KERATOSIS (Lichenoid dermatitis) and ALLERGY TO VACCINE (Allergic to the mRNA (Moderna)) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunisation.     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 CHILLBLAINS (Chilblains), LICHENOID KERATOSIS (Lichenoid dermatitis) and ALLERGY TO VACCINE (Allergic to the mRNA (Moderna)). At the time of the report, CHILLBLAINS (Chilblains), LICHENOID KERATOSIS (Lichenoid dermatitis) and ALLERGY TO VACCINE (Allergic to the mRNA (Moderna)) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant medication not reported.   The patient was allergic to the mRNA vaccines (got COVID fingers: biopsy, x-rays, derm consults X 2, rheumatology consult, heme-onc consults related with dxs lichenoid dermatitis, chilblains, etc and a second opinion from a dermatologist said that patient was probably allergic to the mRNA (Moderna) COVID vaccines.  Treatment medication not reported.  Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the non-serious unexpected which occurred unknown days after administration of a dose of mRNA-1273.222 bivalent vaccine. It was reported that the patient was probably allergic to the mRNA (Moderna) COVID vaccines. Treatment details are not reported. Event outcome was unknown. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   Reporter did not allow further contact
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired covid vaccine that was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired covid vaccine that was administered) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015B22A) for COVID-19 prophylaxis.     Patient had no allergies nor notable health conditions.     On 17-Feb-2023 at 8:30 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Feb-2023 at 8:30 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired covid vaccine that was administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired covid vaccine that was administered) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired covid vaccine that was administered).    No concomitant medications was reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that patient does not had any adverse events. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Therapeutic response unexpected
Clinical narrative: Patient had genital herpes and after 1 year of the vaccine had not any more breakout; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Patient had genital herpes and after 1 year of the vaccine had not any more breakout) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Herpes genital.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Patient had genital herpes and after 1 year of the vaccine had not any more breakout) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Patient had genital herpes and after 1 year of the vaccine had not any more breakout) 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 THERAPEUTIC RESPONSE UNEXPECTED (Patient had genital herpes and after 1 year of the vaccine had not any more breakout).    No concomitant information was reported. It was reported that information can be useful for the people experiencing the same illness as patient. No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine thawed on 13-Nov-2022 and administered on 7-Feb-2023 past 30 day BUD; No adverse event; Thaw date on 13-Nov-2022 and administered thru 7-Feb-2023 providing information on product stability for products in the fridge past the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Thaw date on 13-Nov-2022 and administered thru 7-Feb-2023 providing information on product stability for products in the fridge past the 30 day BUD), PRODUCT STORAGE ERROR (The vaccine thawed on 13-Nov-2022 and administered on 7-Feb-2023 past 30 day BUD) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-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 07-Feb-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 (Thaw date on 13-Nov-2022 and administered thru 7-Feb-2023 providing information on product stability for products in the fridge past the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine thawed on 13-Nov-2022 and administered on 7-Feb-2023 past 30 day BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Thaw date on 13-Nov-2022 and administered thru 7-Feb-2023 providing information on product stability for products in the fridge past the 30 day BUD), PRODUCT STORAGE ERROR (The vaccine thawed on 13-Nov-2022 and administered on 7-Feb-2023 past 30 day BUD) 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 (Thaw date on 13-Nov-2022 and administered thru 7-Feb-2023 providing information on product stability for products in the fridge past the 30 day BUD) and PRODUCT STORAGE ERROR (The vaccine thawed on 13-Nov-2022 and administered on 7-Feb-2023 past 30 day BUD).    No concomitant medications were provided. No treatment medication was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19, Cerebrovascular accident, Myocardial infarction, Neoplasm, Neoplasm malignant
Clinical narrative: heart attacks; strokes; cancers; COVID-19; nerve damage; Tumour; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attacks), CEREBROVASCULAR ACCIDENT (strokes) and NEOPLASM MALIGNANT (cancers) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 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 MYOCARDIAL INFARCTION (heart attacks) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (strokes) (seriousness criterion medically significant), NEOPLASM MALIGNANT (cancers) (seriousness criterion medically significant), COVID-19 (COVID-19), NERVE INJURY (nerve damage) and NEOPLASM (Tumour). At the time of the report, MYOCARDIAL INFARCTION (heart attacks), CEREBROVASCULAR ACCIDENT (strokes), NEOPLASM MALIGNANT (cancers), COVID-19 (COVID-19), NERVE INJURY (nerve damage) and NEOPLASM (Tumour) outcome was unknown.        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 medication information provided. No treatment information provided.  Company comment: This is a spontaneous concerning a unspecified age and gender of the patient, with no medical history, who experienced the unexpected serious (medically significant) AESI events of myocardial infraction, cerebrovascular accident and unexpected serious (medically significant)  event of neoplasm malignant, which occurred unspecified days after a dose of (dose number not specified) mRNA-1273 bivalent BA.4/ BA.5 vaccine. At the time of reporting outcome of the event is unknown. No further information for medical review. The benefit-risk relationship of mRNA-1273 bivalent BA.4/ BA.5 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2023: Follow up contains non significant information.
Sex: U
Vaccine: COVID19-2
Symptoms: Nerve injury
Clinical narrative: heart attacks; strokes; cancers; COVID-19; nerve damage; Tumour; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attacks), CEREBROVASCULAR ACCIDENT (strokes) and NEOPLASM MALIGNANT (cancers) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 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 MYOCARDIAL INFARCTION (heart attacks) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (strokes) (seriousness criterion medically significant), NEOPLASM MALIGNANT (cancers) (seriousness criterion medically significant), COVID-19 (COVID-19), NERVE INJURY (nerve damage) and NEOPLASM (Tumour). At the time of the report, MYOCARDIAL INFARCTION (heart attacks), CEREBROVASCULAR ACCIDENT (strokes), NEOPLASM MALIGNANT (cancers), COVID-19 (COVID-19), NERVE INJURY (nerve damage) and NEOPLASM (Tumour) outcome was unknown.        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 medication information provided. No treatment information provided.  Company comment: This is a spontaneous concerning a unspecified age and gender of the patient, with no medical history, who experienced the unexpected serious (medically significant) AESI events of myocardial infraction, cerebrovascular accident and unexpected serious (medically significant)  event of neoplasm malignant, which occurred unspecified days after a dose of (dose number not specified) mRNA-1273 bivalent BA.4/ BA.5 vaccine. At the time of reporting outcome of the event is unknown. No further information for medical review. The benefit-risk relationship of mRNA-1273 bivalent BA.4/ BA.5 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2023: Follow up contains non significant information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Expired product administered, Extra dose administered, No adverse event
Clinical narrative: He had to re-do his primary series,had two of the three shots; The Moderna Monovalent expires a couple of days before his third shot; Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (He had to re-do his primary series,had two of the three shots), EXPIRED PRODUCT ADMINISTERED (The Moderna Monovalent expires a couple of days before his third shot), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if the patient had relevant medical history/conditions, allergy, concomitant diseases and risk factor. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Stem cell transplant.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (He had to re-do his primary series,had two of the three shots), EXPIRED PRODUCT ADMINISTERED (The Moderna Monovalent expires a couple of days before his third shot), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (He had to re-do his primary series, had two of the three shots), EXPIRED PRODUCT ADMINISTERED (The Moderna Monovalent expires a couple of days before his third shot), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) 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 assessments were provided for EXTRA DOSE ADMINISTERED (He had to re-do his primary series, had two of the three shots), EXPIRED PRODUCT ADMINISTERED (The Moderna Monovalent expires a couple of days before his third shot) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    Concomitant medication was not provided.   Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; inadvertently administered 2 doses of the monovalent vaccine which was beyond the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered 2 doses of the monovalent vaccine which was beyond the published expiration date) and NO ADVERSE EVENT (no adverse event) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023 at 1:15 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered 2 doses of the monovalent vaccine which was beyond the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered 2 doses of the monovalent vaccine which was beyond the published expiration date) 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 EXPIRED PRODUCT ADMINISTERED (inadvertently administered 2 doses of the monovalent vaccine which was beyond the published expiration date).    No concomitant medications were reported. Call warm transferred from Commercial Care line on 17Feb2023 at 12:29pm, Clinic manager reported that they inadvertently administered 2 doses of the monovalent vaccine (for 12 years and above) which was beyond the published expiration date. This report was for the 2nd patient. Patient has not reported any adverse event.  No treatment medications were reported.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; The patient received Moderna Covid 6 month to 5 year old patient received a Moderna bivalent booster dose for his bivalent dose instead of Modern bivalent vaccine booster dose for patients 6 years and older; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient received Moderna Covid 6 month to 5 year old patient received a Moderna bivalent booster dose for his bivalent dose instead of Modern bivalent vaccine booster dose for patients 6 years and older) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (patient received the primary series and the first booster dose with Pfizer Covid-19 vaccine .). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 17-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 17-Feb-2023, the patient experienced WRONG PRODUCT ADMINISTERED (The patient received Moderna Covid 6 month to 5 year old patient received a Moderna bivalent booster dose for his bivalent dose instead of Modern bivalent vaccine booster dose for patients 6 years and older). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient received Moderna Covid 6 month to 5 year old patient received a Moderna bivalent booster dose for his bivalent dose instead of Modern bivalent vaccine booster dose for patients 6 years and older) 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 WRONG PRODUCT ADMINISTERED (The patient received Moderna Covid 6 month to 5 year old patient received a Moderna bivalent booster dose for his bivalent dose instead of Modern bivalent vaccine booster dose for patients 6 years and older).    No concomitant medications were reported. The patient is doing well and did not complain of any other Adverse Reactions. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2023: Live-Significant Follow up received- Narrative and Reporter name was updated.
Age: 57.0
Sex: U
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Vaccine Bivalent on 17Feb2023 but they realized the patient already received a previous Moderna Bivalent on 11Nov2022. This spontaneous case was reported by another health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Vaccine Bivalent on 17Feb2023 but they realized the patient already received a previous Moderna Bivalent on 11Nov2022.) and NO ADVERSE EVENT (No adverse event) in a 57-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7146B and 050D22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:HCP stated patient seemed to have a long medical history, but at this time she had to attend another patients, so Moderna could follow up later if needed.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, Lot number -017B21A) on 31-Mar-2021, Moderna COVID-19 Vaccine (Dose 2, Lot number -014C21A) on 28-Apr-2021, Moderna COVID-19 Vaccine (1st booster and Lot number-058H21A) on 21-Dec-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.   On 11-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Feb-2023, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .5 milliliter. On 17-Feb-2023, the patient experienced EXTRA DOSE ADMINISTERED (Vaccine Bivalent on 17Feb2023 but they realized the patient already received a previous Moderna Bivalent on 11Nov2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Vaccine Bivalent on 17Feb2023 but they realized the patient already received a previous Moderna Bivalent on 11Nov2022.) 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 EXTRA DOSE ADMINISTERED (Vaccine Bivalent on 17Feb2023 but they realized the patient already received a previous Moderna Bivalent on 11Nov2022.).    No concomitant medication details was reported.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. HCP stated she was not sure if the medical assistant knew it was the bivalent and not the monovalent. There were no signs or symptoms currently shown via observation.  No treatment medication details was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: unusual adverse reaction to covid vaccine; This spontaneous case was reported by a physician and describes the occurrence of IMMUNISATION REACTION (unusual adverse reaction to covid vaccine) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) 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 IMMUNISATION REACTION (unusual adverse reaction to covid vaccine). At the time of the report, IMMUNISATION REACTION (unusual adverse reaction to covid vaccine) outcome was unknown.     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 dosage text was reported as unknown.  No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was removed from freezer on 29-Dec-2022 and was administered on 16-Feb-2023.; No adverse event; Vaccine administered after beyond use date 28-jan-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 28-jan-2023), PRODUCT STORAGE ERROR (Vial was removed from freezer on 29-Dec-2022 and was administered on 16-Feb-2023.) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 16-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 28-jan-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was removed from freezer on 29-Dec-2022 and was administered on 16-Feb-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 28-jan-2023), PRODUCT STORAGE ERROR (Vial was removed from freezer on 29-Dec-2022 and was administered on 16-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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 28-jan-2023) and PRODUCT STORAGE ERROR (Vial was removed from freezer on 29-Dec-2022 and was administered on 16-Feb-2023.).    No concomitant medications were reported. The vaccine administered after beyond use date of 28-jan-2023. No treatment medications were reported.
Age: 39.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Drew up a dose of the vaccine from the vial with the blue cap instead of the red cap and inadvertently administered; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Drew up a dose of the vaccine from the vial with the blue cap instead of the red cap and inadvertently administered) and NO ADVERSE EVENT (No adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Feb-2023,  after starting , the patient experienced WRONG PRODUCT ADMINISTERED (Drew up a dose of the vaccine from the vial with the blue cap instead of the red cap and inadvertently administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Drew up a dose of the vaccine from the vial with the blue cap instead of the red cap and inadvertently administered) 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 WRONG PRODUCT ADMINISTERED (Drew up a dose of the vaccine from the vial with the blue cap instead of the red cap and inadvertently administered).    Concomitant medication was not provided.   Nurse stated that drew up a dose of the vaccine from the vial with the blue cap instead of the red cap and inadvertently administered it to a 39 year old patient, it was the vial with the blue cap and a label which states (For booster dose only).   Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Wrong product administered
Clinical narrative: she should have received a Bivalent dose. When I asked her however, she states that she received a Monovalent dose; No adverse event; she should have received a Bivalent dose. When I asked her however, she states that she received a Monovalent dose; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (she should have received a Bivalent dose. When I asked her however, she states that she received a Monovalent dose), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (she should have received a Bivalent dose. When I asked her however, she states that she received a Monovalent dose) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced WRONG PRODUCT ADMINISTERED (she should have received a Bivalent dose. When I asked her however, she states that she received a Monovalent dose). On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (she should have received a Bivalent dose. When I asked her however, she states that she received a Monovalent dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (she should have received a Bivalent dose. When I asked her however, she states that she received a Monovalent dose), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (she should have received a Bivalent dose. When I asked her however, she states that she received a Monovalent dose) 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 WRONG PRODUCT ADMINISTERED (she should have received a Bivalent dose. When I asked her however, she states that she received a Monovalent dose) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (she should have received a Bivalent dose. When I asked her however, she states that she received a Monovalent dose).    No concomitant medications was reported.  Dose of Suspect Moderna vaccine was reported as Initial Booster.  No treatment medications was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Colon cancer stage IV, Myocardial infarction
Clinical narrative: heart attack; stage 4 colon cancer after receiving the Pfizer Covid Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack"; COLON CANCER STAGE IV (medically significant), outcome "unknown", described as "stage 4 colon cancer after receiving the Pfizer Covid Vaccine".  Clinical course: The first one Caller states is a neighbor in (state withheld) who had a heart attack and all these heart problems come up. She was diagnosed with stage 4 colon cancer after receiving the Pfizer Covid Vaccine, which she only took to go to the boat and gamble with her girlfriends.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Memory impairment
Clinical narrative: stroke; can't remember things; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "can't remember things".  Clinical course: Reporter stated that he has a friend, who did not want to take the shot. They made him take the shot in order to get any of his pensions. He had a stroke and was a concert. He now can't remember things and cannot play the violin. Bivalent means 2 times the original dosage and over Labor Day they doubled the dosage of the shot. That is why they are having more problems with the shot then they did with the first shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.