chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NEOPLASM MALIGNANT (Cancer) 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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.            It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication details not reported by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that the those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine is poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors are part of the Kabal along with Moderna.  Treatment details was not reported by the reporter.  This case contains information about 11th patient out of 25 patients.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the unexpected serious (death and medically significant) event of Neoplasm malignant. Latency is unknown but it was reported that the patient developed cancer, with fatal outcome after the administration of mRNA-1273.222 vaccine.  No further information was available in the report. It is unknown if an autopsy was performed.  The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report.     This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) 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.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that cancer rates for jabbed Moderna Cancer patients was up 300 percent. No treatment medication was reported. This case is reported for patient 14 out of 25 patients. Company comment- This is a fatal spontaneous case concerning a patient of unknown gender and age with no medical history reported who experienced the serious (death and medically significant) unexpected event of neoplasm malignant. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It is unknown if autopsy was performed. Reporter stated that vaccine caused cancer in 25 patients who are friends of her. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) 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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 21 out of 25. Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Sex: U
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) 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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that cancer rates for jabbed Moderna Cancer patients was up 300 percent. No treatment medication was reported. This case contains information about 22nd patient out of 25 patients. Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case, Patient 1; Reported Cause(s) of Death: Cancer
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I felt terribly sick, just as if I was having Covid-19 all over again; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I felt terribly sick, just as if I was having Covid-19 all over again) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (about 2 and a half years ago).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 ILLNESS (I felt terribly sick, just as if I was having Covid-19 all over again). At the time of the report, ILLNESS (I felt terribly sick, just as if I was having Covid-19 all over again) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ILLNESS (I felt terribly sick, just as if I was having Covid-19 all over again) to be related.    No concomitant medication was reported.  It was reported that patient feel very sick every time get a shot ,was homebound and sick. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735436 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735436:Bivalent Case
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: SPIKEVAX (Dose 1), MODERNA COVID-19 VACCINE (Dose 3) and SPIKEVAX (Dose 2). Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, SPIKEVAX and SPIKEVAX.    On 22-Sep-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. In October 2022, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) 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.   Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-736299 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736299:Patient 1
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Therapeutic response unexpected
Clinical narrative: lower blood pressure to the extent that he no longer needs blood pressure control medicine; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (lower blood pressure to the extent that he no longer needs blood pressure control medicine) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male 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 Blood pressure high.    On 24-May-2023, the patient received fifth 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 THERAPEUTIC RESPONSE UNEXPECTED (lower blood pressure to the extent that he no longer needs blood pressure control medicine) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (lower blood pressure to the extent that he no longer needs blood pressure control medicine) 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 THERAPEUTIC RESPONSE UNEXPECTED (lower blood pressure to the extent that he no longer needs blood pressure control medicine).    The patient was taking blood pressure medication. It was reported that since the last dose of the vaccine, the patient had experienced lower blood pressure to the extent that he no longer needs blood pressure control medicine. This has been going on for at least 2 months. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-736255 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736255:Monovalent dose case
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: An expired vaccine was given out 04-Aug-2023 (today)/ expired dose was given; vial was stored in the fridge post puncture; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired vaccine was given out 04-Aug-2023 (today)/ expired dose was given), PRODUCT STORAGE ERROR (vial was stored in the fridge post puncture) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7645B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Aug-2023 at 10:15 AM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 04-Aug-2023, the patient experienced NO ADVERSE EVENT (No adverse event). On 04-Aug-2023 at 10:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired vaccine was given out 04-Aug-2023 (today)/ expired dose was given) and PRODUCT STORAGE ERROR (vial was stored in the fridge post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (An expired vaccine was given out 04-Aug-2023 (today)/ expired dose was given), PRODUCT STORAGE ERROR (vial was stored in the fridge post puncture) 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 (An expired vaccine was given out 04-Aug-2023 (today)/ expired dose was given) and PRODUCT STORAGE ERROR (vial was stored in the fridge post puncture).    Concomitant medication was not provided. Treatment information was not reported.  Open vaccine was given three days after being opened. Refrigerated temperature 30.7 F. Vial size was reported as 2.5 ml. The vial was initially stored in the refrigerator on 27-Jul-2023. Vial was first punctured on 1-Aug-2023. Vaccine was administered on 4-Aug-2023 around 10:15 AM. Vial did not undergo any temperature excursion.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2023: Live follow-up received and updated reporter details, event verbatim (Expired vaccine used). Vaccine related details added.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Dizziness, Feeling abnormal, Pain, Retinal artery occlusion
Clinical narrative: Retinal stroke; blind; sore; feeling bad/feeling terrible; dizzy; This spontaneous case was reported by a patient and describes the occurrence of RETINAL ARTERY OCCLUSION (Retinal stroke) and BLINDNESS (blind) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Blood pressure. Concomitant products included AMLODIPINE from 04-Aug-2023 to an unknown date and ACETYLSALICYLIC ACID (ASPIRIN ANALGESIC) from 04-Aug-2023 to an unknown date for Blood pressure.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced RETINAL ARTERY OCCLUSION (Retinal stroke) (seriousness criteria hospitalization and medically significant), BLINDNESS (blind) (seriousness criterion medically significant), PAIN (sore), FEELING ABNORMAL (feeling bad/feeling terrible) and DIZZINESS (dizzy). At the time of the report, RETINAL ARTERY OCCLUSION (Retinal stroke), BLINDNESS (blind), PAIN (sore), FEELING ABNORMAL (feeling bad/feeling terrible) and DIZZINESS (dizzy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that two weeks after the 2nd shot, he had a flash of light and went to the emergency room and was told he had a retinol stroke.He eventually got some vision back in the left eye, but he was left with slight vision problem in the left eye. He was legally blind in the left eye. It was reported that after the second vaccine he went from a healthy man to an old dependable on others to live, person.  No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a 67-year-old male patient with no reported medical history, who experienced the serious (due to medically significant and hospitalization) unexpected, event of retinal artery occlusion and the serious (due to medically significant) event of blindness, which occurred approximately 2 weeks after a dose of mRNA-1273 vaccine, received as the second dose of COVID-19 vaccination schedule, together with other non-serious events. It was reported that two weeks after the 2nd shot, he had a flash of light and went to the emergency room and was told he had a retinol stroke. It was reported that approximately 2 years after the events, he eventually got some vision back in the left eye, but he was left with slight vision problem in the left eye. He was legally blind in the left eye. The outcome of the event was reported as not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 12-Jun-2023 and was administered on vaccine 02-AUG-2023.; No adverse event; Vaccine was stored in the refrigerator on 12Jun2023 and administered after 30-day; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in the refrigerator on 12Jun2023 and administered after 30-day), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-Jun-2023 and was administered on vaccine 02-AUG-2023.) and NO ADVERSE EVENT (No adverse event) 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. AS7184B) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 02-Aug-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 02-Aug-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 (Vaccine was stored in the refrigerator on 12Jun2023 and administered after 30-day). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-Jun-2023 and was administered on vaccine 02-AUG-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in the refrigerator on 12Jun2023 and administered after 30-day), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-Jun-2023 and was administered on vaccine 02-AUG-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 (Vaccine was stored in the refrigerator on 12Jun2023 and administered after 30-day) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-Jun-2023 and was administered on vaccine 02-AUG-2023.).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The 0.5ml vial did not underwent any temperature excursions. No treatment medication was reported.
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.; No Adverse Event; HCP stated they accidentally administered 2 doses beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses beyond use date), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.) and NO ADVERSE EVENT (No Adverse Event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7647B) for COVID-19 prophylaxis.    Co-suspect products included non-company products CBA 1205 for an unknown indication and INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    It was reported that patient relevant medical history/conditions, allergy, concomitant diseases and risk factor were unknown.    On 06-Aug-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient received dose of CBA 1205 (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 06-Aug-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 (HCP stated they accidentally administered 2 doses beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses beyond use date), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-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 (HCP stated they accidentally administered 2 doses beyond use date) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.).    Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023. Vial size was reported as 2.5 ml. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-736294 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736294:Patient 1
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.; No adverse event; HCP stated they accidentally administered 2 doses beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses beyond use date.), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7647B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    Relevant medical history or conditions, allergy, concomitant diseases and risk factor were unknown.    On 06-Aug-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 06-Aug-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 2 doses beyond use date.), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-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 (HCP stated they accidentally administered 2 doses beyond use date.) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023.).    Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Vaccines were stored in the fridge on 06-JUL-2023 and they were administered on 06-AUG-2023. Vial size was reported as 2.5 ml. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-736290 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736290:Patient 2
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Customer called to report temperature excursion for PROQUAD. Caller stated the product was administered to 1 patient after the excursion. Administered 7/31/2023. Caller stated patient had no symptoms. No additional AE/no PQC.          ?    Names of; Customer called to report temperature excursion for PROQUAD. Caller stated the product was administered to 1 patient after the excursion. Administered 7/31/2023. Caller stated patient had no symptoms. No additional AE/no PQC.          ?    Names of; This spontaneous report was received from Other Health Professional and refers to a 4-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 31-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 dose, (lot number X009883 has been confirmed to be valid for PROQUAD).  (strength, and indication were not provided).    On 31-JUL-2023, the On 31-JUL-2023, the patient experienced Customer called to report temperature excursion for PROQUAD. Caller stated the product was administered to 1 patient after the excursion. Administered 7/31/2023. Caller stated patient had no symptoms. No additional AE/no PQC.    The action taken with PROQUAD regarding the events was reported as Not Applicable
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: swelling in her leg; pain in the leg she received the vaccine in; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 02Aug2023 as dose number unknown, single, in leg for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Aug2023, outcome "not recovered", described as "pain in the leg she received the vaccine in"; PERIPHERAL SWELLING (non-serious) with onset 03Aug2023, outcome "not recovered", described as "swelling in her leg". The events "swelling in her leg" and "pain in the leg she received the vaccine in" required physician office visit. Therapeutic measures were taken as a result of peripheral swelling, vaccination site pain. Additional information: The reporter stated that his daughter received it yesterday (02Aug2023) and now (03Aug2023) she has swelling in her leg and pain in the leg she received the vaccine in. The reporter stated that the product was Prevnar "23" (as reported). The reporter was the one who took the patient back to the pediatrician this morning. The swelling didn't improve, and the patient is in a lot of pain and her leg is crazy swollen like balloon. They took her back to the pediatrician because they said they wanted to make sure it was not an infection in her joints or muscles. The reporter stated they have been alternating Tylenol and Motrin to help her stay out of pain. The reporter stated that he is contacting Pfizer because he figures Pfizer would know a lot more about the vaccine than the pediatrician. The pediatrician was not really as aware as he has hoped.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal cobble stone mucosa, Oropharyngeal pain
Clinical narrative: Cobblestone throat/Cobble stone pharynx; Cobblestone throat painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A 62-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: OROPHARYNGEAL COBBLE STONE MUCOSA (non-serious), 7 days after the suspect product(s) administration, outcome "unknown", described as "Cobblestone throat/Cobble stone pharynx"; OROPHARYNGEAL PAIN (non-serious), 7 days after the suspect product(s) administration, outcome "unknown", described as "Cobblestone throat painful".  Additional information: 7 days after Pfizer bivalent. Patient got cobblestone throat. Its painful.   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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: She has an artificial knee and after she got COVID, she has now pain in her knee that continues; extreme tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "artificial knee" (unspecified if ongoing). Concomitant medication(s) included: CLONIDINE HCL; SPIRONOLACTONE; LIPITOR. Past drug history included: Amlodipine for Blood pressure, notes: What I was on before, the last medicine I took for blood pressure, Amlodipine. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "She has an artificial knee and after she got COVID, she has now pain in her knee that continues"; FATIGUE (non-serious), outcome "unknown", described as "extreme tiredness". Additional information: She has an artificial knee and after she got COVID, she has now pain in her knee that continues. She has extreme tiredness like she has been doing a marathon.  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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm and on 31Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Systemic Lupus" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "Sjorgrens" (unspecified if ongoing); "IgA deficiency" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "ptsd" (unspecified if ongoing); "2 shoulder surgeries and 3 c sections" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: AMLODIPINE, start date: 01Sep2010; PROPANOLOL [PROPRANOLOL], start date: 01Sep2010; LEVOTHYROXINE, start date: 01Sep2010; SERTRALINE, start date: 01Dec2016; PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE], start date: 01Aug2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 from 24Jul2023 to 29Jul2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiomegaly
Clinical narrative: developed an enlarged heart; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the parent.  A 29-year-old male patient received BNT162b2 (COMIRNATY 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: CARDIOMEGALY (non-serious), outcome "unknown", described as "developed an enlarged heart".  Additional information: Patient's mother reported that her son was forced to take vaccine and developed an enlarged heart.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: excursion was 3 hours to a maximum temperature of 12.6°C with no reported adverse event; received IPOL after the punctured vial was exposed to the excursion with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case is linked to case 2023SA239617.  This case involves a 13-year-old female patient who received IPV (VERO) [IPOL] after the punctured vial was exposed to the excursion with no reported adverse event and excursion was 3 hours to a maximum temperature of 12.6°c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 28-Jun-2023, the patient received 0.5 ml total dose of suspect IPV (VERO) Suspension for injection (strength: unknown) (lot: W1A101M, expiry date: 10-Feb-2025) via unknown route in unknown administration site for immunization and excursion was 3 hours to a maximum temperature of 12.6°c with no reported adverse event (product storage error) (unknown latency)  On 28-Jun-2023 the patient received ipol after the punctured vial was exposed to the excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: MEN
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Menquadfi were administered to patients after excursion with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 years old male patient to whom meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] were administered to patients after excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine VLP RL1 4V (yeast) (Gardasil) for Immunisation.  On an unknown date, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (strength unknown) (lot number, expiry date unknown) via intramuscular route in unknown administration site for Immunization after excursion with no reported adverse event (poor quality product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event menquadfi were administered to patients after excursion with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA239679: US-SA-2023SA239548: US-SA-2023SA239960:
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion product administered to the patient with no reported adverse event; Initial information received on 04-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11-year-old female patient and temperature excursion product administered to the patient with no reported adverse event with MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Prophylactic vaccination.  On an unknown date, the patient received 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength, expiry date, lot number: unknown) via unknown route in unknown administration site for Immunization and temperature excursion product administered to the patient with no reported adverse event (poor quality product administered) (latency: same day).  It was reported that Max/Low Temperature reached? 31.5° FAHRENHEIT How long did the excursion last? 2 HOURS 45 MINUTES Did it occur due to a human error? NO.  It was unknown if any lab data/tests available.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  Outcome: Unknown.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: pharmacist called in to report that they have administered menactra, that has expired on 24Apr2023 with no reported adverse event; Initial information received on 07-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old male patient and who have administered Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra] that has expired on 24apr2023 with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 5-Component, Tetanus Vaccine Toxoid (Adacel), Vaxoral And Hpv Vaccine Vlp Rl1 4v (Yeast) (Gardasil) for Prophylactic vaccination.  On 05-Aug-2023, the patient received a dose 1 at a dose of 0.5 ml of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine solution for injection (frequency: once, strength: standard, expiry date: 24-Apr-2023 and lot U7273BA) via intramuscular route in the left arm for Prophylactic vaccination (immunization) and administered menactra, that has expired with no reported adverse event (expired product administered) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Skin indentation
Clinical narrative: Pt had a 7cm x 12 cm  redness and indentation of 6cm x 9cm
Age: 19.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Laboratory test, Wrong product administered
Clinical narrative: Patient was suppossed to get a meningitis vaccine for her school requirement and I accidentally gave her a MMR vaccine.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Ear pain, Erythema, Inflammation, Injection site swelling, Local reaction
Clinical narrative: Injection site swelling and localized itching started at about 11pm following vaccination at 6pm. The following day (Aug 9th), redness, swelling, and pain started to spread down the arm and up the neck to the ear. At this point, Patient called me and asked what to do. I advised her to take tylenol for the pain and benadryl for the local reaction.  I also advised use if an ice pack to calm to inflammation.  Nausea and vomiting occurred at around 5:30pm on the 9th. At this time, symptoms seem to be easing up, but she has been advised to rest, hydrate and monitor her symptoms. She will seek medical care if her symptoms worsen or persist despite OTC treatments over the next 12 hours.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Neck pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Injection site swelling and localized itching started at about 11pm following vaccination at 6pm. The following day (Aug 9th), redness, swelling, and pain started to spread down the arm and up the neck to the ear. At this point, Patient called me and asked what to do. I advised her to take tylenol for the pain and benadryl for the local reaction.  I also advised use if an ice pack to calm to inflammation.  Nausea and vomiting occurred at around 5:30pm on the 9th. At this time, symptoms seem to be easing up, but she has been advised to rest, hydrate and monitor her symptoms. She will seek medical care if her symptoms worsen or persist despite OTC treatments over the next 12 hours.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Injection site swelling and localized itching started at about 11pm following vaccination at 6pm. The following day (Aug 9th), redness, swelling, and pain started to spread down the arm and up the neck to the ear. At this point, Patient called me and asked what to do. I advised her to take tylenol for the pain and benadryl for the local reaction.  I also advised use if an ice pack to calm to inflammation.  Nausea and vomiting occurred at around 5:30pm on the 9th. At this time, symptoms seem to be easing up, but she has been advised to rest, hydrate and monitor her symptoms. She will seek medical care if her symptoms worsen or persist despite OTC treatments over the next 12 hours.
Age: 51.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient accidently received an expired dose of vaccine.  Expiration date 1/30/2023.  Contacted GSK who advised to administer 2 additional doses of Hepatitis A as they cannot guarantee effectiveness of the dose administered today.  Patient will come back in to have 2 additional Hepatitis A vaccines administered based on vaccine schedule.
Age: 1.5
Sex: M
Vaccine: COVID19-2, HEPA
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: He has not had any adverse events. He was given 10 doses. (1 complete vial that was not diluted)