chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: product storage error temperature too low with no reported adverse event; administered to patient post excursion with no adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited non-valid non-serious case received from other health professional.  This case is linked to cases 2023SA057733(CLUSTER), 2023SA054981(CLUSTER), 2023SA057309(CLUSTER) and 2023SA068949(CLUSTER).  This case involves adult patient of unknown gender to whom influenza quadrival A-B vaccine [Fluzone Quadrivalent] was administered post excursion with no adverse event and reported product storage error temperature too low with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date there was product storage error temperature too low with no reported adverse event (product storage error) for influenza quadrival A-B vaccine.  On an unknown date, the patient received suspect influenza quadrival A-B vaccine suspension for injection at an unknown dose (lot number: UT7683NA, UT7682JA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date administered influenza quadrival A-B vaccine to patient post excursion with no adverse event (poor quality product administered) (same day latency) following the administration of influenza quadrival A-B vaccine.  Action taken: Not applicable.  Outcome: Unknown for both the events.   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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: product storage error temperature too low, with no reported adverse event; product was administered to patient post excursion, with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves Adult and unknown gender patient to whom influenza quadrival A-B vaccine [Fluzone QIV] product was administered to patient post excursion and product storage error temperature too low, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza quadrival A-B vaccine Suspension for injection lot UT7683NA, UT7682JA expiry date: 30-Jun-2023 (strength, : not reported) via unknown route in unknown administration site for prophylactic vaccination and on the same day product was administered to patient post excursion, with no reported adverse event (poor quality product administered) and product storage error temperature too low, with no reported adverse event (product storage error).  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both events.  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.; Sender's Comments:  US-SA-2023SA057733:
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: product storage error temperature too low/ reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes with no reported adverse event; fluzone administered to adult patient after product experienced an excursion with no reported adverse events; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA057733, 2023SA069712,2023SA069466,2023SA052709,2023SA054981,2023SA069475 (CLUSTER).  This case involves Adult and unknown gender patient to whom influenza quadrival A-B vaccine [Fluzone QIV] was administered after product experienced an excursion with no reported adverse event and product storage error temperature too low/ reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered unknown dose of suspect influenza quadrival A-B vaccine, suspension for injection (dose, strength: not reported; lot UT7683NA; UT7682JA: expiry date: 30-Jun-2023) via unknown route in unknown administration site for immunization after product experienced an excursion with no reported adverse events (product storage error) (poor quality product administered) (unknown latency).  Action taken : not applicable.  Outcome was 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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: product was administered to patient post excursion, with no reported adverse event; product storage error temperature too low, with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an adult patient (gender: unknown) to whom  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] product was administered to patient post excursion and product storage error temperature too low, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection  (strength: unknown, lot number: UT7683NA; UT7683NA; expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination and on the same day product was administered to patient post excursion, with no reported adverse event (poor quality product administered) and product storage error temperature too low, with no reported adverse event (product storage error).  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was Unknown for both events.  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-2023SA069591:01495347 US-SA-2023SA069712:01495415
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: product was administered to patient post excursion, with no reported adverse event; product storage error temperature too low, with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an adult patient (gender: unknown) to whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] product was administered to patient post excursion and product storage error temperature too low, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection  (strength: unknown, lot number: UT7683NA; UT7683NA; expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination and on the same day product was administered to patient post excursion, with no reported adverse event (poor quality product administered) and product storage error temperature too low, with no reported adverse event (product storage error).  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was Unknown for both events.  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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: product storage error temperature too lowwith no reported adverse event; product was administered to patient post excursion with no adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA057309(CLUSTER) and 2023SA057733(CLUSTER).  This case involves adult and unknown gender patient who was administered influenza quadrival A-B vaccine [FLUZONE QIV] to patient post excursion with no adverse event and reported product storage error temperature too low with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date there was product storage error temperature too low with no reported adverse event (product storage error) for influenza quadrival A-B vaccine.  On an unknown date, the patient received suspect influenza quadrival A-B vaccine suspension for injection at an unknown dose (lot number: UT7683NA, UT7682JA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date administered influenza quadrival A-B vaccine to patient post excursion with no adverse event (poor quality product administered) (same day latency) following the administration of influenza quadrival A-B vaccine.  Action taken: Not applicable.  Outcome: Unknown for both the events.   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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administered to patient post excursion with no reported adverse event; product storage error temperature too low (with no reported adverse event); Initial information received on 16-Feb-2023 regarding an unsolicited non-valid non-serious case received from other health professional.  This case is linked to cases 2023SA057733, 2023SA057309 and 2023SA068949.  This case involves adult patient of unknown gender to whom influenza quadrival A-B vaccine [Fluzone Quadrivalent] was administered post excursion with no adverse event and reported product storage error temperature too low with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date there was product storage error temperature too low with no reported adverse event (product storage error) for influenza quadrival A-B vaccine.  On an unknown date, the patient received suspect influenza quadrival A-B vaccine suspension for injection at an unknown dose (lot number: UT7683NA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date administered influenza quadrival A-B vaccine to patient post excursion with no adverse event (poor quality product administered) (same day latency) following the administration of influenza quadrival A-B vaccine.  Action taken: Not applicable.  Outcome: Unknown for both the events.   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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: product storage error temperature too low, with no reported adverse event; product was administered to patient post excursion, with no reported adverse event; Initial information was received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA057733.  This case involves Child and unknown gender patient who experienced product storage error temperature too low, with no reported adverse event and product was administered to patient post excursion, with no reported adverse event after receiving vaccine influenza quadrival a-b vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect influenza quadrival a-b vaccine (Suspension for injection) (lot UT7683NA, Expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination(Immunization).  On an unknown date the patient developed a non-serious event of product storage error temperature too low, with no reported adverse event (product storage error) and product was administered to patient post excursion, with no reported adverse event (poor quality product administered) (unknown latency) following the administration of influenza quadrival a-b vaccine.  Action taken with QUADRIVALENT influenza vaccine (Fluzone QIV) was not applicable  At time of reporting, the outcome was Unknown for the event product storage error temperature too low, with no reported adverse event and was Unknown for the event product was administered to patient post 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 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.; Sender's Comments:  US-SA-2023SA069591:01495415 US-SA-2023SA069475: US-SA-2023SA069466:01495415
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: fluzone administered to adult patient after product experienced an excursion at low temperature with no reported adverse events; fluzone administered to adult patient after product experienced an excursion at low temperature with no reported adverse events; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA057733.  This case involves Adult and unknown gender patient to whom influenza quadrival A-B vaccine [Fluzone QIV] administered after product experienced an excursion at low temperature with no reported adverse events.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered unknown dose of suspect influenza quadrival A-B vaccine, suspension for injection (dose, strength: not reported; lot number: UT7683NA; expiry date: 30-Jun-2023) via unknown route in unknown administration site for immunization after product experienced an excursion at low temperature with no reported adverse events (product storage error)(latency: unknown)  (poor quality product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.  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.; Sender's Comments:  SAD20230220001440:other SAD20230216001803:other
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administered to patient post excursion with no reported adverse event; product storage error temperature too low (with no reported adverse event); Initial information received on 16-Feb-2023 regarding an unsolicited non-valid non-serious case received from other health professional.  This case is linked to cases 2023SA057733(CLUSTER), 2023SA057309(CLUSTER) and 2023SA068949(CLUSTER).  This case involves adult patient of unknown gender to whom influenza quadrival A-B vaccine [Fluzone Quadrivalent] was administered post excursion with no adverse event and reported product storage error temperature too low with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date there was product storage error temperature too low with no reported adverse event (product storage error) for influenza quadrival A-B vaccine.  On an unknown date, the patient received suspect influenza quadrival A-B vaccine suspension for injection at an unknown dose (lot number: UT7683NA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date administered influenza quadrival A-B vaccine to patient post excursion with no adverse event (poor quality product administered) (same day latency) following the administration of influenza quadrival A-B vaccine.  Action taken: Not applicable.  Outcome: Unknown for both the events.   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: 1.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: she administered an expired vaccine to a patient with no reported adverse event; Initial information was received on 27-Feb-2023 and live follow up received on same date both were processed together regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who was treated with expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] 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 HEPATITIS A VACCINE (HEPATITIS A) ; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 27-Feb-2023, the patient received total 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ613AA and expiry 25-Feb-23) (expired product administered, latency same day) (strength: unknown) via intramuscular route in the left thigh for immunization.   At time of reporting, the outcome was Unknown for the event she administered an expired vaccine to a patient 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.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: PENTACEl was given today and expired on Saturday with no reported adverse event; Initial information received on 27-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who received Diphtheria, Tetanus, AC Pertussis, IPV AND HIB Vaccine [Pentacel (Vero)] which was given today and expired on saturday 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 Rotavirus vaccine live oral 1V (Rotarix) for Prophylactic vaccination; and Pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 27-Feb-2023, the patient received a dose of 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test--0.5ml of suspect Diphtheria, Tetanus, AC Pertussis, IPV AND HIB Vaccine Suspension for injection which was expired on saturday with no reported adverse event (expired product administered) of standard strength for one day (QD) (lot: UJ614AAA, expiry date: 25-Feb-2023) via intramuscular route in the right thigh for Immunization.  Action taken: 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: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: DTaP was ordered and administered for patient who should have received Tdap.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Depression, Injection site rash, Injection site swelling
Clinical narrative: Large Area below injection site swollen for a week Rash extending down from injection site Extreme depression for a week
Sex: U
Vaccine: HEP, HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: 1 dose HepA in 2003, not finish series; 1 dose HepB in 2003, not finish series; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Hepatitis A vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis A vaccine (received 1st dose of Hepatitis A vaccine in 2003) and Hepatitis B vaccine (received 2nd dose of Hepatitis B vaccine in 2003).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis A vaccine and the 2nd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination and incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 22-FEB-2023 Reporter's Comment: The reporter had patient who were traveling to and wanted to finish the hepatitis B and hepatitis A series before this trip.  The patient received only one dose of Hepatitis A and Hepatitis B in 2003 but did not finish the series. The vaccines administered were the generic versions of Hepatitis A and Hepatitis B because healthcare professional could not confirm brand names. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Hepatitis A vaccine and Hepatitis B vaccine, which led to incomplete course of vaccination. The case had been linked to US2023029948, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023029948:Same reporter
Age: 1.25
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in a 15-month-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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-2023, 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 06-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) 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 (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    Concomitant medications were not reported.  This case was created for patient 8 out of 17 patients. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live significant follow-up received contains Patient demographics updated On 28-Feb-2023: Follow-up received contains no new information On 28-Feb-2023: Follow-up received contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
Age: 1.5
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in an 18-month-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. 215K22A) 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)) (Intramuscular) 1 dosage form. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) 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 (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    Concomitant medications were not reported.  This case was created for patient 11 out of 17 patients. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live significant follow-up received contains Patient demographics updated On 28-Feb-2023: Follow-up received contains no new information On 28-Feb-2023: Follow-up received contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
Age: 2.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in a 2-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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2023, 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 08-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) 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 (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    Concomitant medications were not reported.  This case was created for patient 15 out of 17 patients. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live significant follow-up received contains Patient demographics updated On 28-Feb-2023: Follow-up received contains no new information On 28-Feb-2023: Follow-up received contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
Age: 3.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Moderna Covid-19 monovalent were administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered) and NO ADVERSE EVENT (No Adverse Event) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered ) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered).    No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 3rd of 15 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271.   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow-up document received includes patient demographics (initial and DOB) added. On 28-Feb-2023: Follow-up document received includes no new information. On 28-Feb-2023: Follow-up document received includes reporter details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 3
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date; No adverse event; administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in an 81-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy and Drug allergy.    On 23-Feb-2023, 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 23-Feb-2023 at 10:21 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 (administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) 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 EXPIRED PRODUCT ADMINISTERED (administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.) to be related and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date).    Concomitant medications details were not reported by the reporter.  Reportedly, 6 veterans administered the Moderna bivalent vaccine on 23-Feb-2023 and the use by date was 22-Feb-2023. Vial size was reported as 2.5 ml. Vial did not undergo any temperature excursion.  On 27-FEB-2023, Case  MOD-2023-712565 became invalid as it was confirmed that there is no single identifiable patient.  Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow up received contains non significant information. On 01-Mar-2023: Significant follow up appended_ patient and product details and narrative part updated
Age: 4.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Moderna Covid-19 monovalent were administered BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD).    Concomitant medications details were not reported by the reporter.  This case was considered for 2nd adult patient out of 15 recipients who received moderna vaccine after by used date.  Treatment details were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live Follow up : Patient demographic details adding On 28-Feb-2023: Live Follow up On 28-Feb-2023: Live Non Significant FU; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 2
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: product was administered to patient post excursion, with no reported adverse event; product storage error temperature too low, with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an adult patient (gender: unknown) to whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] product was administered to patient post excursion and product storage error temperature too low, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection  (strength: unknown, lot number: UT7683NA; UT7683NA; expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination and on the same day product was administered to patient post excursion, with no reported adverse event (poor quality product administered) and product storage error temperature too low, with no reported adverse event (product storage error).  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was Unknown for both events.  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-2023SA069712:01495415 US-SA-2023SA069591:01495347
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: product storage error temperature too low with no reported adverse event; administered to patient post excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves an adult patient of unknown gender to whom influenza quadrival A-B vaccine [Fluzone QIV] was administered after product experienced an excursion with no reported adverse event.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered unknown dose of suspect influenza quadrival A-B vaccine, suspension for injection (dose, strength: not reported; UT7683NA: expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunization) after product experienced an excursion with no reported adverse events (product storage error; latency: unknown) (poor quality product administered; latency: same day).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.   Action taken: Not applicable.   Outcome was 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.; Sender's Comments:  SAD20230220001440: SAD20230216001803:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; The nurse reported that a dose of PNEUMOVAX 23 that was expired was administered to a patient.  No additional AE's and no PQC's were reported.; This spontaneous report was received from licensed practical nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medication, and drug reactions or allergies were not reported.  On 08-FEB-2023, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 1 dosage form (reported as product quantity: 1), lot # U018309, expiration date: 08-JAN-2023, administered as directed to prevent pneumococcal infection (strength, route of administration, and anatomical location were not provided) (expired product administered). No additional adverse events were reported (no adverse event).