chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: stopped my Shingles/ Unexpected therapeutic benefit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Shingles" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "stopped my Shingles"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "stopped my Shingles"; Shingrix (DOSE NUMBER UNKNOWN, SINGLE), for Herpes zoster immunisation, reaction(s): "my shingles were still coming monthly". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "stopped my Shingles/ Unexpected therapeutic benefit".  Additional information: Patient wanted to share that all COVID 19 shorts and the two booster also stopped Shingles. This third booster did not, patient broke back out a week after 3rd booster. Patient know the Pfizer shots for COVID were not for Shingles but it was an added benefit. Even after patient got shingrix shots, shingles were still coming monthly. So patient guessed the 3rd booster was not as strong.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200068025 same patient, different dose/event;
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 1.~reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; 2.~FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported 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 2023SA057733 (CLUSTER) and 2023SA057309 (CLUSTER).   This case involves an adult patient of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature 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, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   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:  Unknown for both the reported 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.  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.
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse evevnt; 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 cases 2023SA054981(CLUSTER) and 2023SA057733(CLUSTER).   This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   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:  Unknown for both the reported 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.   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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature 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 is linked to cases 2023SA057309(CLUSTER) and 2023SA057733(CLUSTER).   This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes (product storage error) (latency: unknown) and was administered to patient post temperature excursion with no reported adverse event (poor quality product administered (latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunization).   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:  Unknown for both the reported 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.   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.
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature 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 is linked to cases 2023SA057733 and 2023SA057309.  This case involves an adult patient of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature 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, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  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:  Unknown for both the reported 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.  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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE QIV NP PFS reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature 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 is linked to cases 2023SA057309 (CLUSTER) and 2023SA057733(CLUSTER).   This case involves adult patient of an unknown age and gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error, latency: Unknown) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  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:  Unknown for both the reported 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.   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.
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 1.~reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; 2.~FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported 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 2023SA057733 (CLUSTER) and 2023SA057309 (CLUSTER).   This case involves child patient of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature excursion with no reported adverse event.   It was 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, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.   Action taken: Not applicable.   Outcome:  Unknown for both the reported 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.   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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature 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 is linked to cases 2023SA057309 and 2023SA057733.   This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes (product storage error) (unknown latency), and was administered to patient post temperature excursion with no reported adverse event (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunization).   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:  Unknown for both the reported 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.   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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature 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 is linked to cases 2023SA057733 and 2023SA057309.   This case involves an adult of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature 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, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  Action taken: Not applicable.  Outcome:  Unknown for both the reported 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.  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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature 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 is linked to cases 2023SA057733 and 2023SA057309.  This case involves a child of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature 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, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  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:  Unknown for both the reported 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.  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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse evevnt; 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 cases 2023SA054981 and 2023SA057733.   This case involves child patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   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:  Unknown for both the reported 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.   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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.   This case is linked to cases 2023SA054981(CLUSTER) and 2023SA057733(CLUSTER).   This case involves an adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   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:  Unknown for both the reported 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.   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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature 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 is linked to cases 2023SA057309 and 2023SA057733.   This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes (product storage error) (latency: unknown) and was administered to patient post temperature excursion with no reported adverse event (poor quality product administered (latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunization).   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:  Unknown for both the reported 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.   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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE QIV NP PFS reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature 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 is linked to cases 2023SA057309 (CLUSTER) and 2023SA057733(CLUSTER).   This case involves Adult patient of an unknown age and gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error, latency: Unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  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:  Unknown for both the reported 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.   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.
Age: 0.25
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of pentacel was administered with no reported adverse event; Initial information received on 01-Mar-2023 regarding an unsolicited valid non-serious case received via health professional. number: 01512650.  This case involves 3 months old male patient who received expired dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was administered 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 B Vaccine (HEPATITIS B) for Immunization; Rotavirus Vaccine Live Oral 1V (Rotarix) for Immunization; and Pneumococcal Vaccine CONJ 13V (CRM197) (Prevnar 13) for Immunization.  On 27-Feb-2023, the patient received expired dose of suspect Pentacel (VERO) Vaccine at dose 0.5ml once (lot: UJ623AA, expiry date: 25-Feb-2023) via intramuscular route in the right thigh for Immunization with no reported adverse event (expired product administered) at same day latency.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  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 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: F
Vaccine: FLU4
Symptoms: Back pain, Immunisation reaction, Neck pain, Pain
Clinical narrative: felt achy; severe pain across her neck and back; severe pain across her neck and back; Initial information received on 01-Mar-2023 regarding an unsolicited valid non-serious case received via Patient.   This case involves an unknown age female patient who experienced felt achy, severe pain across her neck and back after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On unknown date in October 2022, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at (unknown: formulation, strength, dose, lot number, route, administration site) for immunization.  On an unknown date, the patient developed a non-serious event felt achy (pain), severe pain across her neck and back (neck pain, back pain) at unknown latency following the administration of FLUZONE HIGH-DOSE QUADRIVALENT.  It was reported that "Patient reporting, she went to her local pharmacy and was administered the product FLUZONE HD QIV back in OCT2022. Patient states she experienced some adverse reactions after receiving the vaccine. Patient felt achy, severe pain across her neck and back that lasted about 5 days. Patient said she used ice packs for the pain and states she did not have a temperature or any other signs. Patient was curious if the FLUZONE QIV NP also had traces of formaldehyde in it and informed patient there was also traces of it in that product as well. Patient satisfied with information provided. Patient gave consent for a callback to follow up if needed."    Action taken with FLUZONE HIGH-DOSE QUADRIVALENT was not applicable.  Corrective treatment:  used ice packs was received for all events.  At time of reporting, the outcome was Recovered on an unknown date for all the event lasted about 5 days.
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: reporting a patient was administered expired IPOL , with no reported adverse event; Initial information was received on 02-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 6 years old male patient who was reporting a patient was administered expired IPOL, with no reported adverse event after receiving IPV (Vero) [IMOVAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Mar-2023, the patient received a dose 2 of 0.5 ml of suspect IPV (Vero) (Suspension for injection) (lot U1A451M, Expiry date : 20-Feb-2023) (strength was unknown) via intramuscular route in the left deltoid for immunization.  On 01-Mar-2023 the patient developed a non-serious event of reporting a patient was administered expired ipol , with no reported adverse event (expired product administered) (latency: same day) following the administration of IPV (Vero).  No lab data reported.  Action taken :not applicable.  At time of reporting, the outcome was Unknown for the event reporting a patient was administered expired ipol , 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: 32.0
Sex: M
Vaccine: DT
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: adult patient received a dose of the pediatric DT with no reported adverse event; Initial information received on 02-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 32 years old male patient who received a dose of the pediatric DIPHTHERIA AND TETANUS TOXOIDS, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Mar-2023, the patient received a 0.5 ml, once dose 1 of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer (lot: C5864AA, Exp date: 07-Apr-2023) via unknown route in the right deltoid (form, strength: unknown) for prophylactic vaccination.  On 02-MAR-2023 the patient received a dose of the pediatric DIPHTHERIA AND TETANUS TOXOIDS, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported "Caller states the patient has not had any vaccines and is getting them for the first time. He is on the catch-up schedule for his school. First time product used : Yes Still using product : No."  Action taken with DIPHTHERIA AND TETANUS TOXOIDS was 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: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of PENTACEL being administered with no adverse event; Initial information received on 03-Mar-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 months old female patient who had been administered with expired dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13); and Rotavirus vaccine live reassort oral 5V (Rotateq).  On 01-Mar-2023, the patient being administered with an expired dose 2 of 0.5 ml once of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine Suspension for injection with no adverse event (expired product administered) (lot: UJ651AA, expiry date: 25-Feb-2023) via intramuscular route in the left thigh with standard strength 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: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Bone pain, Burning sensation, Decreased appetite, Fatigue
Clinical narrative: THE NIGHT OF THE 1ST DOSE ON (3/26), i EXPERIENCED SEVERE BONE PAIN IN BOTH OF MY LEGS.  I TOOK OVER SOME PRESCEIBED PAIN MEDICATION I HAD (VICODIN) AND IT DID ABSOLUTELY NOTHING TO RELIEVE THE PAIN.  i COULD NOT FALL ASLEEP FOR MORE THAN 30 MINUTE SPURTS.  i was in too much pain to eat and was just stuck in bed for 4 days.  upon getting the 2nd dosage, i experienced the same pain but the severity was worse.  Again, i could not fall asleep or eat.  Upon getting the 3rd dosage on top of the severe joint pain, inability to fall asleep, i began to experience neuropathy (fire and pin and needles on the bottom of my both feet all day every day).  as months went on, my symptoms have stayed and have increase in severity.  By september 2022, both my knees, both hips and finger joints in both hands are affected with pain and now I require medication to help me fall asleep.  I am constantly feeling fatigue and can't do most of the every day things I used to be able to do.  Running an errand now takes twice as long and actually must plan out which errand or chores i will choose to do each day since I'm only able to do 1 each day before I end up in extreme pain at night standing on my feet too long.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Insomnia, Laboratory test, Loss of personal independence in daily activities, Mobility decreased, Neuropathy peripheral
Clinical narrative: THE NIGHT OF THE 1ST DOSE ON (3/26), i EXPERIENCED SEVERE BONE PAIN IN BOTH OF MY LEGS.  I TOOK OVER SOME PRESCEIBED PAIN MEDICATION I HAD (VICODIN) AND IT DID ABSOLUTELY NOTHING TO RELIEVE THE PAIN.  i COULD NOT FALL ASLEEP FOR MORE THAN 30 MINUTE SPURTS.  i was in too much pain to eat and was just stuck in bed for 4 days.  upon getting the 2nd dosage, i experienced the same pain but the severity was worse.  Again, i could not fall asleep or eat.  Upon getting the 3rd dosage on top of the severe joint pain, inability to fall asleep, i began to experience neuropathy (fire and pin and needles on the bottom of my both feet all day every day).  as months went on, my symptoms have stayed and have increase in severity.  By september 2022, both my knees, both hips and finger joints in both hands are affected with pain and now I require medication to help me fall asleep.  I am constantly feeling fatigue and can't do most of the every day things I used to be able to do.  Running an errand now takes twice as long and actually must plan out which errand or chores i will choose to do each day since I'm only able to do 1 each day before I end up in extreme pain at night standing on my feet too long.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: THE NIGHT OF THE 1ST DOSE ON (3/26), i EXPERIENCED SEVERE BONE PAIN IN BOTH OF MY LEGS.  I TOOK OVER SOME PRESCEIBED PAIN MEDICATION I HAD (VICODIN) AND IT DID ABSOLUTELY NOTHING TO RELIEVE THE PAIN.  i COULD NOT FALL ASLEEP FOR MORE THAN 30 MINUTE SPURTS.  i was in too much pain to eat and was just stuck in bed for 4 days.  upon getting the 2nd dosage, i experienced the same pain but the severity was worse.  Again, i could not fall asleep or eat.  Upon getting the 3rd dosage on top of the severe joint pain, inability to fall asleep, i began to experience neuropathy (fire and pin and needles on the bottom of my both feet all day every day).  as months went on, my symptoms have stayed and have increase in severity.  By september 2022, both my knees, both hips and finger joints in both hands are affected with pain and now I require medication to help me fall asleep.  I am constantly feeling fatigue and can't do most of the every day things I used to be able to do.  Running an errand now takes twice as long and actually must plan out which errand or chores i will choose to do each day since I'm only able to do 1 each day before I end up in extreme pain at night standing on my feet too long.