chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP also called yesterday for a TE and was mistakenly given supported outcomes for MMR II and VARIVAX.; This spontaneous report was received from a medical Assistant referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions, and concomitant medications were not reported.      On 08-OCT-2024, the patient was mistakenly vaccinated with improperly stored dose (Product storage error) of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # X018902, expiration date 12-JUL-2025 (strength, dose, dose number, route, and anatomical location were not provided) and varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # Y006582, expiration date 26-MAR-2026, albumin status: rHA (strength, dose, dose number, route, and anatomical location were not provided) for prophylaxis.  No adverse event was reported.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Caller reported expired PNEUMOVAX 23 was administered. No other information provided; This spontaneous report has been received from a pharmacist regarding a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant therapies was not reported.  On 14-OCT-2024, the patient received an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection for prophylaxis, 0.5 milliliters, intramuscularly, on left deltoid, lot number W029533 which has been verified to be valid, expiration date reported and validated as 07-OCT-2024(expired product administered) (no adverse event).
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: the patient was diagnosed with HPV/she tested positive for HPV; This spontaneous report was received from a pharmacist (Doctor of Pharmacy [Pharm. D.]) via Company representative concerning to a 22-year-old female patient.  Her medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On unknown dates, the patient was vaccinated with three doses series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, 0.5 milliliter (lot #, expiry date, and anatomical location were not provided) administered intramuscularly (IM) as prophylaxis (reported as "human papillomavirus [HPV] prevention.")  On an unknown date (reported as "recently"), the patient was diagnosed with HPV, and she tested positive for HPV (papilloma viral infection). It was unknown whether patient sought medical attention or if she received treatment for the event.  The outcome of the event was not reported. Additional information was not provided.  The causal relationship between t papilloma viral infection and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.  Lot # is being requested and will be submitted if received.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, Syncope
Clinical narrative: Syncope; received an expired dose of Bexsero; This serious case was reported by a other health professional and described the occurrence of syncope in a 13-year-old female patient who received Men B NVS (Bexsero) (batch number 3L339, expiry date 30-SEP-2024) for prophylaxis.   On 10-OCT-2024, the patient received Bexsero (intramuscular) .5 ml. On 10-OCT-2024, less than a day after receiving Bexsero, the patient experienced syncope (Verbatim: Syncope) (serious criteria GSK medically significant) and expired vaccine used (Verbatim: received an expired dose of Bexsero). On 10-OCT-2024, the outcome of the syncope was resolved. The outcome of the expired vaccine used was unknown.   It was unknown if the reporter considered the syncope to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the syncope to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-OCT-2024 The patient did not receive any other products. The symptoms were treated. The patient received an expired dose of Bexsero, which led to an expired vaccine used. This case was linked with case US2024127483, reported by the same reporter for different patient.; Sender's Comments: Syncope is a listed event which is considered related to GSK vaccine Bexsero and Bexsero PRE-FILLED SYRINGE DEVICE. US-GSK-US2024127483:Smae reporter/Different patient
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: weak; tired; This is a spontaneous report received from a Pharmacist.  An elderly male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 17Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 17Oct2024, outcome "unknown", described as "tired"; ASTHENIA (non-serious) with onset 17Oct2024, outcome "unknown", described as "weak". It was unknown if therapeutic measures were taken as a result of asthenia, fatigue.  Additional information: Patient felt weak and tired post covid vaccination; exact covid vaccine unknown. Batch/lot number was unknown as Not available/provided to reporter at the time of report completion. It was unknown if the patient receive any other vaccines on the same date as the vaccine(s). It was unknown if the patient receive any other vaccines within 4 weeks PRIOR to the vaccine(s). It was unknown if the patient taking any other medications within 2 weeks of the event starting. Known allergies were unknown.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got the COVID right now; I got the COVID right now; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 17Oct2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 84-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURE UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURE UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE, MANUFACTURE UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, SINGLE, MANUFACTURE UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2024, outcome "unknown" and all described as "I got the COVID right now". Clinical course: During the call caller stated. "I got my 5th vaccination a month before (in Sep2024) for COVID, Pfizer vaccination and I got the COVID right now (in Oct2024)."
Sex: U
Vaccine: RSV
Symptoms: Injection site discharge, Underdose
Clinical narrative: It squirted back out from the patient injection site; It squirted back out from the patient injection site; This is a spontaneous report received from a Pharmacist from medical information team.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884, Expiration Date: Sep2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE DISCHARGE (non-serious), UNDERDOSE (non-serious), outcome "unknown" and all described as "It squirted back out from the patient injection site". Additional information: Pharmacist stated, "I was calling to see what the recommendation is with the Abrysvo vaccine, if majority of it came back out after injection, is the patient recommended to have an additional dose or what the recommendation? Upon injection after it was injected the vaccine came back out, like it squirted back out from the patient injection site. So, I am just wanting to see what the recommendation is as far as any additional vaccination or what the recommendation is?"
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: caught COVID-19 sometime after returning from a trip; caught COVID-19 sometime after returning from a trip; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "caught COVID-19 sometime after returning from a trip". Clinical course: The patient got COVID-19 vaccine (did not indicate if was Comirnaty) the second week of September and caught COVID-19 sometime after returning from a trip.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: extreme immune response; This is a spontaneous report received from a Nurse from medical information team.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary series, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose number unknown (booster), manufacturer unknown. The shingles exacerbation in head lasted for 2 weeks), for COVID-19 immunization, reaction(s): "shingles exacerbation in head"; Pfizer covid-19 vaccine (dose number unknown), for COVID-19 immunization, reaction(s): "extreme immune response". The following information was reported: IMMUNISATION REACTION (non-serious), outcome "unknown", described as "extreme immune response".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400279519 same patient, different dose/event;US-PFIZER INC-202400280245 same patient/event, different dose;
Age: 8.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Crying, Impaired quality of life, Pain in extremity, Vaccination site pain
Clinical narrative: Significant pain in administration arm; Significant pain in administration arm; child was in tears; unable to participate in sports; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An 8-year-old female patient received BNT162b2 omicron (kp.2) (PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 FORMULA)), on 15Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 8 years, in arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 15Oct2024), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 16Oct2024, outcome "recovering" and all described as "Significant pain in administration arm"; CRYING (non-serious) with onset 16Oct2024, outcome "recovering", described as "child was in tears"; IMPAIRED QUALITY OF LIFE (non-serious) with onset 16Oct2024, outcome "recovering", described as "unable to participate in sports". Therapeutic measures were taken as a result of pain in extremity, vaccination site pain, crying, impaired quality of life.  Additional information: It is unknown if the patient received any other vaccines within 4 weeks prior to the reported vaccines. It was unknown if the patient was taking any other medications within 2 weeks of the event starting. Treatment received for the adverse events: Tylenol over the counter from mother.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report received from an Other HCP, Program ID.  A 75-year-old male patient received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), in 2024 as dose 1, 0.3 ml single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown; unknown manufacturer), administration date: Nov2022, for Covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2024, outcome "unknown", described as "flu like symptoms".  Additional information: Patient reported that after his and his wife's last covid vaccine they had flu like symptoms and that they were knocked out for 24 hours. Date of last covid vaccine on file from Pharmacy was Nov2022. unknown if and where patient received 2023 covid shot.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient was pregnant, with no reported adverse event; Initial information received on 25-Sep-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 31-year-old female patient who was exposed to vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] in context of patient was pregnant, with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The reported Patient was pregnant when received vaccine, with no reported adverse event occurred at 24 weeks of pregnancy, during second pregnancy trimester.  The date of last menstrual period was reported as 16-Apr-2024.  The estimated due date is 21-Jan-2025.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient was pregnant with twins.  On 25-Sep-2024, the pregnant patient received an unknown dose (dose 1) of suspect Influenza Quadrival A-B High Dose HV Vaccine of lot UT8423JA and expiry date: Jun-2025 via intramuscular route (formulation, strength: not reported) for Prophylactic vaccination (immunization) with no reported adverse event (maternal exposure during pregnancy) (latency: on same day).
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Off label use
Clinical narrative: Intentional Off Label Prescription by HCP: Imovax is prescribed with off label diagnosis Bitten by other mammals, initial encounter with no reported adverse event; Initial information received on 04-Oct-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves Adult and unknown gender patient who had intentional off label prescription by healthcare professional: Ipv (Vero) [Imovax] is prescribed with off label diagnosis code, bitten by other mammals, initial encounter, 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 (1 ml, once) dose of suspect Ipv (Vero), Suspension for injection (strength: not reported) (lot number, expiry date: not reported) via intramuscular route in unknown administration site for Bitten by other mammals, initial encounter (bite), with no reported adverse event (off label use) (latency: same day). Intentional : yes therapeutic purpose: yes Information on batch number and expiration date corresponding to the one at time of event occurrence could not be requested.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: 4 patients greater than 65 years of age were administered Fluzone SD and not Fluzone HD as requested by the patients with no reported adverse event; Initial information received on 04-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 4 patients greater than 65 years of age were administered Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone] and not Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] as requested by the patients with no reported adverse event.  On an unknown date, the patient received a unknown dose of suspect Influenza Quadrival A-B Multidose Vaccine Preserved Suspension for injection (strength, expiry date and lot number not reported) via intramuscular route in unknown administration site for immunization and not administered Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] as requested by the patients with no reported adverse event (wrong product administered) (same day latency). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   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: COVID19, FLU4
Symptoms: Chills, Tremor
Clinical narrative: shaking; chills; Initial information received on 03-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who experienced shaking and chills after receiving (Elasomeran) Spikevax and influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent].  The patient's past vaccination(s) included COVID-19 vaccine. The patient's past medical history, medical treatment(s) and family history were not provided.   On 30-Sep-2024, the patient received an unknown dose of Spikevax not produced by Sanofi Pasteur (formulation, strength, lot number and expiry date not reported) as COVID-19 prophylaxis and received an unknown dose of influenza quadrival A-B high dose HV vaccine (formulation, strength, lot number and expiry date not reported) both via unknown route in unknown administration site as prophylactic vaccination (Immunization).  On 30-Sep-2024 the patient developed shaking (tremor) and chills (latency- same day) following the administration of influenza quadrival A-B high dose HV vaccine and spikevax.  Information on the batch number cannot be requested corresponding to the one at time of event occurrence.  Reportedly, the patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Further information cannot be requested as additional requests for follow-up will not be responded.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of FLUZONE HD to a patient under 65 years old with no adverse event; Initial information received on 08-Oct-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 55 years old male patient and the reporter reported the administration of fluzone hd (INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE) to a patient under 65 years old with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2024, patient under 65 years old was administered INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe 0.5 ml once lot U8515EA expiry- 30-JUN-2025 via intramuscular route in the left deltoid for Immunization (strength unknown) with no adverse event (product administered to patient of inappropriate age) (latency same day).   Physician reported that they administered FLUZONE HD to three patients under the age of 65 years old. Caller stated that the mistake occurred because the boxes for FLUZONE HD and FLUZONE were both white.  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: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: inappropriate use due to administration of vaccines that are no longer viable to use post temperature excursion with no reported adverse event; Initial information received on 06-Sep-2024 regarding an unsolicited non-serious case received from other health professional, this case became valid on 24-Sep-2024  This case involves Hib (Prp/T) Vaccine [Act-Hib] which was inappropriately administered to Infant (unknown gender) patient that are no longer viable to use post temperature excursion, 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 suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection (strength: not reported) which was inappropriately administered, that are no longer viable to use post temperature excursion, with no reported adverse event (poor quality product administered) (lot: UK010AA, Expiry date: 28-Feb-2025 other lot UJ995AA, UK006AA) via unknown route in unknown administration site for immunization.  Reportedly from 8/24/24 to 9/5/24 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 26 patients. All patients involved in this administration range were one year of age.    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.  Based on data previously received, the following information has been amended and processed along with the additional information received on CSD 24-Sep-2024:  deleted document from S. no 8 to 13 as wrong document has been attached in the additional information tab in the case, Deleted references from S.no 9 and 10 and Deleted IPOL as suspect.  Additional information was received on 24-Sep-2024: patient's age group was added, lot details. Based on this information, the case initially considered as non-valid case was upgraded to valid case.; Sender's Comments:  US-SA-2024SA269677:
Age: 49.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired TENIVAC was inadvertently administered to a patient with no AE; Initial information received on 03-OCT-2024 (with the live follow up processed together CSD - 04-OCT-2024) regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 49-year-old male patient who received expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac]  was inadvertently administered to a patient with no adverse event after receiving vaccine.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Sep-2024, the patient received expired dose of 0.5ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids no Preservative Adult Suspension for injection (lot U7183AA, expiry date: 23-SEP-2024) (unknown route) in unknown administration site for Prophylactic vaccination was inadvertently administered with no adverse event (expired product administered) (latency-same day).  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: 1.08
Sex: F
Vaccine: FLU4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: patient not going back to the clinic to receive her second dose of FLUZONE QIV NP so she only received one dose (with no reported adverse event); Initial information received on 04-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13-month-old female patient who not went back to the clinic to receive her second dose of influenza quadrival A-B vaccine [Fluzone QIV] so she only received one dose (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Nov-2023, the patient received a 0.5 ml dose (dose 1) of suspect Influenza Quadrival A-B Vaccine strength: standard and frequency: once Suspension for injection of lot U8230AA and expiry date: 30-Jun-2024 via intramuscular route in the right deltoid as prophylactic vaccination (immunization) who not went back to the clinic to receive her second dose of so she only received one dose (with no reported adverse event) (incomplete course of vaccination) (unknown latency).   Reportedly, Fluzone NP (no preservative) on 04Oct2024, for the 2024 flu season  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: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Gave ACTHIB this morning to a patient but medical assistant only pulled the vaccine and not with the accompanying diluent/used a sterile diluent as opposed to the 0.4% sodium chloride diluent,with no reported adverse event; Initial information received on 04-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received HIB (PRP/T) Vaccine [ACT-HIB] this morning to a patient but medical assistant only pulled the vaccine and not with the accompanying diluent/used a sterile diluent as opposed to the 0.4% sodium chloride diluent,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), Concomitant medications and family history were not provided.   On 04-Oct-2024, the patient received a unknown dose of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot UJ992AA, Expiry date:28-Feb-2025, strength was unknown) via unknown route in unknown administration site for Immunization and gave acthib this morning to a patient but medical assistant only pulled the vaccine and not with the accompanying diluent/used a sterile diluent as opposed to the 0.4% sodium chloride diluent,with no reported adverse event (product preparation issue) (latency : same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to the use of ACTHIB that was reconstituted using a sterile diluent and not its accompanying diluent.Caller wanted to know if there's anything that needs to be done; should the patient be revaccinated?"   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: 9.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: there was a child who received DAPTACEL today but the child is 9 years old, with no reported adverse event; Initial information received on 04-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 years old female patient who received diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel]   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2024, the patient received a dose 5 of 0.5 ml Suspension for injection of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (lot 2CA54C3, expiry date: 07-Apr-2025, strength: standard) via intramuscular route in the left arm. as Immunization (product administered to patient of inappropriate age) (Latency: same day)   Reportedly, Nurse added that the child will soon be needing the Tdap vaccine so she wanted to know how far in between the last dose of DAPTACEL before the patient can receive the Tdap? Nurse confirmed this would have been the patient's fifth dose of DAPTACEL. She confirmed this would have been the patient's fifth dose of DAPTACEL. She also mentioned that patient received her fourth dose at 16 months of age.  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: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal
Clinical narrative: feels weird all over her body; Initial information received on 04-Oct-2024 regarding an unsolicited valid non-serious case received from a patient.  This case involves an 80 years old female patient who felt weird all over her body after receiving Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone Hd].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-SEP-2024, the patient received a dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (unknown lot number, expiry date, dosage, strength and route) in unknown administration site for Prophylactic Vaccination.  On an unknown date in 2024, the patient felt weird all over her body (feeling abnormal) (unknown latency) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Caller stated her pharmacist gave it to her without asking. She was asking what was in it.  Action taken was 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.
Age: 3.0
Sex: U
Vaccine: DTAP
Symptoms: Incorrect route of product administration, Wrong product administered
Clinical narrative: Daptacel is administered subcutaneously inadvertantly to a 3 year old child with no reported adverse event; Initial information received on 05-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 3 years old and unknown gender patient who administered diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] subcutaneously inadvertently.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received inadvertently a dose of suspect Suspension for injection diphtheria-15/tetanus/5 ac pertussis vaccine (lot 2CA77C1, expiry date: 01-Apr-2025, dose, strength, anatomical site was unknown) via subcutaneous route as immunization  (incorrect route of product administration) (unknown latency)   Reportedly, If a dose of Daptacel is administered SubCutaneously inadvertantly to a 3 year old child, what side effects may be anticipated that are different from the ones listed in the package insert? Should the dose be counted or should it be repeated? If it needs to be repeated, how soon after the SQ dose?.   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: 7.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: due to the fridge door being slightly opened on a hot day.Max/low temperature reached: 60.4FDuration: 86 hours and 35 mins with no adverse event; Administered post-excursion? Yes with no adverse event; Initial information received on 08-Oct-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves punctured IPV (VERO) [IPOL] exposed to temperature excursion due to the fridge door being slightly opened on a hot day, max/low temperature reached: 60.4f duration: 86 hours and 35 mins and was administered post-excursion to a 7-year-old female patient with no 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 vaccine) for Immunisation.  On 26-Aug-2024, the patient received 0.5 ml of dose 4 of punctured IPV (VERO) Suspension for injection with standard strength (lot W1B511M and expiry date- 30-Sep-2025) once via intramuscular route in the left thigh as Immunization exposed to temperature excursion due to the fridge door being slightly opened on a hot day max/low temperature reached: 60.4f duration: 86 hours and 35 mins and was administered post-excursion with no adverse event (product storage error) (unknown latency), (poor quality product administered) (latency- same day). Human error was involved.   Information on the batch number was requested corresponding to the one at time of event occurrence.  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: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Somnolence
Clinical narrative: felt sleepy; tired; some chills; Initial information received on 08-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/Non-Healthcare Professional.  This case involves 81 year old elderly female patient who had felt sleepy, tired and some chills after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd].  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 Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (unknown lot number, expiry date, strength, dosage and route) in unknown administration site for Immunization.  On an unknown date the patient developed felt sleepy (somnolence), tired (fatigue) and some chills (chills) (unknown latency) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine.  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, the patient stated that she is on her late 80s. She wanted to know if these are side effects of the vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was unknown for all the events.
Age: 0.67
Sex: U
Vaccine: MEN, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertently administered MENQUADFI instead of the intended dose of MENVEO with no adverse event; Initial information received on 08-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 8 months old and unknown gender patient who was inadvertently administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] instead of the intended dose of menveo(Meningococcal Vaccine A/C/Y/W Conj (CRM197)) with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (Solution for injection) strength, expiry date, lot number not reported via unknown route in unknown administration site and unknown dose of suspect MENVEO not produced by Sanofi Pasteur formulation, strength, expiry date, lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunization) and inadvertently administered menquadfi instead of the intended dose of menveo with no adverse event (wrong product administered) (latency: same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to administration of product outside of approved product labeling.   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: 52.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Axillary pain, Influenza like illness, Malaise, Oedema peripheral, Pruritus
Clinical narrative: I was sick (flu like symptoms, painful swelling in right armpit) for 2 days after the vaccination, then on the 3rd day I developed itchy weals in two localized spots (right hip, left upper thigh). They are still active and cycle through seeming to get better and then flaring up again about once every 24 hours. I am going to see a doctor about it later this week.
Age: 52.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Urticaria
Clinical narrative: I was sick (flu like symptoms, painful swelling in right armpit) for 2 days after the vaccination, then on the 3rd day I developed itchy weals in two localized spots (right hip, left upper thigh). They are still active and cycle through seeming to get better and then flaring up again about once every 24 hours. I am going to see a doctor about it later this week.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Malaise, Pain in extremity
Clinical narrative: Mild headache, chills, fever (101 F - normal temperature is 97.6 F); VERY sore arm and felt unwell. I didn't really feel nauseous, but didn't feel like eating much either.  I don't know the exact number of Covid shots I've had but I had all available since the beginning of covid-19. All shots I have had were Pfizer. This was the first time I have had ANY side effects from ANY vaccines, other than a slight to somewhat mild sore arm. I would doze off and on and every time I got up for the bathroom, the chills would hit. After sleeping again and waking up at approximately 4:20 a.m. on Monday, October 21st, the chills were gone and I felt okay. Even the arm wasn't as sore!! It felt better over that day.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mild headache, chills, fever (101 F - normal temperature is 97.6 F); VERY sore arm and felt unwell. I didn't really feel nauseous, but didn't feel like eating much either.  I don't know the exact number of Covid shots I've had but I had all available since the beginning of covid-19. All shots I have had were Pfizer. This was the first time I have had ANY side effects from ANY vaccines, other than a slight to somewhat mild sore arm. I would doze off and on and every time I got up for the bathroom, the chills would hit. After sleeping again and waking up at approximately 4:20 a.m. on Monday, October 21st, the chills were gone and I felt okay. Even the arm wasn't as sore!! It felt better over that day.
Age: 1.17
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, MMR, PNC21, UNK, VARCEL
Symptoms: Arthropod bite, Laboratory test normal, Oral disorder, Pustule, Pyrexia
Clinical narrative: High fever and rash starting approximatly one week after the vaccinations. Additional bumps appearing later that week. Turned into full blown chicken pox I think by 10 days after vaccination. Still battling chicken pox infection today 10/23/2024:( Pussing and weeping sores.
Age: 1.17
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, MMR, PNC21, UNK, VARCEL
Symptoms: Rash, Skin weeping, Streptococcus test negative, Varicella
Clinical narrative: High fever and rash starting approximatly one week after the vaccinations. Additional bumps appearing later that week. Turned into full blown chicken pox I think by 10 days after vaccination. Still battling chicken pox infection today 10/23/2024:( Pussing and weeping sores.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Pain
Clinical narrative: Shingles/shingles all over her back; pain; Frail; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles/shingles all over her back), pain (Verbatim: pain) and weakness (Verbatim: Frail). The outcome of the shingles, pain and weakness were not reported.   It was unknown if the reporter considered the shingles, pain and weakness to be related to Shingles vaccine.     It was unknown if the company considered the shingles, pain and weakness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-OCT-2024 This case was reported by a patient via interactive digital media. The reported stated that not to take the shingles shot. The reporter mother was talked into it a few days later she had shingles all over her back. The patient pain was unbearable for a frail old woman.
Age: 68.0
Sex: M
Vaccine: YF
Symptoms: Wrong technique in product usage process
Clinical narrative: - LPN gave Yellow Fever vaccine and made an error. CDC has escalated the vase to validate validity of vaccine. Will receive a response after Yellow Fever committee has reviewed and made a decision.  CDC case #: CDC-3292236-W30956 - LPN called the manufacturer Sanofi Pasteur. they stated that the vaccine is invalid and would need to be given again to the Pt 28 days after the first one was provided.  Called patient to inform patient that Yellow Fever vaccine was administered improperly by the nurse in the clinic inadvertently and the patient may not have coverage of the YF vaccine, althought pt has obtained a YF admission card. Patient was advised to return to clinic per YF manufacture instructions especially if the patient has further plans for travel in countries that have a mandatory policy for the administration of YF vaccine. Patient expressed understanding of recommendation to return in 28 days for additional dose of YF to be fully vaccinated due to error in administration today.
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: We have had multiple reports of the pre-filled influenza vaccine syringes leaking during administration. The vaccine appears to be leaking from the connecting hub prior to where the needle connects to the syringe. This has been reported with both Sanofi Pasteur and GlaxoSmithKline influenza vaccines. We have had 9 reports of this throughout our ambulatory clinics so far. This has resulted in inadequate doses administered, revaccination, and once incident of the vaccine squirting into an employee's eye.
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: We have had multiple reports of the pre-filled influenza vaccine syringes leaking vaccine during administration. The vaccine appears to be leaking from the connecting hub prior to where the needle connects to the syringe. This has been reported with Sanofi Pasteur and GlaxoSmithKline influenza vaccines. We have had 9 reports of this throughout our ambulatory clinics so far. This has resulted in an inadequate dose administered to the patient, and patients have had to be revaccinated.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site warmth
Clinical narrative: Patient received a shingles vaccine on Friday (10/18/2024). Came to the pharmacy with injection site reaction on Monday 10/21/2024. Area seemed inflamed and bit warm to touch (per patient). We checked this vitals, all normal. Gave the patient benedryl and asked him to follow up with us tomorrow morning.
Sex: U
Vaccine: TDAP
Symptoms: Syringe issue
Clinical narrative: While given Tdap (Lot# U8231AA) syringe malfunctioned. Medication would not push in.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Pt received moderna 24-25 vaccine on 8/3/24. She stated about 5 days later she developed vertigo. She still has the vertigo, it occurs whenever she is walking.
Sex: U
Vaccine: FLUX
Symptoms: Infection
Clinical narrative: Patient received his flu shot 4 weeks ago and mentions later in the call that he has had an infection and is just now getting over the infection. patient did not consent to follow-up. AE-51727. No further information provided or available regarding this report.