chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I became infected with Covid from a gathering of 6 thousand people; I became infected with Covid from a gathering of 6 thousand people/Suspected COVID-19; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "I became infected with Covid from a gathering of 6 thousand people"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "I became infected with Covid from a gathering of 6 thousand people/Suspected COVID-19". Clinical course: patient write to say thank you for the vaccine. patient family and patient became infected with Covid from a gathering of 6 thousand people. If it were not for the vaccine, patient family and patient would have possibly lost several family members.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I never got Covid, UNTIL 26May; I never got Covid, UNTIL 26May; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26May2023, outcome "unknown" and all described as "I never got Covid, UNTIL 26May". The patient believed the patient was part of the survey that ended in April or early May this year, the patient never got Covid, Until 26May. Since the survey ended, The patient was unable to report it. + (positive) Covid test, The patient stated. "Grateful I was vaccinated including the bivalent." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300290740 same patient/drug, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a few sore arms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2), 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a few sore arms".  Additional information: Patient did have a relatively high opinion of Pfizer because his wife and him had received their Covid-19 shots and boosters from this company and they had practically no side effects to date apart from a few sore arms for a day or two.  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-202300290946 same patient/AE, vaccine different dose;US-PFIZER INC-202300290947 same patient/AE, vaccine different dose;US-PFIZER INC-202300290948 same reporter/AE, different patient;US-PFIZER INC-202300290949 same reporter/AE, different patient;US-PFIZER INC-202300290950 same reporter/AE, different patient;
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: patient was supposed to receive a dose of plain acthib (prp-t), but consumer got hib conjugated with dtap and a separate dtap as well with no reported adverse event; patient was supposed to receive a dose of plain acthib (prp-t), but consumer got hib conjugated with dtap and a separate dtap as well with no reported adverse event; Initial information received on 28-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who was supposed to receive a dose of plain HIB (PRP/T) vaccine [ACT-HIB] but consumer got hib conjugated with dtap and a separate dtap as well with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Prophylactic vaccination (immunization).  On 08-Jun-2023, the patient received a dose 4 dose 0.5mL but consumer got it twice making it 1 mL of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot UJ794AA expiry date: 08-Oct-2023 via intramuscular route in the thigh not specified for Immunization.  On 08-JUN-2023 the patient was supposed to receive a dose of plain acthib (prp-t), but consumer got hib conjugated with dtap and a separate dtap as well with no reported adverse event (wrong product administered) (extra dose administered) on the same day following the administration of HIB (PRP/T) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: they administered ADACEL to a 71-year-old patient with no reported adverse event; Initial information received on 28-Aug-2023 regarding an unsolicited valid non-serious case received via pharmacist.  This case involves, administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] to a 71-year-old patient with no reported adverse.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine INACT SPLIT 3V (Fluzone High Dose) for Prophylactic vaccination.  On 23-Aug-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength: unknown) (lot: U7648AA, Expiry date: 15-Feb-2025) via intramuscular route in the right deltoid for Immunization and they administered adacel to a 71-year-old patient with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  Action taken with diphtheria, tetanus and acellular pertussis vaccine (Adacel) was not applicable.  Outcome: Unknown.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: RAB
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms; body aches; mild fever; chills; headache; Initial information received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves an unknown age male patient who experienced Flu like symptoms, body aches, mild fever, chills and headache after receiving Rabies (Hdc) Vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Aug-2023, the patient received an unknown dose of suspect Rabies (Hdc) Vaccine Powder and solvent for suspension for injection (With an unknown expiry date, lot number and strength) via unknown route in unknown administration site for immunization.  Information on the batch number was requested.  On an unknown date, the patient developed events of flu like symptoms (influenza like illness), body aches (pain), mild fever (pyrexia), chills and headache (latency: Approximately 5 days).  Relevant laboratory test results included: Body temperature - On an unknown date: [temperature:Unknown, mild Fever]  It was reported, Patient reports that he received the first of the IMOVAX RABIES vaccine about 5 days ago and has since started feeling sick with flu-like symptoms (mild fever, body aches, chills, and headache) and he wants to know if this is a normal side effect.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the reported events.  At time of reporting, the outcome was Unknown for the reported events
Age: 0.08
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: to improper preparation and administration of PENTACEL with no adverse event; Initial information was received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 2 months old male patient who reported that improper preparation and administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Aug-2023, the patient received a unknown dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization and mproper preparation and administration of pentacel with no adverse event (product preparation error) (latency : same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine. The information on batch number was requested.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event to improper preparation and administration of pentacel with no 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.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: expired ACT-HIB was administered with no reported adverse event; Initial information received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2023SA264881(CLUSTER).  This case involves female patient of an unknown age who administered expired Hib (PRP/T) Vaccine [Act-Hib] 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 Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar) for Prophylactic vaccination.  On 21-Aug-2023, the patient received a expired dose of 0.5 ml of suspect Hib (PRP/T) Vaccine Powder and solvent for solution for injection (frequency: once, strength: standard, expiry date: 10-Aug-2023 and lot UJ739ABA) via intramuscular route in unknown administration site for immunization (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: infant was given an expired dose of Act-HIB with no reported adverse event; Initial information received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from Nurse.  This case involves a 1-years-old female patient who was given an expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine (Hepatitis A); pneumococcal vaccine; measles vaccine, mumps vaccine, rubella vaccine (MMR); and varicella zoster vaccine for Prophylactic vaccination (Immunization).  On 29-Aug-2023, the patient received 0.5 mL dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (Frequency: once; Strength: standard) (batch number: UJ796AA; expiry date: 12-Aug-2023) via intramuscular route in right thigh for Immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.  No additional information provided.  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: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: adacel that was exposed to a reported temperature excursion was administered to a patient with no reported adverse event; Initial information was received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] that was exposed to a reported temperature excursion was administered to a 25 years old male patient 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 28-Aug-2023, a dose 2 of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (strength: standard) at dose of 0.5 ml (lot number: U78708A, expiration date: 23-Aug-2025) via intramuscular route in Deltoid NOS for Immunization (immunisation) that was exposed to a reported temperature excursion was administered to a patient with no reported adverse event (poor quality product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event adacel that was exposed to a reported temperature excursion was administered to a patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: patient was accidentally given a dose of Menactra with no reported adverse event; Initial information received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 5 years old male patient where patient was accidentally given a dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine and diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine INACT 3V (MRC 5), tetanus vaccine toxoid (Quadracel) for Prophylactic vaccination.  On 26-Jul-2023, the patient received 0.5 ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine Solution for injection (lot: 7595AC) via intramuscular route in the right thigh (strength and expiration date: not provided) for Immunization (wrong product administered) (latency- same day).  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: patient received a dose of ActHIB instead of the intended dose of Pentacel with no reported adverse event; Initial information received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4-month-old male patient who received a dose of HIB (PRP/T) vaccine [ACT-HIB] instead of the intended dose of Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ 13V (CRM197) (Prevnar 13) and Rotavirus Vaccine Live Reassort ORAL 5V (Rotateq) for Prophylactic vaccination.  On 29-Aug-2023, the patient received a dose 2 of suspect HIB (PRP/T) vaccine (Frequency: ONCE) Powder and solvent for solution for injection of standard strength with unknown batch number & expiry date via intramuscular route in unknown administration site for Immunization instead of the intended dose of Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event (wrong product administered) (latency: same day).  Information on batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of expired vaccine to a patient with no reported adverse event; Initial information received on 30-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who had administration of expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Aug-2023, the patient received an expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection at a dose of 0.5 mL (lot U7092AA, expiry date- 24-JUN-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day).  Reportedly, Pharmacist requested information on what is recommended if a patient was inadvertently administered an expired TENIVAC. He did not know if the patient had received any concomitant vaccines and did not have information on where on the body the vaccine was administered.  Action taken 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: at the 6 month mark, the liquid portion only was given instead with the powder (act-hib component) with no reported adverse event; Initial information received on 30-Aug-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 6 months old and unknown gender patient who was given diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] at the 6 month mark, the liquid portion only was given instead with the powder (act-hib component) with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunization (product preparation error) (latency- same day).  Patient got PENTACEL at the 2 month, 4 month and plans to get for the 12 - 15 months mark but at the 6 month mark, the liquid portion only was given instead with the powder (ACT-HIB component). The caller is asking if the patient is completely protected because they've gotten all of PENTACEL at 2 months and all of PENTACEL at 4 months then they missed the powder potion at the 6th month and they are going to get all PENTACEL at 12 to 15 month.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of act-hib was administered with no reported adverse event; Initial information received on 30-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and gender patient who was administered expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Aug-2023, the patient received unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (batch number: UJ796AA; expiry date: 12-Aug-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (same day latency).  Action taken with haemophilus type B (HIB) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of act-hib was administered 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: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was administered with two FLUZONE HD QIV at the same time with no reported adverse event; Initial information received on 31-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 78 years old male patient who was administered with two Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High Dose Quadrivalent] at the same time with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Aug-2023, the patient received two times a 0.5 dose of suspect Influenza Quadrival A-B High Dose HV Vaccine (lot UT8057AA, Expiry date: 30-Jun-2024 with unknown strength) via intramuscular route in the left arm and right arm as Immunization with no reported adverse event (extra dose administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash, Urticaria
Clinical narrative: Hives; Skin rash; This spontaneous case was received on 24-Aug-2023 from a pharmacist via Communications (reference number: SEQW23-01845) and concerned a 72-year-old, female patient.  The patient's concurrent conditions included cancer and allergy to H1N1. The patient's procedures included chemotherapy or radiation. The patient's concomitant medications included B12 (cyanocobalamin) injection, used for an unreported indication.  On 19-Aug-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration and anatomical location: not reported) for influenza prevention vaccination. The batch number reported was 346336.  On an unspecified date in Aug-2022, reported as 24 hours after receiving Fluad Quadrivalent, the patient had hives and skin rash appeared. The patient took anti-histamine to improve symptoms. The patient felt better.  On an unspecified date, the patient recovered from all events. As reported, no issues after resolution of skin problems.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 72-year-old, female patient was vaccinated with Fluad Quadrivalent. Reportedly, within 24 hours following vaccination, patient experienced rash, and urticaria. Patient took antihistamine and felt better. The patient's concurrent conditions included allergy to H1N1. Causality is assessed as possibly related, due to plausible temporal relationship.; Sender's Comments: A 72-year-old, female patient was vaccinated with Fluad Quadrivalent. Reportedly, within 24 hours following vaccination, patient experienced rash, and urticaria. Patient took antihistamine and felt better. The patient's concurrent conditions included allergy to H1N1. Causality is assessed as possibly related, due to plausible temporal relationship.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Tremor
Clinical narrative: Fluttering of the right temple every hour daily. Sore arm.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue, Single component of a two-component product administered
Clinical narrative: administered only the liquid component of the Arexvy vaccine and not the powder; administered only the liquid component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 80-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2B775, expiry date 13-DEC-2024) for prophylaxis.   On 23-AUG-2023, the patient received Arexvy. On 23-AUG-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: administered only the liquid component of the Arexvy vaccine and not the powder) and inappropriate dose of vaccine administered (Verbatim: administered only the liquid component).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 28-AUG-2023 A pharmacist reported that a patient was administered only the liquid component of the Arexvy vaccine and not the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Healthcare professional planning on revaccinating the patient.  The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient received only the DTAP-IPV component of PENTACEL and that they did not reconstitute the HIB component so the patient did not get that part (with no reported adverse event); patient received only the DTAP-IPV component of PENTACEL and that they did not reconstitute the HIB component so the patient did not get that part (with no reported adverse event); Initial information received on 31-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 2-month-old female patient received only the dtap-ipv component of diphtheria/tetanus/5 hybrid AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and that they did not reconstitute the hib component so the patient did not get that part (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 for Prophylactic vaccination; pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination; and rotavirus vaccine for Prophylactic vaccination.  On 31-Aug-2023, the patient received a 0.5 ml total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength: unknown) (lot: UJ851AA, expiry date: 01-Apr-2024) via intramuscular route in the right thigh for Immunization and patient received only the dtap-ipv component of pentacel and that they did not reconstitute the hib component so the patient did not get that part (with no reported adverse event) (product preparation issue and incorrect product formulation administered) (latency: same day).  Action taken with diphtheria, tetanus, AC pertussis, IPV and HIB vaccine (Pentacel (VERO)) was not applicable.  Outcome: Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: broke out painful like shingles; broke out in his whole body (mentioning stomach, back, arms, thighs) broke out is described painful like shingles; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-AUG-2023, the patient received Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: broke out painful like shingles) and general body pain (Verbatim: broke out in his whole body (mentioning stomach, back, arms, thighs) broke out is described painful like shingles).  The outcome of the shingles was not reported and the outcome of the general body pain was unknown.   The reporter considered the shingles and general body pain to be possibly related to Shingrix.     The company considered the shingles and general body pain to be possibly related to Shingrix.   Additional Information: GSK Receipt date: 28-AUG-2023 A pharmacist reported that a patient broke out in his whole body (mentioning stomach, back, arms, thighs) broke out was described painful like shingles by pharmacist. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix in 2018, the second dose was administered on July 13th 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number MS4G9, expiry date 01-SEP-2023) for prophylaxis.   Previously administered products included Shingrix (In 2018, received first dose).   On 13-JUL-2023, the patient received the 2nd dose of Shingrix. On 13-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of Shingrix in 2018, the second dose was administered on July 13th 2023).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 29-AUG-2023 The reporter called to ask for information about a patient who received the first dose of Shingrix in 2018, and second dose was administered in 2023. The reporter asked if the vaccination was completed or if the patient need to re-start the series. The reporter consented to follow up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Aspiration pleural cavity, COVID-19, Cardiac failure congestive, Chronic obstructive pulmonary disease, Computerised tomogram thorax abnormal
Clinical narrative: acute dyspnea rquiring 10L simple facemask. DC from hosp yesterday, neg COVID during that admission. Did not swab in ER. Malodorus urine, CT chest shows large bilat effusions.  O2 6L NC and lasix, acute CHF. COPD, exacerbation. RRT called, transfer to PCU, placed on bipap. thoracentesis done 1400 ml fluid removed.  pt continued to declined, +COVID test 11/17. dexamethasone, singulair, Vit C&D, zinc. no toci d/t bacteremia. PT DNR. maxed out on bipap. Pt continuously pulling bipap off, then desats. Pt found with bipap off, unresponsive, ambu bag, bipap replaced, sats not above 65%.  palliatvie care on board, care withdrawn.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, General physical health deterioration, Intensive care, Intentional medical device removal by patient
Clinical narrative: acute dyspnea rquiring 10L simple facemask. DC from hosp yesterday, neg COVID during that admission. Did not swab in ER. Malodorus urine, CT chest shows large bilat effusions.  O2 6L NC and lasix, acute CHF. COPD, exacerbation. RRT called, transfer to PCU, placed on bipap. thoracentesis done 1400 ml fluid removed.  pt continued to declined, +COVID test 11/17. dexamethasone, singulair, Vit C&D, zinc. no toci d/t bacteremia. PT DNR. maxed out on bipap. Pt continuously pulling bipap off, then desats. Pt found with bipap off, unresponsive, ambu bag, bipap replaced, sats not above 65%.  palliatvie care on board, care withdrawn.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pleural effusion, Positive airway pressure therapy, SARS-CoV-2 test positive, Therapy cessation
Clinical narrative: acute dyspnea rquiring 10L simple facemask. DC from hosp yesterday, neg COVID during that admission. Did not swab in ER. Malodorus urine, CT chest shows large bilat effusions.  O2 6L NC and lasix, acute CHF. COPD, exacerbation. RRT called, transfer to PCU, placed on bipap. thoracentesis done 1400 ml fluid removed.  pt continued to declined, +COVID test 11/17. dexamethasone, singulair, Vit C&D, zinc. no toci d/t bacteremia. PT DNR. maxed out on bipap. Pt continuously pulling bipap off, then desats. Pt found with bipap off, unresponsive, ambu bag, bipap replaced, sats not above 65%.  palliatvie care on board, care withdrawn.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Urine odour abnormal
Clinical narrative: acute dyspnea rquiring 10L simple facemask. DC from hosp yesterday, neg COVID during that admission. Did not swab in ER. Malodorus urine, CT chest shows large bilat effusions.  O2 6L NC and lasix, acute CHF. COPD, exacerbation. RRT called, transfer to PCU, placed on bipap. thoracentesis done 1400 ml fluid removed.  pt continued to declined, +COVID test 11/17. dexamethasone, singulair, Vit C&D, zinc. no toci d/t bacteremia. PT DNR. maxed out on bipap. Pt continuously pulling bipap off, then desats. Pt found with bipap off, unresponsive, ambu bag, bipap replaced, sats not above 65%.  palliatvie care on board, care withdrawn.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Cardiac arrest, Encephalopathy, Endotracheal intubation
Clinical narrative: from NH in cardiac arrest, cpr started by EMS. EPI x2 given by EMS, ROSC after second dose of EPI. Pt intubated.  Acute encephalopath, acute hypoxic resp failuCOVID +. on multiple pressors, neo, bicarb. no urine output, bolus given. decadron for COVID. transition to comfort care
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Resuscitation, SARS-CoV-2 test positive, Urine output decreased
Clinical narrative: from NH in cardiac arrest, cpr started by EMS. EPI x2 given by EMS, ROSC after second dose of EPI. Pt intubated.  Acute encephalopath, acute hypoxic resp failuCOVID +. on multiple pressors, neo, bicarb. no urine output, bolus given. decadron for COVID. transition to comfort care
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Fatigue
Clinical narrative: Presented with fatigue x3d, body aches; + covid 10/15; CXR:        dx Covid PNA; Labs: D-dimer: 0.67, CRP 10.9; Ferritin 470     Meds: Decadron, Zinc, Vit C, Lovenox, Remdesivir;  Initially on 3 LPM NC; down to 1 LPM at time of dc (baseline is room air); Home on 1 LPM O2, Decadron, zinc and Vit C
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Pain, SARS-CoV-2 test positive, Serum ferritin increased
Clinical narrative: Presented with fatigue x3d, body aches; + covid 10/15; CXR:        dx Covid PNA; Labs: D-dimer: 0.67, CRP 10.9; Ferritin 470     Meds: Decadron, Zinc, Vit C, Lovenox, Remdesivir;  Initially on 3 LPM NC; down to 1 LPM at time of dc (baseline is room air); Home on 1 LPM O2, Decadron, zinc and Vit C
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure congestive, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea
Clinical narrative: Presented with SOB; Acute CHF and COPD exacerbation; Rec'd covid booster 2 days PTA  Labs:  D-dimer 0.59;    TX: Steroids and doxycycline; + covid 10/22 ; back to baseline home O2 at discharge
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, SARS-CoV-2 test positive
Clinical narrative: Presented with SOB; Acute CHF and COPD exacerbation; Rec'd covid booster 2 days PTA  Labs:  D-dimer 0.59;    TX: Steroids and doxycycline; + covid 10/22 ; back to baseline home O2 at discharge
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood lactic acid, C-reactive protein increased, COVID-19, COVID-19 pneumonia
Clinical narrative: Presented with wekaness, fever, SOB; +Covid 15 days PTA; Dx Covid PNA; Labs: D-dimer: 2.35; Ferritin: 422;  CRP: 20.2; Lactic Acid 2.3    Tx:  supplemental O2; Tocilizumab, steroids, Vit C, Zinc, singulair, Tessalon Perles; No remdesivir as out of window to recieve. Home on O2 and continuing steroids
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fibrin D dimer, Pyrexia, SARS-CoV-2 test positive, Serum ferritin increased
Clinical narrative: Presented with wekaness, fever, SOB; +Covid 15 days PTA; Dx Covid PNA; Labs: D-dimer: 2.35; Ferritin: 422;  CRP: 20.2; Lactic Acid 2.3    Tx:  supplemental O2; Tocilizumab, steroids, Vit C, Zinc, singulair, Tessalon Perles; No remdesivir as out of window to recieve. Home on O2 and continuing steroids
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, C-reactive protein, COVID-19, COVID-19 pneumonia, Cardiac arrest
Clinical narrative: Presented after OOH arrest; recent covid infection; + covid in ED, unknown onset of symptoms Dx: Covid PNA, sepsis; Labs: D-dimer 4.18; CRP 4.9; Ferritn 412; Procal 1.27 Tx: Intubated on arrival; extubated on 1/26; 1/27 resp arrest;  reintubated; 2/4 extubated; 2/11 reintubated; 2/15 trach/peg  Meds: Decadron, antibiotics, heparin, vasopressors intially  Discharged to LTAC
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Endotracheal intubation, Fibrin D dimer, Gastrostomy, Malaise, Procalcitonin
Clinical narrative: Presented after OOH arrest; recent covid infection; + covid in ED, unknown onset of symptoms Dx: Covid PNA, sepsis; Labs: D-dimer 4.18; CRP 4.9; Ferritn 412; Procal 1.27 Tx: Intubated on arrival; extubated on 1/26; 1/27 resp arrest;  reintubated; 2/4 extubated; 2/11 reintubated; 2/15 trach/peg  Meds: Decadron, antibiotics, heparin, vasopressors intially  Discharged to LTAC
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory arrest, SARS-CoV-2 test positive, Serum ferritin increased, Tracheostomy
Clinical narrative: Presented after OOH arrest; recent covid infection; + covid in ED, unknown onset of symptoms Dx: Covid PNA, sepsis; Labs: D-dimer 4.18; CRP 4.9; Ferritn 412; Procal 1.27 Tx: Intubated on arrival; extubated on 1/26; 1/27 resp arrest;  reintubated; 2/4 extubated; 2/11 reintubated; 2/15 trach/peg  Meds: Decadron, antibiotics, heparin, vasopressors intially  Discharged to LTAC
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Cough, Dyspnoea, Haemoptysis, Pleural effusion
Clinical narrative: Presented with hemoptysis/dyspnea, fever, cough; CXR: bil pleural effusions TX: Lasix, Steroids, doxycycline, zinc,
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Presented with hemoptysis/dyspnea, fever, cough; CXR: bil pleural effusions TX: Lasix, Steroids, doxycycline, zinc,
Age: 79.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Red raised rash from upper arm half way down to elbow
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored vaccines administered; This spontaneous report was received from other and refers to some patients. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 28-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, three dose series, lot #W014513, expiration date: 26-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).  On 28-JUL-2023, 5 patients in total and additional patients were administered the affected hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) from the lot involved in a temperature excursion at the same location (Product storage error). No adverse events reported (No adverse event).  This is a non-valid case due to no patient's identifiers.  Follow up information has been received from an other health professional on 09-AUG-2023 and refers to a 12-year-old female patient. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) (lot # 213723, expiration date: 17-OCT-2025 via Right Deltoid) and meningococcal vaccine conj (lot # AMVA767A, expiration date: ??-DEC-2023 via Left Deltoid). The date of the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was 04-AUG-2023 via Left Deltoid.  This is one of several reports from same reporter. ; Sender's Comments:  US-009507513-2309USA000747: US-009507513-2309USA000746: US-009507513-2309USA000745: US-009507513-2309USA000744: US-009507513-2309USA000743: US-009507513-2309USA000748: