chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MENB
Symptoms: Intercepted product prescribing error
Clinical narrative: 69 years old patient was prescribed Bexsero; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 69-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Concurrent medical conditions included immunocompromised, cancer and multiple sclerosis.   On an unknown date, the patient did not receive Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced intercepted drug prescribing error (Verbatim: 69 years old patient was prescribed Bexsero). The outcome of the intercepted drug prescribing error was unknown.   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: 20-MAR-2024 The pharmacist had a box which said age 10 to 25 years. The patient was immunocompromised and had cancer and multiple sclerosis. The doctor wrote a prescription for him and pharmacist was not sure if it could be given to patient. The patient did not received the Bexsero vaccine which led to Intercepted drug prescribing error. The reporter consented to follow up.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: a patient was administered a Fluarix dose on 10/19/2023 and the patient received a second/extra dose on 12/11/2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 21-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 9CE79, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT).   On 11-DEC-2023, the patient received Fluarix Quadrivalent 2023-2024 season. On 11-DEC-2023, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: a patient was administered a Fluarix dose on 10/19/2023 and the patient received a second/extra dose on 12/11/2023). The outcome of the extra dose administered was unknown.   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: 21-MAR-2024 The reporter was a registered nurse or nurse manager. The reporter called to inquire for any information on a patient receiving 2 doses of Fluarix, any harm to the patient. The reporter reported a patient was administered a Fluarix dose and the patient received a second/extra dose. The reporter did not consent to follow up.
Sex: F
Vaccine: RSV
Symptoms: Cough
Clinical narrative: she developed a cough; This non-serious case was reported by a consumer via call center representative and described the occurrence of cough in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In DEC-2023, the patient received the 1st dose of Arexvy (intramuscular). In FEB-2024, 2 months after receiving Arexvy, the patient experienced cough (Verbatim: she developed a cough). The outcome of the cough was not resolved.   It was unknown if the reporter considered the cough to be related to Arexvy.   It was unknown if the company considered the cough to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-Mar-2024 The reporter was the patient. About two months later, in late FEB-2024, the patient developed a cough. The cough came and went. The patient currently had the cough. Nothing else was reported. The reporter did not consented to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: dispense to patients who are institutionalized and under 60.; they dispense to patients who are institutionalized and under 60; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dispensing error in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced drug dispensing error (Verbatim: dispense to patients who are institutionalized and under 60.) and inappropriate age at vaccine administration (Verbatim: they dispense to patients who are institutionalized and under 60). The outcome of the drug dispensing error and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 25-Mar-2024 The reporter reported that they dispensed Arexvy vaccine to the patients who are institutionalized and under 60, which led to drug dispensing error and inappropriate age at vaccine administration  The reporter wanted to know how set in stone the age limit was for Arexvy and do they need any documentation for this since they dispense it to patients who are under 60. The reporter did not consent to follow up.
Age: 44.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via eye contact
Clinical narrative: Accidental Exposure; vaccine got into the administrator's eye/squirted into his eye; This non-serious case was reported by a consumer via call center representative and described the occurrence of accidental exposure while administering drug in a 44-year-old male patient who received Herpes zoster (Shingrix) (batch number 2YC74, expiry date 25-JAN-2026) for prophylaxis.   On 26-MAR-2024, the patient received Shingrix. On 26-MAR-2024, an unknown time after receiving Shingrix, the patient experienced accidental exposure while administering drug (Verbatim: Accidental Exposure) and exposure via eye contact (Verbatim: vaccine got into the administrator's eye/squirted into his eye). The outcome of the accidental exposure while administering drug and exposure via eye contact were unknown.   Additional Information: GSK receipt date: 26-MAR-2024 The reporter was an office manager for a medical practice, and reported that Physician in the practice was administering Shingrix to a patient today (on the day of reporting), and part of the vaccine got into the administrator's eye or quirted into his eye (AE Filed Accidental Exposure).  The reporter had no further information to provide about this adverse event. The administrator accidental had eye contact which led to accidental exposure while administering drug and exposure via eye contact. Call Notes:I did not ask for consent to follow up with the HCP.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a female patient received the first dose of Shingrix on December 8th 2020 and they do not have registers of administration of the second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 08th December 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: a female patient received the first dose of Shingrix on December 8th 2020 and they do not have registers of administration of the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-MAR-2024 Pharmacy intern student reported that a female patient received the first dose of Shingrix and they did not have registers of administration of the second dose, which led to incomplete course of vaccination. The Vaccine Administration Facility was the same as Primary Reporter The reporter asked if should restart the series The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Shingrix was injected subcutaneously to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number H379C) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Shingrix was injected subcutaneously to a patient). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 27-MAR-2024 The reporter reported that the Shingrix vaccine was injected subcutaneously to a patient, which led to intramuscular formulation administered by other route. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up.
Age: 0.08
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: they gave a baby the adult dose of RSV (Arexvy) today at 12 PM; they gave a baby the adult dose of RSV (Arexvy) today at 12 PM; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-week-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 39TY3, expiry date 28-APR-2026) for prophylaxis.   On 28-MAR-2024 12:00, the patient received Arexvy. On 28-MAR-2024 12:00, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: they gave a baby the adult dose of RSV (Arexvy) today at 12 PM) and inappropriate age at vaccine administration (Verbatim: they gave a baby the adult dose of RSV (Arexvy) today at 12 PM). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 28-Mar-2024 The reporter reported they gave a baby the adult dose of RSV Arexvy vaccine today at 12 PM, which led to wrong vaccine used and inappropriate age at vaccine administration. The reporter asked if the baby patient still needs to came back and get the recommended vaccine/dose for babies. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received Shingrix on 13Jul2023 and 19Aug2023. He is not immunocompromised; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 19-AUG-2023, the patient received the 2nd dose of Shingrix. On 19-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient received Shingrix on 13Jul2023 and 19Aug2023. He is not immunocompromised). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-MAR-2024 The patient was not immunocompromised. The reporter did not have lot number or expiration date for the 2nd dose as it was given elsewhere. The reporter consented to follow up. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Sex: F
Vaccine: COVID19
Symptoms: Blood disorder
Clinical narrative: STRANGE BLOOD ISSUE; This spontaneous report received from a patient on J&J managed social media, concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration not reported) administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date in MAR-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced  strange blood issue (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of strange blood issue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: having hair fall after taking the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (having hair fall after taking the vaccine) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (having hair fall after taking the vaccine). At the time of the report, ALOPECIA (having hair fall after taking the vaccine) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt yucky; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (felt yucky) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Knee pain.    On 19-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt yucky). At the time of the report, FEELING ABNORMAL (felt yucky) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was unknown that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. It was reported that knee pain was caused by bone on bone that has been X-rayed and not related to any immunization or medication." She was also fully vaccinated previously. Patient had a history of knee pain and scheduled to receive a steroid knee injection on Tuesday 02-APR-2024. Patient also received Spikevax dose on 01-APR-2024 with Lot 3032712. The treatment medication was not reported by reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT RECEIVED A COVID SHOT ON  03/15/2024, AND REPORT THAT SHE IS AVING PAIN ON HER RIGHT ARM TO THE POINT WHERE SHE CAN'T MOVE HER ARM OR PUT HER SEAT BELT WHIE SHE IS IN THE CAR. Patient has had 2 falls on her right side in the past, had complain about swelling on that arm and numbness. So we don't think is related to the vaccine but patient is stating the pain is due to the vaccine
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: Died in his sleep
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PT was administered dose of pfizer for ages 12+ instead of the dose required for her age.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: all my hair fell out; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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.  The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "all my hair fell out".
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: ALL HAIR FELL OUT; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "ALL HAIR FELL OUT".  Additional information: Reporter reported that why all hair fell out after gotten covid vaccine and further reported that saw that there were others too.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness, Myopathy
Clinical narrative: myopathy; neck weakness; This is a spontaneous report received from a Physician.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Botox. The following information was reported: MYOPATHY (medically significant) with onset 16Feb2021, outcome "recovered"; MUSCULAR WEAKNESS (medically significant) with onset 16Feb2021, outcome "recovered", described as "neck weakness". Therapeutic measures were taken as a result of myopathy, muscular weakness.  Clinical course: patient provide information to you regarding the reported adverse event(s) with the use of the product and consider the Pfizer product had a causal effect to the adverse event. Vaccine facility type unknown to us. Neck weakness secondary to myopathy from covid vaccine 13Feb2021. Patient has tolerated previous botox dosing. Treatment: require the initiation of new medication/other treatment/ procedure? Yes  details: Trigger point injection, nerve block.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the implied temporal association, the causal relationship between the events myopathy, muscular weakness and suspect drug is assessed as related.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: medical Assistant gave the DTaP-IPV but forgot to include the powdered ActHIB with no reported adverse event.; Initial information received on 22-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/ gender patient to whom medical assistant gave the dtap-ipv but forgot to include the powdered of acthib with no reported adverse event for Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Mar-2024, the patient received 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine but administered only the dtap-ipv and powdered of acthib was forgot to include with no reported adverse event (single component of a two-component) (Latency: same day) (Suspension for injection) (lot UK015AA) (Expiry, strength not reported) via unknown route in the thigh nos (not otherwise specified) for Immunization.  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: U
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: TYPHIM VI that expired was administered to 7 year old, with no reported adverse event; Initial information received on 27-Mar-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 7 years (and 5 months) old and unknown gender patient who had typhoid VI polysaccharide vaccine [Typhim VI] that expired was administered, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In March 2024, the patient was administered an expired standard dose of suspect Typhoid Vi Polysaccharide vaccine Solution for injection (strength, dose unknown) (lot V1A231M, expiry date- 04-MAR-2024) via unknown route in unknown administration site for Immunization with no reported 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: 4.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired acthib was administered with no reported adverse event; Initial information received on 27-Mar-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 years old female patient who was administered with expired 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 27-Mar-2024, the patient received a dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot- UJ856AB and expiration date- 25-Mar-2024) via unknown route in the right deltoid (dose, strength: not provided) for Immunisation (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: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: inadvertently administered a Pentacel dose subcutaneously rather than intramuscularly with no reported adverse event; Initial information received on 28-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who was inadvertently administered a Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] dose subcutaneously rather than intramuscularly with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Mar-2024, the patient had received 0.5 ml (dose: 2) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) (lot UJ9738A, expiry date: 19-Nov-2024; strength not reported) via subcutaneous route in the left thigh for Immunization with no reported adverse event (incorrect route of product administration) (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: 35.0
Sex: M
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: use of alternate diluent (sterile water) for yf-vax instead of the supplied diluent woth no ae; Initial information received on 01-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 35 years old male patient who use of alternate diluent (sterile water) for Yellow Fever Vaccine -[YF-VAX] instead of the supplied diluent with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided.   On 07-Mar-2024, the patient received a unknown dose of suspect Yellow Fever Vaccine - (Solution for injection) (strength, expiry date, lot number not reported) via intramuscular route in unknown administration site se of alternate diluent (sterile water) for yf-vax instead of the supplied diluent woth no adverse event (product preparation error) (latency : same day). The information on batch number 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.
Age: 1.42
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient that was given an expired act-hib vaccine with no reported adverse event; Initial information received on 01-Apr-2024 regarding an unsolicited valid  non-serious case received from a healthcare professional.  This case involves a 17 months old female patient who was given an expired HIB (PRP/T) VACCINE [ACT-HIB] vaccine 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, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL); HEPATITIS A VACCINE (HEPATITIS A); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Prophylactic Vaccination (Immunisation).  On 01-Apr-2024, the patient received a Dose 4, 0.5 ml of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UJ993AA and expiry:25/MAR/24) (expired product administered, latency same day) (strength: unknown) via intramuscular route in the right thigh for Prophylactic Vaccination.  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: COVID19, COVID19
Symptoms: Atrial fibrillation, Cardiomegaly, Left atrial appendage closure implant, Magnetic resonance imaging heart abnormal, Thrombosis
Clinical narrative: Moderate cardio eagle,  4 chamber enlarged heart,, developed atrial fibulation, resulting in Watchman placement, later developed blood clots in left leg
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Rash larger than the patient's palm at injection site. Tender to touch.
Age: 73.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Cellulitis developed in the patient's left arm, identified on 3/30 by her daughter, who originally thought it was an allergic reaction. Upper left arm was red and swollen.  It was originally treated as an allergic reaction with oral allergy medication and topical allergy cream. The red area on the arm got larger. Patient went to her Doctor's office for an appointment to follow up, it was diagnosed as cellulitis . Patient was prescribed an antibiotic for the infection.
Age: 69.0
Sex: M
Vaccine: PNC20
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Severe body ache, chills/shivers. swollen, painful and redness on injection site and Fever. Took Tylenol 500 mg.
Age: 69.0
Sex: M
Vaccine: PNC20
Symptoms: Pyrexia
Clinical narrative: Severe body ache, chills/shivers. swollen, painful and redness on injection site and Fever. Took Tylenol 500 mg.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Myocarditis
Clinical narrative: CHF and myocarditis
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: PT STATES THAT HE HAS HAD A NAGGING ACHE THAT WILL NOT GO AWAY SINCE THE TIME HE GOT THE SHOT
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Fatigue, Headache, Lethargy
Clinical narrative: Patient felt Dizzy and her blood sugar was 98 which she said is low for her. She also felt lethargic, tired and had a headache. Recommended patient call her primary care doctor for follow up.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Pain
Clinical narrative: SO MUCH PAIN AND HARD TO RAISE HER ARM UP
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Shoulder injury related to vaccine administration
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, warmth, and pain to injection site. Also some stiffness and soreness to left shoulder, neck, and upper back area. Described as difficulty with flexing and extending neck. This started to progress toward her right side. Symptoms starting to trend better by time of office visit appointment.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Mobility decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: Redness, swelling, warmth, and pain to injection site. Also some stiffness and soreness to left shoulder, neck, and upper back area. Described as difficulty with flexing and extending neck. This started to progress toward her right side. Symptoms starting to trend better by time of office visit appointment.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test negative, Urticaria
Clinical narrative: In October and November 2022 I thought I had mosquito bites and in December 2022, I had hives all over. Chronic hives since then. Prior to this vaccination, I had Covid arm for two vaccinations.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Chills, body aches, fatigue, redness and swelling at vaccine site
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, PNC20, VARCEL
Symptoms: Rash
Clinical narrative: Patient developed a rash starting on face and moving down the body to legs.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Electronystagmogram, VIIIth nerve injury
Clinical narrative: HAVE VESTIBULAR NERVE DAMAGE PERMANENT WHICH AFFECTS BALANCE AND DIZZINESS ISSUES 24/7; This spontaneous report received from a patient concerned a patient of unspecified age and sex. Initial information was processed along with additional information received on 26-MAR-2024. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 20-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUN-2021, the patient experienced have vestibular nerve damage permanent which affects balance and dizziness issues 24/7 (Dose number in series 1), and was hospitalized (date unspecified). Patient took the vaccine back in 20-MAR-2021, and patient was wanting a claim regarding the vaccine for health issues. Patient had vestibular nerve damage permanent which affects balance and dizziness issues 24/7. Patient took the vaccine 20-MAR-2021 and then patient got this health issue on 07-JUN-2021 - when symptoms began. Patient went to bed at night on 07-JUN-2021 at 9pm, and patient started spinning and he had not stopped spinning in 2 1/2 years. Patient was in hospital for 4 days and they couldn't figure out what it was and went to 3 different neurologists as well as 3 ENT specialists and then after 17 months they finally ran a Videonystagmography (VNG) test (balance test as patient guessed) and they found that patient's left vestibular nerve was 50 percent damaged. The patient stated that he could send the doctor's paperwork if Janssen contacts him and asks for it.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from have vestibular nerve damage permanent which affects balance and dizziness issues 24/7. This report was serious (Hospitalization Caused / Prolonged). This report is associated with a product quality complaint number 90000318430. The suspected product quality complaint has been confirmed to be complaint number 90000318430: Voided. This record describes an adverse event (i have vestibular nerve damage permanent which affects balance and dizziness issues 24/7), which does not meet the definition of a product quality complaint or explicitly allege a potency issue. This record will be voided as no PQC. Based on the PQC evaluation/investigation performed.; Sender's Comments: V0:  VIIIth nerve injury. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse event
Clinical narrative: HAVE VESTIBULAR NERVE DAMAGE PERMANENT WHICH AFFECTS BALANCE AND DIZZINESS ISSUES 24/7; This spontaneous report received from a patient concerned a patient of unspecified age and sex. Initial information was processed along with additional information received on 26-MAR-2024. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 20-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUN-2021, the patient experienced have vestibular nerve damage permanent which affects balance and dizziness issues 24/7 (Dose number in series 1), and was hospitalized (date unspecified). Patient took the vaccine back in 20-MAR-2021, and patient was wanting a claim regarding the vaccine for health issues. Patient had vestibular nerve damage permanent which affects balance and dizziness issues 24/7. Patient took the vaccine 20-MAR-2021 and then patient got this health issue on 07-JUN-2021 - when symptoms began. Patient went to bed at night on 07-JUN-2021 at 9pm, and patient started spinning and he had not stopped spinning in 2 1/2 years. Patient was in hospital for 4 days and they couldn't figure out what it was and went to 3 different neurologists as well as 3 ENT specialists and then after 17 months they finally ran a Videonystagmography (VNG) test (balance test as patient guessed) and they found that patient's left vestibular nerve was 50 percent damaged. The patient stated that he could send the doctor's paperwork if Janssen contacts him and asks for it.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from have vestibular nerve damage permanent which affects balance and dizziness issues 24/7. This report was serious (Hospitalization Caused / Prolonged). This report is associated with a product quality complaint number 90000318430. The suspected product quality complaint has been confirmed to be complaint number 90000318430: Voided. This record describes an adverse event (i have vestibular nerve damage permanent which affects balance and dizziness issues 24/7), which does not meet the definition of a product quality complaint or explicitly allege a potency issue. This record will be voided as no PQC. Based on the PQC evaluation/investigation performed.; Sender's Comments: V0:  VIIIth nerve injury. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV9, MEN, TDAP
Symptoms: Dizziness, Headache, Tenderness, Vision blurred
Clinical narrative: Product Lot number issue; blurry vision; right arm more tender; dizziness/feeling dizzy; headaches; This spontaneous report has been received from a physician, referring a 11-year-old not pregnant female patient. The patient's concurrent conditions and medical history were not provided. Concomitant medication included ibuprofen (MOTRIN).  On 23-JAN-2024, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, lot number X002626 that upon internal review was not valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and instead valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, syringe formulation with expiration date established as 12-FEB-2025, administered on left arm (product lot number issue) (strength, expiry date, and route of administration were not provided), vaccinated with meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), lot #U7675CG, administered intramuscularly on right arm (strength, formulation, and expiry date were not provided) and with diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL), lot #U7657AA, administered on right arm (strength, formulation, expiry date, and route of administration were not provided), all of them administered for routine immunization.  On 23-JAN-2024, (reported as within minutes of receiving the vaccine), the patient started feeling dizzy/dizziness and at unknown time also on that same date, developed headaches (latency reported as 2 same day).  On 25-JAN-2024, the patient and headaches, experienced blurry vision (vision blurred) and the right arm more tender (tenderness) (latency reported as 2 days). At the time of reporting, the patient continued dizziness and headaches since, the symptoms were still ongoing (not recovered).  On 01-FEB-2024, the patient recovered from headache (conflicting information, also reports as not recovered), vision blurred and tenderness.   The causal relationship between the events and suspect vaccines were not provided.   Lot # was being requested and will be submitted if received.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported.; 25-year-old female received 1st GARDASIL 9 dose on 3/13/2023 and 2nd dose 1 year later on 3/22/2024.; This spontaneous report was received from a pharmacist and refers to a 25-year-old female patient. The patient's medical, concurrent conditions and concomitant therapies were not reported.  On 13-MAR-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, exact dose, lot #, expiry date, and route of administration were not provided) administered for prophylaxis.  On 22-MAR-2024, (also reported as 1 year later) the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1965035 has been verified to be a valid lot number, expiration date was reported and confirmed as 20-SEP-2025, (strength, and route of administration were not provided) administered for prophylaxis (Inappropriate schedule of product administration). Operator of Device was a healthcare professional. The reason for the delayed dose was not provided. No adverse effects reported. No additional adverse event  No PQC.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction, Vomiting
Clinical narrative: female patient, who is an unspecified "teenage" age received GARDASIL 9 and immediately vomited and felt faint; female patient, who is an unspecified "teenage" age received GARDASIL 9 and immediately vomited and felt faint; This spontaneous report was received from a pharmacist via a Company representative and refers to a female patient (also reported as "teenage"). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in November 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/Once (strength, dose number, lot #, expiry date, and route of administration were not provided) administered for prophylaxis.    On that date, after the vaccine administration (also reported as immediately), the patient vomited and felt faint (Dizziness). The reporter was unsure what number dose in the series this was. At the time of reporting, the outcome of the events vomiting, and dizziness was unknown.   The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  regarding the events was not applicable.   The causal relationship between vomiting, dizziness and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Age: 45.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; reported 45-year-old patient receiving 3 dose regimen of GARDASIL 9 outside of Prescribing Information/Caller stated patient received first dose of GARDASIL 9 on 1/3/2023, second dose on 9/28/2023 and final dose on 10/28/2023; This spontaneous report was received from a registered nurse and refers to a 45-year-old patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-JAN-2023, the patient was vaccinated with the first HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 28-SEP-2023 and 28-OCT-2023, the patient received the second and third dose of vaccine (Inappropriate schedule of product administration). No symptoms were reported.   Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Heplisav-B Given For First Dose, Engerix Given For Second Dose; Initial report received on 10-Jan-2024.  A pharmacist in the  reported that a 57-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received ENGERIX-B.   No relevant medical history was reported.    No relevant concomitant medications were reported.    On 10-Jul-2023, the patient received the first dose of HEPLISAV-B (NDC # 43528-002-01; lot #, expiration date, site, and route not reported).  On 19-Aug-2023, 40 days after having been vaccinated with HEPLISAV-B, the patient received a dose of ENGERIX-B (lot #, expiration date, site, route, and NDC # not reported).  The patient went in for her third dose of HEPLISAV-B on 10-Jan-2024.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Headache, Nausea, Vomiting
Clinical narrative: caused severe anxiety; Her stomach is upset every day; Headaches, nausea and vomiting; Headaches, nausea and vomiting; Headaches, nausea and vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (caused severe anxiety), ABDOMINAL DISCOMFORT (Her stomach is upset every day), NAUSEA (Headaches, nausea and vomiting), VOMITING (Headaches, nausea and vomiting) and HEADACHE (Headaches, nausea and vomiting) in an 11-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     She has has had an issue with constipation. She has had mild anxiety. She had an allergy to amoxicillin and mold. She was a preemie- born at 32 weeks. She has a speech delay. Patient was diagnosed with Covid 19.  The patient's past medical history included COVID-19 on 09-May-2022, Anxiety and Constipation. Concurrent medical conditions included Allergy to antibiotic and Speech delay. Concomitant products included PARACETAMOL (TYLENOL) for Headache, ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea.    On 07-Dec-2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On 08-Dec-2022, the patient experienced ANXIETY (caused severe anxiety), ABDOMINAL DISCOMFORT (Her stomach is upset every day), NAUSEA (Headaches, nausea and vomiting), VOMITING (Headaches, nausea and vomiting) and HEADACHE (Headaches, nausea and vomiting). At the time of the report, ANXIETY (caused severe anxiety), ABDOMINAL DISCOMFORT (Her stomach is upset every day), NAUSEA (Headaches, nausea and vomiting), VOMITING (Headaches, nausea and vomiting) and HEADACHE (Headaches, nausea and vomiting) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   No treatment medication was provided. Patient was a preemie- born at 32 weeks. She can no longer eat certain foods without feeling worse. she does not want to do extracurricular activities now because she was not feeling well.