chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: patient was now in ICU with fulminanat lung issues; This is a spontaneous report received from a Physician.  An elderly female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1), for covid-19 immunization; Covid-19 vaccine (dose 2), for covid-19 immunization; Covid-19 vaccine (dose 3), for covid-19 immunization; Covid-19 vaccine (dose 4), for covid-19 immunization; Covid-19 vaccine (dose 5), for covid-19 immunization; Covid-19 vaccine (dose 6), for covid-19 immunization; Covid-19 vaccine (dose 7), for covid-19 immunization; Covid-19 vaccine (dose 8), for covid-19 immunization; Covid-19 vaccine (dose 9), for covid-19 immunization; Covid-19 vaccine (dose 10), for covid-19 immunization; Covid-19 vaccine (dose 11), for covid-19 immunization; Covid-19 vaccine (dose 12), for covid-19 immunization; Covid-19 vaccine (dose 13), for covid-19 immunization. The following information was reported: LUNG DISORDER (hospitalization, life threatening), outcome "not recovered", described as "patient was now in ICU with fulminanat lung issues". It was unknown if therapeutic measures were taken as a result of lung disorder.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the implied temporal relationship, the association between the event "fulminant lung issue" with BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)) can not be fully excluded.  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.
Vaccine: COVID19, FLUX
Symptoms: Illness, Lethargy, Pyrexia
Clinical narrative: sick; feverish; lethargic; This is a spontaneous report received from a Consumer or other non HCP.  An elderly patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose 1, single), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; PYREXIA (non-serious), outcome "unknown", described as "feverish"; LETHARGY (non-serious), outcome "unknown", described as "lethargic". Additional information: patient had Pfizer Covid 19 shot in one arm, and a flu shot for 65 years and older in the other arm, together at the same time and was sick in bed for one day, was feverish and lethargic.
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: have been constantly struggling with my asthma; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), 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: ASTHMA (non-serious), outcome "not recovered", described as "have been constantly struggling with my asthma". Therapeutic measures were taken as a result of asthma.  Additional information: Patient had received the Pfizer shots back in 2020 or 2021 since then patient have been constantly struggling with asthma where as patient never had to use any form of inhaler or anything now patient can even go 1 day without multiple breathing treatments. Patient don't have health insurance, Asked who's going to cover inhalers and breathing treatments.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasticity
Clinical narrative: Reaction to Covid Vaccine (Spasticity in upper torso, Neck, Arms, and Hands); This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2025BI01310025.  A 62-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASTICITY (non-serious), outcome "unknown", described as "Reaction to Covid Vaccine (Spasticity in upper torso, Neck, Arms, and Hands)".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Pneumonia
Clinical narrative: pneumonia; flu; Initial information received on 08-May-2025 regarding an unsolicited valid  serious case received from a consumer/Non-Healthcare Professional.  This case involves an unknown age female patient who experienced pneumonia and flu after receiving influenza USP  trival A-B subvirion no preservative vaccine [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza USP  trival A-B subvirion no preservative vaccine, Suspension for injection, (lot number and expiry date not reported) via unknown route in unknown administration site for Prophylactic vaccination.  Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date the patient developed pneumonia and flu (influenza) (unknown latency).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for both the events (flu, pneumonia).  At time of reporting, the outcome was Unknown for both the events.  Seriousness Criteria: Medically significant for pneumonia.; Sender's Comments: Sanofi Company Comment dated 13-MAY-2025: This case involves an unknown age female patient who experienced pneumonia and flu after receiving influenza USP  trival A-B subvirion no preservative vaccine [Fluzone]. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: FBE calling on behalf of an HCP to report that a female patient in her 20's took her first dose of GARDASIL-9 "a few months ago" and experienced bilateral tingling and numbness in her fingers and hands that lasted "a day or two".  Patient did not re; numbness in her fingers; This spontaneous report was received from a nurse practitioner and refers to an adult female patient (in her 20's). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (reported as a "few months ago"), the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 1, administered by Intramuscular route (lot # and expiration date were not reported). On 25-Apr-2025 (reported as "today"), the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 2, administered by Intramuscular route (lot # and expiration date were not reported); both doses as prophylaxis.  On an unknown date, the patient experienced bilateral tingling and numbness in her fingers and hands that lasted "a day or two".  The patient did not report the issues until a few months later when she went back for her 2nd dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). After the administration of the second dose, the patient informed the doctor of the experience with numbness and tingling on the prior dose and confirmed that she did not seek medical treatment at the time of the event. Patient has not reported any symptoms with second dose.  The causal relationship between the event of bilateral tingling and numbness in her fingers and hands and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: A 17 years old male patient received an expired dose of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 3553D, expiry date 28-FEB-2025) for prophylaxis.   On 05-MAY-2025, the patient received Menveo. On 05-MAY-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: A 17 years old male patient received an expired dose of Menveo). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 05-MAY-2025 A clinical manager called to report the administration of an expired dose of Menveo (1 vial) to a patient on the day of reporting, which led to an expired vaccine used. The reporter wanted to know how long they have to wait to revaccinate the patient.
Sex: F
Vaccine: RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillian- Barre; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An elderly female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, life threatening, medically significant), outcome "recovering", described as "Guillian- Barre". Therapeutic measures were taken as a result of guillain-barre syndrome.  Clinical course: Patient experienced Guillian- Barre after Abrysvo, admitted to hospital and intubated. Still not fully recovered.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillian Barre; This is a spontaneous report received from a Physician from a sales representative.  An elderly female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "recovered", described as "Guillian Barre". The patient was hospitalized for guillain-barre syndrome (hospitalization duration: 2 day(s)). The event "guillian barre" required emergency room visit. Therapeutic measures were taken as a result of guillain-barre syndrome. Clinical course: Patient received Abrysvo and experience Guillian-Barre. She went to ER two days after injection and was admitted to hospital for 2 days, was given IVIg infusion. She is recovered.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on known drug safety profile, and plausible temporal association the event Guillain-Barre syndrome is assessed as related to the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V. 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: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 72-year-old male patient received BNT162b2 (BNT162B2 NOS), 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: COVID-19 (non-serious) with onset 08May2025, outcome "unknown", described as "tested positive for Covid". The event "tested positive for covid" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: During an inbound call for financial assistance the patient stated, "I went to the ER last night and tested positive for Covid. And the doctor wrote the prescription for Paxlovid and sent it in this morning. But they can't fill it. I've had my first symptoms on Monday, I didn't know if they just didn't want to fill it because today's already Friday" . When asked for his member ID, the patient stated, "From Pfizer? No, I mean, I haven't gotten any, this is the first contact I've had with you folks, other than when I got my first vaccination, 3, 5 years ago."   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 57.0
Sex: F
Vaccine: HEPAB, PNC21
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reporting swelling at the injection site, pain, redness, itching, feels hard.  She is currently taking Aleve and benadryl also applying ice pack to the injection site.  Reporting no improvement on day 5
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Gait disturbance, Muscular weakness
Clinical narrative: Bilateral leg weakness, difficulty walking, joint pain over the past month.  Symptoms began 1 day after vaccination.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Miliaria, Urticaria chronic
Clinical narrative: Since about a month after I was vaccinated, I have experienced chronic heat rashes/Urticaria when engaging in exercise primarily, but also anytime I am feeling stressed. This can happen during meetings, arguments, or even when I am mentally stressing myself. It also occurs if my environment is warm. The hives break out along my arms, chest, and back primarily. The reactions last typically 5-10 minutes before subsiding. Allergy medication does nothing. I usually have at least one episode per day unless I remain in a cool and stress-free environment. This never occurred before the vaccination, and I am not obese or live a stagnant lifestyle.  No over-the-counter treatment options have worked thus far, so I will seek a doctor's care now that I have discovered I am not the only one who has experienced this from the Moderna vaccine....
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Laboratory test, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Developed left sided numbness 2 days following my second vaccine
Age: 2.0
Sex: M
Vaccine: RAB
Symptoms: Rash, Urticaria
Clinical narrative: generalized hives and rash
Age: 30.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 57.0
Sex: M
Vaccine: PNC21
Symptoms: Pruritus, Rash
Clinical narrative: Patient's arm developed a rash and itching on 5/9/2025,  He used hydrocortisone cream and took Allegra to help with the itching.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Back pain, Loss of personal independence in daily activities
Clinical narrative: When shot was administered I informed nurse that it felt like she hit a bone. Next day upper shoulder joint was painful, 2nd day upper shoulder joint and upper back are in and still are in severe pain. I can not get dressed or do ordinary daily activities without being in severe pain. Seems vaccine was administered in my shoulder joint, not the muscle in my arm and now I wonder if the vaccine is even effective.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK
Age: 53.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Micturition urgency, Urinary incontinence
Clinical narrative: The patient reports urinary incontinence following the vaccine administration. She received her vaccine around 6:30 and reports symptoms started at bedtime. She says she started experiencing increased urgency and the loss of control of her function before making it to the bathroom. She says the symptoms have improved slightly in the last 24 hours. She does have some underlying urinary incontinence but never as bad as it was before.
Age: 27.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 51.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Sustained fever over 103 for multiple days, chickenpox rash
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 72.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: PATIENT DESCRIBED REDNESS, SWELLING, SOARNESS AT INJECTION SITE. PATIENT STATES RASH ALL OVER FRONT OF CHEST, FATIGUE, PAIN ALL OVER BODY. BUT BREATHING IS FINE, PATIENT DID NOT TAKE ANY OTC ANTIHISTAMINE OR PAIN RELEIVERS. WE ADVISED PATIENT TO TAKE BENADRYL AND TYLENOL OR ADVIL FOR PAIN. WE WILL CHECK UP ON HER IN A DAY; BUT ADVISED HER TO SEEK EMERGENCY/911 HELP IF SHE HAS ANY BREATHING OR SEVER PAIN ANYWHERE TONIGHT.
Age: 72.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Rash
Clinical narrative: PATIENT DESCRIBED REDNESS, SWELLING, SOARNESS AT INJECTION SITE. PATIENT STATES RASH ALL OVER FRONT OF CHEST, FATIGUE, PAIN ALL OVER BODY. BUT BREATHING IS FINE, PATIENT DID NOT TAKE ANY OTC ANTIHISTAMINE OR PAIN RELEIVERS. WE ADVISED PATIENT TO TAKE BENADRYL AND TYLENOL OR ADVIL FOR PAIN. WE WILL CHECK UP ON HER IN A DAY; BUT ADVISED HER TO SEEK EMERGENCY/911 HELP IF SHE HAS ANY BREATHING OR SEVER PAIN ANYWHERE TONIGHT.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Endometrial cancer, Hypoaesthesia, Immediate post-injection reaction, Influenza like illness, Pain in extremity
Clinical narrative: Immediate reaction. My tongue started to swell so they had someone come and take my vitals. They had me pull over and wait there for 30 minutes until they felt I was fine. Then, my arm began to feel numb and it hurt for another month. I also had flu-like symptoms (including fever) for 2 nights. Most importantly though, I started experiencing intermittent post-menopausal bleeding. Several months ago, I was diagnosed with endometrial cancer. I strongly suspect a relationship.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Pyrexia, Swollen tongue, Uterine mass
Clinical narrative: Immediate reaction. My tongue started to swell so they had someone come and take my vitals. They had me pull over and wait there for 30 minutes until they felt I was fine. Then, my arm began to feel numb and it hurt for another month. I also had flu-like symptoms (including fever) for 2 nights. Most importantly though, I started experiencing intermittent post-menopausal bleeding. Several months ago, I was diagnosed with endometrial cancer. I strongly suspect a relationship.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given adult dose of Hep B vaccine but should have been the pediatric vaccine since he is 18.  Attempted to contact patient but no answer. VM was left with patient to follow up with clinic. He has not contacted clinic with any side effects at this time.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bradykinesia, Dysarthria, Dysphonia, Electromyogram, Fatigue
Clinical narrative: My speech, walk, and arm strength were weaker and slower from the moment the 2nd shot went in my arm.  I went from playing tennis 3 times a week to my legs crossing in front of me and almost tripping me and my speech slurring. I can no longer speak in a clear and concise tone.  I have to use a walker & wheelchair to get around.  I need help to wash myself, get out of bed, and go to the bathroom.  I experience fatigue and pain on a daily basis.  I exhibit signs of ALS.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Genetic testing, Immediate post-injection reaction, Laboratory test, Loss of personal independence in daily activities, Magnetic resonance imaging
Clinical narrative: My speech, walk, and arm strength were weaker and slower from the moment the 2nd shot went in my arm.  I went from playing tennis 3 times a week to my legs crossing in front of me and almost tripping me and my speech slurring. I can no longer speak in a clear and concise tone.  I have to use a walker & wheelchair to get around.  I need help to wash myself, get out of bed, and go to the bathroom.  I experience fatigue and pain on a daily basis.  I exhibit signs of ALS.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal disorder, Nerve conduction studies, Neurological symptom, Pain
Clinical narrative: My speech, walk, and arm strength were weaker and slower from the moment the 2nd shot went in my arm.  I went from playing tennis 3 times a week to my legs crossing in front of me and almost tripping me and my speech slurring. I can no longer speak in a clear and concise tone.  I have to use a walker & wheelchair to get around.  I need help to wash myself, get out of bed, and go to the bathroom.  I experience fatigue and pain on a daily basis.  I exhibit signs of ALS.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Slow speech, Ventilation/perfusion scan, Walking aid user, Wheelchair user
Clinical narrative: My speech, walk, and arm strength were weaker and slower from the moment the 2nd shot went in my arm.  I went from playing tennis 3 times a week to my legs crossing in front of me and almost tripping me and my speech slurring. I can no longer speak in a clear and concise tone.  I have to use a walker & wheelchair to get around.  I need help to wash myself, get out of bed, and go to the bathroom.  I experience fatigue and pain on a daily basis.  I exhibit signs of ALS.
Sex: F
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: HCP reports the patient received  newborn vaccination Hep B in December when she was born; No additional AE; This spontaneous report was received from a health care professional referring to a 5 month female patient.  Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On an unknown date when she was born, she was vaccinated with the first dose of Hepatitis B vaccine (Recombinant) suspension for injection for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported).   On 14-APR-2025, she began the catch-up vaccinations due to being a "no show" at her pediatrician appointments (Inappropriate schedule of product administration) no other events were reported (No adverse event).
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Patient's mother did not  report any symptoms or side effects for the patient./No additional AE; Patient's mother reporting an AE for GARDASIL 9 on behalf of the patient. Patient's mother reported that the patient, who is 20 years old, received his first dose of GARDASIL 9 in "August 2024", but the patient never received his second dose. Patie; This spontaneous report was received from the patient's mother and refers to a 20-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   In August 2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection (0.5 ml, strength, route, lot number and expiration date were unknown) for prophylaxis.  The Patient's mother reported that the patient never received his second dose in 2025 (inappropriate schedule of product administration). The patient's mother did not report any symptoms or side effects for the patient/No additional adverse event (No adverse event). Due to the patient's mother declining to provide further information, no patient information was collected, and no healthcare professional information was collected.
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: vaccine mixed with sterile water instead of the saline diluent with no reported adverse event; Initial information received on 07-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and gender patient who received haemophilus type B (HIB) vaccine [ACT-HIB] was mixed with sterile water instead of the saline diluent with no reported adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength- unknown, expiry date- 30-Apr-2026 and lot UK201AC) via unknown route in unknown administration site for Prophylactic Vaccination (Immunization) was mixed with sterile water instead of the saline diluent with no reported adverse event (product preparation error) (latency- same day).   Action taken was not applicable.  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: 1.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: stated that she gave a dose of pentacel that expired nine days ago with no reported adverse event; Initial information received on 08-May-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 16 months old female patient who received dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (VERO)] that expired nine days ago 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 for Immunisation.  On 08-May-2025, the patient received 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of strength: standard, frequency once with lot UK022AA and expiry date: Apr-2025 via intramuscular route in the left Anterior thigh for immunization that expired nine days ago with no reported adverse event (expired product administered) (Latency same day)  Action taken was not applicable.   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: M
Vaccine: DTAP
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7-year-old patient who received DAPTACEL. It is an extra dose with no reported adverse event; 7-year-old patient who received DAPTACEL. It is an extra dose with no reported adverse event; Initial information received on 08-May-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7 years old male patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] which was an extra dose 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 Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR); Polio Vaccine Inact (IPV) and varicella zoster vaccine (Varicella Vaccine) all for Immunisation.  On 02-Apr-2025, the patient received a dose 6 of 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: 3CA20C1; expiry date: 28-Feb-2026; frequency: once; strength: standard) via intramuscular route in the right deltoid for Immunisation which was an extra dose with no reported adverse event (product administered to patient of inappropriate age) (extra dose administered) (latency: same day).  Action taken was not applicable.   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.
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: administration of a dose of ACT-HIB that was reconstituted with sterile water rather than the diluent it came with, with no reported adverse event; Initial information received on 08-May-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and gender patient who was administered with a dose of HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with sterile water rather than the diluent it came with, with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in May 2025, the patient received an unknown dose of HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength- standard, expiry date- 30-APR-2026 and lot UK201AC) once via unknown route in unknown administration site for Immunization was reconstituted with sterile water rather than the diluent it came with, with no reported adverse event (product preparation error) (same day latency).   Reportedly, Caller was stating that they submitted an online request for information on an ACT HIB vaccine. They were looking for information on if the vaccine was reconstituted with sterile water rather than saline. They received some information but were asking if there was any safety information they need to be aware of regarding the vaccine since it was administered to a patient   Action taken was not applicable.  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: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: pentacel was administered to a patient who is 5 years and 4 months old with no reported ae; Initial information received on 08-May-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a is 5 years and 4 months old female patient who was administered 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 Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) [Proquad] for Immunisation.  On 07-May-2025, the patient received 0.5ml dose (once) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection, Strength Standard, lot UK199AA and expiry date: 30-Apr-2026 via intramuscular route in the left thigh for immunization with no reported adverse event (product administered to patient of inappropriate age) (Latency same day).  Reportedly, the patient was due for DTaP and IPV due to which Pentacel (Vero) was administered. No treatment was received by patient.  Action taken was not applicable.   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: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administering pentacel but only the dtap-ipv dose was given with no reported ae; Initial information received on 09-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age male patient who recieved Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] but only the dtap-ipv dose was given with no reported AE (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Apr-2025, the patient received an unknown dose of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine standard strength (lot number, formulation and expiry date-unknown) via unknown route in unknown administration site for Immunization but only the dtap-ipv dose was given with no reported ae (single component of a two-component product administered) (latency-same day).  Reportedly- Only the liquid part of PENTACEL was administered. They further asked if they have to revaccinate or when can they give the Hib component.  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA135316:02514958, 02515969 and 02515973
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administering pentacel but only the dtap-ipv dose was given with no reported adverse event; Initial information received on 09-May-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age male patient who was administered with diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] but only the DTAP-IPV dose was given with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Apr-2025, the patient received an unknown dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection with standard strength (expiry date and lot number not reported) via unknown route in unknown administration site for Immunization but only the DTAP-IPV dose was given with no reported adverse event (single component of a two-component product administered) (latency- same day).  Reportedly, the nurse called to ask if the dose given to a patient is valid- only the liquid part of PENTACEL was administered. She further asked if they had to revaccinate or when can they give the Hib component.   Information on the batch number was requested corresponding to the one at time of event occurrence.    Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA135329:
Age: 0.58
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: supposed to be administered with pentacel but they were only able to inject the liquid part with no reported ae; Initial information received on 09-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old and unknown gender patient to whom administered with Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] but they were only able to inject the liquid part with no reported ae (adverse event)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization and supposed to be administered with pentacel but they were only able to inject the liquid part with no reported ae (product preparation error) (same day latency).  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   Reportedly: Caller asked for the diluent to be mix the powder part with and if they can use other Hib vaccines.  Action taken: not applicable.   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: 48.0
Sex: M
Vaccine: MMR, TDAP, VARZOS
Symptoms: Muscle spasms, Myalgia, Seizure
Clinical narrative: generalized seizure lasting no more than 2 minutes, seizure was treated by giving midazolam (in spray - 1 dose), which allowed patient to calm down and recover.  It took 30 minutes for patient to get back to being situated in time and space. It took 24 hours to recover from muscle pain and cramps.
Age: 61.0
Sex: M
Vaccine: PNC21, PNC21, PNC21
Symptoms: Acute respiratory failure, Blood creatine phosphokinase normal, Endotracheal intubation, Heavy metal test, Hypoaesthesia
Clinical narrative: 61yr old patient with history of gout (recent attack 4/18, patient took colchicine), HTN (baseline 120s/70s on amlodipine and lisinopril at home), and other comorbidities presented on 4/22 for check up with new concern for tinnitus. During visit, patient was prescribed to start rosuvastatin 10mg PO daily (# 850215666) due to risk of CAD. MD also ordered patient to receive Pneumococcal (PCV21) (>=19YRS) Vaccine (Capvaxive) (aka PCV21) [IMM6051] during visit. CMA administered Pneumococcal (PCV21 >=19yrs) vaccine (Capvaxive) LOT # Z005765 IM in patient's left deltoid. On 4/28, patient presented to Urgent Care with severe body aches and numbness (started in lower back and spread to hips, legs, shoulders, arms, neck and On 4/28, patient presented to Urgent Care with severe body aches and numbness (started in lower back and spread to hips, legs, shoulders, arms, neck and head). Pain described by "tingly" and accompanied by numbness in fingers and toes. Patient took acetaminophen without relief. Patient sent to ED for further management. Per H&P, patient reported receiving RSV vaccine on 4/24 (however, not listed within Immunizations,(redacted site name), nor state database). Patient admitted to ICU. Rosuvastatin held on admission however symptoms did not improve (CK levels normal). Patient later intubated 4/29 1550 due to acute respiratory failure. Patient given IVIG x 5 days. Concern for acute inflammatory demyelinating polyradiculoneuropathy (Guillan-Barre Syndrome), pending West Nile virus and heavy metals test. Per online service, myalgia (6-17%) listed as possible adverse reaction for Pneumococcal conjugate vaccine 21 valent as well as rosuvastatin. Team continues to manage symptoms.  Unable to identify cause of AIDP.  535587
Age: 61.0
Sex: M
Vaccine: PNC21, PNC21, PNC21
Symptoms: Immunoglobulin therapy, Intensive care, Pain, Paraesthesia, West Nile virus test
Clinical narrative: 61yr old patient with history of gout (recent attack 4/18, patient took colchicine), HTN (baseline 120s/70s on amlodipine and lisinopril at home), and other comorbidities presented on 4/22 for check up with new concern for tinnitus. During visit, patient was prescribed to start rosuvastatin 10mg PO daily (# 850215666) due to risk of CAD. MD also ordered patient to receive Pneumococcal (PCV21) (>=19YRS) Vaccine (Capvaxive) (aka PCV21) [IMM6051] during visit. CMA administered Pneumococcal (PCV21 >=19yrs) vaccine (Capvaxive) LOT # Z005765 IM in patient's left deltoid. On 4/28, patient presented to Urgent Care with severe body aches and numbness (started in lower back and spread to hips, legs, shoulders, arms, neck and On 4/28, patient presented to Urgent Care with severe body aches and numbness (started in lower back and spread to hips, legs, shoulders, arms, neck and head). Pain described by "tingly" and accompanied by numbness in fingers and toes. Patient took acetaminophen without relief. Patient sent to ED for further management. Per H&P, patient reported receiving RSV vaccine on 4/24 (however, not listed within Immunizations,(redacted site name), nor state database). Patient admitted to ICU. Rosuvastatin held on admission however symptoms did not improve (CK levels normal). Patient later intubated 4/29 1550 due to acute respiratory failure. Patient given IVIG x 5 days. Concern for acute inflammatory demyelinating polyradiculoneuropathy (Guillan-Barre Syndrome), pending West Nile virus and heavy metals test. Per online service, myalgia (6-17%) listed as possible adverse reaction for Pneumococcal conjugate vaccine 21 valent as well as rosuvastatin. Team continues to manage symptoms.  Unable to identify cause of AIDP.  535587
Age: 61.0
Sex: M
Vaccine: PNC21, PNC21, PNC21
Symptoms: Guillain-Barre syndrome, Headache, Hypoaesthesia, Intensive care, Laboratory test
Clinical narrative: 61yr old patient with history of gout (recent attack 4/18, patient took colchicine), HTN (baseline 120s/70s on amlodipine and lisinopril at home), and other comorbidities presented on 4/22 for check up with new concern for tinnitus. During visit, patient was prescribed to start rosuvastatin 10mg PO daily (# 850215666) due to risk of CAD. MD also ordered patient to receive Pneumococcal (PCV21) (>=19YRS) Vaccine (Capvaxive) (aka PCV21) [IMM6051] during visit. CMA administered Pneumococcal (PCV21 >=19yrs) vaccine (Capvaxive) LOT # Z005765 IM in patient's left deltoid. On 4/28, patient presented to Urgent Care with severe body aches and numbness (started in lower back and spread to hips, legs, shoulders, arms, neck and On 4/28, patient presented to Urgent Care with severe body aches and numbness (started in lower back and spread to hips, legs, shoulders, arms, neck and head). Pain described by "tingly" and accompanied by numbness in fingers and toes. Patient took acetaminophen without relief. Patient sent to ED for further management. Per H&P, patient reported receiving RSV vaccine on 4/24 (however, not listed within Immunizations,(redacted site name), nor state database). Patient admitted to ICU. Rosuvastatin held on admission however symptoms did not improve (CK levels normal). Patient later intubated 4/29 1550 due to acute respiratory failure. Patient given IVIG x 5 days. Concern for acute inflammatory demyelinating polyradiculoneuropathy (Guillan-Barre Syndrome), pending West Nile virus and heavy metals test. Per online service, myalgia (6-17%) listed as possible adverse reaction for Pneumococcal conjugate vaccine 21 valent as well as rosuvastatin. Team continues to manage symptoms.  Unable to identify cause of AIDP.  535587