chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: The patient has had 7 Pfizer shots, and the patient still got COVID; The patient has had 7 Pfizer shots, and the patient still got COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 74-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. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization; Bnt162b2 (DOSE 3), for COVID-19 Immunization; Bnt162b2 (DOSE 4), for COVID-19 Immunization; Bnt162b2 (DOSE 5), for COVID-19 Immunization; Bnt162b2 (DOSE 6), for COVID-19 Immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "The patient has had 7 Pfizer shots, and the patient still got COVID". The patient came to pick up a prescription of Paxlovid.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: TDAP
Symptoms: Arm amputation, Injury
Clinical narrative: a very serious injury; Initial information received on 09-May-2025 regarding an unsolicited valid serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves an unknown age female patient who experienced a very serious injury after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  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 suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot number, expiry date and strength not reported) for Immunisation .  On an unknown date the patient developed a  very serious injury (injury) (unknown latency) because they lost their arm and shoulder in amputation following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine. This event was leading to disability.  Action taken was not applicable.  It was reported that  the patient had undergone amputation as a corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved With Sequelae on an unknown date for the event.; Sender's Comments: Sanofi company comment dated 16-MAY-2025: This case involves an unknown age female patient who experienced a very serious injury after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].. Further information regarding event details, onset latency, laboratory investigations, medical history, concomitant medication, administration technique and tolerance, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient reports redness to area of vaccine injection the size went from dime size to size of a fist. Patient reports the area as uncomfortable. She reports that the site is hot to touch. Patient said the at first the site was very red and not today 5/19/25 the area is light pink.  Patient has used ice, Zyrtec, and Sarna lotion for itching.  Patient does have a picture of the site taken on 5/18/25.
Age: 63.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Vaccination error
Clinical narrative: No adverse events, patient received this vaccine in error.
Age: 62.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Vaccination error
Clinical narrative: No adverse events, patient received this vaccine in error.
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Chest discomfort, Haemoptysis, Respiratory tract congestion
Clinical narrative: Chest tightness but more congestion cough w/small amount of blood.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin ulcer
Clinical narrative: Patient called in to report 2 itchy sores on her buttock that appeared the evening of the day she was vaccinated. She did not come to clinic to have these evaluated.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: 101.5 fever, headache, chills and L arm pain.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: In 2024, patient had to follow the Twinrix accelerated schedule due to her travel needs. The accelerated schedule should be 3 doses at 0, 7, and 21-30 days, followed by a booster dose at 12 months. She had her vaccine  on  2/28/2024 , 3/6/2024, 3/20/2024, and her next dose after that should be 12 months later in 2025 . However, she came to the pharmacy  on  3/29/2024 and received another Twinrix dose.  Patient did not complain about any side effects. When she visited pharmacy again for her last dose on 5/18/2025. We checked her previous record, and  we found out she should not receive the dose on 3/29/2024.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was given. Expire 5/17/25.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiomegaly, Dyspnoea, Pneumonia, Polycythaemia vera, Pulmonary oedema
Clinical narrative: moderna second  95 water pct water lungs  pneumonia  , buster  give me  dysventilation  problems to breath
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time abnormal, Antiphospholipid syndrome, Blood test abnormal, Impaired work ability, Laboratory test
Clinical narrative: Blood clots , aps , ablations ,
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic procedure, Thrombosis, Venous occlusion
Clinical narrative: Blood clots , aps , ablations ,
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no known ill effects. Patient was given a third dose of Shingrix vaccine. This was noticed upon checking the report when patient came to request dose #2
Age: 19.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: After about one week of receiving vaccines patient noticed chest pain-not constant, sharp and dull at times, chest tightness, SOB. Still randomly experiences these events.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Balance disorder, Chills, Erythema, Fatigue, Nausea
Clinical narrative: Pt reported  the following symptoms on and off: fever 102.5F on first day, then fever, fatigue, and sleepiness x4 days,  and red swollen arm, body aches, chills, nausea, vomiting, and losing balance x10 days. Pt took tylenol and benadryl.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Pain, Peripheral swelling, Pyrexia, Somnolence, Vomiting
Clinical narrative: Pt reported  the following symptoms on and off: fever 102.5F on first day, then fever, fatigue, and sleepiness x4 days,  and red swollen arm, body aches, chills, nausea, vomiting, and losing balance x10 days. Pt took tylenol and benadryl.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: MENVO given May 16 L upper arm. Noted swelling and redness to site May 17-19. No Fever.
Age: 72.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site pain
Clinical narrative: arm started hurting at injection site on 9/18/24 and has not gone away.  On 3/10/25 the patient stated to the pharmacy staff that her arm was still hurting from the vaccine administered on 9/18/24. As of today 5/19/25, the patient has still not recovered.
Age: 2.5
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Wrong product administered
Clinical narrative: Mom placed wrong patient on exam table & 4 y/o vaccines given to the 30 m/o patient. Provider addressed patient & mother's concerns. See progress note.
Age: 34.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL, VARCEL, VARCEL, VARCEL, VARCEL
Symptoms: Autoimmune disorder, COVID-19, Extra dose administered, Pyrexia
Clinical narrative: Patient was given 3rd dose of Varicella.  She had already received 2 doses.  She had an exposure to shingles at work.  Within approximately 2-3 hours Patient contacted office stating she had an elevated temperature and self reported at 101.5,
Age: 34.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL, VARCEL, VARCEL, VARCEL, VARCEL
Symptoms: Body temperature increased, Exposure to communicable disease, Extra dose administered
Clinical narrative: Patient was given 3rd dose of Varicella.  She had already received 2 doses.  She had an exposure to shingles at work.  Within approximately 2-3 hours Patient contacted office stating she had an elevated temperature and self reported at 101.5,
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs/PQC reported.; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included  Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid (Dtap), Polio vaccine inact (Ipv), and Influenza vaccine.  On 17-Mar-2025, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017511, expiration date: 15-Apr-2026), dose number 1, administered by subcutaneous route in left thigh for prophylaxis, and diluted with sterile diluent (MERCK STERILE DILUENT), administered by subcutaneous route (indication, expiration date, and lot # were not reported). Temperature excursion occurred at -9.8C for 2 hours and 3 minutes. Previous temperature excursion was not reported. No additional adverse event was reported.  This is one of several reports from the same reporter.
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms. No additional AE; HCP reported improperly stored administered GARDASIL 9.; This spontaneous report was received from a medical assistant concerning a patient of unspecified age and gender.   The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.   On 21-Apr-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection pre-filled syringe, lot #Y012864 has been verified to be a valid batch/lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration date reported and upon internal validation established as 29-May-2026, 0.5 mL (dosage regimen, anatomical location and route of administration was not provided) administered as prophylaxis (product storage error). At the time of vaccination, the vaccine administered underwent a temperature excursion at 8.5 degrees Celsius (C) for 0 hours 4 minutes 0 seconds, with a previous temperature excursion at 1.5 C for 90 hours 35 minutes 0 seconds  There were no symptoms nor additional adverse events (AE) (no adverse event.)  This was one of two reports received from the same reporter.
Age: 1.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 18 month old patient was ordered to get Infanrix but they got Boostrix instead; 18 month old patient was ordered to get Infanrix but they got Boostrix instead; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499 exp, expiry date 26-AUG-2027) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   On 09-MAY-2025, the patient received Boostrix. On an unknown date, the patient did not receive Infanrix. On 09-MAY-2025, an unknown time after receiving Boostrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: 18 month old patient was ordered to get Infanrix but they got Boostrix instead) and inappropriate age at vaccine administration (Verbatim: 18 month old patient was ordered to get Infanrix but they got Boostrix instead). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable.   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: 09-MAY-2025 Licensed Practical Nurse explained that on 09 May 2025, an 18 month old patient was ordered to get Infanrix but they got Boostrix instead which led to wrong vaccine administered and inappropriate age at vaccine administration. Consented to follow up.
Vaccine: DTAPIPVHIB, DTP
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: The product administered in error was PENTACEL and the PENTACEL dose should have been the ACT-HIB with no reported adverse event; an inappropriate use due to administration of an extra dose of DTaP from PENTACEL with no reported adverse event; Initial information received on 14-May-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case involves Child and unknown gender patient where product administered in error was diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel] and the pentacel dose should have been the act-hib and an inappropriate use due to administration of an extra dose of diphtheria, tetanus and nos pertussis vaccine from pentacel 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 a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (Strength- standard and frequency- once) lot number not reported via unknown route in unknown administration site (dose and expiration date: not provided) and received a dose of suspect diphtheria, tetanus and nos pertussis vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for prophylactic vaccination (immunization) and the product administered in error was pentacel and the pentacel dose should have been the act-hib with no reported adverse event (wrong product administered) and inappropriate use due to administration of an extra dose of dtap from pentacel with no reported adverse event (extra dose administered) (latency- same day).  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  Reportedly, no other vaccines had been used. Product used : Used.  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: 19.0
Sex: F
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: Merck sterile water was used to reconstitute the vaccine and that the vaccine was administered to a patient with no reported adverse event; Merck sterile water was used to reconstitute the vaccine and that the vaccine was administered to a patient with no reported adverse event; Initial information received on 14-May-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 19 years old female patient who was administered with Yellow Fever Vaccine - [Yf-Vax] which was reconstituted with merck sterile water 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 Water for injection (Sterile water).  On an unknown date, the patient received an unknown dose of suspect Yellow Fever Vaccine - Solution for injection (lot UK134AA, expiry date 30-Nov-2025; strength not reported) via subcutaneous route in the left arm for Immunisation and patient who was administered with Yellow Fever Vaccine - Yf-Vax] which was reconstituted with merck sterile water with no reported adverse event (product preparation error) and (poor quality product administered).  Action taken was not applicable.  Reportedly, wanted to know if they use Merck's sodium chloride diluent, will it affect the vaccine.  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: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: stated that an 11 year-old patient was given daptacel instead of adacel with no reported adverse event; Initial information received on 15-May-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 11 years old male patient who received Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] Instead of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] 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 Meningococcal Vaccine A/C/Y/W Conj (Tet Tox) (Menquadfi) for Immunisation.  On 09-May-2025, the 11 year-old patient received 0.5ml dose (once) of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, strength standard, Expiry date: 30-Sep-2025 and lot 3CA03C3 via intramuscular route in the left arm instead of suspect, Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination [immunisation] with no reported adverse event (wrong 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.
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: stated that a patient was given ACTHIB, however the diluent that was given was a diluent that they use for MMR and Varicella vaccines and not the one for ACTHIB with no reported adverse event; Initial information received on 15-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered with HIB (PRP/T) vaccine [ACT-HIB] however the diluent that was given was a diluent that they use for MMR and varicella vaccines with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-May-2025, the patient received an unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection standard strength (lot UK111AA) (expiry date-unknown) via unknown route in unknown administration site for Immunization however the diluent that was given was a diluent that they use for MMR and varicella vaccines with no reported adverse event (product preparation error) (latency-same day).  Reportedly- Patient age '<'1 year enter as 2m, 4m, etc, the ACTHIB wasn't reconstituted using its accompanying diluent.  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: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administration of an expired vaccine with no reported adverse event; Initial information received on 16-May-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who had inappropriate use due to administration of an expired diphtheria-15/tetanus/5 AC pertussis vaccine 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 suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and had inappropriate use due to administration of an expired vaccine with no reported adverse event (expired product administered) (unknown latency).  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: 0.5
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6-month old male was given the incorrect product formulation for his age; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 3E99M, expiry date 31-DEC-2025) for prophylaxis.   On 21-JAN-2025, the patient received Menveo (intramuscular). On 21-JAN-2025, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: 6-month old male was given the incorrect product formulation for his age). The outcome of the inappropriate age at vaccine administration was not applicable.   Additional Information: GSK receipt date: 05-MAY-2025 The physician reported that they discovered an error that occurred in January 2025.  The 6-month old patient was given the incorrect product formulation (Menveo) for his age, which led to inappropriate age at vaccine administration.  He was given the formulation meant for older children.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Incorrect dose administered
Clinical narrative: Inadvertent exposure to vaccine; residual amount of vaccine leaked on the patients arm after injection; The consumer is concerned he did not receive the full dose of vaccine (potential underdose.); This non-serious case was reported by a other health professional via call center representative and described the occurrence of inadvertent exposure to vaccine in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number e754f, expiry date 27-MAR-2027) for prophylaxis.   On 09-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular, right deltoid) .5 ml. On 09-MAY-2025, an unknown time after receiving Shingrix, the patient experienced inadvertent exposure to vaccine (Verbatim: Inadvertent exposure to vaccine), exposure via skin contact (Verbatim: residual amount of vaccine leaked on the patients arm after injection) and underdose (Verbatim: The consumer is concerned he did not receive the full dose of vaccine (potential underdose.)). On 09-MAY-2025, the outcome of the exposure via skin contact and underdose were not applicable. The outcome of the inadvertent exposure to vaccine was not applicable.   Additional Information: GSK Receipt Date: 12-MAY-2025 The patient was vaccinated with first dose of Shingrix. The health care professional states she was using a retractable needle and the upon removing the needle from the deltoid the needle automatically retracted and some vaccine leaked on the patient's arm, which led inadvertent exposure to vaccine and exposure via skin contact.  The patient was concerned he did not receive the full dose of vaccine (potential underdose/potential administration error.)
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: interval too long between dose 1st and  2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 09-OCT-2021).   On 16-MAY-2025, the patient received the 2nd dose of Shingrix. On 16-MAY-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: interval too long between dose 1st and  2nd dose). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK receipt date: 16-MAY-2025 The patient self-reported this case for herself. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: inappropriate use due to the administration of the PENTACEL DTaP-IPV component to a patient, without the HIB component with no reported adverse event; Initial information received on 16-May-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 15 months old female patient who was administered with dtap-ipv component of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)], and the Hib component was not included with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine for Immunisation.  On 16-May-2025, the patient received 0.5ml (once) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection, Strength standard, lot UK196AA and expiry date 31-Mar-2026 via intramuscular route in the right thigh for immunization, However, only the DTaP-IPV component was administered, and the Hib component was not included with no reported adverse event (single component of a two-component product administered) (Latency Same day).  Reportedly, Reportedly, the patient only received the liquid component of Pentacel and did not receive the 'powder' component. The pharmacist inquired whether ACTHIB can be administered to the patient instead of using the Hib component from Pentacel.  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: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: MMRV given instead of MMR resulting in double dose of Varicella vaccine given. Fever starting on day 4, still ongoing on day 7
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: Aphasia, Blood iron decreased, Confusional state, Decreased appetite, Fatigue
Clinical narrative: OK, I need to clear up some things before the seizure happened. Got one vaccine named Japanese. Encephalitis few days after that vaccine child got a high fever then seizure happened child was in the hospital March 16, 17and 18 of 2025. Then got a doctors appointment for April 3, 2025, which was given quite a few vaccine on the health record stated that the child got the MMR on March 13, 2025, but that isn?t true. The child was not yet back home until March 31 of 2025, so the clinic gave MMR plus 2 other all at once at first they wanted to give five all in one time I said no it was too much so only got three. I don?t know why they lied on the record for a different date, but I have proof to show that the MMR and two other vaccine was given on April 3 of 2025 after receiving that shot on April 3, 2025, the child start having withdrawn Symptoms not wanting to eat lost appetite, fatigue, and also lost speech skills no more babbling no more words even motor skills started to decline child was always active outgoing but after April 3, 2025 child look withdrawn spacing out a lot not responding when called and just stare off into space With a confusion look in, would not eat anything but only drink milk which cause him to go into low iron right now after the vaccine on April 3 the sign is so noticeable that the vaccine had a negative effect on the child and for the other vaccine, the Japanese one that might?ve caused the fever that led to the seizure   Right now the child is seen by the pediatrician already and is referred to a specialist neurology to get an EEG scan. My child is no longer the same all because of the vaccine and I know it.
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: Feeling abnormal, Fine motor skill dysfunction, Social avoidant behaviour, Staring, Unresponsive to stimuli
Clinical narrative: OK, I need to clear up some things before the seizure happened. Got one vaccine named Japanese. Encephalitis few days after that vaccine child got a high fever then seizure happened child was in the hospital March 16, 17and 18 of 2025. Then got a doctors appointment for April 3, 2025, which was given quite a few vaccine on the health record stated that the child got the MMR on March 13, 2025, but that isn?t true. The child was not yet back home until March 31 of 2025, so the clinic gave MMR plus 2 other all at once at first they wanted to give five all in one time I said no it was too much so only got three. I don?t know why they lied on the record for a different date, but I have proof to show that the MMR and two other vaccine was given on April 3 of 2025 after receiving that shot on April 3, 2025, the child start having withdrawn Symptoms not wanting to eat lost appetite, fatigue, and also lost speech skills no more babbling no more words even motor skills started to decline child was always active outgoing but after April 3, 2025 child look withdrawn spacing out a lot not responding when called and just stare off into space With a confusion look in, would not eat anything but only drink milk which cause him to go into low iron right now after the vaccine on April 3 the sign is so noticeable that the vaccine had a negative effect on the child and for the other vaccine, the Japanese one that might?ve caused the fever that led to the seizure   Right now the child is seen by the pediatrician already and is referred to a specialist neurology to get an EEG scan. My child is no longer the same all because of the vaccine and I know it.
Sex: M
Vaccine: HIBV
Symptoms: Product contamination
Clinical narrative: NICU RN called down to pharmacy requesting a new saline diluent vial for an ActHib vaccine for her patient. I prompted the RN to see what was wrong with the diluent vial that was sent up. The RN said when she introduced air to the vial (to draw up the medication), I asked the nurse to please send the vials back down to pharmacy so we can evaluate. Upon return to the pharmacy the saline diluent vial contained bright red liquid inside (doxorubicin red). I tubed up the last dose in the box to replace the defective one and had not heard of any more issues from the RN for that room. Expiration on vials: 05/2026 LOT: UK328AA MFD: Sanofi Pastuer SA
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Per mother, currently has 2x5 inch swollen area on left arm at injection site, left deltoid. Red, warm to touch. Did not check temp. Left arm is sore. Received Bexsero injection in left deltoid 5-7-25. Swelling noted 5-8-2025. Swelling has increased today, 5-9-25.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Presyncope
Clinical narrative: Heart incident after first dose of Pfizer Covid vaccination. Extreme angina and near fainting the day after Pfizer covid vaccine
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Vaccination site discolouration
Clinical narrative: 2nd shingle vaccination on April 16th. Within days the area around the vaccination started turning brown. I am (redacted). It has been 4 weeks today. Still brown and still with fever at the injection site. Please advise how to treat now.. the brown color and the fever.
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Describe Event, Problem, or Product Use Error: The patient received an expired Vaccine. The Vaccine expired on 3/10/2025 and the vaccine was administered on 5/11/2025.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Irritability, Rash, Respiratory tract congestion
Clinical narrative: Spotted rash on torso, limbs began about 8-10:00 AM  5/19/25. Irritability and congestion followed.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pain, Pyrexia, Skin warm
Clinical narrative: patient developed redness over all biceps area, area warm to the touch, had fever over 101  , severe body aches and malaise for a few days
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 5.0
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient should have received Kinrix- Dtap and IPV, however she was administered Vaxelis.  Patient did not have any symptoms or side effects.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: MMR, Varicella and Hep A was ordered by provider. MA pulled the Hep A, Varicella, and Pro Quad (looking and seeing Measles Mumps and Rubella Overlooked Varicella by mistake). Vaccines were given and labs was obtained. Upon documentation MA discovered that Pro Quad was given instead of MMR. Provider, director of physicians and director was notified. Parents were attempted to be contact but no answer on serval attempts. Vaccines were documented in patient's chart and database noting the vaccine given by mistake.
Age: 83.0
Sex: F
Vaccine: TDAP
Symptoms: Agonal respiration, Cardiac arrest, Chest discomfort, Chest pain, Death
Clinical narrative: Patient called out "help me" and patient tech responded to patient. Patient stated that she was having chest pain that was heavy like she had never had. Physician was notified of the complaint and ordered nitroglycerin, stat troponin, stat EKG, repeat EKG with morning labs. Patient continued having conversation about her chest pain to another RN that responded. At 0238, patient was noted to have agonal breathing and NRP mask was placed on patient. Patient noted to be without respirations and heart rate at 0245 (patient was a DNR). Patient subsequently pronounced at 0250 as the ED doctor responded from the ED as the hospitalist does not remain in house at night.
Age: 83.0
Sex: F
Vaccine: TDAP
Symptoms: Respiratory arrest
Clinical narrative: Patient called out "help me" and patient tech responded to patient. Patient stated that she was having chest pain that was heavy like she had never had. Physician was notified of the complaint and ordered nitroglycerin, stat troponin, stat EKG, repeat EKG with morning labs. Patient continued having conversation about her chest pain to another RN that responded. At 0238, patient was noted to have agonal breathing and NRP mask was placed on patient. Patient noted to be without respirations and heart rate at 0245 (patient was a DNR). Patient subsequently pronounced at 0250 as the ED doctor responded from the ED as the hospitalist does not remain in house at night.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: It started swelling and getting red and hurting and not at first was it itching. It started itching 2 days and i was  putting Benadryl cream on it.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: PATIENT PRESENTED TO PHARMACY REQUESTING HER FIRST SHINGRIX VACCINATION. IN THE HEALTH SERVICES ROOM, I CONFIRMED THIS WAS HER FIRST IN THE SERIES AND THAT WE WOULD SCHEDULE HER SECOND SHOT AFTER WE COMPLETED THE FIRST ONE. AFTER I GAVE HER THE SHOT, SHE SHOWED ME SORES ON HER BACK THAT PRESENTED LIKE SHINGLES. I REFERRED HER TO HER DOCTOR AND LET HER KNOW I WOULDN'T HAVE GIVEN HER THE SHOT IF THERE WAS A CHANCE SHE HAD AN ACTIVE SHINGLES VIRUS.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: There were no adverse events.
Age: 48.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: pt states redness, swelling, warm, and some itching, redness has spread to above elbow, pt just tried benadryl this morning and cold compress
Age: 58.0
Sex: M
Vaccine: PNC20
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Balance disorder, Computerised tomogram head normal, Computerised tomogram neck normal
Clinical narrative: acute onset left facial and left upper extremity numbness, peripheral vision loss associated with dizziness and gait imbalance. Per patient above symptoms started around 630 AM. admitted on 05/12/2025 with PMH of HTN, hypothyroidism, asthma, arthritis who presented for acute left facial and arm numbness, vision loss, and dizziness with last known well time at 2230 on 5/11/2025. Neurological examination revealed decreased sensation over left V1-V3 distribution, monocular left eye double vision with left lateral gaze, and NIHSS of 1 for mild-to-moderate sensory loss. CT/CTA head and neck were negative for acute findings with no large vessel occlusion, and MRI Brain and Orbit with and without contrast on 5/12/2025 showed no evidence of acute stroke. The patient was not a thrombolysis candidate as last known well time was beyond 4.5 hours, and was started on ASA 81 mg daily. By 5/13/2025, all neurological symptoms had completely resolved, and TIA was determined to be the most likely diagnosis with secondary stroke prevention measures recommended, including initiation of Crestor 20 mg daily to target LDL <70 mg/dL Patient deferred this for now, advised to discuss with his PCP. Blood pressure was managed with home medications (amlodipine 10 mg daily and lisinopril 40 mg daily) plus PRN IV labetalol/hydralazine with a goal SBP <140 mmHg. The patient's other medical conditions included hypothyroidism (on levothyroxine 125 mcg daily), gout (on allopurinol 450 mg daily), respiratory conditions (asthma, COPD, OSA requiring CPAP), and GERD with esophageal stricture (on pantoprazole 40 mg daily). Incidental findings included sinusitis on MRI, mildly elevated liver enzymes (AST 42 U/L, ALT 38 U/L), and elevated sedimentation rate (13 mm/hr), with a transthoracic echocardiogram with no PFO , no thrombus, no shunts
Age: 58.0
Sex: M
Vaccine: PNC20
Symptoms: Diplopia, Dizziness, Echocardiogram, Echocardiogram normal, Eye movement disorder
Clinical narrative: acute onset left facial and left upper extremity numbness, peripheral vision loss associated with dizziness and gait imbalance. Per patient above symptoms started around 630 AM. admitted on 05/12/2025 with PMH of HTN, hypothyroidism, asthma, arthritis who presented for acute left facial and arm numbness, vision loss, and dizziness with last known well time at 2230 on 5/11/2025. Neurological examination revealed decreased sensation over left V1-V3 distribution, monocular left eye double vision with left lateral gaze, and NIHSS of 1 for mild-to-moderate sensory loss. CT/CTA head and neck were negative for acute findings with no large vessel occlusion, and MRI Brain and Orbit with and without contrast on 5/12/2025 showed no evidence of acute stroke. The patient was not a thrombolysis candidate as last known well time was beyond 4.5 hours, and was started on ASA 81 mg daily. By 5/13/2025, all neurological symptoms had completely resolved, and TIA was determined to be the most likely diagnosis with secondary stroke prevention measures recommended, including initiation of Crestor 20 mg daily to target LDL <70 mg/dL Patient deferred this for now, advised to discuss with his PCP. Blood pressure was managed with home medications (amlodipine 10 mg daily and lisinopril 40 mg daily) plus PRN IV labetalol/hydralazine with a goal SBP <140 mmHg. The patient's other medical conditions included hypothyroidism (on levothyroxine 125 mcg daily), gout (on allopurinol 450 mg daily), respiratory conditions (asthma, COPD, OSA requiring CPAP), and GERD with esophageal stricture (on pantoprazole 40 mg daily). Incidental findings included sinusitis on MRI, mildly elevated liver enzymes (AST 42 U/L, ALT 38 U/L), and elevated sedimentation rate (13 mm/hr), with a transthoracic echocardiogram with no PFO , no thrombus, no shunts
Age: 58.0
Sex: M
Vaccine: PNC20
Symptoms: Glycosylated haemoglobin normal, Hypoaesthesia, Low density lipoprotein normal, Magnetic resonance imaging abnormal, Magnetic resonance imaging head
Clinical narrative: acute onset left facial and left upper extremity numbness, peripheral vision loss associated with dizziness and gait imbalance. Per patient above symptoms started around 630 AM. admitted on 05/12/2025 with PMH of HTN, hypothyroidism, asthma, arthritis who presented for acute left facial and arm numbness, vision loss, and dizziness with last known well time at 2230 on 5/11/2025. Neurological examination revealed decreased sensation over left V1-V3 distribution, monocular left eye double vision with left lateral gaze, and NIHSS of 1 for mild-to-moderate sensory loss. CT/CTA head and neck were negative for acute findings with no large vessel occlusion, and MRI Brain and Orbit with and without contrast on 5/12/2025 showed no evidence of acute stroke. The patient was not a thrombolysis candidate as last known well time was beyond 4.5 hours, and was started on ASA 81 mg daily. By 5/13/2025, all neurological symptoms had completely resolved, and TIA was determined to be the most likely diagnosis with secondary stroke prevention measures recommended, including initiation of Crestor 20 mg daily to target LDL <70 mg/dL Patient deferred this for now, advised to discuss with his PCP. Blood pressure was managed with home medications (amlodipine 10 mg daily and lisinopril 40 mg daily) plus PRN IV labetalol/hydralazine with a goal SBP <140 mmHg. The patient's other medical conditions included hypothyroidism (on levothyroxine 125 mcg daily), gout (on allopurinol 450 mg daily), respiratory conditions (asthma, COPD, OSA requiring CPAP), and GERD with esophageal stricture (on pantoprazole 40 mg daily). Incidental findings included sinusitis on MRI, mildly elevated liver enzymes (AST 42 U/L, ALT 38 U/L), and elevated sedimentation rate (13 mm/hr), with a transthoracic echocardiogram with no PFO , no thrombus, no shunts
Age: 58.0
Sex: M
Vaccine: PNC20
Symptoms: Magnetic resonance imaging head normal, NIH stroke scale abnormal, Red blood cell sedimentation rate increased, Scan with contrast normal, Sensory loss
Clinical narrative: acute onset left facial and left upper extremity numbness, peripheral vision loss associated with dizziness and gait imbalance. Per patient above symptoms started around 630 AM. admitted on 05/12/2025 with PMH of HTN, hypothyroidism, asthma, arthritis who presented for acute left facial and arm numbness, vision loss, and dizziness with last known well time at 2230 on 5/11/2025. Neurological examination revealed decreased sensation over left V1-V3 distribution, monocular left eye double vision with left lateral gaze, and NIHSS of 1 for mild-to-moderate sensory loss. CT/CTA head and neck were negative for acute findings with no large vessel occlusion, and MRI Brain and Orbit with and without contrast on 5/12/2025 showed no evidence of acute stroke. The patient was not a thrombolysis candidate as last known well time was beyond 4.5 hours, and was started on ASA 81 mg daily. By 5/13/2025, all neurological symptoms had completely resolved, and TIA was determined to be the most likely diagnosis with secondary stroke prevention measures recommended, including initiation of Crestor 20 mg daily to target LDL <70 mg/dL Patient deferred this for now, advised to discuss with his PCP. Blood pressure was managed with home medications (amlodipine 10 mg daily and lisinopril 40 mg daily) plus PRN IV labetalol/hydralazine with a goal SBP <140 mmHg. The patient's other medical conditions included hypothyroidism (on levothyroxine 125 mcg daily), gout (on allopurinol 450 mg daily), respiratory conditions (asthma, COPD, OSA requiring CPAP), and GERD with esophageal stricture (on pantoprazole 40 mg daily). Incidental findings included sinusitis on MRI, mildly elevated liver enzymes (AST 42 U/L, ALT 38 U/L), and elevated sedimentation rate (13 mm/hr), with a transthoracic echocardiogram with no PFO , no thrombus, no shunts