chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix B Administration of expired vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HBV (Engerix B) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis.   On 03-APR-2025, the patient received Engerix B. On 03-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix B Administration of expired vaccine). The outcome of the expired vaccine used was 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: 04-APR-2025 A nurse practitioner mentioned that patient received an expired dose of Engerix-B yesterday on 03 April 2025 which led to Expired vaccine used. The nurse asked if the patients should be re vaccinated.; Sender's Comments:  US-GSK-US2025040981:same reporter/ Different patient US-GSK-US2025040985:same reporter/ Different patient US-GSK-US2025040987:same reporter/ Different patient US-GSK-US2025040989:same reporter/ Different patient US-GSK-US2025040991:same reporter/ Different patient
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B - Administration of expired vaccine.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received HBV (Engerix B) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis.   On 03-APR-2025, the patient received Engerix B. On 03-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B - Administration of expired vaccine.). The outcome of the expired vaccine used was 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: 04-APR-2025 The nurse practitioner mentioned that a patient received an expired dose of Engerix-B on 3rd April 2025 which led to expired vaccine used. The nurse asked if the patients should be re vaccinated. This case was one of 5 cases, reported by same reporter; Sender's Comments:  US-GSK-US2025040983:same reporter/ Different patient US-GSK-US2025040985:same reporter/ Different patient US-GSK-US2025040981:same reporter/ Different patient US-GSK-US2025040987:same reporter/ Different patient US-GSK-US2025040989:same reporter/ Different patient
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B - Administration of expired vaccine.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received HBV (Engerix B) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis.   On 03-APR-2025, the patient received Engerix B. On 03-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B - Administration of expired vaccine.). The outcome of the expired vaccine used was 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: 04-APR-2025 The nurse practitioner mentioned that a patient received an expired dose of Engerix-B on 3rd April 2025 which led to expired vaccine used. The nurse asked if the patients should be re vaccinated. The case is 1 of the 5 linked case, by same reporter.; Sender's Comments:  US-GSK-US2025040983:same reporter/ Different patient US-GSK-US2025040985:same reporter/ Different patient
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B expired dose; 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 9-month-old female patient who received HBV (Engerix B) (batch number 95D74, expiry date 28-MAR-2025) for prophylaxis.   On 04-APR-2025, the patient received Engerix B. On 04-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B expired dose). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK receipt date: 04-APR-2025 Other HCP reported that an expired dose of Engerix-B was administered to a patient, which led to expired vaccine used.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: expired vaccine administered; Late second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HBV (Engerix B) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b).   On 25-MAR-2025, the patient received the 2nd dose of Engerix B. On 25-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired vaccine administered) and drug dose administration interval too long (Verbatim: Late second dose). The outcome of the expired vaccine used and drug dose administration interval too long 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: 04-APR-2025 Nurse explained that an 18-year-old patient got an expired dose of Engerix- B on March 25th 2025, the vaccine expired on March 14th 2025,which led to expired vaccine used. Patient received 1 prior dose of Engerix-B on January 14th 2025. The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received HBV (Engerix B) (batch number 553J7, expiry date 28-MAR-2025) for prophylaxis.   On 07-APR-2025, the patient received Engerix B. On 07-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was 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: 07-APR-2025 Nurse explained that they administered an expired dose of Engerix-B to a patien, which led to expired vaccine used. The reporter consented to follow up.
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired drug used; This non-serious case was reported by a consumer via sales rep and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: expired drug used). The outcome of the expired vaccine used was 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: 08-APR-2025 The field representative reported a healthcare office inadvertently administered an expired pediatric dose of Engerix-B which led to expired vaccine used. GSK rep called this report in one callback placed to the reporting HCP but did not reach her.
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Inappropriate dose; Inappropriate dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 19-year-old male patient who received HBV (Engerix B adult) (batch number 79S54, expiry date 04-APR-2025) for prophylaxis.   On 03-APR-2025, the patient received the 1st dose of Engerix B adult. On 03-APR-2025, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Inappropriate dose) and adult product administered to child (Verbatim: Inappropriate dose). The outcome of the overdose and adult product administered to child 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: 08-APR-2025 The reporter called to inform that he/she had a 19-year-old patient that received the adult dose of Engerix-B, which led to overdose and adult product administered to child. According to reporter, such dose was the 1st of the series and was administered in 3rd April 2025.  Also, according to reporter, the patient was going to turn 20 years-old in 15th May 2025. The reporter consented to follow up.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12-year-old patient was administered Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received DTPa (Infanrix) (batch number 9KB9G) for prophylaxis.   On 10-MAR-2025, the patient received Infanrix. On 10-MAR-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 12-year-old patient was administered Infanrix). The outcome of the inappropriate age at vaccine administration was 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: 08-APR-2025 Nurse stated that a 12-year-old patient was administered Infanrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. Healthcare professional did not have expiration date at the time of the call.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6-month-old patient was administered Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3RT9T) for prophylaxis.   On 17-MAR-2025, the patient received Kinrix. On 17-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 6-month-old patient was administered Kinrix). The outcome of the inappropriate age at vaccine administration was 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: 08-APR-2025 The nurse stated that the 6-month-old patient was administered Kinrix which led to inappropriate age at vaccine administration.  The Vaccine Administration Facility was the same as Primary Reporter.
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received first dose over a year ago).   On 08-APR-2025, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 08-APR-2025 Reporter stated that a patient missed their second Shingrix dose. Patient went  on the day of reporting for a Shingrix vaccine and saw they were over a year overdue. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 2P359, expiry date 16-JUN-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14-SEP-2022).   On 08-APR-2025, the patient received the 2nd dose of Shingrix. On 08-APR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix late second dose). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date:08-APR-2025 The Vaccine Administration Facility was the same as Primary Reporter. Only one lot number and expiration date were provided.  The agent asked for the lot and expiration date of the first dose and the health care provider gave the ones that are registered in this report.  But the agent suspected that the pharmacist might have given the data of the second dose, instead of that first dose asked. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd dose of shingrix late; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine in 2023).   In FEB-2025, the patient received the 2nd dose of Shingrix. In FEB-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received 2nd dose of shingrix late). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 08-APR-2025 The patient was older than 50 years old. The other health professional reported that they had a patient who received a Shingrix vaccine in 2023, and then waited another year before getting their second one.  It was usually stated that, in such cases, when an individual had received the Shingrix vaccine, they got the first dose, waited two to six months for the second dose, and were then considered set.  Reporter was enquiring what was recommended for people that have missed one that they had just one injection and then whether they were waiting a year or they never got their second injection also if they did start over. Patient received 2nd dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered
Clinical narrative: accidentally received a dose of Pediarix and Engerix-B administration (same day); This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 4-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2G273) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number K4JH7) for prophylaxis.   On 08-APR-2025, the patient received Pediarix and Engerix B. On 08-APR-2025, an unknown time after receiving Pediarix and Engerix B, the patient experienced accidental overdose (Verbatim: accidentally received a dose of Pediarix and Engerix-B administration (same day)). The outcome of the accidental overdose was 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: 08-APR-2025 The office manager called and reported that the patient was accidentally received a dose of Pediarix as well as Hepatitis B (Engerix-B) at the same time, which led to accidental overdose for hepatitis B antigen. The Vaccine Administration Facility is the same as Primary Reporter.
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received Engerix B  late second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose in  October 2024).   In APR-2025, the patient received the 2nd dose of Engerix B. In APR-2025, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: received Engerix B  late second dose). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK receipt date: 08-APR-2025 The wellness center supervisor called to report multiple patients received late second doses for Engerix-B. The reporter stated that they had individuals that got the vaccine in October 2024, and they were getting their second dose in April 2025, six months later which led to, drug dose administration interval too long. We are probably giving about sixty of these vaccines in the last few months, not all of them were late second doses. Somehow, had about five or six people slip through the cracks in October and they did not know how that happened, but it happened. The reporter mentioned that when asked about patients details information was declined. Patient details, vaccination dates or more specific information was asked but declined during the call.
Sex: F
Vaccine: COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Migraine, Thyroid disorder, Tinnitus
Clinical narrative: I had developed CIDP/ Optic nerve inflammation/ Fatigue/ Falling/ Balance was off/ Parenthesis; Migraine; Had my thyroid removed; Tinnitus; This spontaneous case was reported by a patient and describes the occurrence of CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (I had developed CIDP/ Optic nerve inflammation/ Fatigue/ Falling/ Balance was off/ Parenthesis) and THYROID DISORDER (Had my thyroid removed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (I had developed CIDP/ Optic nerve inflammation/ Fatigue/ Falling/ Balance was off/ Parenthesis) (seriousness criteria disability and medically significant) and MIGRAINE (Migraine). In April 2021, the patient experienced THYROID DISORDER (Had my thyroid removed) (seriousness criterion medically significant) and TINNITUS (Tinnitus). The patient was treated with Surgery (Thyroid removed) for Thyroid disorder. At the time of the report, CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (I had developed CIDP/ Optic nerve inflammation/ Fatigue/ Falling/ Balance was off/ Parenthesis) outcome was unknown and THYROID DISORDER (Had my thyroid removed), TINNITUS (Tinnitus) and MIGRAINE (Migraine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: Developed CIDP. On an unknown date, Nerve conduction studies: Developed CIDP.         No concomitant medications provided by the reporter.  It was reported that patient had her Moderna Covid-19 vaccination in March-2021 and April-2021. After the second Moderna Covid-19 vaccination patient had experienced sever symptom of tinnitus, fatigue optic nerve inflammation. Patient had her thyroid removed. Patient had also experienced symptom of parenthesis, migraines. Patient balance was off, and she started falling a lot. Patent had undergone tests of MRI; nerve conduction test and it was found that patient had developed CIDP. Patient had considered for a wheelchair for her filed work.  Patient requested for research for her present symptom, and she would send her blood and hair sample for research.  No treatment medications provided by the reporter.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Nov2024 as dose 1, single (Lot number: LM2224) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing), notes: Always gets allergies and, sinuses always flare up in spring; "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension, start date: 2015 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Mfg number, NDC: 59267-1000-02, EXP: 30Jun2021, LOT: unknown, Both vaccines in left arm), administration date: 18Mar2021, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, NDC, LOT, EXP: Thinks it is all same as first dose, both listed under same category, the 2 doses. , Both vaccines in left arm), administration date: 08Apr2021, for Covid-19 immunization; BNT162b2 (DOSE 3, SINGLE, NDC: 59267-1000-02, EXP: 31Jul2021, Pfizer LOT: FJ1611 or CJ1611, left arm, Everything given in left arm), administration date: 04Jan2022, for Covid-19 immunization; pfizer omicron (DOSE 4, SINGLE, LOT: GJ2524, NDC, EXP: Unknown, This dose originally provided as fifth dose, later clarified, it was fourth dose.), administration date: 04Oct2022, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Apr2025, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Apr2025) Positive.
Age: 0.5
Sex: F
Vaccine: MEN
Symptoms: Injection site bruising, Product administered to patient of inappropriate age
Clinical narrative: mistakenly given the vaccine, which was not indicated for her age; light bruising at the injection site; Initial information received on 09-Apr-2025 regarding an unsolicited valid non-serious case received from a Patient's Father.  This case involves a 6 months old female patient who was mistakenly given MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI], which was not indicated for her age and had light bruising at the injection site   The patient's past medical history, medical treatment(s) and family history were not provided. No other vaccines   On 07-Apr-2025, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) vaccine Solution for injection, which was not indicated for her age, (Frequency: Once, strength: standard; expiry date and lot number not reported) via intramuscular route in the left thigh for Immunization (Immunization) (product administered to patient of inappropriate age) (same day latency).   Information on batch number and expiry date corresponding to the one at time of event occurrence was requested  On an unknown date in Apr-2025 the patient developed light bruising at the injection site (vaccination site bruising) (latency: approximately few hours to few days)  Reportedly, Patient's Father was further advised to monitor and speak with their HCP (healthcare professional)  Action taken was not applicable  Corrective treatment: none for vaccination site bruising  At time of reporting, the outcome was Unknown for the event vaccination site bruising.  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: 84.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: ADACEL was given to an 84 year old patient, with no reported adverse event; Initial information received on 10-Apr-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 84 years old female patient who received 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.  On 18-Mar-2025, the 84 years old patient received 0.5 ml of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength- standard, expiry date- 31-MAR-2026 and lot U8115AA) once via intramuscular route in the left arm for Immunization with no reported adverse event (product administered to patient of inappropriate age) (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: 77.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Boostrix should still be given to a patient that was incorrectly administered with ADACEL with no adverse event; Initial information received on 10-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 77 years old male patient to whom vaccine Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel]  was incorrectly administered instead of being administered with Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix) with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Apr-2025 at 01:20 pm, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection (strength: standard, Frequency: once, expiry date: 20-Jul-2025 and lot 2CA69C1) via intramuscular route in the left arm as prophylactic vaccination (immunization) instead of Boostrix with no adverse event (wrong product administered) (latency: same day).  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: M
Vaccine: RAB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received the first dose on 02-Apr-2025 and was trying to receive the second dose on 11-Apr-2025 with no reported adverse event; Initial information received on 11-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 years old male patient who received the first dose of rabies (HDC) vaccine [Imovax Rabies] on 02-Apr-2025 and was trying to receive the second dose on 11-Apr-2025 with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Apr-2025, the patient received an unknown dose 1 of rabies (HDC) vaccine Powder and solvent for suspension for injection (strength- standard, expiry date- 31-OCT-2025 and lot W1C431M) via unknown route in unknown administration site and was trying to receive the second dose on 11-Apr-2025 with no reported adverse event (routine immunisation schedule not administered).   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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Memory impairment
Clinical narrative: Memory fogginess,  Tired and Chest pains
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue, Chills and Fever, and Headache
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event
Clinical narrative: NO SIGNS AND SYMPTOMS REPORTED
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Hives starting 4 hr after vaccine
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Fever for a day. Red and rash
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal operation, Abdominal pain
Clinical narrative: Patient stated experiencing pain in abdomen above belly button. Patient had abdominal surgery (unclear what type). Physician told patient he did not think it was related to the Shingles vaccine but to go ahead and proceed with reporting adverse reaction.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate decreased, Hyperhidrosis, Nausea
Clinical narrative: Patient became nauseated, diaphoretic, and dizzy after vaccination. Blood pressure was 90/60 with a low heart rate of 56. EMT were called and recorded vitals of 104/56 with a heart rate of 56. patient states he did not eat well that day, provided fluids. at 4:08pm EMS was called, EMS arrived at 4:17pm. EMS took over the care of the patient at 4:20pm. Facility contact was notified at 4:18pm. The school was notified. Parent was with the patient the entire time.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever 104 with rash
Age: 89.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Memory impairment
Clinical narrative: Patient went to dining room per facility staff and client stated "I'm Falling" did not fall but blanked out per residents at the dining room table. denies breathing problems, denies check, back or arm pain, no nausea. EMS notified per facility staff. Pt. took BP medics this am and had supra pubic catheter flushed. Wife present during event.
Age: 35.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Feeling hot, Syncope
Clinical narrative: At 11:05am the patient fainted following second shot. Nurse moved patient to floor and elevated feet. BP 134/80. at 11:07am patient alert "feels hot" observed for 5 minutes, patient received water to drink. 11:15am pt sitting in chair with BP of 120/73 then sat in the waiting area 15 mins and received 2nd glass of water. 11:28am up walking recovered. S/O continued to observe in the office.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Patient wanted to get a covid shot, but was given a flu shot in error.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Breath holding, Crying, Hypotonic-hyporesponsive episode
Clinical narrative: Liklely hypotonic hyporesponsive episode versus pallid breath holding spell based on response to injections. No syncope, but patient was "silent" crying for a few moments after her injections, appeared dazed and limp, returned to normal crying and normal responsiveness after approx 30 seconds. Advised that this is likely not dangerous, but to keep a close eye on her for today to ensure no recurrence. Discussed reasons to seek urgent/emergent eval.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears.  Apparently this is not treatable.  The ringing continues to this day, 4 years later, both ears.
Age: 74.0
Sex: F
Vaccine: PNC21
Symptoms: Fatigue, Hypersomnia, Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: Patient felt very tired the evening after and woke up the next morning still feeling very tired and slept most of the day. Upon waking later in the day, she found that her left arm was very swollen and she was covered in hives and had a low grade fever. She went to the emergency room and received a steroid injection which she said helped significantly. She felt better after 2-3 days.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure in left leg for 2 min
Age: 67.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 63.0
Sex: F
Vaccine: DTAP, UNK
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Patient reported that the vaccine might have been administered too high in the arm. She reported stiffness and pain when raising her arm. She said this is getting better with time. I asked her to see a doctor to which she declined.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site papule, Injection site reaction, Skin lesion
Clinical narrative: Lesions tiny subcutaneous papule palpable under the skin to anterolateral L thigh where last week's Variax vaccine was administered. There is a 1.5cm periphery of light purple. Then 0.5cm band of clearing, then an outer eryth ring - total diameter is 4.5cm. blanchable, NT, no d/c, no streaking, no ulcers, no pustules, no crusting, no excoriation.  ° Color and pigmentation were normal.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Balance disorder, Blood test, Brain fog, Condition aggravated
Clinical narrative: It was similar to what happened in 2021 after a bad case of Covid.  About 2 or so weeks after the shot, I started having brain stem, neck, and spinal cord pain.  I have a blown disc and 2 bulging discs and we thought it may be that so I went back to phy. therapy.  Things were only getting worse.  About a week later around 10/25, I had one of the worst headaches ever (similar to the ones I had in 2021) About a week after that, I started having severe brain fog.  So bad my boss recommended that I go on medical leave.  I went to see my orthopedic surgeon and he said absolutely nothing had changed and he thought something else may be going on.  My balance was out of whack, severe headaches, neck aches, and pain below the skull up inside sort of near the brain stem.  Once the brain fog began, my pre-frontal cortex was definitely out of whack.  Severe mood swings, uncontrollable anger, memory problems....then  a few weeks after that I started having palpitations and racing heart any time I'd stand up..similar to 2021.  Dr. believes it's all POTS related and that possibly the vaccine flared everything back up
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Impaired work ability, Memory impairment, Mood swings
Clinical narrative: It was similar to what happened in 2021 after a bad case of Covid.  About 2 or so weeks after the shot, I started having brain stem, neck, and spinal cord pain.  I have a blown disc and 2 bulging discs and we thought it may be that so I went back to phy. therapy.  Things were only getting worse.  About a week later around 10/25, I had one of the worst headaches ever (similar to the ones I had in 2021) About a week after that, I started having severe brain fog.  So bad my boss recommended that I go on medical leave.  I went to see my orthopedic surgeon and he said absolutely nothing had changed and he thought something else may be going on.  My balance was out of whack, severe headaches, neck aches, and pain below the skull up inside sort of near the brain stem.  Once the brain fog began, my pre-frontal cortex was definitely out of whack.  Severe mood swings, uncontrollable anger, memory problems....then  a few weeks after that I started having palpitations and racing heart any time I'd stand up..similar to 2021.  Dr. believes it's all POTS related and that possibly the vaccine flared everything back up
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Neuralgia, Palpitations, Postural orthostatic tachycardia syndrome
Clinical narrative: It was similar to what happened in 2021 after a bad case of Covid.  About 2 or so weeks after the shot, I started having brain stem, neck, and spinal cord pain.  I have a blown disc and 2 bulging discs and we thought it may be that so I went back to phy. therapy.  Things were only getting worse.  About a week later around 10/25, I had one of the worst headaches ever (similar to the ones I had in 2021) About a week after that, I started having severe brain fog.  So bad my boss recommended that I go on medical leave.  I went to see my orthopedic surgeon and he said absolutely nothing had changed and he thought something else may be going on.  My balance was out of whack, severe headaches, neck aches, and pain below the skull up inside sort of near the brain stem.  Once the brain fog began, my pre-frontal cortex was definitely out of whack.  Severe mood swings, uncontrollable anger, memory problems....then  a few weeks after that I started having palpitations and racing heart any time I'd stand up..similar to 2021.  Dr. believes it's all POTS related and that possibly the vaccine flared everything back up
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Injection site discolouration, Injection site swelling, Injection site vesicles, Photopsia
Clinical narrative: Patient reported back to pharmacy on 4/15/25 & stated that the day after vaccination while watching TV she had a visual disturbance, including flashing lights & vision loss.  Also, on 4/15/25, patient returned to pharmacy & showed the injection site which now had 3 raised, blistered areas & discoloration.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Patient reported back to pharmacy on 4/15/25 & stated that the day after vaccination while watching TV she had a visual disturbance, including flashing lights & vision loss.  Also, on 4/15/25, patient returned to pharmacy & showed the injection site which now had 3 raised, blistered areas & discoloration.
Age: 44.0
Sex: M
Vaccine: COVID19, FLU3, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 27.0
Sex: M
Vaccine: COVID19, FLU3, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 19.0
Sex: M
Vaccine: HEP, HPV9, MNQ
Symptoms: Hyporesponsive to stimuli, Syncope
Clinical narrative: Client had a syncope episode that started right after being given the last vaccine (HPV9).  Client was seated in a chair the entire time, so no fall or injury took place. RN immediately got the client some water which he drank a little and a fan was retrieved and plugged in beside client to try and cool him off. I was unable to move patient to the exam table due to being the only nurse in the clinic, so client remained in the chair the entire time. Client did not recover promptly as I have seen in the past. I called for assistance from our clerk and had her place a call to 911. During that time, I opened up an ammonia wipe to place under client's nose. Client then became a little more alert, but still kept closing his eyes and laying his head down. After a few more minute's client was fully alert and oriented x3. Client was aware of what was going on but said nothing like that had ever happened to him. Client did not want rescue called, so I canceled the rescue at that time. Client stayed in clinic for monitoring x15 minutes. Vitals including BP was taken after client recovered and were stable and client then left clinic.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Ischaemic stroke
Clinical narrative: ischemic stroke caused death
Vaccine: MMR
Symptoms: Arthralgia, Gait inability, Musculoskeletal discomfort, X-ray limb normal
Clinical narrative: Assumed right ankle pain/discomfort. Prior to vaccine, infant was ambulating well, taking 15+ steps when walking. After vaccine, did not walk for about 2 weeks. Negative x-ray. Self-resolved.
Age: 40.0
Sex: M
Vaccine: COVID19, IPV, VARCEL
Symptoms: Chest pain, Dizziness, Vision blurred
Clinical narrative: Patient came in to complete 6 vaccines required. After the first 3 shots patient started to feel lightheaded, chest pain, and blurred vision. Patient's wife who was present requested an ambulance.  EMS services was contacted. After patient was able to relax for a few minutes he was doing slightly better. EMS showed up shortly after. EMS services evaluated patient for approximately 15 minutes. After that he was doing a lot better and declined further services from EMS. During EMS evaluation patient said that he gets anxious around needles.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: no adverse events or reactions noted
Age: 42.0
Sex: M
Vaccine: HEPAB, IPV, MMR, PNC21
Symptoms: Eye haemorrhage
Clinical narrative: Patient reported the following day with a ruptured blood vessel in left eye, with no pain or changes in vision.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: MMR Vaccine was given to an 18yr male pt at 5:30pm on 4/14/2025 in the right deltoid. A meningococcal vaccine was supposed to be given. Parents of the pt and the pt have been notified via phone. No adverse effects or symptoms reported.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: wrong vaccine was administered. Patient needed either Proquad or Varivax. The patient is traveling and needed certain vaccines. No adverse effects have been found, only wrong vaccine
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient mistakenly received a second dose of the prevnar20 vaccine, she forgot she had previously received it. Patient reported no signs or symptoms after follow up occurred several days later.
Age: 47.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Underdose
Clinical narrative: Patient given pediatric dose of Hepatitis B vaccine instead of adult dose. Patient was given an additional dose of pediatric dose of Hepatitis B vaccine.
Age: 27.0
Sex: F
Vaccine: SMALL
Symptoms: Injected limb mobility decreased, Injection site reaction, Muscle injury, Pain in extremity
Clinical narrative: Pt reported pain and limited motion in her left arm after receiving flucelvax vaccine in her left deltoid.  It was not resolved after 2 weeks and pt made an appointment with her doctor for further evaluation.
Age: 0.75
Sex: M
Vaccine: PNC20
Symptoms: Infant irritability, Injection site swelling, Pyrexia
Clinical narrative: Large swelling across the thigh where the injection occurred. Low grade temp and fussiness.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Had a small bump around vaccine site night of vaccine (4/14/2025), next morning had swelling, irritation, and redness. Seen in the office on 4/15/25 (day after injection) and Dr. prescribed cephalexin. Outcome unknown at this time.
Age: 53.0
Sex: M
Vaccine: PNC21
Symptoms: Headache, Pain in extremity
Clinical narrative: left arm/leg/head/entire left side of body with pain
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt given Injection expired on 2/28/2025 No reaction 9:05 AM
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Blister, Incorrect route of product administration, Local reaction
Clinical narrative: vaccine given IM rather than SC and developed large local response with overlying blisters
Age: 57.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Gave the wrong vaccine for a 57 year old
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Purulent discharge
Clinical narrative: Redness and swelling to entire L thigh. Purulent exudate x 24hrs to at site of injection
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Paraesthesia
Clinical narrative: Directly as injection happened a tingling sensation began in middle and ring finger on the left hand. It gets worse with use of arm and hand.
Age: 87.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site rash, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Injection site rection, warm, erythematous nontender rash on L Bicep area
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injected limb mobility decreased, Myalgia, Pain in extremity, Viral infection
Clinical narrative: Patient states she got a vaccine on 9/15/24 and thinks she is having a reaction to the Covid vaccine because her arm hurts and she is having difficulty using the arm.  After investigating, it is her left arm that hurts now, and she got the flu shot in the left arm.  Also, the arm was fine until late March 2025 when she got a virus, then she states as she was healing from the virus, her arm began to hurt.  Her arm hurts in her muscle.  She wanted paperwork filled out for an adverse reaction to the immunization though the symptoms started 6 monts or so after the vaccine was administered.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Radiculitis brachial
Clinical narrative: Brachial neuritis
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Covid vaccine expired by one day was given to the patient. Patient notified. Patient has since returned to received a non expired covid vaccination.