chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine/more than 6 months following a first dose administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose five years ago in 2019, specific date not provided ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine/more than 6 months following a first dose administration). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-AUG-2024 The patient that received last dose of Shingles vaccine five years ago (from the reporting date).  The pharmacist wanted further assistance or recommendations of what needs to be done in this case, if this patient may receive the two dose or what would be the advise in this regard. The pharmacist did not provide further detail about this patient and related situation in the call. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received her first dose on 7-August-2023 and wants her second dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 7th August 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received her first dose on 7-August-2023 and wants her second dose.). The outcome of the incomplete course of vaccination was not reported.   Additional Information: GSK Receipt Date: 26-AUG-2024 The pharmacist reported that the patient received her first dose and wants her second dose. Till the time of reporting the patient did not received the 2nd dose of Shingrix which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on Lower Back; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced rash (Verbatim: Rash on Lower Back). The outcome of the rash was resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-AUG-2024  The pharmacist stated that a patient received her first dose of Shingrix around 3 months ago and came in to pharmacy yesterday to receive second dose. The patient developed a lower back rash after the first dose. The pharmacist was not sure of the timing of the onset of the rash or the duration, but stated it was resolved. The pharmacist did not believe the patient received any sort of treatment for the rash. The pharmacist did not have the dose lot number/expiration date, patient exact age or DOB (stated she was in her 50s). At the time of call, the patient had not been administered a second dose. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. Outbound call was placed back to HCP to obtain AE details. Reporter gave permission for follow-up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A female patient received the second dose of Shingrix 1 month after the first dose of Shingrix.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On an unknown date, 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 short (Verbatim: A female patient received the second dose of Shingrix 1 month after the first dose of Shingrix.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 26-AUG-2024 On the pharmacist called in behalf of a patient who was vaccinated with Shingrix in another establishment wondering if have any data regarding the situation of the patient because she was given the second dose after 1 month of the first dose of Shingrix, which led to shortening of vaccination schedule. The pharmacist did not know the exact age of the patient, he said she was probably around 70 years old, and also not know the lot number and the expiration date of the vaccine because the patient was vaccinated in other establishment. Consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Shingrix third dose was on 8/23/2024.; Shingrix second dose was on 8/2024; 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received first dose in SEP-2021).   On 23-AUG-2024, the patient received the 3rd dose of Shingrix. In AUG-2024, the patient received the 2nd dose of Shingrix. In AUG-2024, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix second dose was on 8/2024). On 23-AUG-2024, the patient experienced extra dose administered (Verbatim: Shingrix third dose was on 8/23/2024.). The outcome of the drug dose administration interval too long and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 26-AUG-2024 The pharmacist Intern reported that an immunocompetent patient received the third dose earlier than recommended it, which led to extra dose administered. The reporter did not consent to follow-up. Permission to create an Account in Medial Information database declined. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 59.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: inappropriate age at vaccine administration; Expire dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 59-year-old female patient who received Men B NVS (Bexsero) (batch number E74MY, expiry date 31-JUL-2024) for prophylaxis.   Previously administered products included Bexsero (receive 1st dose on an unknown date).   On 26-AUG-2024, the patient received the 2nd dose of Bexsero. On 26-AUG-2024, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: inappropriate age at vaccine administration) and expired vaccine used (Verbatim: Expire dose administered). The outcome of the inappropriate age at vaccine administration was not reported and the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-AUG-2024 The reporter reported that had some expire doses of the Bexsero vaccine that was administer to a patient, which led to expired vaccine used. The patient was received the Bexsero vaccine at an inappropriate age, which led to inappropriate age at vaccine administration. The reporter asks there was stability studies that were done on this lot number or the product in order to determinant the next steps. The vaccine administration facility was the same as primary reporter. The healthcare professional (HCP) did not specify when the 1st dose was administer.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired dose of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA938A, expiry date 31-JUL-2024) for prophylaxis.   On 26-AUG-2024, the patient received Menveo. On 26-AUG-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired dose of Menveo). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-AUG-2024 The nurse reported that the day before reporting they inadvertently administered an expired dose of Menveo two vial to an identifiable male patient which led o expired vaccine used.  The nurse wanted to receive advise in that situation.  No further detail was provided from the nurse.  The Vaccine Administration Facility was the same as Primary Reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: but never completed the 2nd; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix approximately 6 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: but never completed the 2nd). The outcome of the incomplete course of vaccination was not reported.   Additional Information: GSK Receipt Date: 27-AUG-2024 The other health professional asked the recommendations for someone who had the 1st injection but never completed the 2nd and it's been approximately 6 years since that previous 1st injection. The other health professional did not had the lot number or expiration date of the 1st dose nor the vaccination date.  The other health professional mentioned that the patient received the 1st dose at a local pharmacy and he did not had the address of this place. Till the time of reporting the patient did not received the 2nd dose of Shinigrix which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: inadvertently received only the adjuvant portion of Shingrix. It wasn't reconstituted with powder; inadvertently received only the adjuvant portion of Shingrix. It wasn't reconstituted with powder; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently received only the adjuvant portion of Shingrix. It wasn't reconstituted with powder) and inappropriate dose of vaccine administered (Verbatim: inadvertently received only the adjuvant portion of Shingrix. It wasn't reconstituted with powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-AUG-2024 The pharmacist called and reported that the patient inadvertently received only the adjuvant portion of Shingrix and was not reconstituted with powder before administration, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; contracted Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: contracted Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. It was unknown if the company considered the vaccination failure to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-AUG-2024 The patient self-reported this case. The patient received 1st and 2nd dose of Shingrix vaccine and he was contracted with shingles and he was now (during the reporting days) in remission. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding  time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose)
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; 3 shingles episodes; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 3 shingles episodes). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 The reporter reported that the patient had 3 shingles episodes after getting Shingrix vaccine. The HCP mentioned that patient received a vaccine in September 2023 but could not confirm if this was the first or second dose. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix(1 and 2 dose).
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: inadvertent administration of the liquid portion only of Menveo/ diluent was administered without the powder; diluent was administered without the powder; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adolescent patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA982A, expiry date 31-OCT-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: inadvertent administration of the liquid portion only of Menveo/ diluent was administered without the powder) and inappropriate dose of vaccine administered (Verbatim: diluent was administered without the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-AUG-2024 The medical assistant called to asked about the inadvertent administration of the liquid portion only of Menveo-diluent was administered without the powder, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter wanted to know was there any safety data about this, could this vaccine be mixed with other diluent (for example, a Menveo 1 vial vaccine). No further detail was obtained during the call. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Angioedema; This spontaneous case was reported by a patient and describes the occurrence of ANGIOEDEMA (Angioedema) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (Angioedema) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact; Reporter's Comments: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected serious (medically significant) event angioedema unknown days after an unknown dose number of SPIKEVAX NOS vaccine. Outcome of the event was reported as unknown. No further details were provided for medical review. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: developed gout in his big toe in his left foot; This spontaneous case was reported by a patient and describes the occurrence of GOUT (developed gout in his big toe in his left foot) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19.    In October 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In October 2023, the patient experienced GOUT (developed gout in his big toe in his left foot). The patient was treated with CORTISONE in August 2024 at an unspecified dose and frequency. At the time of the report, GOUT (developed gout in his big toe in his left foot) was resolving.            No concomitant medication was reported.  Patient had his last shot in October. Over the weekend, he developed gout in his big toe in his left foot.
Age: 47.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Feeling abnormal, Pain in extremity
Clinical narrative: oral temperature of 99.3F; very sore arm; feeling dizzy; I Feel Terrible; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (oral temperature of 99.3F), PAIN IN EXTREMITY (very sore arm), DIZZINESS (feeling dizzy) and FEELING ABNORMAL (I Feel Terrible) in a 47-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Aug-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (oral temperature of 99.3F), PAIN IN EXTREMITY (very sore arm), DIZZINESS (feeling dizzy) and FEELING ABNORMAL (I Feel Terrible). At the time of the report, PYREXIA (oral temperature of 99.3F), PAIN IN EXTREMITY (very sore arm), DIZZINESS (feeling dizzy) and FEELING ABNORMAL (I Feel Terrible) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.3F.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medication was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Paralysis
Clinical narrative: was allergic to it; paralyzed in 2021, from the neck down; This spontaneous case was reported by an other health care professional and describes the occurrence of PARALYSIS (paralyzed in 2021, from the neck down) and HYPERSENSITIVITY (was allergic to it) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Poor vision. Concomitant products included PREDNISONE for an unknown indication.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PARALYSIS (paralyzed in 2021, from the neck down) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERSENSITIVITY (was allergic to it) (seriousness criterion medically significant). At the time of the report, PARALYSIS (paralyzed in 2021, from the neck down) and HYPERSENSITIVITY (was allergic to it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Suspect vaccine dosage text was reported as unknown. On 2021, the patient started therapy with the Moderna Covid-19 vaccine. It was reported that the patient experienced: was allergic to it and became paralyzed in 2021, from the neck down after the 1st dose. Treatment information was not provided.  Company comment: This spontaneous case concerns a 74-year-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of paralysis and hypersensitivity. The events occurred on an unknown date after the first dose of mRNA-1273. Temporal relationship is unclear. As reported, patient was allergic to mRNA-1273 and became paralyzed in 2021, from the neck down after the 1st dose. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive and Negative.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. The HCP reported that she had COVID-19 for 5 days previously, experienced no adverse reactions, and tested negative afterward. No treatment medication was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site pain
Clinical narrative: chronic pain at the exact spot where it was administered.; the discomfort persists; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (chronic pain at the exact spot where it was administered.) and DISCOMFORT (the discomfort persists) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (chronic pain at the exact spot where it was administered.) and DISCOMFORT (the discomfort persists). At the time of the report, VACCINATION SITE PAIN (chronic pain at the exact spot where it was administered.) and DISCOMFORT (the discomfort persists) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  Reporter causality was not reported.
Sex: U
Vaccine: PNC20
Symptoms: Device breakage
Clinical narrative: Vaccine broke in half as nurse was taking the lid off; The initial case was missing the following minimum criteria: product complaint. Upon receipt of follow-up information on (22Aug2024), this case now contains all required information to be considered valid.   This is a spontaneous report received from a Nurse from a sales representative and product quality group.  A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LC1279, Expiration Date: Dec2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious) with onset 22Aug2024, outcome "unknown", described as "Vaccine broke in half as nurse was taking the lid off". Therapeutic measures were not taken as a result of device breakage.  The reporter considered "vaccine broke in half as nurse was taking the lid off" not related to pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein). Causality for "vaccine broke in half as nurse was taking the lid off" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Age: 11.0
Sex: M
Vaccine: MEN, MENB
Symptoms: Medication error, Wrong product administered
Clinical narrative: inadvertently given BEXSERO instead of MENQUADFI with no reported AE; Initial information received on 26-Aug-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 11 years old male patient where patient was inadvertently given bexsero (Meningococcal vaccine B rfHbp/NadA/NHBA OMV) instead of Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Aug-2024, the patient received a dose of suspect Bexsero (strength- standard) not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site (dose, formulation, and expiration date: not provided) for Immunisation (wrong product administered) (latency- same day).   On an unknown date, the dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation.  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site rash, Injection site warmth, Pain in extremity
Clinical narrative: Left arm was sore within a few hours. Redness/blotchy around injection site, redness has not increased in size. Ongoing warm to touch. Hard area at injection site. Is able to move shoulder/arm fully. Did not check temperature, denies sweating or chills. Denies localized itching
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Left arm was sore within a few hours. Redness/blotchy around injection site, redness has not increased in size. Ongoing warm to touch. Hard area at injection site. Is able to move shoulder/arm fully. Did not check temperature, denies sweating or chills. Denies localized itching
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalized with COVID
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Pt got tenderness in right arm.  Pt said nurse said to use warm compress.  I recommended cold compress.  There was some minor swelling,
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Inappropriate schedule of product administration, No adverse event, Vaccination error
Clinical narrative: No symptoms. This is just reporting an error. Patient had 1st Hep B vaccine 3/11/2024, had a Vaxelis on 6/4/2024, and another Vaxelis on 7/18/2024. This Hep B interval was only 6 weeks when it should have been 8. No symptoms. We have notified provider and will contact parents to notify them they will need a third Hep B dose.
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, Chills, Confusional state, Fatigue, Headache
Clinical narrative: Fever 101F, chills, severe headache, neck and back pain, aches pains, muscle soreness, tiredness/fatigued, confusion,
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Myalgia, Neck pain, Pain, Pyrexia
Clinical narrative: Fever 101F, chills, severe headache, neck and back pain, aches pains, muscle soreness, tiredness/fatigued, confusion,
Age: 80.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Asthenia, Balance disorder, Chills, Gait disturbance, Injection site pain
Clinical narrative: He got his vaccine and noticed a little soreness at the injection site, but was not concerned with that.  That evening he started getting the shakes that lasted for 3 1/2 to 4 hours.  He was unsteady on his feet, was stumbling around the house, lost control of his bladder, starting urinating on himself and had the chills.  He does not feel as it he was running fever.  He went to bed and thinks he took 1 Tylenol.  He had to get up frequently during the night and had a bucket to urinate in.  By the next day he was feeling a lot better, no more shaking but felt kind of weak.  He would say that he is pretty much back to his normal.  He did not call his doctor as this was the first day due to the holiday that he would be back at the office as he is feeling much better.
Age: 80.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Nocturia, Tremor, Urinary incontinence
Clinical narrative: He got his vaccine and noticed a little soreness at the injection site, but was not concerned with that.  That evening he started getting the shakes that lasted for 3 1/2 to 4 hours.  He was unsteady on his feet, was stumbling around the house, lost control of his bladder, starting urinating on himself and had the chills.  He does not feel as it he was running fever.  He went to bed and thinks he took 1 Tylenol.  He had to get up frequently during the night and had a bucket to urinate in.  By the next day he was feeling a lot better, no more shaking but felt kind of weak.  He would say that he is pretty much back to his normal.  He did not call his doctor as this was the first day due to the holiday that he would be back at the office as he is feeling much better.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized redness and swelling to injection site.
Age: 69.0
Sex: U
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: Bruising
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 1.25
Sex: M
Vaccine: FLU4, PNC20
Symptoms: Blood glucose normal, Febrile convulsion, Foaming at mouth, Immunisation reaction, Postictal state
Clinical narrative: Febrile Seizure.  He was napping and began to have a seizure of his arms and foaming at the mouth for 3 minues.  He was post-ictal for 5 minutes.  He was taken to ER where temperature was found to be 103.5.  Vaccines given on 8/31/24, 24 hours before the seizure, were identified as the trigger.  Temp remained 100 for 24 hours.  No further seizure activity.  No fever as of 9/3/24.  Back to normal baseline, healthy toddler.
Age: 1.25
Sex: M
Vaccine: FLU4, PNC20
Symptoms: Pyrexia, Seizure
Clinical narrative: Febrile Seizure.  He was napping and began to have a seizure of his arms and foaming at the mouth for 3 minues.  He was post-ictal for 5 minutes.  He was taken to ER where temperature was found to be 103.5.  Vaccines given on 8/31/24, 24 hours before the seizure, were identified as the trigger.  Temp remained 100 for 24 hours.  No further seizure activity.  No fever as of 9/3/24.  Back to normal baseline, healthy toddler.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A patient of 3 years and 10 days received a dose of Quadracel , the intended vaccine was Pentacel with no reported adverse event; A patient of 3 years and 10 days received a dose of Quadracel , the intended vaccine was Pentacel with no reported adverse event; Initial information received on 27-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of 3 years and 10 days received a dose of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel (VERO)], the intended vaccine was diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Jul-2024, a patient of 3 years and 10 days received 0.5 ml dose (dose 2) of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (VERO) Vaccine of lot U7908AA and expiry date: 03-Oct-2025 via intramuscular route in the right deltoid but the intended vaccine was Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection with no reported adverse event (product administered to patient of inappropriate age) (wrong product administered) (latency: on same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 89.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt got first dose of Twinrix on 8/2/23, second dose on 2/21/24 and third dose on 6/17/24.  There was not sufficient time in between dose 2 and 3.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Osteoarthritis, Pain
Clinical narrative: Abnormal pain at injection site when administered. Had sore arm as other vaccines but never resolved itself and worsened over time that I have now lost full range of motion of left arm with pain upon extending same. At 10 months now I do not think it?s ever going to fully resolve itself.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: X-ray limb abnormal
Clinical narrative: Abnormal pain at injection site when administered. Had sore arm as other vaccines but never resolved itself and worsened over time that I have now lost full range of motion of left arm with pain upon extending same. At 10 months now I do not think it?s ever going to fully resolve itself.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: rash of red dots, approximately 1.5" in diameter, located approximately 2" below injection site.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Pt got Arexvy on 2/4/24.  He was then given a dose of Abrysvo on 8/23/24 so he ended up getting 2 doses of RSV.
Age: 3.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Body temperature increased, Diagnostic procedure, Febrile convulsion, Lethargy, Rash
Clinical narrative: 3 yo F experienced a febrile seizure on 8/21/24. The seizure occurred in the evening after the patient had gone to bed. The patient had been on a boat earlier that day and was mildly sunburnt but exhibited no other acute illness symptoms prior to the seizure. The patient was taken to the ER where her temperature was recorded at 99.8°F after administration of Tylenol. The highest recorded temperature was 103°F before going to the ER. The patient had received her first dose of the MMR vaccine exactly one week prior to the seizure on 8/14/24. The patient had been lethargic after the vaccination with a blistering rash developing on her right flank and arm. The rash started a few days after the vaccination, spread for several days and now appears to be healing.  Appetite and elimination now normal.  Pt still mildly lethargic compared to her usual activity.
Age: 3.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Rash vesicular, SARS-CoV-2 test negative
Clinical narrative: 3 yo F experienced a febrile seizure on 8/21/24. The seizure occurred in the evening after the patient had gone to bed. The patient had been on a boat earlier that day and was mildly sunburnt but exhibited no other acute illness symptoms prior to the seizure. The patient was taken to the ER where her temperature was recorded at 99.8°F after administration of Tylenol. The highest recorded temperature was 103°F before going to the ER. The patient had received her first dose of the MMR vaccine exactly one week prior to the seizure on 8/14/24. The patient had been lethargic after the vaccination with a blistering rash developing on her right flank and arm. The rash started a few days after the vaccination, spread for several days and now appears to be healing.  Appetite and elimination now normal.  Pt still mildly lethargic compared to her usual activity.
Age: 3.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Febrile convulsion, Pyrexia, Rash
Clinical narrative: 3 yo F experienced a febrile seizure on 8/21/24. The seizure occurred in the evening after the patient had gone to bed. The patient had been on a boat earlier that day and was mildly sunburnt but exhibited no other acute illness symptoms prior to the seizure. The patient was taken to the ER where her temperature was recorded at 99.8°F after administration of Tylenol. The highest recorded temperature was 103°F before going to the ER. The patient had received her first dose of the MMR vaccine exactly one week prior to the seizure on 8/14/24. The patient had been lethargic after the vaccination with a blistering rash developing on her right flank and arm. The rash started a few days after the vaccination, spread for several days and now appears to be healing.  Appetite and elimination now normal.  Pt still mildly lethargic compared to her usual activity.
Age: 72.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 80.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events reported to date; patient received two flu vaccines
Age: 70.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Gout
Clinical narrative: Acute gout, left and right thumb
Age: 13.0
Sex: M
Vaccine: HEP, IPV, MNQ, TDAP, VARCEL
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is a pediatric patient receiving an adult dose of Engerix-B. No adverse reactions have been reported by the parents of the child. Our order had not came in yet and staff was borrowing for a dose and did not catch the difference in doses (ped to adult). Attempt to contact parents today, voicemail left, no return call.
Age: 55.0
Sex: F
Vaccine: FLU4, FLUA4
Symptoms: Ear pain, Neck pain, Oropharyngeal pain, Tinnitus
Clinical narrative: Sore throat, ears sore and ringing and minor neck pain
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Client's parent reported that  client had an adverse reaction to vaccine given on 9/29/2024. "Swelling at injection site and hives".  received cortisone treatment.
Age: 14.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient is a pediatric patient receiving an adult dose of Engerix-B. No adverse reactions have been reported by the parents of the child. Our order had not came in yet and staff was borrowing for a dose and did not catch the difference in doses (ped to adult). Unable to contact patient as no phone number or address is on file.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Cough, Oxygen saturation decreased, Urticaria, Wheezing
Clinical narrative: approximately 10 minutes after MMRV vaccine as patient was checking out, he started acutely coughing with wheezing. We brought patient back . His pox was 89-91 % with decreased air entry bilaterally and wheezing throughout. He was covid tested and simultaneously given Albuterol (of note he has has MMR in 2021 and he eats eggs and products with eggs in it without reactions known ) After the albuterol his air entry improved, he still had wheezing throughout, his pox 94% and he was developing urticaria right arm, left neck. No retractions (this was at about 350 pm) .              I ordered 2 mg per kg of prednisolone             Prior to him leaving office, he was not coughing, no trouble breathing, Pulse 96%              Use his albuterol every 4 to 6 hours for 5 to 7 days              Strict avoidance of eggs
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Abdominal pain lower
Clinical narrative: soreness  right lower side of abdomen. day 2-3 after injection.         soreness left lower side of abdomen, day 6-? after injection
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis of Right Arm
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Detoxification, Echocardiogram, Electrocardiogram, Laboratory test, Malaise
Clinical narrative: PFIZER #1 9/23/21 PFIZER #2 10/14/21 DEVELOPED LOSS OF MENTAL CLARITY AND POST EXERTIONAL MALAISE.  TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION WITH NICOTINE PATCH.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mental impairment
Clinical narrative: PFIZER #1 9/23/21 PFIZER #2 10/14/21 DEVELOPED LOSS OF MENTAL CLARITY AND POST EXERTIONAL MALAISE.  TREATED WITH PROTOCOL BASE SPIKE DETOXIFICATION WITH NICOTINE PATCH.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal swelling, Swelling face, Urticaria
Clinical narrative: Swelling of face and throat, hives, went to emergency department, given IV Benadryl, steroids, and saline.,sent home.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Headache, Vertigo
Clinical narrative: 4-5 hours after taking the vaccine I got a headache, felt odd and unstable on my feet, very tired and the room was spinning when I went to bed (early).  The next morning my arm was so sore I could hardly lift it and head hurt.   This is the 4th Moderna shot I have had and none bothered me before but this one hammered me.  Headache lasted about 3 days.  The arm was very sore for 4-5 days and still today I can feel it.
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient does not have any symptoms but received the flu vaccine approved for 18 years and older but was only 16 years old at time of administration.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reported patient administered GARDASIL 9 after product experienced a T/E.; no adverse event; This spontaneous report was received from a medical assistant and refers to a patient of unknown gender of 12-years-old by reporting time. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (ml) (valid lot number 2014790, expiration date: 22-APR-2026), administered for prophylaxis (dose, dose number, vaccination scheme, frequency and route of administration were not provided), after product experienced a temperature excursion (product storage error). No symptoms reported.   No additional adverse event (AE).