chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HIBV
Symptoms: Occupational exposure to product, Syringe issue
Clinical narrative: leak needle puncture site in stopper; Vial of lyophilized vaccine was too pressurized and leaked; half of the reconstituted vaccine squirted out and splashed onto the nurse's arm; vaccine squirted out and splashed onto the nurse's arm; This non-serious case was reported by a nurse via sales rep and described the occurrence of occupational exposure while administering product in a female patient who received Hib (Hiberix) (batch number 2A95F, expiry date 20-JAN-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient did not receive Hiberix. On 20-JUN-2024, an unknown time after receiving Hiberix, the patient experienced occupational exposure while administering product (Verbatim: half of the reconstituted vaccine squirted out and splashed onto the nurse's arm) and inadvertent exposure to vaccine (Verbatim: vaccine squirted out and splashed onto the nurse's arm). On an unknown date, the patient experienced needle leak (Verbatim: leak needle puncture site in stopper) and pharmaceutical product complaint (Verbatim: Vial of lyophilized vaccine was too pressurized and leaked). The outcome of the occupational exposure while administering product, inadvertent exposure to vaccine, needle leak and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the needle leak to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device.     It was unknown if the company considered the needle leak to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-JUN-2024 GSK field representative received the initial complaint from a registered nurse, who experienced Hibrix vaccinator. Reporter reported that a vial of lyophilized vaccine was too pressurized and leaked. When the needle was withdrawn from the vial, about half of the reconstituted vaccine squirted out and splashed onto the nurse's arm, which led to occupational exposure while administering product and inadvertent exposure to vaccine. The vaccine was not administered. Confirmed that all operations were performed appropriately before defect was discovered. This suspect vial was the last dose in the box. Reporter reported that attempted to inject air after dilutant injected into vial, nurse tried to inject 0.5 milliliter of air but met resistance and was unable to inject the air. Also had met resistance during reconstitution when diluent was injected into vial.   Reporter reported that the leak coming from the needle puncture site in stopper and no vial rubber stopper/metallic skirt detach or become loose during handling or without any manipulation, and only removed the flip-off cap. No any evidence of leakage in package or carton were available. The packaging, vial and pre-filled syringe were discarded and are not available for return to GSK. No picture was taken.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: gave a dose of Hiberix to an 8 week old patient and after noticed it expired on 15-JUN-2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 8-week-old female patient who received Hib (Hiberix) (batch number EX777, expiry date 15-JUN-2024) for prophylaxis.   On 21-JUN-2024, the patient received Hiberix. On 21-JUN-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: gave a dose of Hiberix to an 8 week old patient and after noticed it expired on 15-JUN-2024). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2024 The licensed practical nurse reported that they gave a dose of Hiberix to the patient and after that noticed it was expired, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consent to follow-up via postal.
Sex: F
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Extra dose administered
Clinical narrative: she got titer strong and she was not responding; Doctor gave her 2 doses at the same time.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 20-year-old female patient who received HBV (Engerix B adult) (batch number YY37B, expiry date 24-AUG-2026) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b).   On 19-JUN-2024, the patient received the 5th dose of Engerix B adult. On an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On 19-JUN-2024, an unknown time after receiving Engerix B adult and not applicable after receiving Engerix B, Engerix B and Engerix B, the patient experienced overdose (Verbatim: Doctor gave her 2 doses at the same time.). On an unknown date, the patient experienced therapy non-responder (Verbatim: she got titer strong and she was not responding). The outcome of the overdose and therapy non-responder were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 21-JUN-2024 A reporter reported that he/she had a patient who went to the doctor, and got the Engerix booster, the hep B booster, and it sounds that they gave 2 doses at one time which led to overdose. The reporter wanted to know we couldn't really sing any information of that site, and he/she just curious if there was any information if that was ok to do. The reporter also let us know that this patient received the primary series, of 3 dose, when she was younger, and then she got titer strong and she was not responding so the Doctor gave her 2 doses at the same time.  The two doses that this patient received have same batch number and expiration date.
Sex: M
Vaccine: VARZOS
Symptoms: Cancer screening normal, Induration, Laboratory test normal, Lymphadenectomy, Lymphadenopathy
Clinical narrative: lymph glands swelling/ lymph glands was very hard; Fever; This serious case was reported by a pharmacist via call center representative and described the occurrence of lymphadenopathy in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   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 lymphadenopathy (Verbatim: lymph glands swelling/ lymph glands was very hard) (serious criteria hospitalization and clinically significant/intervention required) and fever (Verbatim: Fever) (serious criteria hospitalization). The outcome of the lymphadenopathy and fever were not resolved.   It was unknown if the reporter considered the lymphadenopathy and fever to be related to Shingrix.     The company considered the lymphadenopathy to be unrelated to Shingrix. The company considered the fever to be related to Shingrix.   Additional Information: GSK receipt date: 24-JUN-2024 Pharmacist reported that his brother received second dose of Shingrix vaccine and started with fever and lymph glands was very swelling and very hard.  This was removed, the lab results showed no infection and was negative for preliminary cancer test.  The patient was released from the hospital after the surgery.  The reporter stated that one day or so, fever came back and the lymph glands right next to the one was removed was swelling, and now he was back to the emergency room.  The reporter stated that the patient was still bad. The reporter consented to follow up.; Sender's Comments: Pyrexia  is a listed event which is considered related to GSK vaccine Shingrix. Lymphadenopathy is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: lymph glands swelling/ lymph glands was very hard; Fever; This serious case was reported by a pharmacist via call center representative and described the occurrence of lymphadenopathy in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   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 lymphadenopathy (Verbatim: lymph glands swelling/ lymph glands was very hard) (serious criteria hospitalization and clinically significant/intervention required) and fever (Verbatim: Fever) (serious criteria hospitalization). The outcome of the lymphadenopathy and fever were not resolved.   It was unknown if the reporter considered the lymphadenopathy and fever to be related to Shingrix.     The company considered the lymphadenopathy to be unrelated to Shingrix. The company considered the fever to be related to Shingrix.   Additional Information: GSK receipt date: 24-JUN-2024 Pharmacist reported that his brother received second dose of Shingrix vaccine and started with fever and lymph glands was very swelling and very hard.  This was removed, the lab results showed no infection and was negative for preliminary cancer test.  The patient was released from the hospital after the surgery.  The reporter stated that one day or so, fever came back and the lymph glands right next to the one was removed was swelling, and now he was back to the emergency room.  The reporter stated that the patient was still bad. The reporter consented to follow up.; Sender's Comments: Pyrexia  is a listed event which is considered related to GSK vaccine Shingrix. Lymphadenopathy is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: after she received the Shingrix vaccine she developed Guillain-Barre.; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2024, the patient received Shingrix. In APR-2024, immediately after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: after she received the Shingrix vaccine she developed Guillain-Barre.) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     The company considered the guillain barre syndrome to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 24-JUN-2024 This case was reported by patient itself. The patient received Shingrix vaccine she developed guillain barre and was hospitalized shortly after for one month. The patient called the response center asking for assistance in paying the medical bills she accrued while in the hospital. The reporter did not consent to follow-up.; Sender's Comments: Guillain-Barre syndrome  is an unlisted events which is considered unrelated to GSK vaccine Shingrix.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7P27X, expiry date 30-JUN-2025) for prophylaxis.   On 27-JUN-2024, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 27-JUN-2024 Pharmacist contacted GlaxoSmithKline to solicit thermostability information for Arexvy. The vaccines reached a temperature of 74 degree Fahrenheit for a cumulative 14 hours which led to incorrect storage of drug. The Pharmacist solicited medical information be sent. Possible adverse event was collected and filed with the data that was given.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: patients received their first dose of Shingrix on June 19th 2024 but the vaccine was given subcutaneously; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 4935H, expiry date 17-MAY-2026) for prophylaxis.   On 19-JUN-2024, the patient received the 1st dose of Shingrix (subcutaneous). On 19-JUN-2024, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: patients received their first dose of Shingrix on June 19th 2024 but the vaccine was given subcutaneously). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 27-JUN-2024 Medical Assistant stated that 2 patients received their first dose of Shingrix on June 19th 2024 but the vaccine was given subcutaneously by accident which led to intramuscular formulation administered by other route. This case is linked with US2024080433, same reporter, different patient.; Sender's Comments:  US-GSK-US2024080433:Same reporter/different patient
Age: 57.0
Sex: M
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 57-year-old male patient who received Herpes zoster (Shingrix) (batch number MG5EJ, expiry date 24-JAN-2026) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st February 2021).   On 01-MAR-2024, the patient received the 2nd dose of Shingrix. On 01-MAR-2024, 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 unknown.   Additional Information: GSK Receipt Date: 27-JUN-2024 Pharmacist called to report that a patient waiting, he came to receive the booster dose of Shingrix but when checking on our system, they realized that he received a first dose on February 1, 2021, yet he came for a booster for a dose received on March 2024, so they do not know if he can receive a third shot. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: 2 pulmonary embolisms in his lungs; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (2 pulmonary embolisms in his lungs) in a male 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 PULMONARY EMBOLISM (2 pulmonary embolisms in his lungs) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (2 pulmonary embolisms in his lungs) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Suspect vaccine was reported as unknown.  Treatment information was not provided.  Reporter causality was not reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) AESI of Pulmonary embolism, which occurred on an unknown date after an unspecified dose of SPIKEVAX NOS vaccine. Since no vaccination nor event dates were provided, temporal association and latency cannot be properly assessed. As reported, patient experienced 2 pulmonary embolisms in his lungs. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of SPIKEVAX NOS is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: there are other people here where I live that have also been sick from it/have talked to six people; The initial case was missing the following minimum criteria: specific number of patients. Upon receipt of follow-up information on 24Jun2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "there are other people here where I live that have also been sick from it/have talked to six people". Additional information included: There are other people here where the reporter live that have also been sick from Pfizer covid shot. The reporter could not telling how many people sick from the covid shot but the reporter had talked to six people. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2022 as dose number unknown, single at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Only nurtec, reaction(s): "Known Allergies: Only Nurtec". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: COVID 19 Treatment, brand: Pfizer/BioNTech with treatment start date on 21Jun2024 and treatment stop date on 26Jun2024.
Sex: U
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site pain; Injection site swelling; Injection site redness; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Injection site swelling"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Injection site redness". Additional information: So one of the medical assistants let the reporter know that she administered a dose of Prevnar 20, couple of days ago and she asked if it was normal, if there was pain at the injection site and injection site swelling and redness.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: where the injection was, it turn to really kind of hot; Redness on where the injection was; it was large, bigger and bigger; redness area now get keep enlarging; there was soreness/pain where the injection was; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 22Jun2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 24Jun2024, outcome "not recovered", described as "Redness on where the injection was; it was large, bigger and bigger; redness area now get keep enlarging"; VACCINATION SITE PAIN (non-serious) with onset 24Jun2024, outcome "unknown", described as "there was soreness/pain where the injection was"; VACCINATION SITE WARMTH (non-serious) with onset 24Jun2024, outcome "unknown", described as "where the injection was, it turn to really kind of hot".  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: they have taken shots before due to covid/covid before; they have taken shots before due to covid/covid before; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 54-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "they have taken shots before due to covid/covid before". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient stated they have taken shots before due to COVID, patient stated that the shots they took before were most like from Pfizer. Paxlovid was taken for COVID.
Age: 11.0
Sex: M
Vaccine: HPV4, MEN
Symptoms: Injection site reaction
Clinical narrative: injection site reaction; Initial information received on 20-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who had injection site reaction after receiving Gardasil (HPV Vaccine VLP RL1 4V (Yeast) ) and Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (Solution for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site and also received a  unknown dose of suspect Gardasil not produced by Sanofi Pasteur (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for all Prophylactic vaccination (Immunization). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested.  On 15-MAR-2024 the patient developed injection site reaction (vaccination site reaction) (unknown latency) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine and Gardasil.  Action taken with Meningococcal Vaccine (Menquadfi) and HPV Vaccine VLP RL1 4V (Yeast) (Gardasil) was not applicable.  It was not reported if the patient received a corrective treatment for the event (injection site reaction).  At time of reporting, the outcome was Unknown for the event injection site reaction.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient was administered with ACT-HIB that was reconstituted with sterile water, instead of the saline diluent that came with it with no reported adverse event; patient was administered with ACT-HIB that was reconstituted with sterile water, instead of the saline diluent that came with it with no reported adverse event; Initial information received on 20-Jun-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 15 months old female patient where patient was administered with HIB (PRP/T) Vaccine [ACT-HIB] that was reconstituted with sterile water, instead of the saline diluent that came with it with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Infanrix) and pneumococcal vaccine conj 20v (crm197) (Prevnar 20) for Prophylactic vaccination.  On 19-Jun-2024, the patient received 0.5 ml (TOTAL) dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (Strength- standard) (lot- UK010AA and expiration date- Feb-2025) via intramuscular route in the right thigh for Immunisation (product preparation error) and (poor quality product administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: inadvertently administered pentacel past the expiration date with no reported adverse event; Initial information received on 20-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who had inadvertently administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] past the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine and Ipol for Immunisation.  On 07-Jun-2024, the patient received a (Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Powder and suspension for suspension for injection) (lot UJ957AB , Expiry date: 01-Jun-2024) (expired product administered) (latency : same day) via intramuscular route RT(Abbreviation not specified)  in unknown administration site for Prophylactic vaccination (immunization).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Rash, Rash erythematous, Rash pruritic, Skin discolouration
Clinical narrative: swelling/ right palm it started to swell; red bumps; right palm it started to swell, itchy, and turned white in color for 10 minutes, then the next day the color changed happened again on the pinky finger; itchy red bumps on chest; Initial information received on 20-Jun-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 35-year-old female patient who had itchy red bumps on chest, swelling/ right palm it started to swell, red bumps and right palm it started to swell, itchy, and turned white in color for 10 minutes, then the next day the color changed happened again on the pinky finger after receiving diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 03-Jun-2024, the patient received an unknown total dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (strength, lot number, expiry date: unknown) via intramuscular route in left arm as Immunization.  Information on batch number and expiry date was requested.  On 19-Jun-2024 the patient had events of itchy red bumps on chest (pruritus), swelling/ right palm it started to swell (swelling), red bumps (erythema), right palm it started to swell, itchy, and turned white in color for 10 minutes, then the next day the color changed happened again on the pinky finger (skin discolouration) (latency: 16 days) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  It was unknown if any lab data/test results were available.  Action taken: not applicable.  The patient was treated with Diphenhydramine Hydrochloride (Benadryl) for all the events.  Outcome: Unknown for the event itchy red bumps on chest, swelling/ right palm it started to swell, red bumps and was Not Recovered / Not Resolved for the event right palm it started to swell, itchy, and turned white in color for 10 minutes, then the next day the color changed happened again on the pinky finger.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate use due to administration of menquadfi doses less than a year apart with no reported adverse event; Initial information received on 20-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old female patient with inappropriate use due to administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] doses less than a year apart with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in August 2023, the patient received a dose 2, 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection lot number not reported via intramuscular route in the right arm and On 17-Jun-2024 received the same vaccine dose 0.5 ml with U7939AC via intramuscular route in the right arm for immunization (strength and expiry date unknown) inappropriate use due to administration of menquadfi doses less than a year apart with no reported adverse event (inappropriate schedule of product administration) (latency same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product preparation error
Clinical narrative: medication error due to the administration of menquadfi that had been diluted with sterile water to a patient with no reported adverse event; diluted dose of menquadfi was administered to a patient with no reported adverse event; Initial information received on 25-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 years old female patient, medication error due to the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] that had been diluted with sterile water to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE (POLIO), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACC.) for Prophylactic vaccination.  On 24-Jun-2024, the patient received MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE dose1.2 ml, Solution for injection lot U7986AC via intramuscular route in the right deltoid for immunization (strength, expiry date unknown) medication error due to the administration of menquadfi that had been diluted with sterile water to a patient with no reported adverse event (product preparation error) (poor quality product administered) (latency same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: used sterile water to reconstitute ACT-HIB, instead of the included saline diluent, with no reported adverse event; Initial information received on 26-Jun-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient and used sterile water to reconstitute HIB (PRP/T) Vaccine [ACT-HIB], instead of the included saline diluent, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Jun-2024, the patient received a dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Strength- standard) lot number not reported via intramuscular route in unknown administration site (dose, expiration date: not provided) for Immunisation (product preparation error) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence cannot be 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.  No follow up is possible as reporter declined for a follow up.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: nurse only used the vial with a blue cap/lid/ nurse didn't mix the liquid with the powder, with no reported adverse event; Initial information received on 26-Jun-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 16 months old female patient who received the vial with a blue cap/lid/ nurse didn't mix the liquid with the powder of 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 26-Jun-2024, the patient received 1X, total of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection (lot UK038AA and expiry 30-JUN-2025) (dose and strength: unknown) only used the vial with a blue cap/lid/ nurse didn't mix the liquid with the powder, with no reported adverse event (single component of a two-component product administered) (latency same day) via intramuscular route in the right thigh for Immunization.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 47.0
Sex: M
Vaccine: JEV1
Symptoms: Injection site pain, Pain, Vaccination site paraesthesia
Clinical narrative: Left deltoid pain/paresthesia radiating down left arm into thumb and second phalange. S/sx noted are intermittent and random throughout the day without any notable onset. Symptoms were felt x1 after vaccine and have been present x2 weeks.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: We gave the Varivax vaccine which has temperature excursion (the delivery date was 1 day over)by mistake.  We spoke to mom/Aunt(mom doesn't speak the language) to check the child is fine and she has not gotten any adverse reactions.  We are planning  to check chickenpox antibody titer in the future.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: erythema, tenderness, swelling
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt was administered a second set of "4yr vaccines"  dtap/IPV combo on 9/11/23 and on 6/13/24, MMRV combo on 9/11/23 and on 6/13/24.  No adverse signs or symptoms, just an inadvertent administration of
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Cat scratch disease, Erythema, Immunisation reaction, Pruritus, Swelling
Clinical narrative: Pt was scratched and bit by feral kitten on 6/3/24. Needed tdap on 6/6/24. Sx started on 6/8/24 with progressive redness at scratched/biten areas, swelling and full body hives. Possible Bartonella Vs Vaccine reaction.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Pt was scratched and bit by feral kitten on 6/3/24. Needed tdap on 6/6/24. Sx started on 6/8/24 with progressive redness at scratched/biten areas, swelling and full body hives. Possible Bartonella Vs Vaccine reaction.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC20
Symptoms: Computerised tomogram normal, Cytogenetic analysis, Electroencephalogram normal, Endotracheal intubation, Haemophilus test positive
Clinical narrative: Had a 90 minute seizure, was intubated. Tested positive for haemophilis type B and the adenovirus while in the hospital. Stayed in the hospital just short of 4 days and was sent home with emergency medication.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC20
Symptoms: Magnetic resonance imaging abnormal, Seizure
Clinical narrative: Had a 90 minute seizure, was intubated. Tested positive for haemophilis type B and the adenovirus while in the hospital. Stayed in the hospital just short of 4 days and was sent home with emergency medication.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lip swelling, Pruritus, Sleep disorder, Urticaria
Clinical narrative: At 5:00 p.m. day of shot developed itching of armpits. Awakened by palms of hands itching at midnight that night. Inside of elbows, torso, scalp, shoulders also itchy. Itching kept me awake for about 1 1/2 hours. Upon waking itching had improved somewhat but still had episodes of mild-moderate itching throughout the day. Awakened at 10:50 night of June 30 with intense itching over most of body but concentrated on hands, arms, shoulders, scalp, abdomen, legs. Got up to check skin and found covered in red welts/hives in scratched areas. Also noted significant swelling of upper lip, minor swelling of lower lip. Went to local grocery store, purchased Allegra Hives (180 mg) and took one tablet at 11:15 p.m.. Itching subsided enough to sleep after about 1 hour. Upon waking, welts/hives were mostly gone. Upper lip still significantly swollen, lower lip moderately swollen. Itching minor to non existent. Lip swelling completely gone by about 4:00 p.m. on July 1st. Took another dose of Allegra Hives (180 mg) at 11:30 a.m. on July 1st to prevent relapse. As of 5:50 p.m. on July 1st, welts/hives gone, itching gone, lip swelling gone.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient is experiencing pain, deep, almost like a spasm, ice with relief, this is third day, pain from shoulder to wrist. Swollen, red, and hot.
Age: 19.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Feeling hot, Hyperhidrosis, Syncope
Clinical narrative: Patient received M-M-R first. Patient was doing fine. After giving Varicella the patient fainted. Pharmacist called 911 and ambulance was dispatched.  Patient was out for 30 second to a minute. Patient was breathing  and came back too. Patient complained about being warm and sweaty. She was slow to recover. We had the patient sit on the floor next to the wall. Pharmacy tech stayed with the patient till paramedics arrived. Parent came and paramedics let the patient go home with parent.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Mass
Clinical narrative: PATIENT HAS A ATYPICAL LUMP, SKIN IS RAISED, ALMOST POOL LIKE. PHARMACIST ADMINISTERING SHOT RECALLED PATIENT WAS SMALLER IN STATURE SO A 5/8 INCH NEEDLE WAS USED, HOWEVER THE SKIN WAS NOT PINCHED. THE LUMP IS NOWHERE NEAR THE INJECTION SITE, OPPOSITE / UNDERARM. VACCINE WAS ADMINSTERED IN THE DELTOID REGION.
Age: 51.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Limb injury, Peripheral swelling
Clinical narrative: arm swelling and injury
Age: 0.08
Sex: M
Vaccine: DTAPIPV, HIBV, PNC20, RV1
Symptoms: CSF cell count, CSF culture negative, CSF test normal, Culture urine negative, Fatigue
Clinical narrative: Fever and fussiness. Had to be admitted overnight for full sepsis workup including lumbar puncture. o Patient got his 2 month old vaccines on 6/28. On 6/29, around 1800, he felt warm, so mom took temp. First temp was 100.6, then 100.8. Called EMS, who brought to ED. o Since starting to have fevers, he has been slightly more tired and fussy but is waking up for feeds Normally eats 3oz at feeds, but now eating about 1oz. No sick contacts. No emesis, cough, rhinorrhea. Still having normal wet diapers
Age: 0.08
Sex: M
Vaccine: DTAPIPV, HIBV, PNC20, RV1
Symptoms: Feeling hot, Gram stain negative, Herpes simplex test negative, Hypophagia, Infant irritability
Clinical narrative: Fever and fussiness. Had to be admitted overnight for full sepsis workup including lumbar puncture. o Patient got his 2 month old vaccines on 6/28. On 6/29, around 1800, he felt warm, so mom took temp. First temp was 100.6, then 100.8. Called EMS, who brought to ED. o Since starting to have fevers, he has been slightly more tired and fussy but is waking up for feeds Normally eats 3oz at feeds, but now eating about 1oz. No sick contacts. No emesis, cough, rhinorrhea. Still having normal wet diapers
Age: 0.08
Sex: M
Vaccine: DTAPIPV, HIBV, PNC20, RV1
Symptoms: Neutrophil count increased, Pleocytosis, Pyrexia
Clinical narrative: Fever and fussiness. Had to be admitted overnight for full sepsis workup including lumbar puncture. o Patient got his 2 month old vaccines on 6/28. On 6/29, around 1800, he felt warm, so mom took temp. First temp was 100.6, then 100.8. Called EMS, who brought to ED. o Since starting to have fevers, he has been slightly more tired and fussy but is waking up for feeds Normally eats 3oz at feeds, but now eating about 1oz. No sick contacts. No emesis, cough, rhinorrhea. Still having normal wet diapers
Age: 79.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: No adverse event, Wrong patient received product
Clinical narrative: Wrong patient vaccinated; Vaccinations tolerated well, no adverse reactions to report, provider and supervisor notified immediately.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous
Clinical narrative: patient came to pharmacy on 07/01/24 stating after receiving the vaccine she started developing red spots and rash on her stomach private area and on her arms. per patient the rash was not getting better . no other adverse reaction reported by patient. patient was recommended to seek medical assistance
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received an administration error, getting a second hepatitis B vaccine 2 days after the first dose of hepatitis B vaccine.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was instructed to come to ER morning of 6/28 to get a vaccine booster. Patient was seen in ER on 6/25 for a dog bite. Patient arrived and notified staff she needed a tetanus booster. Staff pulled up patient chart, no orders were found, instructions in provider discharge note stated she needed a rabies booster on 6/28. Patient received another tetanus booster, and returned later that day for the needed rabies booster. No adverse effects
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Activated partial thromboplastin time normal, Alanine aminotransferase normal, Anion gap, Antinuclear antibody negative, Aspartate aminotransferase normal
Clinical narrative: Diagnosed with Steven Johnson Syndrome. Hospitalized for severe rash across body, in mouth, throat, and vaginal area. Urgent care in Oct 10th 2023, again on the 12th. ER visits on Oct 13th and 14th. Oct 14th transferred and admitted to Hospital after SJS diagnosis at another hospital.  Received steroids, antibiotics, and pain management until Oct 22nd 2023.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Bacterial test positive, Basophil count decreased, Bilirubin urine, Blood bicarbonate normal, Blood bilirubin normal
Clinical narrative: Diagnosed with Steven Johnson Syndrome. Hospitalized for severe rash across body, in mouth, throat, and vaginal area. Urgent care in Oct 10th 2023, again on the 12th. ER visits on Oct 13th and 14th. Oct 14th transferred and admitted to Hospital after SJS diagnosis at another hospital.  Received steroids, antibiotics, and pain management until Oct 22nd 2023.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Blood calcium decreased, Blood chloride normal, Blood creatinine normal, Blood culture negative, Blood glucose normal
Clinical narrative: Diagnosed with Steven Johnson Syndrome. Hospitalized for severe rash across body, in mouth, throat, and vaginal area. Urgent care in Oct 10th 2023, again on the 12th. ER visits on Oct 13th and 14th. Oct 14th transferred and admitted to Hospital after SJS diagnosis at another hospital.  Received steroids, antibiotics, and pain management until Oct 22nd 2023.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Blood lactic acid normal, Blood phosphorus decreased, Blood potassium normal, Blood sodium normal, Blood urea decreased
Clinical narrative: Diagnosed with Steven Johnson Syndrome. Hospitalized for severe rash across body, in mouth, throat, and vaginal area. Urgent care in Oct 10th 2023, again on the 12th. ER visits on Oct 13th and 14th. Oct 14th transferred and admitted to Hospital after SJS diagnosis at another hospital.  Received steroids, antibiotics, and pain management until Oct 22nd 2023.