chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Urticaria
Clinical narrative: Inappropriate age at vaccine administration; patient had hives after GARDASIL 9 was administered; This spontaneous report was received from a pharmacist, referring to a 29 year old female patient. The patient's pertinent medical history and concomitant therapies were not reported. Her historical drugs included naproxen (NAPROSYN) and her drug reactions/allergies include that same therapy.  On 05-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate age at vaccine administration) as prophylaxis (valid lot number R024259, expiration date was not reported but upon internal validation established as 30-MAY-2021) (strength, dose number, route of administration and anatomical site of injection were not provided).         On approximately 10-NOV-2019 (also reported as "5 days after administration"), the patient experienced hives (urticaria). The patient received treatment with diphenhydramine hydrochloride (BENADRYL) and an unspecified hydrocortisone cream.  On 11-NOV-2019 (also reported as "yesterday"), the patient was started on methylprednisolone (MEDROL) dose pack, and at night of the same day (also reported as "last night") the patient went to the Emergency Room (ER) and was treated with unspecified intravenous steroids and unspecified antihistamines; it was unknown by the reporter if the patient was admitted to the hospital or if any laboratory diagnostics or studies were performed to the patient.  At the time of this report, the patient had not recovered from urticaria. The outcome of inappropriate age at vaccine administration was unknown.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administration and the event urticaria, was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received a dose of PROQUAD following a temperature excursion.; No adverse symptoms were reported; This spontaneous report was received from a medical assistant referring to a patient, age and gender were not reported. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with improperly measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (lot # S017240  has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 01-DEC-2020) (strength, dose, route of administration and frequency were not provided).  The temperature of storage and time frame of the excursion were 47° Fahrenheit (F) to 77° F and 47 hours. A digital data logger was involved but there was no previous temperature excursion. No adverse effect was reported.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever; body aches the first full day after; chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th November 2019, the patient received the 1st dose of Shingrix. On 13th November 2019, 1 days after receiving Shingrix, the patient experienced fever, general body pain and chills. On an unknown date, the outcome of the fever, general body pain and chills were unknown.   It was unknown if the reporter considered the fever, general body pain and chills to be related to Shingrix.  Additional details were provided as follows: It was reported that, as warned, the patient experienced fever and chills, body aches the first full day after receiving Shingrix. The patient was supposed to receive a booster dose of Shingrix in two to six months after the 1st dose.  The patient asked if the she should expect the same sickness after the 2nd dose of Shingrix.
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting; Fever; This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 24PP4, expiry date 30th June 2020) for prophylaxis.   In October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced vomiting and fever. On an unknown date, the outcome of the vomiting and fever were unknown.   It was unknown if the reporter considered the vomiting and fever to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant stated that, the patient received dose of Flulaval quadrivalent season 2019-2020 either on 18th October 2019, or within the week afterwards. The patient experienced events either the day of vaccination, or the day after vaccination. The reporter consented to follow up. This case has been linked with case US2019207552, reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting; Fever; This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 24PP4, expiry date 30th June 2020) for prophylaxis.   In October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced vomiting and fever. On an unknown date, the outcome of the vomiting and fever were unknown.   It was unknown if the reporter considered the vomiting and fever to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The medical assiatant stated that, the patient received dose of Flulaval quadrivalent 2019-2020 season either on 18th October 2019, or within the week afterwards. The patient experienced vomiting and fever either the day of vaccination, or the day after vaccination. The reporter consented to follow up. This is 1 of the 2 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; patient came back with rash down left arm/chest/and travel down back all on left side; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and generalized rash. The patient was treated with antivirals nos. On an unknown date, the outcome of the vaccination failure, shingles and generalized rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and generalized rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that patient having slight rash after injection of 2nd dose on left arm. The patient had no treatment and rash subsided on own. In Mid October, the patient came back with rash down left arm/chest/and travel down back all on left side. The patient was diagnosed with Shingles. The patient prescribed antiviral. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for herpes zoster was unknown. The reporter did not agree to follow up from GlaxoSmithKline.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dysuria, Headache, Pain, Pollakiuria
Clinical narrative: headache; body aches; chills/Shivering; frequent urination; difficulty urinating; This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included enlarged prostate. Concomitant products included finasteride (Proscar) and tamsulosin hydrochloride (Flomax).   On 13th November 2019, the patient received the 1st dose of Shingrix. On 13th November 2019, 2 hrs after receiving Shingrix, the patient experienced headache, general body pain, chills and urinary frequency. In November 2019, the patient experienced urination difficulty. On an unknown date, the outcome of the headache, general body pain, chills, urinary frequency and urination difficulty were unknown.   It was unknown if the reporter considered the headache, general body pain, chills, urinary frequency and urination difficulty to be related to Shingrix.  Additional details were provided as follows: The patient reported that, 2 hours aafter Shingrix vaccination, he began to experience headaches and body aches. About 8 hours later, he experienced chills and shivering and frequent urination. About 12 hours later, he experienced frequent urination and difficulty urinating and had to urinate about 6 times. The patient consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Optic ischaemic neuropathy
Clinical narrative: optic ischemic neuropathy; blind; This case was reported by a physician via sales rep and described the occurrence of ischemic optic neuropathy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced ischemic optic neuropathy (serious criteria disability and GSK medically significant) and blind (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the ischemic optic neuropathy was unknown and the outcome of the blind was recovering/resolving.   It was unknown if the reporter considered the ischemic optic neuropathy and blind to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The reporter stated that patient of one of his friends experienced optic ischemic neuropathy after getting Shingrix and was now permanently blind. The physician declined to provide any additional information.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash, Skin warm
Clinical narrative: rash; warm to touch; Pain/ soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 18th November 2019, less than a day after receiving Shingrix, the patient experienced pain. On 19th November 2019, the patient experienced rash and skin warm. On an unknown date, the outcome of the pain, rash and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the pain, rash and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received his second dose of Shingrix on Monday. The event pain started to develop later that day but the next day the patient noticed a rash. A day before reporting, it seemed to spread and remains the same at time of report. The reporter did not consent to follow-up. This case has been linked with US2019210318, having same reporter. The outcome of pain, rash and skin warm were reported as not recovered/resolved in the Source however in source document, it was mentioned as recovering/resolving.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix on Monday and had experienced some pain. The reporter did not consent to follow-up. This case has been linked with US2019210316,having same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: linear rash; This case was reported by a physician via sales rep and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient experienced a linear rash after receiving Shingrix. The reporter consented to follow up.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally vaccinated with Fluzone Quadrivalent vaccine that expired on 30-Jun-2019 with no AE; Initial and live follow-up (on the same date) information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA293059.  This case involves a 35 years old male patient who received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE prefilled syringe (lot UJ049AB, expiry date: 30-Jun-2019) via intramuscular route in the right arm on 18-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used. It was reported that the nurse accidentally vaccinated a male patient with Fluzone Quadrivalent vaccine that expired on 30-Jun-2019.  At the time of reporting, the patient had no adverse event.  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 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: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered with an expired Fluzone; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer via nurse.  This case involves a 35 year old male patient who received an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number: unknown, expiry date: 30-Jun-2019), via unknown route.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to expired product administered. It was reported that the patient administered with an expired Fluzone. At the time of the report, it is unknown if Fluzone was continued or not. Reporter could not verify the type of Fluzone given, if it's the Fluzone High-Dose or Fluzone Quadrivalent.  At the time of reporting, no adverse event was reported.  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 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.  Information on the batch number was requested.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: The patient was given expired Daptacel; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from another health professional.  This case involves a 1-year-old male patient who was administered expired diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] (PT: expired product administered)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were given. Only Flu vaccine of unknown brand given.  On 25-Oct-2019, the patient received 1 dose of expired Diphtheria-15/Tetanus/5 AC Pertussis vaccine (lot number: lot C5307AA; expiry date: 23-Oct-2019) in right thigh, for immunization (PT: expired product administered).  It was a case of actual medication error due to expired vaccine used.  Information on the batch number is available.  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 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: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired Fluzone HD with no adverse event; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 50 months old patient of unknwon gender who received expired Fluzone HD with no adverse event (Expired product administered) vaccine of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ048AA via intramuscular route in the left deltoid.  It was a case of expired product administered.  At the time of this report, no adverse event was reported.   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 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: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Daptacel was inadvertently administered to a patient; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from another health professional.  This case involves a male patient (age unknown) who was administered expired diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] (PT: expired product administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and and family history were not provided.  On 25-Oct-2019, the patient received expired diphtheria-15/tetanus/5 ac pertussis vaccine (dosing details unknown; lot number: lot: C5307AA; expiry date: 23-Oct-2019), as prophylactic vaccination (PT: expired product administered).  It was a case of actual medication error due to expired vaccine used.  Information on the batch number is available.  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 Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: Exposure via skin contact, Injection site haemorrhage, Syringe issue, Underdose
Clinical narrative: There was some blood at the injection site; Fluzone Quadrivalent prefilled syringe that leaked from where the needle attaches; the patient did not get the full dose; Initial information regarding an unsolicited valid non-serious case received from a pharmacist and transmitted to Sanofi on 09-Oct-2019.  This case involves a male patient of unknown age for whom it was reported that Fluzone Quadrivalent prefilled syringe that leaked (Preferred term: Syringe issue) from where the needle attaches so that the patient did not get the full dose (Preferred term: Underdose), and some of the vaccine ran down the patient's arm and there was some blood at the injection site (Preferred term: Vaccination site haemorrhage), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment, vaccination and family history were not provided.   No concomitant medication was reported.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6681LA and expiration date: 30-Jun-2020) via unknown route in unknown administration site.  On an unknown date (latency unknown) after vaccination it was reported that Fluzone Quadrivalent prefilled syringe that leaked (Preferred term: Syringe issue) from where the needle attaches so that the patient did not get the full dose (Preferred term: underdose), and some of the vaccine ran down the patient's arm and there was some blood at the injection site (Preferred term: Vaccination site haemorrhage).  Final diagnosis was Not Applicable the patient did not get the full dose, Not Applicable fluzone quadrivalent prefilled syringe that leaked from where the needle attaches and there was some blood at the injection site.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for Vaccination site haemorrhage and as not applicable for rest of the events.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: received a shipment of Fluzone that had been too long in transit. One of the vaccines was administered to an employee before they realized it was too long in transit, no AE; received a shipment of Fluzone that had been too long in transit. One of the vaccines was administered to an employee before they realized it was too long in transit, no AE; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/ non health care professional (office staff).  This case involves a 39 years old female patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] Lot # UT6719KA, exp; 30-JUN-2020 via intramuscular route in unknown administration site on 12-Nov-2019.  Medical history, past treatment, family history and concomitant therapies were unknown.  It was a case of actual medication error due to product distribution issue and product storage error.  It was reported that they received a shipment of Fluzone that had been too long in transit. One of the vaccines was administered to an employee before they realized it was too long in transit.   No adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and  module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU3, FLUX
Symptoms: No adverse event, Wrong product administered
Clinical narrative: HCP requested Fluzone High-Dose, but was administered " a different flu vaccine" that he did not identify, no adverse event; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional (physician assistant).  This case involves a 70 years old male patient who received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route and site of administration on an unknown date instead of USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to wrong vaccine administered. It was reported that HCP requested Fluzone High-Dose, but was administered a different flu vaccine that he did not identify.  No adverse event was reported.  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 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: 1.42
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 17 month old received Fluzone Quadrivalent too early. Instead of waiting 4 weeks she gave it in less than 2 weeks, no AE; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a Office Staff.  This case involves a 17 months old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] too early in less than 2 weeks instead of waiting 4 weeks (inappropriate schedule of product administration).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ247AA via intramuscular route in the left thigh less than 2 weeks Instead of waiting 4 weeks.  It was a case of inappropriate schedule of product administration.  At the time of this report, no adverse event was reported.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a female child age 5 months 22 days old on 12-Nov-2019 received a Fluzone Quadrivalent, no AE; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 month 22 day old female patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6656NA and expiry date: 30-Jun-2020) not reported via intramuscular route in the right thigh on 12-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was an actual medication error due inappropriate age at vaccine administration. It was reported that a female child age 5 months 22 days old on 12-Nov-2019 received a Fluzone Quadrivalent.  At the time of reporting, the patient had no adverse event.  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 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: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: shipment was delayed by 2 days with no adverse event; shipment was delayed by 2 days with no adverse event; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case is linked to 2019SA320289 (same reporter).  This case involves a female patient of unknown age who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6719NA, Expiration date: unknown), via unknown route in the left deltoid, on an unknown date.  Relevant medical history and concomitant medication were unknown.  It was an actual medication error due to the incorrect product storage (Product storage error). It was reported that shipment was delayed by 2 days (Product supply issue).  No adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: shipment was delayed by 2 days, no averse event; shipment was delayed by 2 days, no averse event; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case is linked to 2019SA320288 (same reporter).  This case involves a male patient of unknown age who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6719NA, Exp date: unknown), via unknown route in the left deltoid, on an unknown date.  Relevant medical history and concomitant medication were unknown.  It was an actual medication error due to the incorrect product storage. It was reported that shipment was delayed by 2 days (Product supply issue).  No adverse event was reported.  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 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: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: delayed shipment of Fluzone HD shipped on 06Nov2019 and not received until 11Nov2019 at 13:08; delayed shipment of Fluzone HD shipped on 06Nov2019 and not received until 11Nov2019 at 13:08; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp (lab technician).  This case is linked to case 2019SA316735 (same reporter).  This case involves 5 patients who inadvertently received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] after shipment delay.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage and product shipment delay.  Lab technician reported delayed shipment of Fluzone HD which was shipped on 06-Nov-2019 and not received until 11-Nov-2019 at 13:08. Caller reported that Fluzone HD was inadvertently administered to 5 patients.  At the time of report no adverse event was reported.  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 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.  Information on the batch number was requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel was given, however it was not mixed only the DTAP/Ipol portion was provided, Act-Hib portion was not given/No AE; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves an eight weeks old female patient who was given first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE [PENTACEL], lot UJ013AA, dose: 0.5 ml and expiry date: 10-OCT-2020  via intramuscular route in the left thigh on 08-Nov-2019, however, it was not mixed (only DTAP / Ipol portion was provided to the patient, the Act-HIB portion was not administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) oral.  It was a case of actual medication error due to inappropriate reconstitution technique (only DTAP/Ipol portion of Pentacel was provided to the patient, the ActHIB portion was not provided).  No Adverse events were reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: child was administered the DTaP-IPV diluent only instead of complete Pentacel dose, no AE; Initial information received on 18-Nov-2019 and additional information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a six months old patient who was administered with the DTaP-IPV diluent only instead of complete pentacel while receiving a 0.5 ml third dose of  vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] ( DTaP [IPV lot U6524BA, expiry date: 03-Feb-2021 ,Hib lot UJ157AA, expiry date: 03-Feb-2021) via intramuscular route and in the left thigh on 8-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX); HEPATITIS B VACCINE (HEPATITIS B VACCINE); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT).  It was a case of actual medication error due to product preparation issue.  No AE was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: dose of Act Hib administered using an alternative diluent/ no AE; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 18 month old male patient who was administered with HIB (PRP/T) VACCINE [ACT-HIB] (dose 3) using an alternative diluent i.e. diluent of MMR vaccine while he received first dose of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (Pentacel) (lot: UJ117AAA, Expiry date 25-Nov-2020) 0.5 ml via intramuscular route in the right thigh on 14-Nov-2019.  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, TETANUS VACCINE TOXOID (DTAP), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS A VACCINE (Hepatitis A) and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  It was actual medication error case due to wrong solution used in drug reconstitution.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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: F
Vaccine: FLUR4
Symptoms: Exposure via skin contact, No adverse event
Clinical narrative: medicine squirted everywhere down the patient's arm /no AE; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 54 years old female patient who was being vaccinated with 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot: QFAA1959 Expiry date: 30-JUN-2020 via intramuscular route in the left arm and a part of the vaccine touched the skin of the arm on 16-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was actual medication error case due to exposure via skin contact as the medicine squirted everywhere down the patient's arm while injecting into the arm.  At the time of reporting, the patient had no adverse event.  It was reported that the patient received a dose of the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1959 Expiry date 30-JUN-2020 via intramuscular route in the right arm as a corrective treatment.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: an infant patient was administered an expired dose of Daptacel vaccine/No AE; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a eight months old female patient who was administered an expired 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5281AA, expiry date: 05-OCT-2019 via unknown route in the left thigh on 19-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB).  It was an actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: a female patient received a dose of an expired dose of Menactra/No AE; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves  a female patient (age not reported) who was vaccinated with an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] vaccine on 17-Nov-2019 lot number: U6002CA and expiry date: 24-Sep-2019) via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired component of ActHIB (diluent) was inadvertently administered to a 2 month old male patient/No AE; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a two months old male patient who was inadvertently administered with an expired component of ACT-HIB (diluent) 0.5 ml second dose of vaccine HAEMOPHILUS TYPE B (HIB) VACCINE  [ACT-HIB] (Diluent (liquid) Lot : UI918AAA, expiry Date: 27-Oct-2019; Act-HIB (powder) Lot : UI918AAA, expiry date: 05-Dec-2019; Carton Lot :UI918AAA, expiry Date: 05-Dec-2019) via intramuscular route in the right thigh on 08-Nov-2019.(Reporter reports that the diluent expired prior to the expiration date listed on the carton. Carton expiration date reflected the expiration of the Act-HIB (powder) vial - as reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired product administered.  AE symptoms: None reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 9 months old male patient was given with expired diluent of Act-Hib vaccine,no AE; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse in the.  This case involves a nine months old male patient who was vaccinated with an expired diluent of vaccine HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] dose: 0.5 ml third dose, lot UI912AA and expiry 19-NOV-2019 via intramuscular route on left leg on 19-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 3V (FLULAVAL).  It was a case of actual medication error due to expired product administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.