chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA274329 (same reporter). This case involves a female patient (age was not reported) who received a 0.5 mL dose of FLUBLOK QIV (lot number, expiry date, dose in series and site of administration was not reported) via intramuscular route. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that vaccine had been over a total of 24 hours out of range, too warm. No known adverse reaction, symptoms were 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. List of documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA274335. This case involves a 17 years old female patient and reported that gave the wrong vaccine to the wrong age group, while she received vaccine FLUBLOK QIV which looks like Fluzone Quadrivalent. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 01-Oct-2018, the patient received a once first dose suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1802 and expiry date: 30-May-2019) (dose, dose in series and route was not reported) in the right deltoid which looks like FLUZONE QUADRIVALENT. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. It was unknown if any adverse event occurred. 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. List of documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA274333 (same reporter). This case involves a 16 years old female patient who received vaccine FLUBLOK QIV instead of FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. No concomitant medication was taken. On 01-Oct-2018, the patient received a first single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1802 and expiry date: 30-May-2019) (dose, dose in series and route was not reported) in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration and Product appearance confusion and wrong vaccine administered. It was reported that wrong vaccine was given to the wrong age group and the box for the Flublok Quadrivalent looked like Fluzone Quadrivalent, both boxes were navy on a white box and they were close enough in appearance. It was unknown whether any adverse event occurred or not. 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. List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from an-other health professional. This case is linked to cases 2018SA274341 and 2018SA274344 (same reporter). This case involves an 8 years old patient (gender not reported), who was vaccinated with a dose of DAPTACEL (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date (second patient). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because children's of greater than 6 years old are vaccinated. It was unknown if any adverse event was occurred or not following the vaccination. 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. Documents held by sender: none.
Age: 8.0
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from an-other health professional. This case is linked to cases 2018SA274340 and 2018SA274344 (Same reporter). This case involves an 8 years old patient (gender not reported), who was vaccinated with a dose of DAPTACEL (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date (second patient). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration (reported as The 3 children were administered Daptacel, but were greater than 6 years old). It was unknown if any adverse event was occurred or not following the vaccination. 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. Documents held by sender: none.
Age: 8.0
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA274340 and 2018SA274341 (Same reporter). This case involves a 8 years old patient who was vaccinated with a dose of DAPTACEL (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because children's of greater than 6 years old are vaccinated. It was unknown if any adverse event was occurred or not following the vaccination. 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. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: Initial unsolicited report received from other Healthcare Professional on 01-Oct-2018. This case involves an unknown demographic patient who was vaccinated with a dose of less than 0.5 ml of FLUZONE HIGH DOSE (batch number, expiration date were not reported) via Intramuscular in left deltoid on an unknown date. The patient's medical history, medication and treatment were not reported. It is an actual medication error due to vaccine underdose and exposure via skin contact as it was reported the needle loosed and quite a bit of the vaccine leaked out on the patient's arm. The immunization leaked out of where the needle attached to the syringe. Less than 0.5 mL, was injected IM in the left deltoid. It is also a case of syringe issue. 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. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 30 years old female patient who was exposed to vaccine ADACEL in context of administered to a pregnant patient. The reported administered to a pregnant patient. Occurred at unknown gestation period and the patient was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at 7 weeks of pregnancy, during first pregnancy trimester for DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The date of last menstrual period was reported as 29-Aug-2018. The estimated due date is 05-Jun-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Oct-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5658A via intramuscular route in the left deltoid. The patient developed a non-serious administered to a pregnant patient. (Exposure during pregnancy) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. (Other relevant tests included No lab data). Final diagnosis was administered to a pregnant patient. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for administered to a pregnant patient. Additionally, at time of reporting, the pregnancy is still ongoing. Documents held by sender: none.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 9 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI994AB, expiry date: 09-APR-2019 via intramuscular route in the left deltoid on 01-Oct-2018. 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 Inappropriate age at vaccine administration and overdose. It was reported that yesterday, 3 patients under the age of 65 had been given FLUZONE HD. It was unknown whether patient experienced any adverse reaction after vaccination. 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. Documents held by sender: none.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 56 years old male patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE, lot UI994AB, expiry date: 09-APR-2019 via intramuscular route in the left deltoid on 01-Oct-2018. 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 Inappropriate age at vaccine administration and overdose. It was reported that 3 patients under the age of 65 had been given FLUZONE HD. It was unknown whether patient experienced any adverse reaction after vaccination. 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. Documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 42 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI994AB, expiry date: 09-APR-2019 via intramuscular route in the right deltoid on 01-Oct-2018. 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 inappropriate age at vaccine administration and overdose. It was reported that 3 patients under the age of 65 had been given FLUZONE HD. Pre-filled syringes were used. It was unknown whether patient experienced any adverse reaction after vaccination. 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. Documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: DTAPIPVHIB, IPV
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a 4 years old patient (gender not reported) who received a dose of vaccine IPOL and along with a dose of PENTACEL (lot number not reported) via unknown route in unknown administration site on 28-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. It was not reported if the patient experienced any adverse event or not. 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. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, IPV, MMR, VARCEL
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a four years old female patient who experienced leg pain, while she received vaccines IPOL and PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA VACCINE for Immunisation; and MMR for Immunisation. On 28-Sep-2018, the patient received a dose of suspect IPV (VERO) lot N1K931M via intramuscular route in the right vastus lateralis and a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number, dose, route and site of administration were not reported. On an unknown date, the patient developed a non-serious leg pain, following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and IPV (VERO). It was also a case of actual medication error due to extra dose administered. It was reported that patient had received both IPV and then also the Pentacel so had the IPV twice. Relevant tests were not reported. The patient was treated with MOTRIN for Product used for unknown indication. The outcome was not reported for leg pain. 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. List of documents held by sender- none.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old female patient who received 0.5 mL dose of vaccines PENTACEL lot C5576AB, expiry date: 18-OCT-2019 via unknown route in the right thigh on 28-Sep-2018 with Merck sterile water (Lot N030721, Exp: 20-Jul-2020). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR and ROTARIX and  for Immunisation On 28-Sep-2018. It was an actual medication error due to Inappropriate reconstitution technique. It was reported that Act HIB portion of Pentacel given with sterile water. It was unknown whether patient experienced any adverse reaction after vaccination. 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. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a patient (reported as one of the three patient) who received diluent potion of the vaccine PENTACEL only. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (date not captured as it was not confirmed which patient received diluent), the patient received a First dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE lot C5545AA expiry date: 06-Oct-2019 via intramuscular route in the right thigh. It was case of actual medication error due to inappropriate reconstitution technique. No adverse event was experienced. 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. List of documents held by sender: none.
Sex: M
Vaccine: DTAP, FLUX, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old male patient who received vaccine DAPTACEL lot C5171AA, expiry date: 23-MAR-2019 via unknown route in the left thigh (dose not reported) on 01-Oct-2018. instead of Adacel. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENACTRA for Immunisation and Influenza vaccine for immunization. It was an actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration. It was reported that 11y male received Daptacel when they were due to receive the first dose of Adacel. No known reported symptoms. 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. Documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB, HEP, HIBV, PNC13
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from Other health professional (Medical assistant). This case involves a 6 months old female patient who received vaccines Hepatitis B vaccine, PENTACEL and ACT-HIB. The patients past medical history and family history were not provided. Concomitant medications included PREVNAR 13 given on 26-Sep-2018. On 26-Sep-2018, the patient received a 0.5ml dose of suspect HIB (PRP/T) VACCINE lot UI903AA, expiry date 21-Nov-2018 via unknown route in the right thigh. On 26-Sep-2018, the patient received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. The patient was ordered for injection of suspect HEPATITIS B VACCINE not produced by Sanofi Pasteur lot number not reported. It was an actual medication error due to extra dose administered and wrong vaccine administered. It was reported that 6-month old who received double the dose of HIB vaccine, PENTACEL and ACTHIB. They were ordered for Hep B which has not yet been given. The patient did not experienced any adverse reaction after the injection. 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. List of documents held by sender- none.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, HIBV, MMRV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years 11 months old male patient who received an expired 0.5 mL dose of vaccine ACTHIB lot UI207AAA, expiry date: 02-Oct-2018 via unknown route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUARIX for Immunisation; KINRIX for Immunisation; and PROQUAD for Immunisation. It was a case of actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse reaction after vaccination. 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. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Injection site rash, Rash
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves female patient (age not reported) who experienced mild flu like symptoms and rash on L deltoid that then spread to chest and back, while she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Sep-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and Exp. Date not reported) via unknown route in the left deltoid. On 10-Oct-2018, the patient developed a non-serious mild flu like symptoms (influenza like illness) and rash on L deltoid that then spread to chest and back (rash) 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. No information about relevant tests reported. Final diagnosis was rash on L deltoid that then spread to chest and back and mild flu like symptoms. No information about corrective treatment reported. The patient outcome was unknown for events. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid serious case received from Office-staff. This case involves female of an unknown age patient who experienced Guillain Barre, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported (expiry date, dose, route and site of administration were not reported). On an unknown date, patient developed a serious Guillain-Barre like symptoms, following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. Relevant tests were not reported. Final diagnosis was Guillain-Barre syndrome. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. List of documents held by sender- none. Sender's Comments: This case involves a patient of an unknown age who experienced Guillain-Barre like symptoms post vaccination with FLUZONE QUADRIVALENT. Time to onset is unknown. Guillain-Barré Syndrome is a expected following FLUZONE vaccination. However, further information including patient's medical history, medical condition at the time of vaccination, clinical description of GBS, lab investigation reports result would be relevant for accurate assessment. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU3
Symptoms: Injection site rash, Rash, Wrong drug administered
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a patient of an unknown demographics who was vaccinated with a dose of FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patients medical history and concomitant medications were not reported. On an unknown date, the patient developed a non-serious rash on their L deltoid and back (rash) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also a case of actual medication error due to wrong vaccine was administered. No information reported whether the patient had any adverse event. 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. List of documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pruritus generalised
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 22 years old female patient who experienced whole body itching and red, swelling, hard-red and hot at site, while she received vaccine FLUBLOK QIV. The patient' past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious whole body itching and red, swelling, hard-red and hot at site (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. It was reported that all the symptoms lasted for one week. (Other relevant tests included No lab data.) Final diagnosis was red, swelling, hard-red and hot at site and whole body itching. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for whole body itching and red, swelling, hard-red and hot at site. List of documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: FLUR4
Symptoms: Vaccination site inflammation
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 22 years old female patient who experienced whole body itching and red, swelling, hard-red and hot at site, while she received vaccine FLUBLOK QIV. The patient' past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious whole body itching and red, swelling, hard-red and hot at site (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. It was reported that all the symptoms lasted for one week. (Other relevant tests included No lab data.) Final diagnosis was red, swelling, hard-red and hot at site and whole body itching. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for whole body itching and red, swelling, hard-red and hot at site. List of documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: Feeling hot, Generalised erythema, Induration, Injection site erythema, Injection site induration
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from Office-staff. This case involves a 23 years old female patient who experienced itchy at site as well as whole body and swelling, hard-red and hot at site as well as whole body, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1813 (expiry date, route, dose and site of administration were not reported). On an unknown date, patient developed a non-serious itchy at site as well as whole body (itching lasted one week) and swelling, hard-red and hot at site as well as whole body of an unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Relevant tests were not reported. Final diagnosis was swelling, hard-red, hot and itchy at site as well as whole body. It was not reported if the patient received a corrective treatment. The outcome of the events were reported as unknown. List of documents held by sender- none.
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pruritus generalised, Swelling
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from Office-staff. This case involves a 23 years old female patient who experienced itchy at site as well as whole body and swelling, hard-red and hot at site as well as whole body, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1813 (expiry date, route, dose and site of administration were not reported). On an unknown date, patient developed a non-serious itchy at site as well as whole body (itching lasted one week) and swelling, hard-red and hot at site as well as whole body of an unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Relevant tests were not reported. Final diagnosis was swelling, hard-red, hot and itchy at site as well as whole body. It was not reported if the patient received a corrective treatment. The outcome of the events were reported as unknown. List of documents held by sender- none.
Age: 19.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 19 years old female patient who experienced whole body itching, red, swelling, hard-red and hot at site and itchy at site, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1819 via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious whole body itching, itchy at site and red, swelling, hard-red and hot at site (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. It was reported that all the symptoms lasted for one week. (Other relevant tests included No lab data.) Final diagnosis was itchy at site, red, swelling, hard-red and hot at site, and whole body itching. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for itchy at site, red, swelling, hard-red and hot at site and whole body itching (duration one week). List of documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: FLUR4
Symptoms: Pruritus generalised, Vaccination site inflammation
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 19 years old female patient who experienced whole body itching, red, swelling, hard-red and hot at site and itchy at site, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1819 via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious whole body itching, itchy at site and red, swelling, hard-red and hot at site (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. It was reported that all the symptoms lasted for one week. (Other relevant tests included No lab data.) Final diagnosis was itchy at site, red, swelling, hard-red and hot at site, and whole body itching. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for itchy at site, red, swelling, hard-red and hot at site and whole body itching (duration one week). List of documents held by sender: none.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site pain, Vomiting, Weight decreased
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 78 years old female patient who experienced had severe diarrhea that lasted one week and lost 10 pounds, diarrhea, throwing up and had soreness in left upper arm where shot was given, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm (expiry date and dose were unknown). On 18-Sep-2018, the patient developed a non-serious diarrhea that lasted one week and lost 10 pounds, diarrhea, throwing up and had soreness in left upper arm where shot was given, four-days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Relevant tests were not reported. Final diagnosis was had soreness in left upper arm where shot was given, throwing up, diarrhea and had severe diarrhea that lasted one week and lost 10 pounds. The patient was treated with IMODIUM for Product used for unknown indication but that did not help much with the diarrhea. On 19-Sep-2018, the patient was recovered from throwing up. On 23-Sep-2018, the patient was recovered from diarrhea. On an unknown date, the patient recovered from other events. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from Non-health professional. This case involves female patient of an unknown age who experienced itchy, slightly raised red rash developed all over top half of arm and rash is warm to touch and the arm is still very red, swollen, itchy and painful, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported (expiry date, route and site of administration were unknown). On an unknown date, the patient developed a non-serious itchy, slightly raised red rash developed all over top half of arm and rash is warm to touch and the arm is still very red, swollen, itchy and painful of an unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Relevant tests were not reported. Final diagnosis was rash is warm to touch and the arm is still very red, swollen, itchy and painful, slightly raised red rash developed all over top half of arm and itchy. It was not reported if the patient received a corrective treatment. The outcome of the events were reported as unknown. List of documents held by sender- none.
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from Non-health professional. This case involves female patient of an unknown age who experienced itchy, slightly raised red rash developed all over top half of arm and rash is warm to touch and the arm is still very red, swollen, itchy and painful, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported (expiry date, route and site of administration were unknown). On an unknown date, the patient developed a non-serious itchy, slightly raised red rash developed all over top half of arm and rash is warm to touch and the arm is still very red, swollen, itchy and painful of an unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Relevant tests were not reported. Final diagnosis was rash is warm to touch and the arm is still very red, swollen, itchy and painful, slightly raised red rash developed all over top half of arm and itchy. It was not reported if the patient received a corrective treatment. The outcome of the events were reported as unknown. List of documents held by sender- none.
Sex: F
Vaccine: FLU4
Symptoms: Chills, Influenza, Malaise, Pain, Pyrexia
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 03-Oct-2018 from a consumer. This case involves a 49 years old female patient who experienced flu symptoms, chills, body aches last night, general not feeling well and low grade fever (below 100.4 f), while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication(s), vaccination(s) and family history were not provided. On 01-Oct-2018, the patient received a 0.5 ml dose of suspect Influenza Quadrival A-B Vaccine, lot U6263CA via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious chills (Chills) and body aches last night (General body pain) five hours following the administration of Influenza Quadrival A-B Vaccine. On an unknown date, the patient developed a non-serious flu symptoms (influenza), general not feeling well (Feeling unwell) and low grade fever (below 100.4 f) (Fever) (Unknown latency) following the administration of Influenza Quadrival A-B Vaccine. Other relevant tests included no lab data. Final diagnosis was low grade fever (below 100.4 f), general not feeling well, body aches last night, chills and flu symptoms. It was not reported if the patient received a corrective treatment. The patient outcome is unknown for all events. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product storage error, Pyrexia, Vomiting projectile
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient who experienced projectile vomiting, fever of 101.4 and shipment of Pentacel that came in and it took greater than 2 days, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Oct-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5590AA via intramuscular route in the right arm. The patient developed a non-serious projectile vomiting following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. The patient developed a non-serious fever of 101.4 following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. It was also a case of actual medication error due to incorrect product storage. (Other relevant tests included No lab test.) Final diagnosis was shipment of pentacel that came in and it took greater than 2 days, fever of 101.4 and projectile vomiting. The patient was treated with TYLENOL ER. The patient outcome is reported as Unknown for projectile vomiting, as Unknown for fever of 101.4 and as Not Applicable for shipment of pentacel that came in and it took greater than 2 days. 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.