chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Protein total, Urine protein/creatinine ratio
Clinical narrative: Focal segmental glomerulosclerosis; recurrence of FSGS; This is a literature report for the following literature source(s):   The authors report a case of a 21-year-old male with a history of focal segmental glomerulosclerosis (FSGS) who underwent deceased donor KT at 13 years of age complicated by early disease recurrence requiring 6 months of plasmapheresis and rituximab therapy. He was then stable for the following 8 years, with serum creatinine 0.8 mg/dL and serum albumin 4.8 g/dL until 1 month after completion of mRNA COVID-19 two vaccination series when he presented with edema, nephrotic-range proteinuria (urine protein/creatinine ratio (UPCR)?>?6.21 mg/mg with?>?2500 mg/dL of protein), albumin of 1.7 g/dL, and peak sCr of 1.3 mg/dL. Kidney biopsy showed diffuse foot process effacement, concerning for recurrence of FSGS. He was treated with methylprednisolone, plasmapheresis, and rituximab (two 375 mg/m2 doses). His nephrotic syndrome resolved after 4 weeks of plasmapheresis. Now 10 months after recurrence, he remains in remission of nephrotic syndrome with a normal UPCR (0.18 mg/mg), sCr (0.66 mg/dL) and serum albumin (4.3 g/dL) on mycophenolate mofetil, tacrolimus (goal trough 4-6), and prednisone 5 mg daily. While there are isolated reports of new onset or recurrence of proteinuric kidney disease after mRNA COVID-19 vaccine, to their knowledge, this is the first report of FSGS recurrence in a kidney transplant recipient after COVID-19 vaccination. The pathogenesis of COVID-19 vaccine-related glomerular pathology remains poorly understood; though T-cells are hypothesized to play a prominent role given the rapid disease presentation in relationship to vaccine receipt. Although causality is not proven, the temporal relationship of this case strongly suggests an association between vaccination and disease recurrence. While the risk-benefit ratio of COVID-19 vaccination for kidney transplant recipients remains favorable and vaccination is encouraged by national clinical guidelines, close monitoring for disease recurrence after vaccination in kidney transplant patients at risk is warranted.; Sender's Comments: This 21-year-old male had a history of focal segmental glomerulosclerosis (FSGS) and underwent deceased donor kidney transplant (KT) at 13 years of age complicated by early disease recurrence requiring 6 months of plasmapheresis and rituximab therapy.  There are many factors which may have impacted the recurrence of FSGS.  Considering temporal relationship, a possible contribution role of COVID-19 vaccination to the recurrence of FSGS cannot be excluded in this case.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Heart rate, Heart rate increased, Hypoaesthesia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-000002690 (Novavax). A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), FACIAL PAIN (non-serious), outcome "unknown" and all described as "The patient experienced numbing and pain in the face, numbness of arms"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "heart beating really fast". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: On 20Jul2022, it was reported that a patient started treatment on an unreported date with Pfizer Biontech COVID-19 Vaccine at unreported dose and frequency for an unreported indication. The patient experienced numbing and pain in the face, numbness of arms and heart beating really fast. No further follow-up is anticipated. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: The patient experienced post-menopausal bleeding.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002693.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "The patient experienced post-menopausal bleeding.".  Clinical course: On 20Jul2022, it was reported that a patient started treatment on an unreported date with Covid-19 Vaccine at unreported dose and frequency for an unreported indication.The patient experienced post-menopausal bleeding.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion involving ACTHIB, were administered twice post excursion, The condition was 31.5F for 1 hour and 58 minutes due to a refrigerator malfunction with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient who had temperature excursion involving HIB (PRP/T) VACCINE [ACT-HIB], were administered twice post excursion, the condition was 31.5f for 1 hour and 58 minutes due to a refrigerator malfunction with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On 06-Jul-2022, the patient received a 0.5ml 1X(once) dose of suspect HIB (PRP/T) VACCINE (strength, formulation was unknown, lot UJ604AAA and expiry date: 29-Oct-2022) via intramuscular route in the left thigh for Immunization.  On 06-Jul-2022 the patient developed a non-serious event of temperature excursion involving acthib, were administered twice post excursion, the condition was 31.5f for 1 hour and 58 minutes due to a refrigerator malfunction (not human error) with no reported adverse event (poor quality product administered) (Latency: same day) following the administration of HIB (PRP/T) VACCINE.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: exposure to an out of date menactra vaccine that was administered to a patient, with no reported adverse event; Initial information received on 02-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who had exposure to an out of date MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] vaccine that was administered to a patient, with no reported adverse event.   The patient's past medical history, medical treatment(s),concomitant medication,  vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE Solution for injection (strength, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination. Information regarding batch and expiry date was requested.  On an unknown date the patient developed a non-serious event of exposure to an out of date menactra vaccine that was administered to a patient, with no reported adverse event (expired product administered) (latency: same day)   Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: DTPPVHBHPB, UNK
Symptoms: Extra dose administered
Clinical narrative: both Vaxelis and Pentacel was given to patient at 2 month visit by nurse with no reported adverse event; Initial information received on 04-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2022SA321965(CLUSTER).  This case involves a 2 months old patient of an unknown gender and it was reported that both Vaxelis and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was given to patient at 2 month visit by nurse with no reported adverse event .  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)], (lot number and expiry date: not reported ) via unknown route in unknown administration site for  prophylactic vaccination (immunization) and also received an unknown  dose of suspect VAXELIS not produced by Sanofi Pasteur, ( lot number and expiry date: not reported) in unknown administration site. for prophylactic vaccination (immunization)  It was reported that both Vaxelis and Pentacel was given to patient at 2 month visit by nurse with no reported adverse event (extra dose administered) (latency: same day). It is unknown if there were lab data/results available  Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered, Medication error, No adverse event
Clinical narrative: patient was administered ACTHIB that was not reconstituted with the supplied diluent and another diluent was used to reconstitute the vaccine with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics, and the patient was administered acthib (HIB (PRP/T) VACCINE) that was not reconstituted with the supplied diluent and another diluent was used to reconstitute the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (formulation, strength, route: unknown) lot UJ600AA, expiration date: 30-Nov-2022, in unknown administration site as Immunization.  On an unknown date the patient was administered acthib that was not reconstituted with the supplied diluent and another diluent was used to reconstitute the vaccine with no reported adverse event (incorrect product formulation administered) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  The patient was administered ACTHIB that was reconstituted with another diluent other than the supplied 0.4% Sodium Chloride ACTHIB diluent. Caller stated that she was doing inventory and there was an extra diluent left in the box, so she thinks that someone must have used another diluent to reconstitute the ACTHIB. She was not sure which alternative diluent was used and did not know which patient received the vaccine. This situation was reported as a medication error due to a patient being administered ACTHIB that was not reconstituted with the supplied diluent and another diluent was used to reconstitute the vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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, DTPPVHBHPB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: pentacel administered to patient instead of vaxelis with no reported adverse event; Initial information received on 01-Aug-2022 regarding an unsolicited valid non-serious case received from health professional. GMI number: 01215610  This case involves a patient of unknown demographics who was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] instead of VAXELIS with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect VAXELIS not produced by Sanofi Pasteur at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for immunization. On 01-Aug-2022, the patient was administered suspect Pentacel once instead of Vaxelis at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for immunization with no reported adverse event (wrong product administered, latency same day).  Action taken: Not applicable for both suspects.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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: 0.17
Sex: M
Vaccine: UNK
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: only gave the liquid component of the DTAP and IPV,the ACTHIB portion was not administered with no adverse event; only gave the liquid component of the DTAP and IPV,the ACTHIB portion was not administered with no adverse event; Initial information received on 01-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and it was noticed that the patient was only given the liquid component of the dtap and ipv,the acthib portion was not administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination.  On 15-Jul-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot U7197BA, expiration date: 28-Jan-2023 via intramuscular route in the left thigh as Immunization.  On 15-JUL-2022 the patient developed a non-serious only gave the liquid component of the dtap and ipv,the acthib portion was not administered with no adverse event (incorrect dose administered) (product preparation error) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE  Nurse stated that a MA (medical assistant) was supposed to give a 2 month old patient VAXELIS, Prevnar, and Rotovirus, however the MA gave the 2 month old patient Rotovirus and PENTACEL instead. As a result the 2nd Hep B vaccine was not administered. The nurse believed that the confusion happened because they just recently switched from Glaxo Smith Klein to Sanofi. Upon attempting to give the patient PENTACEL, the MA only gave the liquid component of the DTAP and IPV. The ACTHIB portion was not administered. The nurse asked how the remaining ACTHIB portion could be administered. The nurse asked if Pedvaxhib and ACTHIB are equivalent. She asks if it safe to give PENTACEL at 18 months instead of just DTAP and HIB, because it would result in an extra IPOL injection.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Quadracel given to 1 years old patient with no Adverse event; Initial information received on 02-Aug-2022 regarding an unsolicited valid non-serious case received from a physician.  This case is related to 2022SA318115(same patient).  This case involves a 1 years old female patient who was administered quadracel with no adverse event after receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 27-Jul-2022, 1 years old patient received suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE at a dose of 0.5 ml total (lot C59708A, expiry date: 02-Feb-2024) via unknown route in unknown administration site for immunization(product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: Cellulitis
Clinical narrative: presumptive cellulitis; Initial information received on 01-Aug-2022 regarding an unsolicited valid  serious case received from a physician.  This case is linked to 01226124 and 01226199.  This case involves a 20 months old of an unknown gender who had presumptive cellulitis after receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE , with an unknown formulation and strength, (lot : C5816AA ; expiry date: not reported) for immunization.  On an unknown date the patient had presumptive cellulitis (cellulitis) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  It was reported that 3 kids received the suspect vaccine and 2 out of the 3 were started on antibiotics for presumptive cellulitis. All three kids were doing better.   Action taken : not applicable.  At time of reporting, the outcome was Recovering for the event presumptive cellulitis.; Sender's Comments: Sanofi company comment date 09-Aug-2022: This case involves a 20 months old of an unknown gender who had presumptive cellulitis after receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. Other medication, current illness, preexisting conditions and allergies were not reported. Also,  the time to onset of event and latency is not provided to assess the role of the vaccine. Further information such as circumstances leading to and patient's health status directly preceding the reported event and the results of investigations to research an alternative etiology such as infectious check-up is missing to fully assess the case
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: DAPTACEL given to an 11 year old instead of the intended ADACEL with no adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who was given daptacel [DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE] instead of the intended adacel with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9) for Immunisation; MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation; and COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation.  On 03-Aug-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5816AA, expiration date: 28-Feb-2023, via intramuscular route in the right thigh (Right Vastus Lateralis) as Immunization.   On 03-AUG-2022 the daptacel was given to an 11 year old instead of the intended adacel with no adverse event (wrong product administered) same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the 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 the guidelines. 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: 12.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Medication error, Wrong product administered
Clinical narrative: had the Menactra 2 years ago and was given Menquadfi yesterday with no reported adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient who experienced had the menactra 2 years ago and was given menquadfi yesterday with no reported adverse event while receiving vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 02-Aug-2022, the patient received a  o.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE once (lot U7294AC; expiry date: 23-May-2024)  via intramuscular route in the left arm and On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, dose, formulation, route,lot number: not reported) both for prophylactic vaccination.  On 02-AUG-2022 the patient reported had the menactra 2 years ago and was given menquadfi yesterday with no reported adverse event (wrong product administered) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken:not applicable.   At time of reporting, the outcome was Unknown for the event wrong product administered.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Fall
Clinical narrative: patient was administered the vaccine on 7/22/2022,the same form listed an exp date for the product of 7/11/2022 with no reported adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was administered the vaccine on 7/22/2022,the same form listed an exp date for the product of 7/11/2022 with no reported adverse event involving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5ml 1X(once) dose of suspect HIB (PRP/T) VACCINE (strength, formulation was unknown, lot UJ525AAB and expiry date: 11-Jul-2022) via unknown route in unknown administration site for Immunization.  It was reported that the patient developed a non-serious event was administered the vaccine, the same form listed an exp date for the product of 11-Jul-2022 with no reported adverse event (expired product administered) (onset date: 22-Jul-2022, latency: same day) following the administration of HIB (PRP/T) VACCINE. They received the vaccination report for the patient and the expiry date listed falls about 11 days before the vaccination was administered. They were asking if we can confirm the expiration date based on the lot number of the product, and how to proceed from here. Reporter does not have the actual product so they cannot see the date on the package, it was located at another pharmacy that administered the vaccine.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: adverse reaction to a Tetanus shot; Initial information received on 03-Aug-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. GMI number: 01219979  This case involves an unknown age female patient who experienced adverse reaction to a tetanus shot while receiving vaccine TETANUS TOXOID.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On unknown date in 2011, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for purposes of allergy testing component parts.  On an unknown date, the patient developed a non-serious adverse reaction to a tetanus shot (allergy to vaccine) (unknown latency).  Action taken with TETANUS TOXOID (TETANUS TOXOID) was not applicable.  It was not reported if the patient received a corrective treatment for the event (adverse reaction to a Tetanus shot).  At time of reporting, the outcome was Unknown for the event adverse reaction to a tetanus shot.
Age: 0.75
Sex: M
Vaccine: UNK
Symptoms: Product preparation error
Clinical narrative: Medical Assistant gave two patients the liquid portion of PENTACEL only on 01AUG2022 without re-constituting the powder portion with no reported adverse event; Medical Assistant gave two patients the liquid portion of PENTACEL only on 01AUG2022 without re-constituting the powder portion with no reported adverse event; Initial information was received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a Nurse Practitioner.   This case involves a 9 months old male patient who experienced medical assistant gave two patients the liquid portion of pentacel only on 01aug2022 without re-constituting the powder portion with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  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) for Prophylactic vaccination.  On 01-Aug-2022, the patient received single 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U7197BA, expiry 28-jan-2024) (strength: unknown) via intramuscular route in the right thigh for routine prophylactic vaccination.    On 01-AUG-2022 the patient developed a non-serious medical assistant gave two patients the liquid portion of pentacel only on 01aug2022 without re-constituting the powder portion with no reported adverse event (product preparation error and single component of a two-component product administered) (latency same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  It was reported that "This situation is reported as a medication error due to the liquid portion of PENTACEL being administered without re-constituting the powder portion'.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event medical assistant gave two patients the liquid portion of pentacel only on 01aug2022 without re-constituting the powder portion with no reported adverse event (product preparation error and single component of a two-component product administered)  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.; Sender's Comments:  01220255:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered
Clinical narrative: patient being administered both IPOL and KINRIX and therefore received an extra polio dose,with no reported adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who was being administered both ipol and kinrix and therefore received an extra polio dose,with no reported adverse event while receiving vaccines KINRIX and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On 01-Aug-2022, the patient received a  dose of suspect IPV (VERO) (lot T1E871M and expiration date: 10-Oct-2022) at a dose of 0.5ml via intramuscular route in the right deltoid and suspect KINRIX not produced by Sanofi Pasteur lot number not reported at  a dose of 0.5ml via unknown route at unknown  administrative site for immunization.  On 01-Aug-2022 (latency: same day),  the patient being administered both ipol and kinrix and therefore received an extra polio dose,with no reported adverse event (extra dose administered).   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event .  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 0.5
Sex: M
Vaccine: UNK
Symptoms: Product preparation issue
Clinical narrative: patient receiving only the liquid portion of PENTACEL, did not receive the lyophilized powder portion with no reported adverse event; Initial information received on 04-Aug-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 6 months old male patient who received only the liquid portion of pentacel, did not receive the lyophilized powder portion with no reported adverse event, after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination.  On 04-Jun-2022, the patient received a dose number 1 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE ( lot LUJ660AAA and expiration date: 25-Feb-2023) at a dose of 0.5ml once via unknown route in unknown administration site for immunization.  On 04-Jun-2022 (latency: same day),the patient received only the liquid portion of pentacel, did not receive the lyophilized powder portion with no reported adverse event (Single component of a two-component product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: TTOX
Symptoms: Allergy to vaccine, Hypersensitivity, Immunisation reaction, Mass, Mobility decreased
Clinical narrative: tetanus hypersensitivity/reaction to the vaccine; lumps in my body; difficulty with mobility; Initial information received on 04-Aug-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced tetanus hypersensitivity/reaction to the vaccine while receiving vaccine tetanus toxoid.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date in 2011, the patient received suspect tetanus toxoid produced by unknown manufacturer at an unknown dose (lot number, expiry date, form, strength: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date the patient developed a non-serious tetanus hypersensitivity/reaction to the vaccine (allergy to vaccine) with lumps in my body (mass) and difficulty with mobility (mobility decreased) (unknown latency) following the administration of TETANUS TOXOID.  Health care professionals initially thought she has rheumatoid arthritis, but the allergist believed it was a reaction to the vaccine. Her health issues have since resolved, but she was trying to determine the causative factor, so she would know what to avoid in future vaccines.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Recovered / Resolved on an unknown date for the event tetanus hypersensitivity/reaction to the vaccine.
Age: 16.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: administered Ipol post excursion after it had exceeded extended stability data and was no suitable for use with no reported adverse event; Initial information received on 04-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient who was administered IPV (VERO) [IPOL] post excursion after it had exceeded extended stability data and was no suitable for use with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) ; HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) ; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) ; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) ; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) all for prophylactic vaccination  (Immunization).  The reporter informed that the temperature excursion was caused by a air conditioner malfunction and the temperature reached 0.8 C for duration of 36 hours 38 minutes. The punctured Ipol was not covered under the extended stability data.  On 29-Jul-2022, the patient received first  dose of suspect IPV (VERO), with an unknown formulation and strength, at dose of 0.5 ml once, (lot: U1A451M ; expiry date: 20-Feb-2023)  via intramuscular route in the right deltoid for immunization.  It was reported that  the patient was administered Ipol post excursion after it had exceeded extended stability data and was no suitable for use with no reported adverse event (poor quality product administered) (onset date: 29-Jul-2022) (latency: same day)  following the administration of IPV (VERO).  Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Poor quality product administered
Clinical narrative: condition was from 0.17C to 10.33C for 1 hour and 59 minutes due to transport (human error)/MENQUADFI was not supported by the extended stability information with no reported AE; misuse as per local labelling due to being administered post excursion with no reported adverse event; Initial information received on 04-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient who reported condition was from 0.17c to 10.33c for 1 hour and 59 minutes due to transport (human error)/ MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] was not supported by the extended stability information with no reported ae (adverse event) and misuse as per local labelling due to being administered post excursion with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 03-Aug-2022, the patient received a 0.5ml 1X(once)  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (strength, formulation was unknown, lot U7294AA and expiry date: 23-May-2024) via intramuscular route in Left deltoid for Immunization.  On 03-Aug-2022 the patient developed a non-serious event condition was from 0.17c to 10.33c for 1 hour and 59 minutes due to transport (human error)/menquadfi was not supported by the extended stability information with no reported ae (product storage error).  On 03-Aug-2022 the patient developed a non-serious event of misuse as per local labelling due to being administered post excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.   Outcome: unknown     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Medication error
Clinical narrative: patient who was given the first dose of MENACTRA at age 12. Parent is not sure if second dose was given at age 16. Patient is now 18 with no reported adverse event; Initial information received on 04-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 18 years old female patient who was given the first dose of menactra at age 12. parent was not sure if second dose was given at age 16. patient is now 18 with no reported adverse event after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization. Information for batch and expiry date was requested.  On an unknown date the patient developed a non-serious event of patient who was given the first dose of menactra at age 12. parent was not sure if second dose was given at age 16. patient was now 18 with no reported adverse event (product dose omission issue) (latency: unknown) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The pharmacist states that they do not have records to show if a patient received their initial MENACTRA shots between 9-23 months of age. She knows that the patient received the Menactra at age 12 but she was not sure if she received a dose at 16. She asks if they should go ahead and give a MENACTRA dose at 18 for college, despite not knowing if the patient received the MENACTRA at age 16.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: YF
Symptoms: Product preparation issue
Clinical narrative: dose of YF-Vax that was incorrectly reconstituted with sterile water instead of the sodium chloride diluent provided with the product with no reporter; Initial information received on 04-Aug-2022 regarding an unsolicited valid non-serious case received from health professional. Agency number: 01222412  This case involves a 43-year-old male patient to whom dose of YELLOW FEVER VACCINE -  [YF-VAX] was administered that was incorrectly reconstituted with sterile water instead of the sodium chloride diluent provided with the product with no reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included TYPHOID VACCINE (TYPHOID VACCINE) for Prophylactic vaccination; and RABIES VACCINE (RABIES VACCINE) for Prophylactic vaccination.  On 15-Jul-2022, the patient received   dose of yf-vax that was incorrectly reconstituted with sterile water instead of the sodium chloride diluent provided at dose 0.5 ml once (lot UJ563AA) via unknown route in right arm for Immunization with no reported (product preparation error, latency same day). A medical assistant administered the vaccine. A staff member accidently combined it.   First time product used : Yes  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.