chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm Hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm Hurting".  Additional information: Reporter states, she is calling about a complaint about her arm. Reporter states, she took the shot; verified Pfizer COVID 19 Vaccine. Reporter states, she took her first shot last year at the end of Apr and it is still aching from that long ago and it is hard to bend it and it won't go away. Reporter states, her sister's arm is hurting too, she has the same problem.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac function test, Gastrointestinal examination, Hiccups
Clinical narrative: Hiccups; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 2, single (Lot number: EN5318) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic", start date: 2019 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose:1, Lot Number:  EN5318), administration date: 08Jan2021, when the patient was 67-year-old, for Covid-19 Immunization. The following information was reported: HICCUPS (non-serious) with onset 2021, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hiccups.  Additional information: Reporter states that he was a nurse. Says he went from Risk Management to Infectious Disease and worked Infectious Disease during Covid. Reporter states that he took both vaccines when they first came out. He has also had the two boosters. Reporter verifies that he was calling about the Pfizer Product: Covid Vaccine. Reporter that shortly after the vaccine he started having hiccups. he didn't relate them to the vaccine at first. Reporter mentions knowing others with hiccups, does not provide how many people or any identifiers. Reporter states he wants to know if anyone else has report the same problem? What are they doing for it?. Reporter states that he has taken every drug on the market for chronic hiccups and had procedures. States now he was on the last medical procedure, for when nothing else will help. Reporter states that he takes Thorazine three times a day, after about a week it will not work for his hiccups, and he will take Lyrica twice a day. Caller states that after about a week the Lyrica will not work for his hiccups. Reporter states that he has almost had to overdose to get something to work for a week. Reporter states that the hiccups started for him shortly after he got the initial series, the first two vaccines. States that the hiccups has gotten worse, and it has been about 2 years now. Seriousness Criteria: When probed for specific seriousness criteria related to all of his symptoms the caller states no and that he has not been hospitalized. Reporter states that he was now trying to see a neurologist to either paralyze or sever the phrenic nerve. Reporter states this was the last resort for intractable hiccups. Reporter begins hiccupping during call, states that the hiccups he was having during the call aren't as bad as the ones he normally has. Reporter states that he takes Thorazine three times a day, after about a week it will not work for his hiccups, and he will take Lyrica twice a day. Caller states that after about a week the Lyrica will not work for his hiccups.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis". In another study, anaphylaxis was confirmed after the first dose in 7 patients who received BNT-162b2 vaccine and 9 patients who received mRNA-1273 vaccine. The CDC had reported a rate of 2.5 cases per million doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported event and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202200681973 Same article/ drug/event and different patient:;US-PFIZER INC-202200681973 Same article/ drug/event and different patient:
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis". In another study, anaphylaxis was confirmed after the first dose in 7 patients who received BNT-162b2 vaccine and 9 patients who received mRNA-1273 vaccine. The CDC had reported a rate of 2.5 cases per million doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and ANAPHYLACTIC REACTION cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202200681973 Same article/ drug/event and different patient:
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis". In another study, anaphylaxis was confirmed after the first dose in 7 patients who received BNT-162b2 vaccine and 9 patients who received mRNA-1273 vaccine. The CDC had reported a rate of 2.5 cases per million doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event anaphylaxis and BNT162b2.,Linked Report(s) : US-PFIZER INC-202200681973 Same article/ drug/event and different patient:
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis". In another study, anaphylaxis was confirmed after the first dose in 7 patients who received BNT-162b2 vaccine and 9 patients who received mRNA-1273 vaccine. The CDC had reported a rate of 2.5 cases per million doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Anaphylactic reaction" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.  ,Linked Report(s) : US-PFIZER INC-202200681973 Same article/ drug/event and different patient:
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis". In another study, anaphylaxis was confirmed after the first dose in 7 patients who received BNT-162b2 vaccine and 9 patients who received mRNA-1273 vaccine. The CDC had reported a rate of 2.5 cases per million doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. ,Linked Report(s) : US-PFIZER INC-202200681973 Same article/ drug/event and different patient:
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: IPOL was used post excursion but upon further probing with no reported adverse event; Initial information regarding an unsolicited valid  non-serious case received from a other health professional received on 06-May-2022.  This case involves a 4 years old male patient who reported administration of IPV (VERO) [IPOL] was used post excursion but upon further probing 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 measles vaccine, mumps vaccine, rubella vaccine (mmr) for immunization; varicella zoster vaccine (varicella vaccine) for immunization; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (daptacel) for immunization.  On 18-Mar-2022, the patient received a dose 4  dose of suspect IPV (VERO) at dose 0.5ml (lot T1D481M, expiry date 25-Jul-2022 ) via intramuscular route in unknown administration site for prophylactic vaccination.  The vaccine was exposed to highest temperature of 48 degrees F for 30 minutes at most. On 18-MAR-2022, the patient developed a non-serious ipol was used post excursion but upon further probing with no reported adverse event (product storage error) latency same day following the administration of IPV (VERO).  Action taken: Not applicable.  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: 1.5
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: nurse gave a Tdap to an 18 month old instead of a Dtap with no reported adverse event; Initial information received on 03-May-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 18 months old of an unknown gender patient who was administered a tdap instead of a dtap with no reported adverse event, while receiving vaccine Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  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 Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection lot number not reported at an unknown dose via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date ,it was reported that nurse gave a tdap to an 18 month old instead of a dtap with no reported adverse event (wrong product administered) (latency: Same day) . No problems were stated as of yet.   Action taken :not applicable  At time of reporting, the outcome was Unknown for the event nurse gave a tdap to an 18 month old instead of a dtap with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: DTAPIPVHIB
Symptoms: Pyrexia
Clinical narrative: has a temperature; Initial information received on 05-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient who experienced has a temperature while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].   The patient's past medical treatment included HEPATITIS B VACCINE.  The patient's past medical history, vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number and expiry date was unknown not reported via unknown route in unknown administration site for Tetanus.  On an unknown date the patient developed a non-serious has a temperature (pyrexia) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (has a temperature).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event has a temperature.
Sex: U
Vaccine: DTAPIPVHIB, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: medication error due to administration after a possible temperature excursion with no reported adverse event; Initial information received on 03-May-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to case IDs 2022SA161486 and 2022SA159339.  This case involves medication error due to administration of pentacel to 3 infants after a possible temperature excursion with no reported adverse event involving the vaccines IPV (vero) [ipol] and diphtheria/tetanus/5 hybrid AC PERTUSSIS/IPV(mrc5)/HIB(PRP/T) vaccine [pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date 3 dosage forms (DF) of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (Batch number: UJ474AAA) were administered to 3 infants and one dosage form of IPV (vero) (batch number: unknown) after a possible temperature excursion with no reported adverse event (product storage error) (latency: unknown) (formulation, strength, route, administration site expiry date unknown for both vaccines).  It was reported that "Vaccine Compliance Officer called for guidance. She had unpunctured IPOL x5 and unopened Pentacel x3 and fluzone QIV (caller could not confirm presentation of FLUZONE) x1. Caller states due to a change in staffing and this "being a high-profile case" no temperature data has been taken since 1-Feb-2022. Caller stated before that date the temperatures were known to be in recommended range. Since no temperatures could be given, no stability information could be given. Caller was requesting information on whom to reach out to next for more information. Caller requests callback. Outbound Call to caller made at 3:45pm, where caller was directed to the CDC Vaccines Storage Handling Toolkit for further direction regarding her vaccines. Upon this outbound call, caller informs agent that 1 dose of IPOL was administered, 3 doses of Pentacel were administered and 1 dose of Fluzone QIV was administered. Caller provided information regarding the vaccines being unopened that could be inconsistent with the information provided regarding the administration to patients. Caller was unable to give most safety report information due to the "high priority status of this case". This reports AEs for potential administration following a temperature excursion regardless."  Action taken: Not applicable with both suspects.  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: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of menactra, with no adverse event; Initial information received on 04-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient who experienced patient received an expired dose of menactra, with no adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hpv Vaccine (Hpv Vaccine) for Immunisation.  On 03-May-2022, the patient received a  dose (dose: 0.5ml )of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine (lot U6921AB)  via intramuscular route in the left deltoid for Immunisation.  On 03-May-2022 the patient developed a non-serious patient received an expired dose of menactra, with no adverse event (expired product administered) following the administration of Meningococcal A-C-Y-W135 (D Conj) Vaccine.  Action taken with: not applicable.  It was not reported if the patient received a corrective treatment for the event (patient received an expired dose of menactra, with no adverse event).  Outcome: Unknown for the event patient received an expired dose of menactra, with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given expired doses of pentacel with no adverse event; Initial information received on 05-May-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 4-month-old male patient who was given expired doses of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Pentacel) with no adverse event.  The patient's past medical history, medical treatment, vaccination, and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 04-Apr-2022, the patient received 0.5ml total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ414AAA and expiry date: 12-Mar-2022) via intramuscular route in the left thigh for Immunization.  On 04-Apr-2022 the patient developed a non-serious event, patient who was given expired doses of pentacel with no adverse event (expired product administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event patient who was given expired doses of pentacel with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered MENACTRA yesterday and after the event, they found out that it expired on 13APR2022 with no adverse event; Initial information received on 05-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient who experienced administered menactra yesterday and after the event, they found out that it expired on 13apr2022 with no adverse event while receiving vaccine Meningococcal a-c-y-w135 (d conj) vaccine [menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-May-2022, the patient received suspect Meningococcal a-c-y-w135 (d conj) vaccine at a dose of 0.5 ml once (strength, formulation :unknown) lot U6919AA expiry date :13-apr-2022 via unknown route in unknown administration site for immunization.  On 04-MAY-2022 the patient developed a non-serious administered menactra yesterday and after the event, they found out that it expired on 13apr2022 with no adverse event (expired product administered) (latency :same day) following the administration of Meningococcal a-c-y-w135 (d conj) 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.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Daptacel dose was administered to a patient and realized after giving it that it had expired with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from a other health professional received on 06-May-2022.  This case involves a 15-month-old male patient who reportedly was administered Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] dose and realized after giving it that it had expired 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 HIB Vaccine CONJ (TET TOX) (ACTHIB) for Immunization.  On 02-May-2022, the patient received suspect Daptacel vaccine at dose 0.5 ml once (lot C5732AA, expiry date: 24-Apr-2022) via intramuscular route in the left vastus lateralis for prophylactic vaccination (expired product administered, latency same day).  Action taken: Not applicable.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: just administered the diluent ( DTAP-IPV) component of the vaccine and wanted to know if the ACT-HIB portion can be administered to complete the dose with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid non-serious case received from healthcare professional.  This case involves a 4 months old female patient who was administered with the diluent (DTAP-IPV) component of the vaccine and nurse wanted to know if the ACT-HIB portion can be administered to complete the dose with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar) (lot: UJ668AA and Expiry date 13-May-2023) and Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) (lot: UJ668AA and Expiry date 13-May-2023) for Immunisation.  On 06-May-2022, the patient received 0.5 ml 2nd dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine [Pentacel] (lot U7256AB and expiry date 13-may-2023) (formulation: unknown) via intramuscular route in the right vastus lateralis for immunization.  On 06-May-2022 the patient developed a non-serious event "just administered the diluent (DTAP-IPV) component of the vaccine and wanted to know if the ACT-HIB portion can be administered to complete the dose with no reported adverse event" (Incorrect dose administered) same day following the administration of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine [Pentacel].  Action taken: not applicable.  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 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: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: vaccines given post excursion (with no reported adverse event); vaccines being given post temperature excursion (with no reported adverse event); Initial information received on 06-May-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 11 years old male patient who experienced vaccines given post excursion (with no reported adverse event) while receiving meningococcal A-C-Y-W135 (D conj) vaccine [Menactra].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) for Prophylactic vaccination; and hpv vaccine (HPV vaccine) for prophylactic vaccination.  On 02-May-2022, the patient received a dose of 0.5 ml 1 day total Strength: standard suspect meningococcal a-c-y-w135 (d conj) vaccine lot U7208AA, expiry date:10-Feb-2023 via intramuscular route in the left deltoid for prophylactic vaccination.  On 02-May-2022 (Latency: same day) vaccines given post excursion (with no reported adverse event) (poor quality product administered) and (product temperature excursion issue). This situation was reported as a medication error due to vaccines being given post temperature excursion.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for all the events.   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.; Sender's Comments:  PENTACEL case 01092869: PENTACEL case 01092879: QUADRACEL case 01092814: QUADRACEL case 01092832: QUADRACEL case 01092891: ADACEL case: 01092687: DAPTACEL case:  01092746: FLUZONE QIV case 01092709: FLUZONE QIV case 01092741: FLUZONE QIV case 01092787: FLUZONE QIV case 01092803: FLUZONE QIV case 01092850:
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: received the DTap-IPV portion of PENTACEL in the office on 05MAY2022 without reconstituting with the Hib portion with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid  non-serious case received a other health professional.  This case involves a 4 months old male patient who received the dtap-ipv portion of pentacel in the office on 05-May-2022 without reconstituting with the hib portion with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  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); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On 05-May-2022, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE  (lot : UJ593AA and  expiry date: 18-Dec-2022 for powder vial; lot: U7054AA and expiry date: 18-Dec-2022 for liquid vial) via intramuscular route for immunization.  It was reported that the patient received the dtap-ipv portion of pentacel in the office on 05-May-2022 without reconstituting with the hib portion with no reported adverse event (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (received the DTap-IPV portion of PENTACEL in the office on 05MAY2022 without reconstituting with the Hib portion with no reported adverse 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: M
Vaccine: TDAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vaccines given post excursion with no reported adverse event; vaccines being given post temperature excursion with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid  non-serious case received from other health care professional.  This case involves a 11 years old male patient to whom vaccines given post excursion with no reported adverse event and vaccines being given post temperature excursion with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  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) for Prophylactic vaccination; and HPV VACCINE (HPV VACCINE)  for Prophylactic vaccination.  On 02-May-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE , once (lot: U6737AA; expiry date: 09-Jul-2022)  via intramuscular route in the left deltoid for immunization.  It was reported that vaccines were given post temperature excursion (product storage error) (Poor quality product administered) (latency: same day).  Action taken: not applicable.  Corrective treatment: not reported  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.; Sender's Comments:  01090544: 01092869: 01092879: 01092814: 01092832: 01092891: 01092746: 01092709: 01092741: 01092787: 01092803: 01092850:
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines being given post temperature excursion with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 7 years old male patient who experienced vaccines being given post temperature excursion with no reported adverse event while receiving vaccine influenza quadrival a-b vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Covid-19 Vaccine for Prophylactic vaccination.  On 02-May-2022, the patient received a dose of suspect influenza quadrival a-b vaccine at a dose of 0.5 ml with lot UT7376NA via intramuscular route in the left deltoid for Immunization.  On 02-May-2022 (latency: same day) the patient developed vaccines being given post temperature excursion with no reported adverse event (poor quality product administered) following the administration of influenza quadrival a-b vaccine.   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.; Sender's Comments:  01092869: 01092879: 01092814: 01092832: 01092891: 01092687: 01092746: 01092709: 01092787: 01092803: 01092850:
Age: 1.92
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: vaccines being given post temperature excursion (with no reported adverse event); Initial information received on 06-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 23 months old female patient who experienced vaccines being given post temperature excursion (with no reported adverse event) while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); HEPATITIS A VACCINE (HEPATITIS A); and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On 03-May-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT7376NA(expiry date:30-Jun-2022)  via intramuscular route in the left thigh for Immunization.  On 03-MAY-2022 (latency: Same day) the patient developed a non-serious vaccines being given post temperature excursion (with no reported adverse event) (product storage error) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (vaccines being given post temperature excursion (with no reported adverse event)).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event vaccines being given post temperature excursion (with no reported adverse event).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 3.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines being given post temperature excursion with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old female patient whom influenza quadrival A-B vaccine [Fluzone QIV] was given post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-May-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine, suspension for injection (lot UT7376NA expiry date : 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination was given post temperature excursion with no reported adverse event (intercepted product storage error).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event vaccines being given post temperature excursion with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.; Sender's Comments:  01092869: 01092879: 01092814: 01092832: 01092891: 01092687: 01092746: 01092709: 01092741: 01092787: 01092850:
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines given post excursion with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who experienced vaccines given post excursion with no reported adverse event while receiving vaccine diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (Proquad).  On 03-May-2022, the patient received a dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine Suspension for injection at a dose of 0.5 ml (total) (lot C5916AA; expiry date: 06-Jul-2022) via intramuscular route in the left deltoid as Immunization.  On 03-May-2022, the vaccines were given post excursion with no reported adverse event (product storage error) following the administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (latency: same day).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event vaccines given post excursion with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines being given post temperature excursion (with no reported adverse event); Initial information received on 06-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient  to whom  diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] was given post temperature excursion (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 COVID-19 VACCINE; and measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (Proquad).  On 04-May-2022, the patient received 0.5 ml  dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection (lot C5916AA; expiry date: 06-Jul-2023) via intramuscular route in the right deltoid for prophylactic vaccination vaccine was given post temperature excursion (with no reported adverse event) (product storage error) (latency: same day).  Action taken :not applicable.  At time of reporting, the outcome was Unknown for the event vaccines being given post temperature excursion (with no reported adverse event).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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:  01092869: 01092879: 01092814: 01092832: 01092687: 01092746: 01092709: 01092741: 01092787: 01092803: 01092850:
Age: 20.0
Sex: M
Vaccine: RAB
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: covid; received his first dose on 18Apr2022, then he caught Covid and was unable to come in, he received his second dose on 02May2022; Initial information received on 09-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional via Nurse.  This case involves a 20 years old male patient who experienced covid and inappropriate schedule of vaccine administered while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Apr-2022 , the patient received a dose 1 of suspect RABIES (HDC) VACCINE, powder and solvent for suspension for injection, 0.2 ml (lot T1E321M: expiry date 16-Sep-2022)  via intramuscular route in the left deltoid  and  On 02-May-2022 he also received 0.25ml dose 2  of the same vaccine  lot T1E321M via intramuscular route in the left deltoid for prophylactic vaccination.  It was reported that the patient received his first dose on 18-Apr-2022, then he caught covid and was unable to come in, he received his second dose on 02-May-2022 (inappropriate schedule of product administration) (covid-19).  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events (covid).  At time of reporting, the outcome was Unknown for  both the events.   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.