chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: sick for 3 days; got my flu shot and it made me real sick for 3 days ,no more shots for me.; Initial information received on 26-Jan-2022 with live follow up 26-Jan-2022(processed together) regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who reported sick for 3 days and got my flu shot and it made me real sick for 3 days ,no more shots for me. while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event "sick for 3 days" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious event "got my flu shot and it made me real sick for 3 days ,no more shots for me" (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got my flu shot and got very Ill for 3 days could not get outta bed. Never again".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (sick for 3 days, got my flu shot and it made me real sick for 3 days ,no more shots for me).  At time of reporting, the outcome was Unknown for the event sick for 3 days and was Unknown for the event got my flu shot and it made me real sick for 3 days ,no more shots for me.  Additional information was received on 28-Jan-2022 from consumer/non-Health care professional : event( malaise) added and narrative amended accordingly.
Sex: F
Vaccine: FLUX
Symptoms: Death
Clinical narrative: died in her sleep; Initial information received on 13-Feb-2022 with live follow up 13-Feb-2022 (processed together) regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 40 years old female patient who reported died in her sleep while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a serious events died in her sleep (death) ( latency same day) following the administration of Influenza Vaccine.   It was reported that she "took her first shot and was in good health. She died in her sleep that night."  Action taken :Not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event outcome : At time of reporting, the outcome was Fatal for the event died in her sleep.  Seriousness criteria : This event(death) was assessed as medically significant and was leading to death (fatal).; Sender's Comments: Sanofi company comment dated 18-Feb-2022: This case involves a 40 years old female patient who reported died in her sleep after receiving vaccine Influenza Vaccine. The time to onset was compatible. However, further information regarding the patient's event details, concomitant medications and tolerance, allergic history, autopsy reports, laboratory investigations for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: died in her sleep
Sex: U
Vaccine: FLUX
Symptoms: Heart rate increased, Injected limb mobility decreased, Injection site pain
Clinical narrative: thought my heart was going to explode; can't raise my arm over my head at all; Initial information received on 20-Feb-2022 regarding an unsolicited valid Social Media non-serious case from a patient.  This case involves an adult patient of unknown demographics who thought my heart was going to explode and cannot raise my arm over my head at all while receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (dose, form, route, strength, batch number and expiry dates: unknown) and one other booster dose all in unknown administration site for immunization. Information on batch number has been requested.  It was reported that the 2 shots didn't hurt the patient, but when the patient took the booster shot 2 myths ago still down can't raise the arm over the head at all (injection site pain) and patient thought his/her heart was going to explode (heart rate increased) (onset and latency: unknown).   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (heart rate increased and injection site pain).  At time of reporting, the outcome was Unknown for the events (heart rate increased and injection site pain).
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: influenza A; Initial information received on 22-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a patient with unknown demographics who had influenza a while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer,with unknown dose,lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient had a serious influenza a (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza A).  At time of reporting, the outcome was Unknown for the event influenza a.; Sender's Comments: Sanofi company comment dated 01-Mar-2022: This case involves a patient with unknown demographics who had influenza a while receiving vaccine INFLUENZA VACCINE. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, latency, medical history, concomitant medications,findings would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Death, Myocardial infarction
Clinical narrative: heart attack; Initial information received on 22-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp (Patient Friend).  This case involves an adult patient of unknown demographics who suffered heart attack after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer (form, strength, route, administration site, batch number expiry date: unknown) for immunization.  It was reported patient was in perfect health.  On an unknown date the patient suffered a serious event of heart attack (myocardial infarction) (unknown latency) following the administration of Influenza Vaccine.   Action taken was not applicable  Corrective treatment: not reported  Outcome was Fatal   The event was assessed as medically significant and was leading to death.  It is unknown if an autopsy was done. The cause of death was reported as Heart attack.; Sender's Comments: Sanofi Company Comment dated 28-Feb-2022: This case involves an adult patient of unknown demographics who suffered heart attack and died after receiving Influenza Vaccine.The causal role of the company suspect drug cannot be excluded based on the temporal relevance instead of the time to onset is compatible with the role of the vaccine. However, information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: heart attack
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 23-Feb-2022 regarding an unsolicited valid non-serious case received from Social Media via patient.  This case involves adult patient with unknown age and gender who developed flu while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer at unknown dosage (formulation and strength: unknown) once ( lot number and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number is requested.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event Influenza.  At time of reporting, the outcome was Unknown for the event Influenza.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: always got sick from the shot; Initial information received on 23-Feb-2022 regarding an unsolicited valid Social Media non-serious case was received from a patient.  This case involves an unknown age and unknown gender patient who always got sick from the shot while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (dose, frequency, lot number, expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  It was reported that every year that the patient received the vaccine, the patient always got sick from the shot (illness) (event onset date and latency: unknown). The patient reported not taking the flu shot again.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (always got sick from the shot).  At time of reporting, the outcome was Unknown for the event always got sick from the shot.
Sex: U
Vaccine: FLUX
Symptoms: Drug ineffective, Influenza
Clinical narrative: Every time I get a flu shot, I get the flu , and an excuse why the shot never worked; Every time I get a flu shot, I get the flu , and an excuse why the shot never worked; Initial information received on 24-Feb-2022 regarding an unsolicited valid social media non-serious case received from a consumer.  This case involves an unknown age and unknown gender patient who experienced every time i get a flu shot, i get the flu , and an excuse why the shot never worked while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect Influenza vaccine produced by unknown manufacturer (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site for immunization. Information on batch lot number is requested. On an unknown date the patient developed a non-serious event every time i get a flu shot, i get the flu, and an excuse why the shot never worked (influenza) (drug ineffective) (unknown latency) following the administration of Influenza Vaccine.  Action taken: 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 both events.
Sex: U
Vaccine: FLUX
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: Made a-fib worse; Initial information received on 24-Feb-2022 regarding an unsolicited valid Social Media serious case received via consumer/non-hcp.  This case involves adult and unknown gender patient who experienced made a-fib worse while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine (formulation, dose and frequency: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious made a-fib worse (atrial fibrillation) (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Made a-fib worse).  At time of reporting, the outcome was Unknown for the event made a-fib worse.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: was administered the PENTACEL that expired 3 weeks ago; Initial information was received on 12-Jul-2021 regarding an unsolicited valid non-serious case from a other health professional (Agency Inquiry number: 00677892).  This case involves a 15 month old female patient who received the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that expired 3 weeks ago (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 12-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number: UJ349AAA, expiry date: 22-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination (expired product administered) (latency: 1 day).  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  It was reported that "Nurse reports that a patient was administered the PENTACEL that expired 3 weeks ago, should they revaccinate the 15 month old? They were confused with the date."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: The dose of ActHIB was reconstituted with sterile water instead of the diluent provided; Initial information was received on 13-Jul-2021 regarding an unsolicited valid non-serious case from other health professional (Agency Inquiry number: 00680213).  This case involves a 12-month-old male patient who experienced the dose of HIB (PRP/T) VACCINE [ACT-HIB] which was reconstituted with sterile water instead of the diluent provided (product preparation issue).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE.  On 08-Jul-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE [lot number: UJ3999AAC, expiry date: 02-Oct-2021] via an unknown route at left thigh for prophylactic vaccination (product preparation issue) (latency: 1 day).  It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of reporting, no adverse event was reported.  It was reported that "A patient received ActHIB on 08Jul2021 in the left thigh. The dose of ActHIB was reconstituted with sterile water instead of the diluent provided. Dose # if series #4--This was the first HIB the patient received that was ActHIB alone. Doses #1 through #3 of HIB received were as part of Pentacel."  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: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Infection, Wound complication
Clinical narrative: infection; a tunneling wound the size of a quarter; Initial information received on 17-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional(non-Hcp).  This case involves a 44 years old female patient who experienced infection and a tunneling wound the size of a quarter while receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone QIV] and Antibiotic unspecified.  The patient's past medical history included Pneumonia and patient was hospitalized for the event on an unknown date. The patient's past medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect Influenza Quadrival A-B Vaccine suspension for injection (dose and strength; unknown) (lot UJ027AA and expiry date:30-Jun-2019) via intramuscular route in the left deltoid and received a second dose of vaccine (lot UT5899MA and expiry date 30-Jun-2018) via intramuscular route in an unknown administration site (AL) for immunization.  On an unknown date, 3years ago, the patient started taking Antibiotics unspecified (formulation, dose, strength, route, expiry date and lot number: unknown) for unknown indication.  On an unknown date the patient developed a non-serious infection and a tunneling wound the size of a quarter(wound complication),(unknown latency)following the administration of  Influenza Quadrival A-B Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events infection, wound complication.  At time of reporting, the outcome was Unknown for the event infection and wound complication.
Sex: U
Vaccine: IPV, MNQ
Symptoms: Product storage error
Clinical narrative: temperature excursion; Initial information received on 18-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had temperature excursion while receiving vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and IPV (VERO) [IPOL].  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 MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE with unknown dose, lot number, route, administration site for immunization.  On an unknown date, the patient received a  dose of suspect IPV (VERO)with unknown dose lot T1D482M via unknown route, administration site for immunization. 1 other doses were administered on unknown dates for suspect IPV (VERO).  On an unknown date the patient had temperature excursion (product temperature excursion issue) (unknown latency) following the administration of IPV (VERO) and (unknown latency) 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 (temperature excursion).  At time of reporting, the outcome was Unknown for the event temperature excursion.   Additional information was received on 18-Feb-2022 from Other health care professional: Case updated from Non-case to valid case.
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: exposed to lowest temperature 32.1-33.4 F to highest temperature 35.2 F for 14 days in total from 28Dec2021 to 10Jan2022 and has been administered to patient with no reported adverse event; Initial information was received on 22-Feb-2022 regarding an unsolicited non-valid non-serious case received from other health professional via call center.  This case involves an 8years old male patient who received a dose of vaccine which was exposed to lowest temperature 32.1-33.4 F to highest temperature 35.2 F for 14 days in total from 28-Dec-2021 to 10-Jan-2022 and had received post excursive vaccine with no reported adverse event while receiving Poliomyelitis vaccine (inactivated) (Ipol).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Jan-2022, the patient received a dose of suspect Poliomyelitis vaccine (inactivated) (Lot: T1D482M, expiration: 25-Jul-2022; Lot: U1A452M, expiration: 20-Feb-2023) (formulation, strength, dose: unknown) for prophylactic vaccination.  On 11-Jan-2022, the patient received a dose of vaccine which was exposed to lowest temperature 32.1-33.4 F to highest temperature 35.2 F for 14 days in total from 28-Dec-2021 to 10-Jan-2022 and had received post excursive vaccine with no reported adverse event (product temperature excursion issue) (unknown latency) following the administration of Poliomyelitis vaccine (inactivated).  Action Taken: not applicable.  At time of reporting, the outcome was Unknown for the event (product temperature excursion issue).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  Additional information was received on 22-Feb-2022: Case was updated from non-valid to Valid with no AE, patient's details were added, event verbatim was updated and narrative was amended accordingly.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: unopened ADACEL and TUBERSOL as well as punctured TUBERSOL, exposed to 64 F for 24 hours, with no reported adverse event; Initial information received on 23-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had unopened adacel and tubersol as well as punctured tubersol, exposed to 64 f for 24 hours, with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and while treated with TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection dosage unknown (lot - C5841AB, 17-Jan-2023)for unknown indication.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE with unknown dosing lot U7283AA via unknown route in unknown administration site for immunization.  On an unknown date the patient had unopened adacel and tubersol as well as punctured tubersol, exposed to 64 f for 24 hours, with no reported adverse event (product temperature excursion issue) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of TUBERCULIN TEST.  On an unknown date the patient developed a non-serious unopened adacel and tubersol as well as punctured tubersol, exposed to 64 f for 24 hours, with no reported adverse event (product temperature excursion issue) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (unopened ADACEL and TUBERSOL as well as punctured TUBERSOL, exposed to 64 F for 24 hours, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event unopened adacel and tubersol as well as punctured tubersol, exposed to 64 f for 24 hours, with no reported adverse event.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Burning sensation, Chest discomfort, Drug ineffective, Dyspnoea
Clinical narrative: Rash on face, hairline/ Rash was now on chest near heart; Pain; Itching; Blisters; Fever; Tightness in chest; Shortness of breath; Feels like sandpaper; then starts throbbing and turns blood red and burning hot; she has not seen any improvement with the medication.; egg allergy; Initial information received on 23-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 63 years old female patient who had rash on face, hairline/ rash was now on chest near heart, pain, itching, blisters, fever, tightness in chest, shortness of breath, feels like sandpaper, then starts throbbing and turns blood red and burning hot, she has not seen any improvement with the medication. and egg allergy 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.  At the time of the event, the patient had ongoing Diabetic and Migraine with has suffered from them for many years.  Concomitant medications included DOXYCYCLINE (DOXYCYCLINE) for Rash, Pain, Itching, Blisters, Feeling abnormal, Fever, Tightness in chest and Shortness of breath.  On 03-Nov-2021, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE with the dose of 0.5ml once,lot number not reported via intramuscular route in unknown administration site.  On 03-NOV-2021 the patient had rash on face, hairline/ rash was now on chest near heart (rash),pain,itching (pruritus),blisters (blister),fever (pyrexia) , tightness in chest (chest discomfort),shortness of breath (dyspnoea),feels like sandpaper (feeling abnormal),starts throbbing and turns blood red and burning hot (burning sensation), she has not seen any improvement with the medication (drug ineffective) ans egg allergy (food allergy) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (Rash on face, hairline/ Rash was now on chest near heart, Pain, Itching, Blisters, Fever, Tightness in chest, Shortness of breath, Feels like sandpaper, then starts throbbing and turns blood red and burning hot, she has not seen any improvement with the medication., egg allergy).  outcome was Not Recovered / Not Resolved
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Pain, Pruritus, Pyrexia, Rash
Clinical narrative: Rash on face, hairline/ Rash was now on chest near heart; Pain; Itching; Blisters; Fever; Tightness in chest; Shortness of breath; Feels like sandpaper; then starts throbbing and turns blood red and burning hot; she has not seen any improvement with the medication.; egg allergy; Initial information received on 23-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 63 years old female patient who had rash on face, hairline/ rash was now on chest near heart, pain, itching, blisters, fever, tightness in chest, shortness of breath, feels like sandpaper, then starts throbbing and turns blood red and burning hot, she has not seen any improvement with the medication. and egg allergy 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.  At the time of the event, the patient had ongoing Diabetic and Migraine with has suffered from them for many years.  Concomitant medications included DOXYCYCLINE (DOXYCYCLINE) for Rash, Pain, Itching, Blisters, Feeling abnormal, Fever, Tightness in chest and Shortness of breath.  On 03-Nov-2021, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE with the dose of 0.5ml once,lot number not reported via intramuscular route in unknown administration site.  On 03-NOV-2021 the patient had rash on face, hairline/ rash was now on chest near heart (rash),pain,itching (pruritus),blisters (blister),fever (pyrexia) , tightness in chest (chest discomfort),shortness of breath (dyspnoea),feels like sandpaper (feeling abnormal),starts throbbing and turns blood red and burning hot (burning sensation), she has not seen any improvement with the medication (drug ineffective) ans egg allergy (food allergy) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (Rash on face, hairline/ Rash was now on chest near heart, Pain, Itching, Blisters, Fever, Tightness in chest, Shortness of breath, Feels like sandpaper, then starts throbbing and turns blood red and burning hot, she has not seen any improvement with the medication., egg allergy).  outcome was Not Recovered / Not Resolved
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: administered the DTAP-IPV portion of PENTACEL without first reconstituting with the HIB portion, with no reported adverse event; Initial information received on 23-Feb-2022 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a 4 months old male patient who was administered the dtap-ipv portion of pentacel without first 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 7v (Crm197) (Prevnar) and Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) for Prophylactic vaccination.  On 21-Feb-2022, the patient received one Dosage form of 0.5 ml, once a day of suspect Pentacel Vaccine (lot UJ569ABA, expiry date: 11-Sep-2022) via intramuscular route in the left thigh for immunization.  On 21-FEB-2022 the patient was administered the dtap-ipv portion of pentacel without first reconstituting with the hib portion, with no reported adverse event (product preparation error) (latency: same day) following the administration of Pentacel Vaccine.  Action taken was not applicable.  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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product preparation error
Clinical narrative: patient received only the ACT-HIB portion of the PENTACEL with no adverse event; Initial information was received on 23-Feb-2022 regarding an unsolicited valid Social media non-serious case received from other health professional.  This case involves a patient of unknown demographics who received only the act-hib portion of the 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.  On an unknown date, the patient received a dose of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (formulation, strength, batch number, expiration date: unknown) via unknown route in an unknown administration site for immunization. Information on batch number was requested.  On an unknown date, the patient reported that he/she received only act-hib portion of Pentacel (product preparation error) (unknown latency) following the administration of Diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.  Action Taken: not applicable.  At time of reporting, the outcome was Unknown for the event (product preparation error).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: ACTHIB was reconstituted with sterile water; Initial information received on 24-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 1 years old male patient who had acthib was reconstituted with sterile water while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  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); INFLUENZA VACCINE (INFLUENZA VACCINE); and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On 23-Feb-2022, the patient received a  dose of suspect HIB (PRP/T) VACCINE with the dose of 0.25 mL to 2 mL for vaccines,lot UJ614AB via intramuscular route for immunization.  On 23-FEB-2022 the patient developed a non-serious acthib was reconstituted with sterile water (medication error) following the administration of HIB (PRP/T) VACCINE.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (ACTHIB was reconstituted with sterile water).  At time of reporting, the outcome was Unknown for the event acthib was reconstituted with sterile water.  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: Expired product administered
Clinical narrative: inadvertently received MENACTRA with no reported adverse event; inadvertently received MENACTRA on 24FEB2022 in the office which had expired on 18FEB2022 with no reported adverse event; Initial information received on 24-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who inadvertently received menactra on 24-Feb-2022 in the office which had expired on 18-Feb-2022 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 HPV vaccine (HPV vaccine); influenza vaccine (flu); and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP).  On 24-Feb-2022, the patient received a 0.5 ml  dose (First Dose) of suspect meningococcal A-C-Y-W135 (D conj) vaccine (lot U6827BA, expiry date: 18-Feb-2022) (strength and formulation not reported) via intramuscular route in the left deltoid as prophylactic vaccination   An hour after the administration, the reporter informed that 2 patients had inadvertently received Menactra on 24-Feb-2022 which had expired on 18-Feb-2022 (expired product administered) (accidental exposure to product) (latency same day). Caller asked if these patients needed to be revaccinated and if it was safe to give another full dose of MENACTRA right away since full doses were given on 24FEB2022.   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 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.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: inadvertently received MENACTRA on 24FEB2022 in the office which had expired on 18FEB2022 with no reported ae; Initial information received on 24-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old male patient who inadvertently received Menactra on 24-Feb-2022 in the office which had expired on 18-Feb-2022 with no reported adverse event (AE) 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 Vaxero, Meningitis B, Flu Shot (Influenza Vaccine).   On 24-Feb-2022, the patient was administered 0.5 ml dose of suspect meningococcal A-C-Y-W135 (D Conj.) vaccine subcutaneously by a physician in the office (with lot number U6827BA, Expiry date: 18-Feb-2022) via intramuscular route in the left deltoid as prophylactic vaccination (immunisation).  An hour after the administration, the reporter informed that 2 patients had inadvertently received Menactra on 24-Feb-2022 which had expired on 18-Feb-2022. Patient was administered full dose of expired product (expired product administered) (latency: Same day) by the physician, but had not reported any adverse event. Enquiry was made if patient needed to be re-vaccinated  or if it was safe to give another full dose of Menactra right away since full doses were given on 24-Feb-2022.  Action taken with meningococcal vaccine (MENACTRA) 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 was reported as potential AE because of use against local labelling. To be evaluated. No further information was provided by the reporter.  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: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: had two temperature excursions; Initial information received on 24-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult and unknown gender patient who had two temperature excursions 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.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE with unknown dosing lot UJ422AAA via unknown route in unknown administration site.  On an unknown date the patient had two temperature excursions (product temperature excursion issue) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (had two temperature excursions).  At time of reporting, the outcome was Unknown for the event had two temperature excursions.
Age: 35.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: accidentally gave a expired Menactra four days after the expiration date with no reported adverse event; Initial information received on 25-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 35 years old female patient who experienced accidentally gave a expired menactra four days after the expiration date with no reported 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 Measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination.  On 22-Feb-2022, the patient received a suspect Meningococcal a-c-y-w135 (D Conj) vaccine at a dose of 0.5 mg (strength; not reported) lot U6827BD via intramuscular route in unknown administration site for immunization.  On 22-FEB-2022 the patient developed a non-serious accidentally gave a expired menactra four days after the expiration date with no reported adverse event (latency :same day) (expired product administered).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (accidentally gave a expired Menactra four days after the expiration date with no reported adverse event).  At time of reporting, the outcome was Unknown for the event accidentally gave a expired menactra four days after the expiration date 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: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: Early 5th dose of Daptacel was inadvertently administered with no reported AE; intended to administer Prevnar to the patient on 11 July 2018, but an early 5th dose of Daptacel was inadvertently administered instead, with no reported AE; Initial information was received on 25-Feb-2022 regarding an unsolicited valid non-serious case received from other health professional via call center.  This case involves an 18months old male patient who reported that early 5th dose of Daptacel was inadvertently administered with no reported adverse event, intended to administer Prevnar to the patient on 11 July 2018, but an early 5th dose of Daptacel was inadvertently administered instead, with no reported AE (adverse event) while 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.  Concomitant medications included HIB Vaccine (HIB Vaccine) for Immunisation.  The patient received first dose of suspect Diphtheria-15/tetanus/5 AC pertussis vaccine (formulation, strength, batch number, expiration date: unknown) via intramuscular route in unknown administration site on 02-Jun-2017, second dose on 03-Mar-2017, third dose on 19-Jul-2017, fourth dose via subcutaneous route on 30-Apr-2018 for immunization. On 11-Jul-2018 he also received a dose of the same vaccine (batch number: C5254AA, expiration date: 18-Sep-2019) via intramuscular route in the left vastus lateralis for immunization  On 11-Jul-2018 the patient reported that early 5th dose of Daptacel was inadvertently administered with no reported adverse event (product administered to patient of inappropriate age) and intended to administer Prevnar to the patient on 11 July 2018, but an early 5th dose of Daptacel was inadvertently administered instead, with no reported AE (Wrong product administered) (latency: 1 year 4 months) following the administration of Diphtheria-15/tetanus/5 AC pertussis vaccine.  Action Taken: not applicable.  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.