chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: U
Vaccine: FLUX
Symptoms: Sudden death
Clinical narrative: dead suddenly and unexpectedly; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 64 years old and unknown gender patient who was dead suddenly and unexpectedly while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer  (formulation, frequency, route, lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date the patient was dead suddenly and unexpectedly (sudden death, latency: Unknown).  This event was assessed as medically significant and was leading to death. The cause of death and autopsy details were unknown at the time of report.  Action taken:  not applicable.  It was not reported if the patient received a corrective treatment for the event (dead suddenly and unexpectedly).  At time of reporting, the outcome was Fatal for the event dead suddenly and unexpectedly.; Sender's Comments: Sanofi company comment dated 27-Jan-2022: This case involves 64 years old patient of unknown gender who was dead suddenly and unexpectedly (sudden death) with influenza Vaccine (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: dead suddenly and unexpectedly
Sex: U
Vaccine: FLUX
Symptoms: Cardiac failure, Death
Clinical narrative: heart failure during a race; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case was received from a consumer/non-hcp (non health care professional) via social media.  This case involves a 59 year old and unknown gender patient who had heart failure during a race and died 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 and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  It was reported that the patient was a long-distance runner and on an unknown date, the patient developed a serious heart failure during a race (cardiac failure) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant and was leading to death. It was unknown if an autopsy was done. Final diagnosis was (fatal) heart failure during a race.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (heart failure during a race).  At time of reporting, the outcome was Fatal for the event heart failure during a race.; Sender's Comments: Sanofi company comment dated 07-Feb-2022: This case concerns a 59 year old patient of unknown gender who had heart failure during a race and died after vaccination with vaccine Influenza Vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Further information such as condition at the time of vaccination, medical history, concomitants and autopsy report would be needed to rule out alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: heart failure during a race
Sex: F
Vaccine: FLUX
Symptoms: Death
Clinical narrative: Got the Flu Vax and Died shortly thereafter; Initial information received on 30-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves Adult female patient who got the flu vax and died shortly thereafter 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 event got the flu vax and died shortly thereafter (death) (unknown latency) following the administration of Influenza Vaccine.   It was reported that My mom got the Flu Vax and died shortly thereafter.  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 got the flu vax and died shortly thereafter. It is unknown if an autopsy was done. The cause of death was reported as Death NOS.  Seriousness criteria : This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) got the flu vax and died shortly thereafter.; Sender's Comments: Sanofi company comment dated 04-Feb-2022. This case involves Adult female patient who got the flu vax and died shortly thereafter while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.; Reported Cause(s) of Death: died
Sex: F
Vaccine: FLUX
Symptoms: Cardiac disorder
Clinical narrative: heart problems; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had heart problems 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.  On an unknown date the patient had heart problems (cardiac disorder) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (heart problems).  At time of reporting, the outcome was Unknown for the event heart problems.
Age: 27.0
Sex: U
Vaccine: FLUX
Symptoms: Arrhythmia, Cardiac operation
Clinical narrative: cardiac arrhythmias; Initial information received on 27-Jan-2022 regarding an unsolicited valid serious case from was received from a consumer/non-healthcare professional.  This case involves a 27 years old patient of unknown gender who experienced cardiac arrhythmias, while receiving vaccine influenza vaccine.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. The patient had no medical history, concurrent disease or risk factor.   On an unknown date, the patient received influenza vaccine produced by unknown manufacturer (strength, formulation, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number was requested.   On an unknown date, the patient developed severe cardiac arrhythmias (arrhythmia) (unknown latency) following the administration of influenza vaccine. Reportedly, it went on and on, and on; it's happening everywhere and was not normal.  This event was assessed as medically significant.  Action taken with influenza vaccine was not applicable.  Corrective treatment: the patient had to undergo an operation because of severe cardiac arrhythmias.  At time of reporting, the outcome was Unknown for the event of cardiac arrhythmias.; Sender's Comments: Sanofi Company Comment dated 07-Feb-2022: This case involves a 27 years old patient of unknown gender who experienced cardiac arrhythmias, while receiving influenza vaccine. Further information regarding medical history, 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 suspect vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Eczema, Illness, Psoriasis
Clinical narrative: chronic illness; psoriasis; eczema; Initial information received from on 31-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult male patient who experienced psoriasis, eczema and chronic illness 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 , strength, formulation and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  In 2016 the patient developed a non-serious psoriasis (unknown latency) following the administration of INFLUENZA VACCINE.  In 2016 the patient developed a non-serious eczema (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious chronic illness (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"As if you didn't have enough autoimmune diseases.. my dad got psoriasis and eczema with his in 2016. Cha Ching for them.. for you chronic illness es and lots of tests and pills and potions procedures and doctor visits It is unknown if the patient experienced any additional symptoms/events".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (psoriasis, eczema, chronic illness).  At time of reporting, the outcome was Unknown for the event psoriasis, was Unknown for the event eczema and was Unknown for the event chronic illness.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick for 2 weeks; Initial information received on 31-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult of an unknown gender patient who experienced sick for 2 weeks ,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 (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient reported made me sick for 2 weeks (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick for 2 weeks).  At time of reporting, the outcome was Unknown for the event sick for 2 weeks.; Reporter's Comments: Made me sick for 2 weeks
Sex: U
Vaccine: FLUX
Symptoms: Illness, Oropharyngeal pain
Clinical narrative: sick; sore throat; Initial information received on 01-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who reported sick and sore throat 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" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious event "sore throat" (oropharyngeal pain) (unknown latency) following the administration of INFLUENZA VACCINE.  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, sore throat).  At time of reporting, the outcome was Unknown for the event sick and was Unknown for the event sore throat.
Sex: U
Vaccine: FLUX
Symptoms: Near death experience
Clinical narrative: almost died from mine , never; Initial information received on 02-Feb-2022 regarding an unsolicited valid Social Media serious case was received from a consumer/non-hcp (non health care professional) via social media.  This case involves an unknown age and unknown gender patient who almost died from the vaccine 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 and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  It was reported that on an unknown date the patient almost died from the vaccine, never (near death experience) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (almost died from mine, never).  At time of reporting, the outcome was Unknown for the event (almost died from mine, never).; Sender's Comments: Sanofi company comment dated 07-Feb-2022: This case concerns a patient of unknown age and gender who had almost died after vaccination with vaccine Influenza Vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Further information such as condition at the time of vaccination, medical history and concomitants would be needed to rule out alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 01-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult  patient who had 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, with (unknown dose, strength, lot number, route, administration site expiry date).  On an unknown date the patient had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Laryngitis, Malaise, Upper respiratory tract infection
Clinical narrative: laryngitis; upper respiratory flu; Initial information was received on 03-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer.  This case involves Adult female patient who experienced laryngitis and upper respiratory 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 (strength, formulation, dose route, batch number and expiry date: unknown) on an unknown administration site for prophylactic vaccination. Information on batch number was requested.   It was reported after getting the flu shot patient got sick with laryngitis for 10 days,also she was sick with upper respiratory flu (respiratory disorder) for 23 days in november (onset :unknown). It is unknown if the patient experienced any additional symptoms/events.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (laryngitis, respiratory disorder).  At time of reporting, the outcome was Unknown for the event laryngitis and was Unknown for the event respiratory disorder.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza, Malaise
Clinical narrative: Flu; being sick; Initial information received on 05-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who had 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 for immunization produced by unknown manufacturer via unknown route and administration site and lot number was not reported .  On an unknown date the patient developed a non-serious events are "flu (influenza) (unknown latency) and being sick (illness) (unknown latency)" following the administration of influenza vaccine. It was reported that the patient take the flu shot every year, this year the patient took this shot in October, sick that night, next day Patient was fine and again got sick about two weeks ago and patient was tested twice for covid and both times it came back Negative for corvid but tested pos. For the flu, just got over being sick for two weeks with the flu.  Action taken with Influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events (being sick, Flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Malaise
Clinical narrative: sick; Initial information received on 05-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who reported sick while receiving vaccine INFLUENZA USP TRIVAL A-B VACCINE-UNSPECIFIED [FLUZONE UNSP].  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 USP TRIVAL A-B VACCINE - UNSPECIFIED 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" (illness) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED.  It was reported "Every time I get a flu shot I get sick with the flu. I ask my doctor why. He said there's over 200 variants and I happen to get the wrong one. Now I been healthy and well since I haven't gotten the shot. It's like playing roulette with over 200 chances".  INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED was discontinued on an unknown date.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event sick.
Sex: U
Vaccine: FLUX
Symptoms: Critical illness
Clinical narrative: Deathly ill; Initial information received on 05-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp (non health care professional).  This case involves an unknown age and unknown gender patient who experienced deathly ill 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 suspect influenza vaccine (strength and dose: 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 "deathly ill (critical illness)" (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant.  It was reported that "Flu shots make me deathly ill. Never more".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Deathly ill).  At time of reporting, the outcome was Unknown for the event deathly ill.; Sender's Comments: Sanofi Company Comment dated on 10-Feb-2022: This case involves an unknown age and unknown gender patient who experienced deathly ill while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. However, lack of information of past and concomitant medication/vaccination, any family history and any relevant medical history of patient, any concurrent conditions, lab data to exclude other etiologies, precludes comprehensive case assessment. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: came down with the flu within a week; Initial information received on 05-Feb-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who came down with the flu within a week while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site for flu. Lot number cannot be requested.  In 1987, 35 years ago, the patient came down with the flu within a week (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" Ah got the flu shot once, came down with the flu within a week !!! That was 35 years ago haven't gotten another shot and haven't had the flu in 35 years so don't bother me with something that doesn't work."  There were no lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (came down with the flu within a week).  At time of reporting, the outcome was Unknown for the event came down with the flu within a week.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site hypersensitivity
Clinical narrative: allergic reaction to an injection; Initial information received on 07-Feb-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 18 years old male patient who had allergic reaction to an injection while receiving vaccine [MENACTRA].  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 lot number, route,unknown administration site,dose,frequency,strength)for immunization.  On an unknown date the patient had allergic reaction to an injection (injection site hypersensitivity) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken not applicable.  It was not reported if the patient received a corrective treatment for the event (allergic reaction to an injection).  At time of reporting, the outcome was Unknown for the event allergic reaction to an injection.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered DAPTACEL to a patient on 25JAN2022 that expired in May 2021 (with no reported adverse event); Initial information received on 26-Jan-2022 regarding an unsolicited valid non-serious case was received from a consumer/non-hcp via sales rep.  This case involves a 1 year old female patient who was administered diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] on 25-Jan-2022 that expired in May 2021 (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 pneumococcal vaccine conj 7v (crm197) (Prevnar) for prophylactic vaccination; influenza vaccine (Fluzone) for prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine for Prophylactic vaccination.  On 25-Jan-2022, the patient received a 0.5 ml, total dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: May-2021) via unknown route in unknown administration site as Immunization (expired product administered, latency: same day). There will be no information available on the batch number for this case.  It was reported "Sales representative was calling on behalf of a client at a facility that administered DAPTACEL to a patient on 25-JAN-2022 that expired in May-2021. Sales representative states that the head nurse would like to know if the DAPTACEL needs to be re-administered."  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered DAPTACEL to a patient on 25-JAN-2022 that expired in May-2021 (with no reported adverse event)).  At time of reporting, the outcome was Unknown for the event administered daptacel to a patient on 25-Jan-2022 that expired in May-2021 (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.
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: child received an expired dose of the IPOL vaccine with no reported adverse event; Initial information received on 26-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient who received an expired dose of the ipol vaccine with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Prophylactic vaccination.  On an unknown date, the patient received a  dose of suspect IPV (VERO) lot R1F971M via intramuscular route in unknown administration site.  On 25-JAN-2022 the patient received an expired dose of the ipol vaccine with no reported adverse event (expired product administered) (unknown latency) following the administration of IPV (VERO).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (child received an expired dose of the IPOL vaccine with no reported adverse event).  At time of reporting, the outcome was Unknown for the event child received an expired dose of the ipol vaccine 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: PENTACEL was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no ae; Initial information received on 26-Jan-2022 regarding an unsolicited valid non-serious case was received from an other health professional.  This case involves an intercepted product storage error which involved diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Pentacel) which was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no adverse event (ae).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient was supposed to receive a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (lot UJ523AAA and U6986AA, expiry date: 22-Jul-2022; ) via unknown route in unknown administration site to be given as prophylactic vaccination.  It was reported that on 21-Jan-2022 the diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no adverse event (intercepted product storage error). The reporter enquired if she could still reconstitute and administer the vaccine and if she should wipe off the top of the vial.  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 (PENTACEL was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no ae).  At time of reporting, the outcome was Unknown for the event pentacel was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no ae.  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: F
Vaccine: COVID19, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HIGH DOSE to a 55 year old with no reported adverse event; Initial information received on 26-Jan-2022 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 55 year old female patient who received influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] 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 tozinameran (Pfizer biontech covid-19 vaccine) for Prophylactic vaccination.  On 26-Jan-2022, the patient received a 0.7 ml dose, total of suspect influenza quadrival a-b high dose hv vaccine (lot UJ779AA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid as prophylactic vaccination.  On 26-JAN-2022 the patient developed a non-serious "fluzone high dose to a 55 year old with no reported adverse event (product administered to patient of inappropriate age)" following the administration of influenza quadrival a-b high dose hv vaccine.  It was reported "Nurse states she gave the FLUZONE HIGH DOSE to a 55 year old female. What should they do? Pharmacist came on the line and wants to know if there is any information that the Fluzone High Dose would be needed in the under 65 age range? Additional Description of event Adverse events: Nurse states she gave a 55 year old consumer the Fluzone High Dose today. Product used : Used Still using product : No"  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the event (FLUZONE HIGH DOSE to a 55 year old with no reported adverse event).  At time of reporting, the outcome was Unknown for the event fluzone high dose to a 55 year old 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: 1.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Caller reported accidentally giving a child the FLUBLOCK, with no reported AE; Initial information received on 26-Jan-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 1 years old and unknown gender patient who experienced caller reported accidentally giving a child the flublock, with no reported ae while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK 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 (DTAP) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination.  On 26-Jan-2022, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA2154 via intramuscular route in the right thigh for prophylactic vaccination.  On 26-JAN-2022 the patient developed a non-serious event "caller reported accidentally giving a child the flublock, with no reported ae" (product use issue) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Caller reported accidentally giving a child the FLUBLOCK, with no reported AE).  At time of reporting, the outcome was Unknown for the event caller reported accidentally giving a child the flublock, with no reported ae.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAP, DTAPIPVHIB, FLU4, IPV, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: had a power outages and they packed the vaccines up to be moved to another refrigerator with a generator but no one put a data logger in the cooler.; Initial information received on 27-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had a power outages and they packed the vaccines up to be moved to another refrigerator with a generator but no one put a data logger in the cooler while having [DAPTACEL], [IPOL],[PENTACEL],  [ADACEL], (D CONJ) [MENACTRA] and [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, with an unknown dose ,frequency, route (lot UT7356LA).  On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE with an unknown dose ,frequency, route (lot U7208AA).  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE with an unknown dose ,frequency, route (lot C5854AA).  On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE with an unknown dose ,frequency, route (lot UJ580AAA).  On an unknown date, the patient received a  dose of suspect IPV (VERO) lot U1C571M via unknown route in unknown administration site.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE with an unknown dose ,frequency, route (lot C5774BA).  On an unknown date the patient  had a power outages and they packed the vaccines up to be moved to another refrigerator with a generator but no one put a data logger in the cooler. (product temperature excursion issue) (unknown latency) 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 event (had a power outages and they packed the vaccines up to be moved to another refrigerator with a generator but no one put a data logger in the cooler.).  At time of reporting, the outcome was Unknown for the event had a power outages and they packed the vaccines up to be moved to another refrigerator with a generator but no one put a data logger in the cooler.
Age: 0.5
Sex: F
Vaccine: DTAPIPV, PNC13, RVX
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 6 month old female received the QUADRACEL vaccine with no reported adverse event; Initial information received on 27-Jan-2022 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 6 months old female patient who received the quadracel vaccine with no reported adverse event, after receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 24-Jan-2022, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (strength, formulation, dose: unknown, frequency: once, (product use issue, onset, latency; same day) with lot C5763AA, expiry date:26-Aug-2022 via intramuscular route in the right thigh as immunization.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) 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 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: 19.0
Sex: M
Vaccine: FLUR4
Symptoms: Myocarditis, Suspected COVID-19
Clinical narrative: 3 days after receiving the FLUBLOK vaccine ended up in the Emergency Room with Myocarditis; not sure if this was symptoms of COVID or if he was truly having a reaction to the FLUBLOK; Initial information received on 27-Jan-2022 regarding an unsolicited valid serious case was received from a pharmacist via sales representative.  This case involves a 19 years old male patient who was not sure if this was symptoms of COVID or if he was truly having a reaction to the FLUBLOK and ended up in the emergency room with myocarditis 3 days after receiving the influenza quadrivalent recombinant vaccine [Flublok QIV] vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received influenza quadrivalent recombinant vaccine (strength, formulation, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number was requested.   Reportedly, patient's mom was not sure if this was symptoms of COVID (Suspected COVID-19; unknown latency) or if he was truly having a reaction to the influenza quadrivalent recombinant vaccine. On an unknown date, 3 days after receiving the influenza quadrivalent recombinant vaccine ended up in the emergency room with myocarditis (myocarditis). The event (myocarditis) was assessed as medically significant.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (myocarditis, Suspected COVID-19).  At time of reporting, the outcome was Unknown for the event of myocarditis and unknown for Suspected COVID-19.; Sender's Comments: Company Comment dated 07-Feb-2022: This case involves a 19 years old male patient who ended up in the emergency room with myocarditis 3 days after receiving the influenza quadrivalent recombinant vaccine [Flublok QIV] vaccine. The time to onset was compatible for the event. Further information regarding medical history, 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 suspect vaccine cannot be assessed.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: No adverse event, Product preparation issue
Clinical narrative: gave a patient the Hib component of PENTACEL that was reconstituted with sterile water with no reported adverse event; Initial information received on 27-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who experienced gave a patient the hib component of pentacel that was reconstituted with sterile water 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 HEPATITIS A VACCINE INACT (VAQTA) for Prophylactic vaccination.  On 25-Jan-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ577AA (Strength and expiry date was unknow) via intramuscular route in unknown administration site for prophylactic vaccination.  On 25-JAN-2022 the patient developed a non-serious gave a patient the hib component of pentacel that was reconstituted with sterile water with no reported adverse event (product preparation error) 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 (gave a patient the Hib component of PENTACEL that was reconstituted with sterile water with no reported adverse event).  At time of reporting, the outcome was Unknown for the event gave a patient the hib component of pentacel that was reconstituted with sterile water 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.