chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case involves an unknown age male patient who experienced "got very sick" (illness), after receiving INFLUENZA VACCINE. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications 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 an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious "got very sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE. Details of laboratory data not reported. It was not reported if the patient received any corrective treatment for the event. It was reported "The only one who ever got the flu shot was my mother and she was the only one to get severely sick with the flu. My son did it one time and he got very sick. Nope I will rely on my immune system." At time of reporting, the outcome was unknown for the event. There will be no information available on the batch number for this case.; Sender's Comments: SanofiPVPortal20211122000939:
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Malaise, Vaccination failure
Clinical narrative: This case involves an unknown age female patient who experienced came down with the flu (influenza ), took 4 days before she got sick and got a flu shot (illness). 6 days later she came down with the flu (vaccination failure) after receiving vaccine INFLUENZA VACCINE. The patient's past medical treatments, concomitant medications and family history were not provided. It was unknown if the patient had any concomitant disease or risk factor. 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 for prophylactic vaccination. On an unknown date,  the patient developed a non-serious came down with the flu (influenza), took 4 days before she got sick (illness), got a flu shot. 6 days later she came down with the flu (vaccination failure) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/ event. It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome of the events was reported as unknown.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves a female patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.   It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient 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 for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "The only one who ever got the flu shot was my mother and she was the only one to get severely sick with the flu. My son did it one time and he got very sick. Nope I will rely on my immune system."  There were no lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: This case involves Neonate female patient who had dermal swelling at injection site (injection site swelling) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's medical treatment(s), vaccination(s), concomitant medication(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 a dose of suspect FLUZONE QUADRIVALENT (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious dermal swelling at injection site (injection site swelling) (unknown latency) following the administration of vaccine. It was unknown if the patient experienced any additional symptoms/events. No laboratory data reported. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the event. There would be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: This case involves a patient (unknown demographic) who was home sick for at least a week (illness) after receiving INFLUENZA VACCINE. The patient had no medical history, concomitant disease or risk factor. The patient 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 for prophylactic vaccination. On an unknown date the patient developed a non-serious was home sick for at least a week (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Haven't gotten one in over 35 years and I don't get the flu. When I did get the shot I was home sick for at least a week." There were no lab data/results available. It was unknown if the patient experienced any additional symptoms/event. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the reported event. There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case involves an adult patient with an unknown gender who felt sick (malaise) after receiving INFLUENZA VACCINE. The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided. It was unknown if the patient had any concomitant disease or risk factor. 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 for prophylactic vaccination. On an unknown date the patient became so sick (malaise) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Used to get mine at the hospital. The last one was at drug store. May not be another. Made me so sick brother." It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome of event was reported as unknown. There will be no information on lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case involves an adult patient with an unknown gender who got sick as a dog 45 mins (illness) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant medications, vaccinations, 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 for prophylactic vaccination.   On an unknown date the patient developed a non-serious got sick as a dog 45 mins after (illness) following the administration of INFLUENZA VACCINE.  It was reported "I got flu shot years ago. Almost die. Got my (coronavirus disease) COVID shots not even a sore arm. No flu shots for me thank you very much."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was reported as unknown.  There will be no information on lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: This case involves an unknown demographics gender patient who experienced sick (illness) after receiving vaccine INFLUENZA VACCINE.  The patient past medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome of events was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves adult and unknown gender patient who had worst case of flu (influenza) after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease, or risk factor. The patient, medical treatment(s), vaccination(s), concomitant medication, 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 an unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient had non-serious event worst case of flu ever (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "no shot since, no flu since". It is unknown if there were laboratory data/results available. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome was unknown for the event had worst case of flu. There will be no information available on the batch number for this case.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Anosmia, Asthma, Taste disorder
Clinical narrative: severe asthma; still cannot taste anything; still cannot smell anything; Initial information received on 20-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional under reference number: US-SA-SAC20211127000140 in   This case involves Elderly and unknown gender patient who experienced severe asthma (asthma), still cannot taste anything (taste disorder) and still cannot smell anything (anosmia)  after receiving INFLUENZA VACCINE and while treated with TOZINAMERAN [PFIZER BIONTECH COVID-19 VACCINE].  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient started taking PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) formulation unknown dosage unknown route unknown (with an unknown batch number) for Prophylactic vaccination. a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date  not reported via unknown route in unknown administration site for Prophylactic vaccination respectively.  On an unknown date the patient developed a non-serious severe asthma (asthma), still cannot taste anything (taste disorder) and still cannot smell anything (anosmia)  (unknown latency) following the first dose intake and (unknown latency) INFLUENZA VACCINE and  following the last dose intake of TOZINAMERAN.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome of the events was reported as unknown.   There was be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves an adult patient who had flu (influenza) after receiving INFLUENZA VACCINE. The patient had no medical history, concomitant disease or risk factor. The patient 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 for prophylactic vaccination. On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Last time I got a flu shot I got the flu." There were no lab data/results available. It was unknown if the patient experienced any additional symptoms/events. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the reported event. There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: This case involves a patient (unknown demographics) who had "got tired of them making me sick" (illness), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  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 VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious "got tired of them making me sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got tired of them making me sick. I'll pass, just like I did on the half accede vaccine."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: This case involves a patient of (unknown demographics) who experienced got sick (illness), after receiving vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(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 an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. No additional laboratory data was reported. 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. There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves adult patient (unknown gender) who got the flu (influenza), after receiving INFLUENZA VACCINE. The patient had no medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitant medication(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 were not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "I have only had a flu shot once and got the flu. I asked my Doctor Why? He said influenza mutates into different variants and Science cannot keep up. Kinda like boosters cannot keep up with  corona virus disease (COVID)." There were no lab data/results available. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome was unknown for the event. There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves patient (unknown age and gender) who got the flu (influenza), after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s), concomitant medication(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 expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient got the flu (influenza, non-serious), four days following the administration of INFLUENZA VACCINE. It was reported "Got it got the flu four days later still down with it" It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported event. There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case involves a patient (unknown age and gender) who was so sick for 3 days (illness), after receiving INFLUENZA VACCINE. The patient had no medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s), concomitant medication(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 expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient was so sick for 3 days (illness, non-serious), it was awful [unknown latency] following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events. There were no laboratory data/results available. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported events. There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves an unknown age and unknown gender patient who experienced flu (influenza) after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease, or risk factor. The patient medical history, medical treatment(s), vaccination(s)concomitant medication 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 an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if there were laboratory data/results available. It was not reported if the patient received any corrective treatment for the event (flu). At time of reporting, the outcome was unknown for the event flu. There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves an unknown age and gender patient who experienced flu (influenza), after receiving INFLUENZA VACCINE. The patient's past medical treatments, vaccinations, concomitant medications and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient experienced a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Funny, when I stopped taking flu shots, I stopped getting the flu. Officially it's not supposed to work that way, but there it is." It is unknown if the patient experienced any additional symptoms/ events. It is unknown if there were laboratory data/ results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome of the event was reported as unknown. There will be no information on the lot number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Gait disturbance, Gait inability, Pain
Clinical narrative: This case involves an unknown age female patient who experienced couldn't walk (gait disturbance) and body hurt so bad (pain) after receiving INFLUENZA VACCINE. The patient's medical history, past medical treatments, vaccinations, concomitant medications 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 prophylactic vaccination. On an unknown date the patient developed a non-serious events couldn't walk (gait disturbance) and body hurt so bad (pain) (unknown latency) following the administration of INFLUENZA VACCINE. No laboratory data reported. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome of the events was reported as unknown.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity, Tenderness
Clinical narrative: This case involves a patient (unknown age and gender) whose both arms were little bit sore and they hurt worse if press on them (pain in extremity), after receiving INFLUENZA VACCINE. The patient had no medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitant medication(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 an unknown administration site for prophylactic vaccination. On an unknown date, the patient's both arms were a little bit sore and they hurt worse if press on them (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Got flu shot and booster. Both arms a little bit sore. They hurt worse if i press on them (Haha)." It was unknown if the patient experienced any additional symptoms/events. There were no laboratory data/results available. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported event. There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: Got sick every year; Initial information was received on 23-Nov-2021 regarding an unsolicited valid social media non-serious case from a consumer/non-healthcare professional.  This case involves Adult (unknown gender) patient who experienced got sick every year (illness) after receiving INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got sick every year (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient had the flu; Initial information received on 25-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves an adult (unknown gender) patient who had the flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(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 an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had the non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I haven't gotten a flu shot in almost 40 years... That's been how long it's been since I had the flu."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
Sex: U
Vaccine: DTAP, FLU3, FLUR4, TD, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine were exposed to negative 7.7 degree celsius for 30 days/no AE; Initial information received on 18-Nov-2021 regarding an unsolicited valid non-serious case received from an other health professional and consumer or non health care professional via Medical Information (MI) (under reference: 00864731).  This case involves an unknown age and unknown gender patient who was administered INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD], INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA-2/TETANUS-5 TOXOIDS WITH PRESERVATIVE [TENIVAC] (product storage error).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 TOXOIDS WITH PRESERVATIVE lot number: U6831AA and expiry date: 08-Oct-2022 via an unknown route in an unknown administration site, a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site, a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site, a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site and a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  It was reported "stated that the vaccines were administered to patients, with an estimate of maybe 50 patients. Want to know what to do".  It was case of an actual medication error due to product storage error temperature too low (latency: same day).  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: DTAP, FLU3, FLUR4, TD, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine were exposed to negative 7.7 degree celsius for 30 days /no AE; Initial information received on 18-Nov-2021 regarding an unsolicited valid  non-serious case received from a other health professional and non health care professional via Medical Information (MI) number: 00864804.  This case involves an unknown age and unknown gender patient who was administered  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (product storage error).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number: UJ702AC and expiry date: 30-JUN-2022 via unknown route in unknown administration site, a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number: U7055BA and expiry date: 03-JUN-2023 via unknown route in unknown administration site, a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number: C5774BA and expiry date: 18-SEP-2022 via unknown route in unknown administration site, a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number: U6831AA and expiry date: 08-OCT-2022 via unknown route in unknown administration site and a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number: QFAA2110 and expiry date: 01-JUN-2022 via unknown route in unknown administration site for prophylactic vaccination respectively.  It was case of an actual medication error due to Product storage error temperature too low (latency: same day).  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: This case involves a 78 years old male patient whom administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] which was left in the box (product storage error). The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 19-Nov-2021, the patient received a dose of suspect ADACEL (0.5 ml, total, lot U7187AA expiration date: 28-SEP-2023) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to incorrect product storage (same day latency). It was reported "Caller would like to know how ADACEL is suppose to look before you shake it. Caller stated that he notice a cloudy white appearance. Caller stated that the ADACEL was brought out of the fridge and he noticed a white, cloudy, clumped particulate at the bottom of the vial prior to shaking it. The caller had never seen the medication sediment. The solution became a homogenous liquid after it was shaken. The remaining supply of ADACEL all looked similar with the same white, cloudy, clumped particulate. Caller would like to know whether these ADACEL vials are suitable for use?" No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 7.0
Sex: F
Vaccine: FLUX, IPV, TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Expired dose of IPOL was accidently administered with no reported adverse event; Initial information received on 22-Nov-2021 regarding an unsolicited valid non-serious case received from physician and other healthcare professional phone via Agency (Reference number- 00868820).  This case involves a 7 years old female patient who accidently administered expired dose of IPV (VERO) [IPOL] (expired product administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and INFLUENZA VACCINE for prophylactic vaccination.  On 22-Nov-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) (total, lot number: R1G101M and expiry date: 08-OCT-2021) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day).  It was reported "Nurse states an expired dose of IPOL was accidently administered to a patient on 22Nov2021, and the dose expired on 08Oct2021. Nurse is looking for information how possible adverse effects, if they need to revaccinate, and any other relevant information."  At the time of reporting, no adverse event reported.  The reporter assessed the causal relationship for event with the IPOL as not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient under the age of 18 years old received the product with no reported adverse event; Initial information was received on 22-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist via Agency (under Inquiry Number: 00868860).  This case involves a patient under the age of 18 years old who received the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] with no reported adverse event (product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported "Caller stated that one of the clinics reported that a patient under the age of 18 years old received the product. Caller wanted to know if there was events that they should look out for. Caller stated that he would be leaving in 20 minutes and would like a back tomorrow."  At the time of reporting, no adverse event was reported.  There will be no information on lot number for this case.  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: 53.0
Sex: F
Vaccine: FLUR4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: received two doses of FLUBLOK QUADRIVALENT, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Agency (Reference number- 00869084) and transmitted to Sanofi on 22-Nov-2021.  This case involves a 53 year old female patient who was vaccinated with two doses of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (extra dose administered).  The patient's medical history, medical treatment(s), past vaccination(s) and family history were not provided.  She had no other vaccines  On 22-Nov-2021, the patient received first dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE produced by Sanofi Pasteur via unknown route in unknown administration site for prophylactic vaccination.  On 22-Nov-2021, the patient received 0.5 ml second dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE produced by Sanofi Pasteur (Suspension for injection, lot number: QFAA2122 and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency same day).  It was reported "Call received from Nurse reporting a patient received two doses of FLUBLOK QUADRIVALENT. Caller reporting both doses were administered today. Caller reporting the patient had a doctors appointment (where she received the first dose of FLUBLOK QUADRIVALENT) and then a flu shot appointment, both at their practice but in separate buildings. The script information contains data from the patient's second dose. Caller with question on what adverse reactions to expect. Caller also with question on what reactions need reporting"  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: FLU4
Symptoms: Hypersensitivity, Mouth swelling, Swelling face
Clinical narrative: allergic reactions; mouth swelling; jaw swelling; Initial information received on 23-Nov-2021 regarding an unsolicited valid non-serious case from another health professional via (under reference 00870031).  This case involves a 67 years old male patient who had allergic reactions (hypersensitivity), which includes mouth swelling and jaw swelling (swelling face), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history included Tracheostomy.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 19-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ775AA and expiration date: 30-Jun-2022) via unknown route in an unknown administration site for prophylactic vaccination.  On 20-Nov-2021, the patient developed non-serious allergic reactions (hypersensitivity), which includes mouth swelling and jaw swelling (swelling face), one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "The caller is requesting the ingredients of FULZONE QUAD."  No laboratory data were reported.  He went to the Emergency Room (ER) and was treated with oral medication, he did not  know what the medication was.   He still had some swelling. It had not resolved completely (he did not recover from the reported events).
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: This case involves a 77-year-old female patient who received an INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], intended vaccine was INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccines. On 22-Nov-2021, the patient received a dose of suspect FLUZONE QUADRIVALENT (0.5 ml, total, once, lot UT7330JA and expiration date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to wrong vaccine administered (same day latency). No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This case involves a 5 weeks and 5 days old female patient who was vaccinated with a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Product administered to patient of inappropriate age). The patient's medical history, medical treatment(s), past vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for prophylactic vaccination. On 23-Nov-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE produced by Sanofi Pasteur (lot number: UJ474AA and expiry date: 09-Jul-2022) via intramuscular route in the left thigh for prophylactic vaccination. It was a case of actual medication error due to inappropriate age at vaccine administration (latency same day). It was reported "Physician states a dose of PENTACEL was administered to a patient on 23Nov2021, and it was realized the patient was just under 6 weeks old. Physician is looking for information on how to handle, and if there are any issues as the patient will be turning 6 weeks old soon. The physician reported that a patient received a dose of PENTACEL at 5 weeks and 5 days old. The caller would like to know if this is considered a valid dose and whether it should be repeated". No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: F
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 3 year old patient was given a Flublock vaccination /no AE; 3 year old patient was given a Flublock vaccination /no AE; Initial information was received on 23-Nov-2021 regarding an unsolicited valid non-serious case from pharmacist via call center via Agency (Reference number- 00870412).  This case involves a 3-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On 19-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency: same day).  It was reported "What would they watch for?"  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.