chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, FLUX, PPV
Symptoms: Influenza virus test, Malaise, Pyrexia, SARS-CoV-2 test, Unevaluable event
Clinical narrative: bad reaction; not doing very well; high fever; Initial information received on 15-Oct-2021 regarding an unsolicited valid  non-serious case received from a physician and consumer/non-healthcare professional.  This case involves a 65 years old female patient who experienced high fever (pyrexia), not doing very well (malaise) and bad reaction (unevaluable event) while treated with DUPILUMAB [DUPIXENT], while receiving PNEUMOCOCCAL VACCINE, INFLUENZA VACCINE and MODERNA COVID-19 VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  In May 2021, the patient started taking DUPIXENT (DUPILUMAB) solution for injection 300 mg every other week subcutaneous (with an unknown batch number) for dermatitis atopic.  On 13-Oct-2021, the patient received a dose of suspect INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE (batch number and expiry date not reported) produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect MODERNA COVID-19 VACCINE not produced by Sanofi Pasteur lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On 13-OCT-2021 the patient developed a non-serious high fever (pyrexia), not doing very well (malaise) and bad reaction (unevaluable event) same day following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE, (unknown latency) following the dose intake of DUPILUMAB and administration of MODERNA COVID-19 VACCINE.  Patient stated she was tested for flu and COVID and had a blood culture drawn her flu test was negative and COVID test was not received yet.  It was unknown if there were other lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  DUPILUMAB (DUPIXENT) was continued.  It was not reported if the patient received a corrective treatment for the events (high fever, not doing very well, bad reaction).  On an unknown date, the patient recovered from high fever (temperature is now back to normal).  The event outcome was unknown for not doing very well, bad reaction.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Pityriasis rosea
Clinical narrative: pityriasis rosea; Initial information was received on 20-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media (under reference number : US-SA-SAC20211022000959).  This case is linked to case 2021SA352054(CLUSTER).  This case involves a 37-years old female patient who experienced pityriasis rosea, after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, 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 pityriasis rosea (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I'm sorry for your losses.  All the people who have suffered after being vaccinated or death. I understand it's not one size fits all this so called vaccination! No one knows on any specific vaccine or drug how it will affect them.  I had a flu vaccination once.  Was in the hospital a month, in a coma for a week with meningitis.  We believe she had COVID-19 in the very beginning 2020 but they weren't testing people then.  My doctor said the vaccination it would probably kill me.  I can't take antibiotics without reactions.  So I do what is best with my body.  Plus I know vaccinated people sick with COVID-19 too.  Some died being vaccinated too.  How in God's name do the big pharma know how in any situation a person's body will react to either getting COVID.  Or a vaccination who can do more harm for them? It's a shot in the dark with or without.  Prayers for us all."  There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.; Sender's Comments:  SanofiPVPortal20211021000555:
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: arm pain; vaccine exposure during pregnancy; Initial information received on 22-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.   This case involves Adult female patient who had arm pain (pain in extremity) after receiving INFLUENZA VACCINE (exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The reported events occurred at unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's previous pregnancy/ies were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (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 arm pain (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was an actual medication error due to vaccine exposure during pregnancy (same day latency).  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "Okay to be honest (tbh) I don not usually get my flu shot, but I got it this year bc my doc said it was highly recommended for pregnant women. So I got it. And here comes the arm pain lol."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported events.   Additionally, at time of reporting, the outcome of the pregnancy was unknown.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Pyrexia
Clinical narrative: got sick bad every year after getting it; their fevers were so high and kept going up after flu shot; Initial information was received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (under reference number: US-SA-SAC20211026000924).  This case is linked to cases 2021SA354487, 2021SA350364 and 2021SA356107 (cluster).  This case involves 3 childrens with an unknown age and gender who got sick bad every year after getting it (illness) and their fevers were so high and kept going up after receiving INFLUENZA VACCINE (pyrexia).  The patients medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.  The other two patients had no medical history, concomitant disease or risk factor.   At the time of the event, the one of the patients had ongoing peanut allergy.  On an unknown date, the patients 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 patients developed non-serious events got sick bad every year after getting it (illness) and their fevers were so high and kept going up after flu shot (pyrexia) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "every time I have gotten the flu shot I ended up in the hospital that week from severe dehydration. Not everyone's bodies are the same! My brother gets it and does well! Swears by it keeping him from getting flu bad! So people do end up in the hospital from the flu vaccine. No one should be pressured to make medical decisions for themselves! The first two times I had the flu vaccine I thought it was coincidence that I ended up with the flu that bad same week. After the third time I ended up in the hospital after I said to myself never again! I have not had the flu bad like that since. Same for my kids. They got sick bad every year after getting it. Have gone a couple of years now without getting it! No 105 fevers, No throwing up, no diarrhea bad at the same time! I have triplets so when they all get bad sick like that and I do too it is exhausting! Never again! They had to go to the emergency room also because their fevers were so high and kept going up after flu shot! One of my triplets has peanut tree nut allergies so not taking chances anymore."  There were no lab data/results available.  It was not reported if the patients received a corrective treatment for the events.  At time of reporting, the outcome of events was reported as unknown.  There will be no information on lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: feel sick; Initial information was received on 23-Oct-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had feel sick (malaise) 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 fourth dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious feel sick (malaise) two days following the administration of INFLUENZA VACCINE.  It was reported "I got my fourth (4x) flu shot two days ago, and today I feel sick; Google says that's normal. So why does no one question the flu shots?"  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 for the event.  At time of reporting, the event was not resolved.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU3
Symptoms: Eczema
Clinical narrative: eczema; Initial information was received on 24-Oct-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 eczema, after receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  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 (5 years ago), the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] (lot number and expiry date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious eczema (unknown latency) following the administration of vaccination.  It was reported " When I stopped getting flu Vax my eczema stopped. 5 years ago"  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 events.  At time of reporting, the outcome of the events was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: very sore; Initial information received on 23-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.   This case involves female patient who experienced event very sore (pain) while receiving INFLUENZA VACCINE.  It was unknown if the patient had any, concomitant disease or risk factor.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE).  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 event very sore (pain) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "what a beautiful woman, wish I knew her- got moderna booster and high dose flu shot yesterday and very sore".  It was 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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Everytime end up with a flu; Initial information was received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media (under reference number US-SA-SAC20211027000252).  This case involves a patient of (unknown demographics) who every time end up with a flu (influenza) when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, 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 at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious every time end up with a flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Why every time I end up with a flu anyways stopped taking once I found out it contained MERCURY."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome was unknown for the event (influenza).  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got the flu; Initial information received on 22-Oct-2021 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via social media. This case involves adult male patient who had got the flu (Influenza) after receiving INFLUENZA VACCINE.  The patient past vaccination(s) included INFLUENZA VACCINE for prophylactic vaccination.  The patient medical treatment, family history and concomitant medication 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, frequency: not provided] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.(duration: 4 days)  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 was unknown for the reported event.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves an adult male patient who presented with Influenza after the vaccination with INFLUENZA VACCINE (unknown manufacturer).Time of onset is unknown. The patient was hospitalized for this influenza event. Further information regarding medical condition during vaccination, previous vaccination and tolerance, other 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: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: know get very sick from the flu shot; Initial information was received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown demographic patient (unknown age and unknown gender) who experienced know get very sick from the flu shot (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 know get very sick from the flu shot (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.  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: Infection, Respiratory tract infection viral
Clinical narrative: stopped getting my 6 week long respiratory virus; infection throughout the holidays; Initial information received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves adult and unknown gender patient who stopped getting my 6 week long respiratory virus (Respiratory tract infection viral) and infection throughout the holidays (Infection) while receiving INFLUENZA VACCINE.  The patient had no 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 event stopped getting my 6 week long respiratory virus (respiratory tract infection viral) and infection throughout the holidays (infection) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I stopped getting my annual flu shots 6 years ago. I stopped getting my 6 week long respiratory virus and infection throughout the holidays".  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 22-Oct-2021 regarding an unsolicited valid non-serious case received from a non-health care professional (patient) via social media via Global Digital Media.  This case involves a patient of unknown age and gender who had flu (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, 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 non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Had the flu one time in my life. Also happened to be a few months after I had the only flu vaccine I've ever taken".  It was unknown if the patient experienced any additional symptoms/events  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: pneumonia; Initial information received on 25-Oct-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional.  This case involves a patient (unknown demographics) who experienced pneumonia after receiving INFLUENZA VACCINE.  The patient's medical treatment, vaccination, 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 serious pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event. This event was assessed as medically significant.   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.  At time of reporting, the outcome was unknown for the reported event.  Information on the batch number was requested.; Sender's Comments: This case involves a patient (unknown demographics) who had pneumonia, after receiving INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of the events, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient were administered expired Fluzone Quad vaccination; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Global Medical Information (GMI) (Reference number- 00816469).  This case involves Adult and unknown gender patient who was vaccinated with the expired dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ567AB and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  At 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 by the regulatory authority. 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: FLU4
Symptoms: Device connection issue, Exposure via skin contact, No adverse event, Occupational exposure to product, Syringe issue
Clinical narrative: states that the hub on the end of the syringe is loose (like its stripped) with no AE; Product splashed on the nurse and the patient with no AE; When they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere /As the product was being injected into the patientwith noAE; When they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere with noAE; Initial information received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 48-year-old female patient for whom it was reported "when they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere (Device leakage) states that the hub on the end of the syringe is loose (like its stripped) (syringe issue), product splashed on the nurse and the patient (Occupational exposure to product) and when they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere /As the product was being injected into the patient  Underdose)" while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient past medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.  On 15-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ765AC and expiry date:30-Jun-2022] via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to device leakage, syringe issue, underdose and occupational exposure to product [Latency: on the same day].  It was reported "product leaking from the tip of the syringe".   At time of reporting, the outcome was unknown for the events.   At the time of report, no adverse event was reported.
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: states that the hub on the end of the syringe is loose (like its stripped) with no AE; Product splashed on the nurse and the patient with no AE; When they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere /As the product was being injected into the patientwith noAE; When they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere with noAE; Initial information received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 48-year-old female patient for whom it was reported "when they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere (Device leakage) states that the hub on the end of the syringe is loose (like its stripped) (syringe issue), product splashed on the nurse and the patient (Occupational exposure to product) and when they go to administer the shot the needle disconnects from the syringe and the product leaks out everywhere /As the product was being injected into the patient  Underdose)" while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient past medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.  On 15-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ765AC and expiry date:30-Jun-2022] via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to device leakage, syringe issue, underdose and occupational exposure to product [Latency: on the same day].  It was reported "product leaking from the tip of the syringe".   At time of reporting, the outcome was unknown for the events.   At the time of report, no adverse event was reported.
Sex: U
Vaccine: FLU4
Symptoms: Abdominal pain, Chills, Headache, Muscle spasms, Pain in extremity
Clinical narrative: cramps; fever; chills; headache; patient received 0.07 ml dose; abdominal pain; vomiting; sore arm; Initial information was received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2021SA357151 (CLUSTER).  This case involves an unknown demographic patient (unknown age and unknown gender) patient who experienced fever (pyrexia), chills, headache, abdominal pain, cramps (muscle spasms), vomiting, sore arm (pain in extremity) and patient received 0.07 ml dose (underdose), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  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 0.07 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ732AB, expiry date- 30-Jun-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious fever (pyrexia), chills, headache, abdominal pain, cramps (muscle spasms), vomiting, sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  It was reported "2 patient had severe reactions. One had abdominal pain, cramps, vomiting and a sore arm. The other patient had those symptoms and also fever, chills and headache".  At time of reporting, the outcome was unknown for the events.
Sex: U
Vaccine: FLU4
Symptoms: Pyrexia, Underdose, Vomiting
Clinical narrative: cramps; fever; chills; headache; patient received 0.07 ml dose; abdominal pain; vomiting; sore arm; Initial information was received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2021SA357151 (CLUSTER).  This case involves an unknown demographic patient (unknown age and unknown gender) patient who experienced fever (pyrexia), chills, headache, abdominal pain, cramps (muscle spasms), vomiting, sore arm (pain in extremity) and patient received 0.07 ml dose (underdose), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  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 0.07 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ732AB, expiry date- 30-Jun-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious fever (pyrexia), chills, headache, abdominal pain, cramps (muscle spasms), vomiting, sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  It was reported "2 patient had severe reactions. One had abdominal pain, cramps, vomiting and a sore arm. The other patient had those symptoms and also fever, chills and headache".  At time of reporting, the outcome was unknown for the events.
Sex: M
Vaccine: FLU4
Symptoms: Headache, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: runny nose; chest congestion; severe sore throat; headache; body temperature of 99.8 Fahrenheit; Initial information was received on 22-Oct-2021 regarding an unsolicited valid non-serious case from a Consumer via Media Information (under reference- 00824391) and transmitted to Sanofi on 22-Oct-2021.  This case involves a 67-year-old male patient who experienced runny nose (Rhinorrhoea), severe sore throat (Oropharyngeal pain), chest congestion (Respiratory tract congestion), headache and body temperature of 99.8 Fahrenheit (Pyrexia) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 12-Oct-2021, the patient received a 0.7 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not provided] via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date in Oct-2021 the patient developed non-serious runny nose (Rhinorrhoea), severe sore throat (Oropharyngeal pain), chest congestion (Respiratory tract congestion) and body temperature of 99.8 Fahrenheit (Pyrexia) (on 3rd day after shot) and headache (5th or 6th day after shot) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory test results included: Body temperature - On an unknown date: 99.8 Fahrenheit  Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test negative - On 20-Oct-2021: Negative  The patient was treated with paracetamol (tylenol) for Headache and performed steam inhalation and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  At the time of report, patient was recovering from Oropharyngeal pain and outcome of other events was unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLU4
Symptoms: SARS-CoV-2 test negative
Clinical narrative: runny nose; chest congestion; severe sore throat; headache; body temperature of 99.8 Fahrenheit; Initial information was received on 22-Oct-2021 regarding an unsolicited valid non-serious case from a Consumer via Media Information (under reference- 00824391) and transmitted to Sanofi on 22-Oct-2021.  This case involves a 67-year-old male patient who experienced runny nose (Rhinorrhoea), severe sore throat (Oropharyngeal pain), chest congestion (Respiratory tract congestion), headache and body temperature of 99.8 Fahrenheit (Pyrexia) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 12-Oct-2021, the patient received a 0.7 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not provided] via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date in Oct-2021 the patient developed non-serious runny nose (Rhinorrhoea), severe sore throat (Oropharyngeal pain), chest congestion (Respiratory tract congestion) and body temperature of 99.8 Fahrenheit (Pyrexia) (on 3rd day after shot) and headache (5th or 6th day after shot) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory test results included: Body temperature - On an unknown date: 99.8 Fahrenheit  Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test negative - On 20-Oct-2021: Negative  The patient was treated with paracetamol (tylenol) for Headache and performed steam inhalation and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  At the time of report, patient was recovering from Oropharyngeal pain and outcome of other events was unknown.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Headache, Incorrect dose administered, Oropharyngeal pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: 58 year patient was administered Fluzone High-Dose Quadrivalent; 58 year patient was administered Fluzone High-Dose Quadrivalent/ no AE; runny nose; chest congestion; severe sore throat; headache; body temperature 99.8 Farenheit; Initial information was received on 22-Oct-2021 regarding an unsolicited valid non-serious case from a Physician via Global Media Information (under reference- 00824391) and transmitted to Sanofi on 22-Oct-2021.  This case involves a 58-year-female patient who experienced Overdose and Product administered to patient of inappropriate age, runny nose (Rhinorrhoea), severe sore throat (Oropharyngeal pain), chest congestion (Respiratory tract congestion), headache and body temperature of 99.8 Fahrenheit (Pyrexia) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 18-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not provided] via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date in Oct-2021 the patient developed non-serious runny nose (Rhinorrhoea), severe sore throat (Oropharyngeal pain), chest congestion (Respiratory tract congestion) and body temperature of 99.8 Fahrenheit (Pyrexia) (on 3rd day after shot) and headache (5th or 6th day after shot) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was a case of actual medication error due to Overdose and Inappropriate age at vaccine administration (latency was on the same day).  Relevant laboratory test results included: Body temperature - On an unknown date: 99.8 Fahrenheit  Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test negative - On 20-Oct-2021: Negative  The patient was treated with paracetamol (tylenol) for Headache and performed steam inhalation and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  At the time of report, patient was recovering from Oropharyngeal pain and outcome of other events was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. 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.
Sex: F
Vaccine: FLU4
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: 58 year patient was administered Fluzone High-Dose Quadrivalent; 58 year patient was administered Fluzone High-Dose Quadrivalent/ no AE; runny nose; chest congestion; severe sore throat; headache; body temperature 99.8 Farenheit; Initial information was received on 22-Oct-2021 regarding an unsolicited valid non-serious case from a Physician via Global Media Information (under reference- 00824391) and transmitted to Sanofi on 22-Oct-2021.  This case involves a 58-year-female patient who experienced Overdose and Product administered to patient of inappropriate age, runny nose (Rhinorrhoea), severe sore throat (Oropharyngeal pain), chest congestion (Respiratory tract congestion), headache and body temperature of 99.8 Fahrenheit (Pyrexia) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 18-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not provided] via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date in Oct-2021 the patient developed non-serious runny nose (Rhinorrhoea), severe sore throat (Oropharyngeal pain), chest congestion (Respiratory tract congestion) and body temperature of 99.8 Fahrenheit (Pyrexia) (on 3rd day after shot) and headache (5th or 6th day after shot) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was a case of actual medication error due to Overdose and Inappropriate age at vaccine administration (latency was on the same day).  Relevant laboratory test results included: Body temperature - On an unknown date: 99.8 Fahrenheit  Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test negative - On 20-Oct-2021: Negative  The patient was treated with paracetamol (tylenol) for Headache and performed steam inhalation and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  At the time of report, patient was recovering from Oropharyngeal pain and outcome of other events was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. 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.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error, Product preparation issue, Underdose
Clinical narrative: Did not administer the liquid (DTAP/IPV) portion and mixed the powder (ACTHIB) portion with normal saline with no adverse event/ no AE; Did not administer the liquid (DTAP/IPV) portion and mixed the powder (ACTHIB) portion with normal saline with no adverse event/ no AE; Initial information was received on 22-Oct-2021 regarding an unsolicited valid non-serious case from a Physician via Media Information (under reference- 00824421) and transmitted to Sanofi on 22-Oct-2021.   This case involves a one-year-old male patient while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] did not administer the liquid (DTAP/IPV) portion and mixed the powder (ACTHIB) portion with normal saline with no adverse event (Product preparation error and Underdose).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On 26-Aug-2021, the patient received fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot U6940BA and expiry date 21-May-2022] via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to Active ingredient not added to diluent and Vaccine underdose (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Abnormal uterine bleeding, Exposure during pregnancy, Thrombosis, Ultrasound foetal
Clinical narrative: 2 large clots; heavy bleeding like the first day of a period; The pregnant patient had her FLUZONE QUADRIVALENT vaccine; Initial information received on 22-Oct-2021 regarding an unsolicited valid serious case received from consumer/non-healthcare professional and physician via call center via Global Medical Information (GMI) (Reference number- 00824506) in the United States.  This case involves a 38-year-old female patient who experienced heavy bleeding like the first day of a period (abnormal uterine bleeding), 2 large clots (thrombosis) after received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].   Data regarding this pregnancy were received prospectively, that is before pregnancy outcome was known. The reported events occurred at 15 weeks of pregnancy.  The date of last menstrual period was reported as 16-Jul-2021.  The estimated due date is 15-Jun-2022.  The patient's medical history, medical treatments, vaccinations, concomitant medivation and family history were not provided.  On 14-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) (Dosage text: once) via an intramuscular route at an the left arm for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (same day latency).  On 17-Oct-2021, the patient developed a non-serious heavy bleeding like the first day of a period (abnormal uterine bleeding) and 2 large clots (thrombosis) 3 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Thrombosis event was assessed as medically significant.  Relevant laboratory test results included:  Ultrasound scan - On an unknown date: [the fetus was ok]  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  Information on the batch number was requested for this case.; Sender's Comments: This case concerns a 38-year-old female patient who experienced abnormal uterine bleeding, thrombosis (3 days) and Exposure during pregnancy (same day) after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible. There is no further information regarding patient's medical condition at the time of vaccination was not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Hepatic enzyme increased
Clinical narrative: elevated liver enzymes; Initial information received on 22-Oct-2021 regarding an unsolicited valid non-serious case from physician and consumer/ non health care professional via Global Media Information (under reference 00824765).  This case involves patient (unknown age and gender) who had elevated liver enzymes (hepatic enzyme increased), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, 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 QUADRIVAL A-B HIGH DOSE HV VACCINE (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 developed a non-serious elevated liver enzymes (hepatic enzyme increased) (unknown latency) following the administration of vaccine.  It was reported "Physician states he has a patient currently in the Emergency Room (ER) with elevated liver enzymes. Physician is looking for information in regards to this being a common side effect of FLUZONE HD QIV as patient was recently administered the vaccine, as well as how to possibly treat and handle."  No laboratory data were reported.  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.