chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose #1, 2, 3, 5: Moderna; Dose #4: Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received bnt162b2 (BNT162B2), on 09Sep2022 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Mar2021 as dose 1, single (Lot number: 027a21a), on 12Apr2021 as dose 2, single (Lot number: 0271a21a), on 29Nov2021 as dose 3 (booster), single (Lot number: 031HZIA) and on 07Apr2023 as dose 5 (booster), single (Lot number: AS7145B), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "unknown", described as "Dose #1, 2, 3, 5: Moderna; Dose #4: Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 01Oct2023 to 05Oct2023.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Oct2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Mar2023 at 13:15 as dose 6 (booster), single (Lot number: GH9702) at the age of 71 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Elevated cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Sep2023, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Covid-19 rebound (re-tested positive on 01Oct2023 with milder symptoms; (01Oct2023) Positive, notes: Covid-19 rebound (re-tested positive on 01Oct2023 with milder symptoms). Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Sep2023, outcome "not recovered", described as "COVID 19 Treatment". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Patient took Paxlovid from  29Sep2023 to 03Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild chronic seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, Paxlovid took from  27Sep2023 to 01Oct2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Hypoacusis, Tinnitus
Clinical narrative: your Covid vaccine caused me 30% hearing loss and tinnitus; tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOACUSIS (medically significant), outcome "not recovered", described as "your Covid vaccine caused me 30% hearing loss and tinnitus"; TINNITUS (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: 30% hearing loss. Therapeutic measures were taken as a result of hypoacusis, tinnitus. Clinical course: Patient was acquiring today to hope to get a reimbursement for hearing aids because your Covid vaccine caused patient 30% hearing loss and tinnitus which patient's insurance did not cover.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: you recently had Covid; you recently had Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "you recently had Covid".  Additional information: The reporter tried to use the form at # but when he entered his employee ID for validation it kept kicking him back to the main screen and asking if this was about the COVID-19 Vaccine in an endless loop. Last night his mother told him that her oncologist from (Clinic name withheld) told her she should not get the COVID vaccine and sent her the following: Dr. (Name withheld) said: 1. "Because you recently had Covid, you are both better vaccinated that you would be with the vaccine. 2. Increasing doses of the Covid vaccine, leads to increasing the risk for more severe side effects, including immunosuppression, blood clots, secondary cancers, and many other things. 3. This iteration of the vaccine was approved and released without human trials. This time it was based on the results from 7 rabbits, rather than just 4 with the bivalent. We do not know if it will be effective, but likely it will be just as worthless as the bivalent vaccine and the booster before it were. 4. The current administration, FDA and CDC have an undoubtable record now (with a complicit press) of blatant deception regarding these vaccines. 5. The pharmacist is under- and potentially mis-informed. I ascribe no ill intent to him, as he is simply parroting governmental directives from untrustworthy sources. 6. Yes, you both have several of the factors that place you in the highest risk group, but as I stated in #1 you are already more potentently immunized, without the additional risk of short and long term side effects. You will of course have to make your own decision, but at this point, my conclusion after reviewing vast amounts of literature, sorting out the propaganda from reality, is that the Covid vaccines are likely worthless for their stated purpose, and are unacceptably toxic. 7. As yet, I do not have the same concerns about the influenza vaccinations, or RSV, and thus I support those. As we know flu shots are often not protective, but when they are, it is great. They certainly do not have the toxicity created by mRNA technology. 8. Getting the flu vaccine as close to Nov as you can prior to your departure the better, as it will provide coverage further into the early months of 2024."  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: UNK
Symptoms: Death, Pulmonary thrombosis
Clinical narrative: 1 week from the booster dose, the patient had blood clots in her lungs, and died in the hospital; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001226 (Novavax).  An 82-year-old female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (primary immunization series), for Covid-19 immunization. On 26Sep2023, it was reported that a patient started treatment on unreported dates with Pfizer BioNTech COVID-19 vaccine primary series and booster for COVID-19 indication. The following information was reported: PULMONARY THROMBOSIS (death), outcome "fatal", described as "1 week from the booster dose, the patient had blood clots in her lungs, and died in the hospital". The patient date of death was unknown. Reported cause of death: "1 week from the booster dose, the patient had blood clots in her lungs, and died in the hospital". It was not reported if an autopsy was performed. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: 1 week from the booster dose, the patient had blood clots in her lungs, and died in the hospital
Sex: M
Vaccine: UNK
Symptoms: Arrhythmia, COVID-19
Clinical narrative: has irregularity in his heart rhythm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001227.  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number unknown), for COVID-19 immunization; Bnt162b2 (Dose 2, lot number unknown), for COVID-19 immunization. The following information was reported: ARRHYTHMIA (medically significant), outcome "unknown", described as "has irregularity in his heart rhythm". It was also reported that the patient started treatment on unreported dates with Pfizer BioNTech COVID-19 vaccine primary series and booster. The patient had COVID-19 multiple times and has irregularity in his heart rhythm.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300323615 same patient, different events after different doses of the vaccine;
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: has had numbness in her arm and now does not have any feeling down her entire left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001228 (Novavax).  A female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "has had numbness in her arm and now does not have any feeling down her entire left arm". Additional information: On 26Sep2023, it was reported that a patient (Age: 65, units not specified) started treatment on unreported date with Pfizer BioNTech COVID-19 vaccine primary series and booster for COVID-19 immunization. It was reported that since her injections, the patient has had numbness in her arm and now does not have any feeling down her entire left arm.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300168694 Same patient/event, different dose;US-PFIZER INC-PV202300168695 Same patient/event, different dose;
Sex: F
Vaccine: UNK
Symptoms: Intensive care, Respiratory disorder
Clinical narrative: severe respiratory issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001225 (Novavax).  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary series of immunization completed, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: RESPIRATORY DISORDER (hospitalization), outcome "unknown", described as "severe respiratory issues". Clinical course: had severe respiratory issues, was hospitalized, and ended up in the ICU (Intensive Care Unit). The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Headache, Illness
Clinical narrative: ill; severe headache; checked my blood pressure and it was162/96 it was 196/122; dizziness; blurry vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious) with onset 03Oct2023, outcome "unknown", described as "blurry vision"; DIZZINESS (non-serious) with onset 03Oct2023, outcome "unknown"; BLOOD PRESSURE INCREASED(medically significant) with onset 06Oct2023, outcome "unknown", described as "checked my blood pressure and it was162/96 it was 196/122"; HEADACHE (non-serious) with onset 06Oct2023, outcome "unknown", described as "severe headache"; ILLNESS (non-serious), outcome "unknown", described as "ill". The events "checked my blood pressure and it was162/96 it was 196/122" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (06Oct2023) 162/96 mmHg; (07Oct2023) 196/122 mmHg. The clinical course was reported as follows: "on 03Oct2023, I awoke with dizziness and blurry vision. I worked for 4 hours and left to go home and slept for approximately 8 hours. The following 2 days I was still ill and on Friday I checked my blood pressure and it was 162/96 and I had a severe headache. The following day I checked my BP  again and it was 196/122 and I went to the emergency room. I have no history of hypertension". The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: ill; severe headache; checked my blood pressure and it was162/96 it was 196/122; dizziness; blurry vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious) with onset 03Oct2023, outcome "unknown", described as "blurry vision"; DIZZINESS (non-serious) with onset 03Oct2023, outcome "unknown"; BLOOD PRESSURE INCREASED(medically significant) with onset 06Oct2023, outcome "unknown", described as "checked my blood pressure and it was162/96 it was 196/122"; HEADACHE (non-serious) with onset 06Oct2023, outcome "unknown", described as "severe headache"; ILLNESS (non-serious), outcome "unknown", described as "ill". The events "checked my blood pressure and it was162/96 it was 196/122" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (06Oct2023) 162/96 mmHg; (07Oct2023) 196/122 mmHg. The clinical course was reported as follows: "on 03Oct2023, I awoke with dizziness and blurry vision. I worked for 4 hours and left to go home and slept for approximately 8 hours. The following 2 days I was still ill and on Friday I checked my blood pressure and it was 162/96 and I had a severe headache. The following day I checked my BP  again and it was 196/122 and I went to the emergency room. I have no history of hypertension". The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: hives/welts; red spots; My arms were itchy with hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), 10 days after the suspect product(s) administration, outcome "recovering", described as "hives/welts"; RASH MACULAR (non-serious), 10 days after the suspect product(s) administration, outcome "recovering", described as "red spots"; PRURITUS (non-serious), 10 days after the suspect product(s) administration, outcome "recovering", described as "My arms were itchy with hives". Therapeutic measures were taken as a result of urticaria, rash macular, pruritus. Additional information: Patient received the new Covid vaccine recently and 10 days later have had hives, welts and red spots. The arms were itchy with hives. The welts and red spots on the thighs and torso were not itchy. After 2 days, patient took diphenhydramine (this morning) and that has helped a lot. Patient asking if it was a side effect of the vaccine stated "I'm not one to have skin problems or issues like that".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal operation
Clinical narrative: abdominal surgery; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A 3-year-old female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot number not reported), for covid-19 immunization. The following information was reported: ABDOMINAL OPERATION (medically significant), outcome "unknown", described as "abdominal surgery".  Clinical Course:The reporter had a three year old grand daughter who's going to be having surgery on Nov and they haven't scheduled the date and they really wanted to get her the vaccine for Covid-19 beforehand. Reporter said that her grand daughter already had two shots of the vaccine and would just like to know where they can be able to get the availability of the vaccine. Reporter said that they tried and is not getting yet and said that their granddaughter is having the abdominal surgery in Nov with no confirmed dates. Reporter wanted to get a hold of the vaccine in their county and wanted some help.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Maternal vaccine exposure with no reported adverse event; Initial information was received on 04-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an adult female patient who was exposed to vaccine influenza vaccine in context of maternal vaccine exposure with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Maternal vaccine exposure with no reported adverse event occurred at unknown gestation period the gestation period at onset and gestation period at exposure data needs to be populated, if available  The date of last menstrual period was reported as 07-Jul-2023. The estimated due date is 12-Apr-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancies. It is unknown if the patient had any medical history, concomitant disease or risk factor.   Concomitant medications included hepatitis b vaccine for Prophylactic vaccination; and hepatitis a vaccine for Prophylactic vaccination.  On an unknown date, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on batch number was requested.  On an unknown date the patient was maternal vaccine exposure with no reported adverse event (maternal exposure timing unspecified) (unknown latency) following the administration of influenza vaccine. Relevant prenatal testing after exposure included  It is unknown if there were lab data/results available.   Action taken with influenza vaccine was not applicable.  At time of reporting, the outcome was Unknown for the event maternal vaccine exposure with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is unknown. Outcome of the pregnancy was reported as and fetal outcome was reported as unknown.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got so sick; Initial information received on 07-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a patient of an unknown age and gender who experienced got so sick after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown strength, formulation, expiry date and lot number) via unknown route in unknown administration site for flu (Influenza).  On an unknown date, the patient got so sick (illness) (unknown latency).  It was reported, No flu shot for me - got a shot years ago and got so sick. Since then haven't had a shot or gonna so sick again.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (got so sick).  At time of reporting, the outcome was Unknown for the event got so sick.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: FLUZONE QIV PFS at a high temperature of 72.7F out of range for 7 weeks with no reported adverse event; patients were administered post excursion with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 47 years old male patient who was administered influenza quadrival A-B vaccine [FLUZONE QIV] post excursion at a high temperature of 72.7f out of range for 7 weeks with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Oct-2023, the patient received a dose 0.5 ml of suspect Influenza Quadrival A-B Vaccine Suspension for injection expiry date: 30-jun-2024 lot UT8055JA via intramuscular route in unknown administration site for immunization and exposed to a high temperature of 72.7f out of range for 7 weeks with no reported adverse event (product storage error) (unknown latency) and was administered post excursion with no reported adverse event (poor quality product administered) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event fluzone qiv pfs at a high temperature of 72.7f out of range for 7 weeks with no reported adverse event and was Unknown for the event patients were administered post excursion with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA305541: US-SA-2023SA305537:
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: received the FLUZONE HD QIV post transit duration excursion with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 83-years-old female patient who had received the influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] post transit duration excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included covid-19 vaccine for Immunisation.  On 03-Oct-2023, the patient received 0.7 mL dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (batch number: U8138DA; expiry date: Jun-2024) via intramuscular route in the right deltoid for Influenza and immunization, post transit duration excursion with no reported adverse event (poor quality product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Musculoskeletal discomfort, Sleep disorder
Clinical narrative: unable to get a good night's sleep due to the discomfort; discomfort; significant pain; Initial information received on 04-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 66 years old male patient who was unable to get a good night's sleep due to the discomfort and significant pain after receiving vaccine Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Back pain on 30-SEP-2023.  Concomitant medications included paracetamol (Tylenol).  On 02-Oct-2023, the patient received a dose of suspect Influenza Quadrival A-B High Dose HV Vaccine formulation, strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a unable to get a good night's sleep due to the discomfort (sleep disorder), discomfort and significant pain (back pain) (unknown latency) following the administration of Influenza Quadrival A-B High Dose HV Vaccine .  Reportedly, He also mentioned that he had tweaked his back over the weekend before getting the flu shot. He says that he asked the pharmacist which OTC would be good for his back pain and not interfere with the effectiveness of the Flu shot. The pharmacist directed him towards Tylenol. Caller wants to know if he can take more Tylenol or if he would be able to take. Caller injured his back on 30sep2023. He received FLUZONE HIGH-DOSE QUADRIVALENT on 02oct2023. He did not want to take the 6-day course of Medrol that he has used before in similar situations, and the Tylenol recommended by his pharmacist is not effective, so he has been experiencing significant pain since receiving the vaccine. He states that he has been unable to "get a good night's sleep" due to the discomfort.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events unable to get a good night's sleep due to the discomfort, discomfort, significant pain.  At time of reporting, the outcome was Unknown for the event unable to get a good night's sleep due to the discomfort, discomfort and significant pain.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: fluzone hd qiv experience a temperature excursion which was not covered by the extended stability data with no reported adverse event; fluzone hd qiv was administered to a patient after experiencing a temperature excursion with no reported adverse event; Initial information received on 05-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 85 years old female patient who was administered vaccine Influenza Quadrival A-B High dose HV vaccine [Fluzone High-Dose Quadrivalent] after experiencing a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2023, the patient received 0.7 ml dose (frequency: once) of suspect Influenza Quadrival A-B High Dose HV vaccine of lot UT8150CA and expiry: 30-Jun-2024 via intramuscular route in the right deltoid for immunization.  On an unknown date, it was reported that the suspect Influenza Quadrival A-B High Dose HV vaccine experience a temperature excursion which was not covered by the extended stability data with no reported adverse event (product storage error) (unknown latency).  On 04-Oct-2023, the patient was administered Influenza Quadrival A-B High Dose HV vaccine (Fluzone HD QIV) after experiencing a temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: received a partial injection of fluzone states that the baby jumped, and the needle got pulled out with no reported adverse event; Initial information was received on 06-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 years old and unknown gender patient who received a partial injection of  influenza quadrival a-b vaccine [Fluzone QIV] states that the baby jumped, and the needle got pulled out with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect influenza quadrival a-b vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization and received a partial injection of fluzone states that the baby jumped, and the needle got pulled out with no reported adverse event (incorrect dose administered) (latency: same day) following the administration of influenza quadrival a-b vaccine. The information on batch number was requested.  Reportedly "The nurse was asked the reason for the partial injection, and she states that the baby jumped, and the needle got pulled out. She states that she wanted to know if the 2-year-old needs to be rescheduled for a full dose. This situation is reported as a medication error due to the baby jumping and the needle got pulled out. "  Action taken with QUADRIVALENT influenza vaccine (Fluzone QIV) was not applicable.  At time of reporting, the outcome was Unknown for the event received a partial injection of fluzone states that the baby jumped, and the needle got pulled out with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: was given fluzone high dose quadrivalent instead of fluzone quadrivalent with no reported adverse event; less than 65 years of age who was given fluzone high dose quadrivalent with no reported adverse event; Initial information received on 06-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2023SA310779.  This case involves a 59-years-old male patient who was given influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] instead of influenza quadrival A-B vaccine [Fluzone Quadrivalent] at less than 65 years of age with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the 59-years-old patient received unknown dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (batch number: U8135BA; expiry date unknown) via unknown route in unknown administration site for immunization instead of suspect influenza quadrival A-B vaccine, suspension for injection (batch number, expiry date unknown) with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 64.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 2 patients less than 65 years of age who was given fluzone high dose quadrivalent instead of fluzone quadrivalent with no reported adverse event; 2 patients less than 65 years of age who was given fluzone high dose quadrivalent instead of fluzone quadrivalent with no reported adverse event; Initial information received on 06-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA309081.  This case involves a 64 years old male patient where reporter reported 2 patients less than 65 years of age who was given influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] instead of influenza quadrival a-b vaccine [Fluzone quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine (lot- U8135BA and expiration date- 30-Jun-2023) via unknown route in unknown administration site (dose, formulation, strength: not provided) for Immunisation and received a dose of suspect influenza quadrival a-b vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength: not provided) for Immunisation (wrong product administered) and (product administered to patient of inappropriate age) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 42.0
Sex: F
Vaccine: FLUC3
Symptoms: Hypoaesthesia oral, Rash
Clinical narrative: Numb tongue and lips; Rash all over; This spontaneous case was retrieved on 03-Oct-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2683063-1) reported by other healthcare professional and concerned a 42-year-old, female patient.    The patient's medical history and concomitant medications were not reported. The patient had no other known allergies.  It was reported that on 07-Sep-2023, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose reported as '1', route of administration: intramuscular, anatomical location: right arm (RA), and indication: not reported). The batch number reported was 370651. The reported batch number was identified by Seqirus to be linked to the suspect product Flucelvax Quadrivalent (influenza vaccine inact sag 4v) instead of the reported suspect product Afluria Quadrivalent. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent vaccine.  On the same date (discrepancy reported as 18-Sep-2023), after receiving Flucelvax Quadrivalent, the patient experienced numb tongue and lips. Soon after, the patient experienced a rash all over. The patient was seen at an emergency room (ER). The patient had taken Benadryl (diphenhydramine hydrochloride) at the recommendation of a nurse practitioner (NP). As reported, the patient was going to see an allergy doctor.  On an unspecified date in Sep-2023, the patient recovered from both events.  The reporter did not provide a causality assessment.   The events of 'hypoaesthesia oral' and  rash all over were considered to be medically significant by a Physician within CSL Seqirus' Pharmacovigilance Department.  Company comment: On the same date, after receiving Flucelvax Quadrivalent, the patient experienced numb tongue and lips, as well as rash. The patient was seen at an emergency room (ER) and had taken Benadryl. The patient recovered from both events. Causal role of influenza vaccine is assessed as possibly related for rash and hypoesthesia oral, due to suggestive chronology.; Sender's Comments: On the same date, after receiving Flucelvax Quadrivalent, the patient experienced numb tongue and lips, as well as rash. The patient was seen at an emergency room (ER) and had taken Benadryl. The patient recovered from both events. Causal role of influenza vaccine is assessed as possibly related for rash and hypoesthesia oral, due to suggestive chronology.
Age: 86.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Pruritus
Clinical narrative: Bruising; Swallow; Redness from both arms to chest and both hands; Both arms itching; This spontaneous case was received on 03-Oct-2023 from other non-healthcare professional (consumer) (reference number SEQW23-02905) and concerned an 86-year-old, female patient.  The patient's concurrent condition included arthritis. The patient's past procedure included stent placement (reported as 'stunt'). The patient's concomitant medications included Astatin (astaxanthin), clopidogrel, Centrum (minerals nos, vitamins nos), aspirin, vitamin d and cortisone injection, all used for an unreported indication.  On an unspecified date in 2023 (dispcrepantly reported as 09-Nov-2023), the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for every year shot, as reported. The batch number reported was 371593.  On an unspecified date in 2023, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced both arms itching and she was scratching all night. The patient had redness from both arms to chest and both hands. The patient had bruising because she took anticoagulants and swelling (swallow, as reported) maybe due to itching. The patient applied Benadryl (diphenhydramine hydrochloride) cream to relive the scratching.  At the time of initial reporting, the patient had not recovered from all events.   The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: A 86-year-old female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving the vaccine, patient experienced both arms pruritus, erythema from both arms to chest and both hands, contusion and swelling. Patient's concomitant medication aspirin and clopidogrel may have contributed to the development of the event of contusion. Considering the limited information provided, lack of information regarding the vaccination date and events onset dates, and unclear temporal relationship, causality for the events including contusion, swelling, erythema and pruritus is unassessable.; Sender's Comments: A 86-year-old female patient was vaccinated with Fluad Quadrivalent. An unknown amount of time after receiving the vaccine, patient experienced both arms pruritus, erythema from both arms to chest and both hands, contusion and swelling. Patient's concomitant medication aspirin and clopidogrel may have contributed to the development of the event of contusion. Considering the limited information provided, lack of information regarding the vaccination date and events onset dates, and unclear temporal relationship, causality for the events including contusion, swelling, erythema and pruritus is unassessable.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came in wondering if due for tdap. floater rph working didn't carefully check and gave pt another shot on 10/5/23 thinking pt didn't receive yet. found out later pt did receive already 3/16/23. pt having no adverse reaction so far.