chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested with an in-house COVID test and came out strongly positive; tested with an in-house COVID test and came out strongly positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) 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 "tested with an in-house COVID test and came out strongly positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested with an in-house COVID test and came out strongly positive; Positive, notes: also positive on a second test. Clinical course: A caller said that a family member received a Pfizer COVID vaccine on Wednesday and was not feeling really well afterward, but it was a typical vaccine response. It persisted into the next day and was then tested with an in-house COVID test and came out strongly positive, and it persisted into this morning, also positive on a second test. His question is, can that person take Paxlovid or will that interfere with the vaccine. The caller said he is an HCP who is calling on behalf of a retired HCP.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Fatigue, Malaise, Myalgia, SARS-CoV-2 test
Clinical narrative: tested with an in-house COVID test and came out strongly positive; tested with an in-house COVID test and came out strongly positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) 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 "tested with an in-house COVID test and came out strongly positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested with an in-house COVID test and came out strongly positive; Positive, notes: also positive on a second test. Clinical course: A caller said that a family member received a Pfizer COVID vaccine on Wednesday and was not feeling really well afterward, but it was a typical vaccine response. It persisted into the next day and was then tested with an in-house COVID test and came out strongly positive, and it persisted into this morning, also positive on a second test. His question is, can that person take Paxlovid or will that interfere with the vaccine. The caller said he is an HCP who is calling on behalf of a retired HCP.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: tested with an in-house COVID test and came out strongly positive; tested with an in-house COVID test and came out strongly positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) 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 "tested with an in-house COVID test and came out strongly positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested with an in-house COVID test and came out strongly positive; Positive, notes: also positive on a second test. Clinical course: A caller said that a family member received a Pfizer COVID vaccine on Wednesday and was not feeling really well afterward, but it was a typical vaccine response. It persisted into the next day and was then tested with an in-house COVID test and came out strongly positive, and it persisted into this morning, also positive on a second test. His question is, can that person take Paxlovid or will that interfere with the vaccine. The caller said he is an HCP who is calling on behalf of a retired HCP.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: fluzone quadrivalent received during pregnancy with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 35 years old female patient who who was at 16 weeks of pregnancy and was exposed to vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] during second pregnancy trimester.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was reported as 02-Jun-2023. The estimated due date is 08-Mar-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 13-Sep-2023, the pregnant patient received a dose 1 with unknown dose of suspect Influenza Quadrival A-B Vaccine (expiry date, strength: not reported and lot 4T80404A ) via intramuscular route in unknown administration site as prophylactic vaccination (maternal exposure during pregnancy) (latency: same day).   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: fluzone quadrivalent given to pregnant with no reported adverse event; Initial information received on 14-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 30-year-old female patient, influenza quadrival A-B vaccine [Fluzone Quadrivalent] given to pregnant with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The patient was exposed to Influenza quadrival A-B vaccine at 19 weeks of pregnancy.  The date of last menstrual period was reported as 09-May-2023. The estimated due date is 13-Feb-2024. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 14-Sep-2023, the patient received an unknown dose of suspect influenza quadrival A-B vaccine Suspension for injection (strength, expiry date: unknown) (lot: 4T80404A) via unknown route in unknown administration site for Prophylactic vaccination (immunization) and fluzone quadrivalent given to pregnant with no reported adverse event (maternal exposure timing unspecified) (latency: same day).  It was unknown if any lab data/test results available.  Action taken with quadrivalent influenza vaccine (Fluzone Quadrivalent) was not applicable.  Outcome: unknown.  Additionally, at time of reporting, the pregnancy was still ongoing.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza, Pruritus
Clinical narrative: itched all nigh; got the flu a week later; sick; Initial information received on 19-Sep-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves an unknown age and unknown gender patient who itched all nigh, got the flu a week later and sick after receiving Influenza Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown strength, expiry date, formulation and lot number) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient itched all nigh (pruritus), got the flu a week later (influenza) and sick (illness) (unknown latency).  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available.  It was reported, This is a social media case received Description: Not this year. I had my first reaction last year. I itched all nigh, got the flu a week later. I was sick as could be.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events
Sex: U
Vaccine: FLUR3
Symptoms: Local reaction
Clinical narrative: she had felt she had more local reactions with Flublok and more each year she's received it; Initial information was received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who experienced she had felt she had more local reactions with flublok and more each year she's received it after receiving influenza quadrivalent recombinant vaccine [Flublok].  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 quadrivalent recombinant vaccine (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 developed a non-serious event of she had felt she had more local reactions with flublok and more each year she's received it (local reaction) (unknown latency) following the administration of influenza quadrivalent recombinant vaccine.  Action taken with QUADRIVALENT RECOMBINANT influenza vaccine (Flublok) was not applicable.  It was not reported if the patient received a corrective treatment for the event (she had felt she had more local reactions with Flublok and more each year she's received it).  At time of reporting, the outcome was Unknown for the event she had felt she had more local reactions with flublok and more each year she's received it.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone High Dose was accidentally administered to a patient 37 years old with no reported adverse event; Fluzone High Dose was accidentally administered to a 29 weeks pregnant with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professionl.  This case involves a 37 years old female patient and 29 weeks pregnant who was accidentally exposed to vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The reported Fluzone High Dose was accidentally administered to a patient 37 years old and was accidentally administered to a 29 weeks pregnant with no reported adverse event occurred at 29 Weeks of pregnancy  The date of last menstrual period was not reported.  The estimated due date was not reported.  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 formulation, strength, expiry date, dose, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) and fluzone high dose was accidentally administered to a patient 37 years old with no reported adverse event (product administered to patient of inappropriate age) and fluzone high dose was accidentally administered to a 29 weeks pregnant with no reported adverse event (exposure during pregnancy) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.  Additionally, at time of reporting, the outcome of the pregnancy is unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Feeling abnormal
Clinical narrative: got the flu shot last week felt bad a day, this week got the Covid shot felt really bad yesterday; Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional) via social media.  This case involves an unknown age and unknown gender patient who got the flu shot last week felt bad a day, this week got the covid shot felt really bad yesterday after receiving Covid-19 Vaccine and Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in SEP-2023, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, dosage, expiry date, lot number -not reported) for prophylactic vaccination (Immunisation) and a dose of suspect covid-19 vaccine not produced by Sanofi Pasteur (formulation, strength, dosage, expiry date, lot number -not reported) via unknown route in unknown administration site for Covid-19 immunisation. Information on the batch number was requested.  In SEP-2023 the patient got the flu shot last week felt bad a day, this week got the covid shot felt really bad yesterday (feeling abnormal) (latency- few days approximately) following the administration of influenza vaccine and covid-19 vaccine.  Reportedly, Patient stated Hopefully today will be better, However this was nothing compared to my friends almost dying with flu and Covid last year, Their thoughts: Wouldn't get the shots, government trying to kill you.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 53.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: excursion lasted for about 6 hours, in middle of night and the lowest temperature reached is 0C with no reported adverse event; 2 of the FLUBLOK vaccines have been administered since the excursion with no reported adverse event; Initial information received on 14-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 53-year-old male patient who experienced excursion lasted for about 6 hours, in middle of night and the lowest temperature reached is 0c and 2 of the flublok vaccines have been administered since the excursion with no reported adverse event while receiving vaccine Influenza Quadrivalent Recombinant Vaccine [Flublok QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date the excursion lasted for about 6 hours, in middle of night and the lowest temperature reached is 0c with no reported adverse event (product storage error) (unknown latency).  On an unknown date, the patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine post excursion (lot: U8058AA, Expiry date: 31-May-2024) with unknown strength, formulation via unknown route in unknown administration site for Immunization 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 both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: 4-month-old receiving PENTACEL described as the liquid portion was not administered, with no reported adverse event; 4-month-old receiving PENTACEL described as the liquid portion was not administered and the powder portion was mixed with the wrong diluent of 0.5 % NaCl, with no reported adverse event; Initial information received on 18-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] described as the liquid portion was not administered and the powder portion was mixed with the wrong diluent of 0.5 % nacl, 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 Rotavirus Vaccine (Rotavirus Vaccine) for Prophylactic vaccination.  On 18-Sep-2023, the patient received 0.5 ml total (1x) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ853AB, Expiry date: 13-Apr-2024) (Strength: standard) (Frequency: once) via intramuscular route in the left thigh for Immunization.  On 18-Sep-2023, the patient received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine described as the liquid portion was not administered and the powder portion was mixed with the wrong diluent of 0.5 % nacl, with no reported adverse event (single component of a two-component product administered) (product preparation error) (latency: same day).  It was reported, A Clinic wanting to know how to proceed after a Medication error with a 4-month -old receiving PENTACEL described as the liquid portion was not administered and the powder portion was mixed with the wrong diluent of 0.5 % NaCl.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 71.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: fluzone quadrivalent vaccine was administered instead of fluzone high-dose quadrivalent vaccine that was indicated with no adverse event; Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA288621 (CLUSTER).  This case involves a 71 years old male patient who was administered the influenza quadrival A-B vaccine [Fluzone Quadrivalent] rather than the Influenza Quadrival A-B High Dose HV Vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Sep-2023, the patient received a dose 0.5 ml of suspect Influenza Quadrival A-B Vaccine Suspension for injection lot UT8055JA expiry date: not reported via intramuscular route in unknown administration site for immunisation rather than the Influenza Quadrival A-B High Dose HV Vaccine with no reported adverse event (wrong product administered) (latency same day).  Action taken was unknown.  At time of reporting, the outcome was Unknown for the event administered the fluzone quadrivalent vaccine rather than the fluzone high-dose quadrivalent vaccine with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: administering fluzone quadrivalent to a 72-year-old patient instead of fluzone high dose quadrivalent with no reported adverse event; administering fluzone quadrivalent at a dose of 0.25 ml with no reported adverse event; Initial information received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 72-years-old female patient who was administered influenza quadrival A-B vaccine [Fluzone Quadrivalent] instead of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] at a dose of 0.25 ml with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant(s): No other vaccines.  On 19-Sep-2023, the patient received 0.25 mL dose of suspect influenza quadrival A-B vaccine, Suspension for injection (Frequency: once; Strength: standard) (batch number: UT8134LA; expiry date: 30-Jun-2024) instead of influenza quadrival A-B high dose HV vaccine (batch number; expiry date: unknown) via intramuscular route in unknown administration site for Immunization with no reported adverse event (wrong product administered) (incorrect dose administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: U
Vaccine: DTAP, DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: mistakenly given QUADRACEL in place of the intended DAPTACEL with no adverse event; Inappropriate age at vaccine adminstration; Initial information was received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old and unknown gender patient to whom mistakenly diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel (VERO)] was given in place of the intended diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no 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 0.5 ml dose (once, total) of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine (Solution for injection) (lot number, expiry date, strength: unknown) via unknown route in unknown administration site for Immunization (Product administered to patient of inappropriate age) and mistakenly given quadracel in place of the intended daptacel with no adverse event (wrong product administered) (latency: same day). The information on the batch number was requested.  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: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error
Clinical narrative: 2 doses of fluzone QIV high dose was given to patient on the same day with no reported adverse event; Initial information was received on 20-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 88 years old female patient who received 2 doses of fluzone qiv high dose on the same day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Sep-2023 at 8:00, the patient received a Dose 1 of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (dose, route, lot, expiry formulation and strength: unknown) for immunization .  On 20-SEP-2023 at 13:15, the patient received a Dose 2, 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE(lot:UT8057AA and expiry:30-06-24) (formulation and strength: unknown) via intramuscular rout in left deltoid for immunization (extra dose adminsterered)  (latency same day).   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for the event 2 doses of fluzone qiv high dose was given to patient on the same day with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Dysphagia, Oropharyngeal pain
Clinical narrative: experienced having sore throat; difficulty swallowing after receiving the vaccine; Initial information received on 20-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA288656(CLUSTER).  This case involves patient of unknown demographics who is having sore throat and difficulty swallowing after receiving the vaccine influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection strength, dose, expiry date: not reported lot UT8055NA via unknown route in unknown administration site for Immunization.  On an unknown date the patient experienced having sore throat (oropharyngeal pain) and difficulty swallowing after receiving the vaccine (dysphagia) (unknown latency) following the administration of Influenza Quadrival A-B Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events experienced having sore throat, difficulty swallowing after receiving the vaccine.  At time of reporting, the outcome was Unknown for the event experienced having sore throat and difficulty swallowing after receiving the vaccine.
Age: 59.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Hypersensitivity, Pain, Product administered to patient of inappropriate age, Swelling
Clinical narrative: Pain from the shoulder to the elbow; Redness from the shoulder to the elbow; Swelling from the shoulder to the elbow; Consumer wants to know which ingredients does Fluad have that maybe caused the allergic reaction.; Fluad Quadrivalent administered to a 59-year-old patient; This spontaneous case was received on 19-Sep-2023 from a consumer via agency (reference number: SEQW23-02392) and concerned a 59-year-old, female patient.  The patient had no relevant medical history. The patient's concomitant medications included Synthroid (levothyroxine sodium), Liothyronine (liothyronine sodium), simvastatin, and Fosamax (alendronate sodium), all used for unreported indications.  On 18-Sep-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) (explicitly coded as 'inappropriate age at vaccine administration'), for travel, as reported. The batch number reported was 371593.  On 19-Sep-2023, one day after receiving Fluad Quadrivalent, the patient experienced pain, redness, and swelling from the shoulder to the elbow, but received no treatment. As reported, the patient wanted to know the ingredients of Fluad Quadrivalent that might have caused an allergic reaction.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 59-year-old female patient was vaccinated with Fluad Quadrivalent (explicitly coded as: 'Product administered to patient of inappropriate age'). One day after receiving Fluad Quadrivalent, patient experienced pain, erythema, swelling and hypersensitivity. Medical history was not provided. Due to plausible temporal relationship, causality for the events including pain, erythema, swelling and hypersensitivity is assessed as possibly related. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.; Sender's Comments: A 59-year-old female patient was vaccinated with Fluad Quadrivalent (explicitly coded as: 'Product administered to patient of inappropriate age'). One day after receiving Fluad Quadrivalent, patient experienced pain, erythema, swelling and hypersensitivity. Medical history was not provided. Due to plausible temporal relationship, causality for the events pain, erythema, swelling, and hypersensitivity is assessed as possibly related. Product administered to patient of inappropriate age is assessed as unrelated per company conventions.
Sex: U
Vaccine: FLUA4
Symptoms: Death
Clinical narrative: Death of a patient the day after taking the Fluad Quad vaccine; This spontaneous case was received on 22-Sep-2023, from other healthcare professional via Communications (reference number: SEQW23-02546) and concerned a patient with unspecified age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.   On an unspecified date, reported as 'the day after' receiving Fluad Quadrivalent, the patient died. The cause of death and information on whether an autopsy was performed, were not provided.  The reporter did not provide a causality assessment.  The event of death was considered serious due to the seriousness criteria of a fatal outcome. Additionally, the event of death was considered to be medically significant by a Physician within CSL Seqirus's Pharmacovigilance Department.  Company comment: A patient with unspecified age and gender was vaccinated with Fluad Quadrivalent. On an unspecified date, reported as 'the day after' vaccination, the patient died. The cause of death was not reported, and it was not reported if an autopsy was performed. The patient's medical history and concomitant medications were not reported. Information regarding relevant laboratory findings and diagnostic data was not reported. Causal role of the suspect vaccine is unassessable for the event death, due to lack of information provided.; Sender's Comments: A patient with unspecified age and gender was vaccinated with Fluad Quadrivalent. On an unspecified date, reported as 'the day after' vaccination, the patient died. The cause of death was not reported, and it was not reported if an autopsy was performed. The patient's medical history and concomitant medications were not reported. Information regarding relevant laboratory findings and diagnostic data was not reported. Causal role of the suspect vaccine is unassessable for the event death, due to lack of information provided.; Reported Cause(s) of Death: Death of a patient the day after taking the Fluad Quad vaccine
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Delusion, Night sweats, Pyrexia
Clinical narrative: FEVER FOR 2 DAYS. DELUSIONS 1ST NIGHT. NIGHT SWEATS FOR 2 NIGHTS
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram abnormal, Ear discomfort, Sudden hearing loss, Tinnitus
Clinical narrative: Starting the day after the vaccine, noticed that some songs on the radio sounded wrong, with a lot of static. 3 days after the vaccine, my ears felt "full" and right ear started ringing. 4 days after vaccine (today) had audiogram and was diagnosed with sudden hearing loss in my right ear.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Urticaria
Clinical narrative: Hives on body began one day after immunizations. Hive would appear with contact and last about 20 minutes.  Parent did preventative things like switch to mild detergent, lotion and soap.  Mom breastfeeding switched to an elimination diet.  Plan to vaccinate at 4 months with observation.
Age: 50.0
Sex: M
Vaccine: COVID19-2, FLU4, VARZOS
Symptoms: Parosmia
Clinical narrative: Altered sense of smell.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives
Age: 92.0
Sex: F
Vaccine: FLUA4
Symptoms: Fatigue, Influenza like illness, Mobility decreased, Pain in extremity
Clinical narrative: Patient claims she has soar arm.  She also said that she was fatigued and tired for 3-5 days and can't get out of bed.  "It felt like I had the flu," said the patient.
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 40.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Death, Road traffic accident
Clinical narrative: Pt came in for Spikevax and Flucelvax. Vaccines administered. Shortly after leaving pharmacy patient was involved in car accident in which he died.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit
Age: 77.0
Sex: F
Vaccine: FLU4, RSV, RSV
Symptoms: Feeling hot, Hypotension, Loss of consciousness, Pulse abnormal
Clinical narrative: At 12:35pm the patient received both vaccines in her left arm per her request since she had lymp nodes removed from right side due to breast cancer. Patient was advised to remain in the pharmacy for at least 15 minutes after vaccination. At 12:50 pm patient was unconscious in the pharmacy lobby chair and EMS was called, patient then became responsive. Her pulse was faint and her blood pressure was low with 87/54. Patient reported feeling very hot and states that she has fainted in the past with a blood draw but not with a vaccine. Patient was taken to the hospital by paramedics.
Age: 77.0
Sex: F
Vaccine: FLU4, RSV, RSV
Symptoms: Blood pressure decreased, Electrocardiogram normal, Feeling hot, Syncope
Clinical narrative: At 12:35pm the patient received both vaccines in her left arm per her request since she had lymp nodes removed from right side due to breast cancer. Patient was advised to remain in the pharmacy for at least 15 minutes after vaccination. At 12:50 pm patient was unconscious in the pharmacy lobby chair and EMS was called, patient then became responsive. Her pulse was faint and her blood pressure was low with 87/54. Patient reported feeling very hot and states that she has fainted in the past with a blood draw but not with a vaccine. Patient was taken to the hospital by paramedics.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: THE PATIENT RECEIVED HIS SECOND SHINGRIX SHOT ON 08/28/23.  THE PATIENT SAYS THAT WHEN HE TOOK OFF THE BANDAID A FEW DAYS LATER, THERE WAS A RAISED AREA AT SITE OF INJECTION.  A MONTH LATER,  HE SHOWS UP AT THE PHARMACY TO SHOW US THE SPOT THAT IS STILL RAISED AND RED.  HE ASKED IF THE SPOT WILL EVENTUALLY GO AWAY OR WILL IT STAY?  I TOLD HIM I DIDN'T KNOW WHAT IT WOULD DO.  I RECOMMENDED THAT THE PATIENT SHOW IT TO HIS PRIMARY CARE DOCTOR.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Headache, fatigue, fever
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Vomiting
Clinical narrative: significant vomiting
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit
Age: 73.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Eye discharge, Urticaria
Clinical narrative: SHINGLES VACCINATION IN LEFT ARM.  HIVES ALL AROUND TORSO ON LEFT SIDE.  TWO OR THREE ON RIGHT ARM, THEN MY LEFT EYE BEGAN WEEPING CONSTANTLY. I'M USING ARTIFICIAL TEARS IN MY EYE AND I'M USING CALAMINE LOTION ON THE HIVES, i HAVE TAKEN 500MG OF TYLENOL TWICE AND DIDN'T NOTICE AND DIFFERENCE. THE HIVES ARE STILL OCCURING BUT DO SEEM TO BE SLOWING DOWN.
Age: 75.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Arthralgia, Brain fog, Feeling abnormal, Malaise, Nightmare
Clinical narrative: approximately 8 hours after getting my two shots started to feel a little achy, which I expected.  I took two Tylenol and went to bed about 10:00. I woke a couple hours later in horrible pain throughout my whole body. I hurt so bad I couldn't stand it. I took some Nyquil hoping to go to sleep. Then I tried to get in a warm bath, due to my arthritis I could not sit in the tub. I was absolutely miserable. My arthritic knees were throbbing. I put Capsaicin cream on them to no avail. I used ice pack, to no avail. My right foot with the tendon problem was throbbing. My skin was painful to the touch. I tried using lotion, to no avail. When I finally dosed off I had terrible night mares about wanting to kill myself. In my dream I was having a conversation with my deceased aunt, mother, and late husband.  This lasted All day Sunday and Monday. I was able to get up and around yesterday but still foggy. I am better today and finally able to function. Please tell me what I can do next time to prevent from going through this again. Horrible1
Age: 75.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Pain, Pain in extremity, Pain of skin, Sleep disorder
Clinical narrative: approximately 8 hours after getting my two shots started to feel a little achy, which I expected.  I took two Tylenol and went to bed about 10:00. I woke a couple hours later in horrible pain throughout my whole body. I hurt so bad I couldn't stand it. I took some Nyquil hoping to go to sleep. Then I tried to get in a warm bath, due to my arthritis I could not sit in the tub. I was absolutely miserable. My arthritic knees were throbbing. I put Capsaicin cream on them to no avail. I used ice pack, to no avail. My right foot with the tendon problem was throbbing. My skin was painful to the touch. I tried using lotion, to no avail. When I finally dosed off I had terrible night mares about wanting to kill myself. In my dream I was having a conversation with my deceased aunt, mother, and late husband.  This lasted All day Sunday and Monday. I was able to get up and around yesterday but still foggy. I am better today and finally able to function. Please tell me what I can do next time to prevent from going through this again. Horrible1
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site swelling, Injection site haemorrhage, Injection site induration
Clinical narrative: RIGHT AFTER I GAVE THE SHOT, THE SITE OF ADMINISTRATION BECAME SWOLLEN AND THE BLOOD WAS MORE THAN USUAL THAT THE BAND AID GOT SOAKED AND BLOOD WAS RUNNING THROUGH HER ARM. I CLEANED IT WITH COTTON AND ALCOHOL SWAB AND IMMEDIATELY THE BLEEDING STOPPED SO I STARTED MASSAGING IT AND IT BECAME SMALLER AND AT FIRST IT WAS KIND OF HARD LIKE A BALL BUT EVENTUALLY AFTER A FEW MINUTES OF MASSAGING IT BECAME SOFTER AND REDUCED OF SWELLING IMPROVED. SHE DID NOT COMPLAIN OF ANY PAIN OR UNCOMFORTABILITY. SHE WAS JUST SURPRISED HAVING THAT REACTION FOR THE FIRST TIME. SHE LEFT THE VACCINATION AREA FEELING AND LOOKING OKAY BUT I WILL FOLLOW UP ON HER OVER THE PHONE LATER AND TOMORROW TO MAKE SURE SHE'S OKAY.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Balance disorder, Decreased appetite, Fatigue, Headache
Clinical narrative: poor appetite, rapid water weight gain (one pound per day), trouble with balance, shallow breathing, fatigue, fever, headache, severe urinary tract infection, itching skin, severe pain in joints, muscle soreness, vertigo.  Lasted several days.  UTI resolved with medication.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypopnoea, Myalgia, Pruritus, Pyrexia, Urinary tract infection
Clinical narrative: poor appetite, rapid water weight gain (one pound per day), trouble with balance, shallow breathing, fatigue, fever, headache, severe urinary tract infection, itching skin, severe pain in joints, muscle soreness, vertigo.  Lasted several days.  UTI resolved with medication.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urine analysis, Vertigo, Weight increased
Clinical narrative: poor appetite, rapid water weight gain (one pound per day), trouble with balance, shallow breathing, fatigue, fever, headache, severe urinary tract infection, itching skin, severe pain in joints, muscle soreness, vertigo.  Lasted several days.  UTI resolved with medication.
Age: 74.0
Sex: F
Vaccine: COVID19-2, FLU4, PNC20, RSV
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in an unapproved storage unit
Age: 21.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given peds/adol dose instead of adult dose. No adverse effect noted.
Age: 62.0
Sex: F
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Fluad even though patient was underage at 62 years old
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Palpitations
Clinical narrative: This vaccine is the updated Pfizer version.  I have had the standard vaccine, boosters, and the bivalent prior to this vaccine.   I was tired on September 24 and heart palpitations started Monday September 25 and have continued through September 26.  I have dizziness and some shortness of breath, although the shortness of breath is not constant.  The heart palpitations are frequent (very).  There is no pain whatsoever.
Age: 13.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Dizziness, Pallor
Clinical narrative: On 9/26/23 at approximately 1556 a nurse alarm was called. At approximately 1557, 2 PHNs  arrive on scene with patient and Mother of patient, 13 year old female was found conscious, pale, and sitting on floor of lobby accompanied by mother and patient's sister. Per patient's mother and patient shortly after receiving vaccines patient felt dizzy upon exiting clinic and was assisted to the floor by patient sister prior to nurse arrival. Patient's mom reported patient waiting 10 minutes after vaccination for observation period prior to nurse arrival. Patient was alert to name, location, and situation. Patient denied any current medications or chronic conditions. Patient's sister and patient's mom denied patient fainting. Patient's mother reported history of vaccine anxiety and dizziness with previous vaccinations.  Patient's vital signs were O2 99%, heart rate 66 bpm, respirations 16, blood pressure was 86/60. Pt. had water bottle with her and PHN encouraged her to drink and she drank. Pt. reported feeling better, denied pain. EMS offered to be called, patient's mother declined services. Patient and patients mom encouraged to stay to further observation, patient's mom declined. Patient's mother educated to monitor pt. closely for signs and symptoms of concussion and seek medical attention. Patient's mother provided concussion fact sheet for patients and educated patient and patient mom to eat and hydrate prior to future vaccinations. Patient's mother verbalized understanding and had no further questions. At approximately 1610 patient stood without assistance and exited the building with a steady gait accompanied by patient's mother and patient sister. Patient received HPV and MenACWY vaccines.