chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TBE
Symptoms: Chronic obstructive pulmonary disease, Emphysema
Clinical narrative: COPD; Emphysema; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A female patient received tick-borne encephalitis vaccine (TICOVAC), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer-biontech covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD"; EMPHYSEMA (non-serious), outcome "unknown". Additional information: The patient was asking about the tick vaccination in her area. It was stated that clinical trials were done since summer of unknown year it and wanted to know why they were canceling it. She already got the first one but not the second one yet, as the company hasn't sent them yet. The patient was asking information about this vaccine because the second vaccine was for the clinical trial and were paying people to get the vaccination and said that she already got the first one but not the second one yet and said that the reason is that Pfizer hasn't sent them yet the Tick vaccine. She said that it's the fourth time the change appointment has been made and told her that the second one was just for a trial. The patient also mentioned that she had all the Covid vaccinations. It was stated that the patient had emphysema and COPD and would like to have the information for immunocompromised on email program.  The information on the batch/lot number for tick-borne encephalitis vaccine has been requested and will be submitted if and when received.  Follow-up (09Nov2023): This is a spontaneous follow-up report received from a contactable consumer (patient). Updated information included: additional information regarding previous Covid-19 vaccinations.  The information on the batch/lot number for tick-borne encephalitis vaccine, tick-borne encephalitis vaccine  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: My wife walked with a cane for three months after her last booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunisation. The following information was reported: GAIT DISTURBANCE (disability), outcome "unknown", described as "My wife walked with a cane for three months after her last booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chromaturia, Faeces pale, Hepatic enzyme, Hepatic pain
Clinical narrative: dark urine; liver pain; light colored stools; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccine (Dose 1, single), for Covid-19 immunisation; Moderna vaccine (Dose 2, single), for Covid-19 immunisation; Moderna vaccine (Dose 3, single), for Covid-19 immunisation. The following information was reported: FAECES PALE (non-serious) with onset 2023, outcome "unknown", described as "light colored stools"; CHROMATURIA (non-serious), outcome "unknown", described as "dark urine"; HEPATIC PAIN (non-serious), outcome "unknown", described as "liver pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that "I have had 3 previous Moderna vaccines. I received a Pfizer vaccine ( I thought it was going to be Moderna) in Oct2023. I have never had any ill side effects until the Pfizer shot. I have a fatty liver. I am tested for liver enzymes every 6 months. My enzymes are always low, 20 and around 17-19. After the Pfizer shot I had light colored stools and dark urine for 10 days. I had AND HAVE liver pain.".  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: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage
Clinical narrative: brain bleed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male 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: CEREBRAL HAEMORRHAGE (medically significant), outcome "unknown", described as "brain bleed". Clinical course: Reporter's husband, had brain bleed in January, she had read up on the COVID vaccine and had been told by a physician that brain bleeds were directly related to the COVID vaccine.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Had stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), 5 months after the suspect product(s) administration, outcome "unknown", described as "Had stroke". Clinical course: 5 months after vaccine patient regret, patient had stroke.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300369357 same reporter/drug, different patient/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid and have been very sick ever since; tested positive for Covid and have been very sick ever since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 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: Covid-19 vaccine (Primary immunization series completed; Unknown Manufacturer), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "not recovered" and all described as "tested positive for Covid and have been very sick ever since". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) positive, notes: tested positive for Covid. Clinical course: The patient tested positive for Covid one month after the vaccination and had been very sick ever since. The patient was fully vaccinated and never had Covid.  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-202300369382 same reporter/drug/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: Was diagnosed with a one of the best neurosurgeons/know of another person that is around her age that was diagnosed with this around the same time/Myasthenia gravis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: MYASTHENIA GRAVIS (medically significant) with onset 2023, outcome "unknown", described as "Was diagnosed with a one of the best neurosurgeons/know of another person that is around her age that was diagnosed with this around the same time/Myasthenia gravis". The event "was diagnosed with a one of the best neurosurgeons/know of another person that is around her age that was diagnosed with this around the same time/myasthenia gravis" required physician office visit. Clinical course: Reporter mentioned that she knew someone who had the same experience with her after receiving the vaccines and booster. She knew of another person that was around her age in (City withheld) (State withheld) that was diagnosed with this around the same time.  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-202201185389 same reporter/product, different patient/event;US-PFIZER INC-PV202300186632 same reporter/product, different patient/event;US-PFIZER INC-PV202300186639 same reporter/product, different patient/event;
Sex: U
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: Was diagnosed with a one of the best neurosurgeons/know of two people (person 1) that that have recently got it that have been diagnosed with it after they received the COVID shot/Myasthenia gravis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: MYASTHENIA GRAVIS (medically significant) with onset 2023, outcome "unknown", described as "Was diagnosed with a one of the best neurosurgeons/know of two people (person 1) that that have recently got it that have been diagnosed with it after they received the COVID shot/Myasthenia gravis". The event "was diagnosed with a one of the best neurosurgeons/know of two people (person 1) that that have recently got it that have been diagnosed with it after they received the covid shot/myasthenia gravis" required physician office visit. Clinical course: reporter mentioned that she knew her twin brother knew the patient that that had recently got it that had been diagnosed with it after receiving the COVID shot.  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-202201185389 same reporter/product, different patient/event;US-PFIZER INC-PV202300186639 same reporter/product, different patient/event;US-PFIZER INC-PV202300186627 same reporter/product, different patient/event;
Sex: U
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: Was diagnosed with a one of the best neurosurgeons/know of two people that that have recently got it that have been diagnosed with it after they received the COVID shot/Myasthenia gravis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: MYASTHENIA GRAVIS (medically significant) with onset 2023, outcome "unknown", described as "Was diagnosed with a one of the best neurosurgeons/know of two people that that have recently got it that have been diagnosed with it after they received the COVID shot/Myasthenia gravis". The event "was diagnosed with a one of the best neurosurgeons/know of two people that that have recently got it that have been diagnosed with it after they received the covid shot/myasthenia gravis" required physician office visit. Clinical course: reporter mentioned that she knew her twin brother knew the patient that that had recently got it that had been diagnosed with it after receiving the COVID shot.  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-202201185389 same reporter/product, different patient/events.;US-PFIZER INC-PV202300186627 same reporter/product/event, different patient;US-PFIZER INC-PV202300186632 same reporter/product/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: developed blood clots in the lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 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. The following information was reported: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "developed blood clots in the lungs". Clinical course: Reporter had been working with pfizer of after effects of the vaccine. Reporter's daughter just had a shot and developed blood clots in the lungs.  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-PV202300139392 Same reporter, different dose and events/patient;
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she's not feeling well today; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) 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. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "she's not feeling well today". Additional information: Patient's age was 36. Patient's mother called and stated, "my daughter got a covid shot on Friday and she's not feeling well today. I'm wondering if she took a covid test because of the shot on Friday would it give it an automatic like she has it like a false positive."
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: The caller said that she got COVID in early 2020/when the vaccines started to wear off, she got the symptoms back; The caller said that she got COVID in early 2020/when the vaccines started to wear off, she got the symptoms back; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "The caller said that she got COVID in early 2020/when the vaccines started to wear off, she got the symptoms back". Clinical course: The reporter said that she got COVID in early 2020, and then in Jan, the vaccines were available, and she started picking Pfizer. The reporter said that she had long-haul symptoms, and Pfizer helped her remove almost all of her long-haul symptoms. The caller stated that when the vaccines started to wear off, she got the symptoms back, and Pfizer took them away again. The caller said that she got one booster in the spring. The caller said that it was keeping her healthy. So this year she had not gotten the vaccine, and she was having a hard time finding Pfizer bivalent.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are  related to bnt162b2 (BNT162B2)  cannot be excluded.  This case will be reassessed should additional information become available.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: shoulder pain and soreness; Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 68-year-old female patient who had shoulder pain and soreness after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient had no medical history, concomitant disease or risk factor.  On 30-Sep-2023, the patient received 0.7 mL dose of suspect influenza quadrival A-B high dose HV vaccine, suspension for injection in pre-filled syringe (strength; batch number; expiry date unknown) via intramuscular route in unknown administration site for Annual flu shot (influenza immunization).  On 30-Sep-2023 the patient had shoulder pain and soreness (arthralgia) (same day latency) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, Patient claimed the vaccine administrator administered the fluzone HD too high on the shoulder which then led to ongoing shoulder pain and soreness.  Patient did not experience any additional symptoms/events.  There were no lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (shoulder pain and soreness).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event shoulder pain and soreness.
Age: 0.17
Sex: U
Vaccine: DTPPVHBHPB, IPV
Symptoms: No adverse event, Vaccination error
Clinical narrative: administered vaxelis and ipol at the same day with no reported adverse event; Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 months old patient of an unknown gender who was administered VAXELIS and IPV (VERO) [IPOL] at 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 an unknown date, the patient received an unknown dose of suspect IPV (VERO) Suspension for injection (strength, lot number and expiry: not reported) via unknown route in unknown administration site as prophylactic vaccination. On the same date the patient was also administered with an unknown dose of suspect Vaxelis not produced by Sanofi Pasteur (strength, formulation, lot number and expiry: not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization), with no reported adverse event (product administration error) (latency: same day). Information on the batch number was requested.  No lab data was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority 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-2023SA341553:
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Occupational exposure to product, Syringe issue
Clinical narrative: IMOVAX leaked down the nurse's wrist, down her arm and on the floor,leaking occurred while the nurse was "drawing up" the vaccine, the plunger separated from the syringe and all of the vaccine leaked out with no reported adverse event; IMOVAX leaked down the nurse's wrist, down her arm and on the floor,leaking occurred while the nurse was "drawing up" the vaccine, the plunger separated from the syringe and all of the vaccine leaked out with no reported adverse event; Initial information was received on 06-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA353114.  This case involves an unknown age female patient who experienced RABIES (HDC) VACCINE [IMOVAX RABIES] leaked down the nurse's wrist, down her arm and on the floor,leaking occurred while the nurse was "drawing up" the vaccine, the plunger separated from the syringe and all of the vaccine leaked out with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Nov-2023, the RABIES (HDC) VACCINE,powder and solvent for suspension for injection leaked down the nurse's wrist, down her arm and on the floor, leaking occurred while the nurse was "drawing up" the vaccine, the plunger separated from the syringe and all of the vaccine leaked out with no reported adverse event (lot V1E121M and expiry:04-OCT-2024) (occupational exposure to product and exposure via skin contact) (latency same day).  Vaccine was not administered.   At time of reporting, the outcome was Unknown for the event imovax leaked down the nurse's wrist, down her arm and on the floor,leaking occurred while the nurse was "drawing up" the vaccine, the plunger separated from the syringe and all of the vaccine leaked out with no reported adverse event and was Unknown for the event imovax leaked down the nurse's wrist, down her arm and on the floor,leaking occurred while the nurse was "drawing up" the vaccine, the plunger separated from the syringe and all of the vaccine leaked out with no reported adverse event.
Age: 35.0
Sex: M
Vaccine: RAB
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: missing second scheduled dose resulting in deviation from IMOVAX schedule for pre-exposure with no adverse event; Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA349373(CLUSTER).  This case involves a 35 years old male patient who missed second scheduled dose resulting in deviation from RABIES (HDC) VACCINE [IMOVAX RABIES] schedule for pre-exposure 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 missed second scheduled dose resulting in deviation from RABIES (HDC) VACCINE for pre-exposure due to his dose leaking with no adverse event (routine immunisation schedule incomplete) (Powder and solvent for suspension for injection) (unknown latency) (Frequency = ONCE) (Strength = standard) (lot V1E121M and expiry date: 04-Oct-2024).   It was reported that "Caller reporting a dose of IMOVAX leaked while the nurse was preparing for use, "the plunger came apart from the syringe and all of the vaccine leaked out of the back" of the barrel of the syringe. The leaking occurred while the nurse was "drawing up" the vaccine, the plunger separated from the syringe and all of the vaccine leaked out the back of the syringe by the plunger stopper. The vaccine then ran down the nurse's arm and onto the floor. Unknown to caller if the plunger came all of the way out of the barrel of the syringe. No other doses available at clinic. patient received first dose on 30-OCT-2023 and missed second on 06-Nov-2023."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.08
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: fluzone qiv pfs due to age 13 months. doses were given 3 weeks apart instead of 4 weeks apart with no reported adverse event; Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 13-month-old male patient who was given influenza quadrival A-B vaccine [Fluzone QIV]; 3 weeks apart instead of 4 weeks apart with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-Oct-2023, the patient received unknown Dose 1 of suspect influenza quadrival A-B vaccine, Suspension for injection (Batch number: UT8040NA; Expiry date: 30-Jun-2024) and then on 24-Oct-2023 he again received unknown Dose 2 of the same vaccine (Batch number: UT8134MA; expiry date: 30-Jun-2024) via unknown route in unknown administration site for Immunization; doses were given 3 weeks apart instead of 4 weeks apart with no reported adverse event (inappropriate schedule of product administration) (same day latency).  Reportedly, Pt needed a 2 dose series of FLUZONE QIV PFS due to age 13 months. Doses were given 3 weeks apart instead of 4 weeks apart.  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: 69.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: expired acthib that was administered to a patient of 69 years old yesterday with no reported adverse event; expired acthib that was administered to a patient of 69 years old yesterday with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 69 years old female patient who was administered expired HIB (PRP/T) VACCINE [ACT-HIB] yesterday with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Nov-2023, the patient of 69 years old was administered 0.5 mL dose of expired HIB (PRP/T) VACCINE [ACT-HIB] yesterday with no reported adverse event (expired product administered) and (product administered to patient of inappropriate age) (Powder and solvent for solution for injection) (Frequency = once) (Strength = Standard) (latency: same day) (lot UJ803AA and expiry date: 13-Aug-2023) via intramuscular route in unknown administration site for pre-operative immunization (Immunization).  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 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: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient inadvertently administering extra dose of FLUZONE HIGH DOSE QIV in one flu season with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 74 years old female patient who inadvertently administered extra dose of  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in one flu season with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Sep-2023, the patient received 0.7 mL dose 1 of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UT8157CA and expiry date: 30-Jun-2024) (Frequency = ONCE), (Strength = FLUZONE HIGH DOSE) via intramuscular route in the left deltoid and On 26-Oct-2023 she also received 0.7 mL dose 2 of the same vaccine.  On 26-Oct-2023, the patient inadvertently administering extra dose of  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE in one flu season with no reported adverse event (extra dose administered) (latency: 28 days).  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: 6.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of TYPHIM VI with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from non-healthcare professional.  This case involves a 6 years old female patient who received an expired dose of Typhoid VI Polysaccharide vaccine [TYPHIM VI] 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 Influenza vaccine (Influenza) for Prophylactic vaccination.  On 06-Nov-2023, the patient received an expired 0.5 ml dose (strength: standard) of suspect Typhoid VI polysaccharide vaccine Solution for injection of lot U2A471M and expiry: 02-Nov-2023 via intramuscular route in the right deltoid for immunization; with no reported adverse event (expired product administered) (latency: same day).  No lab data was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired dose of fluzone qiv np with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to case 2023SA345594.  This case involves a 21-year-old female patient who received an expired dose of influenza quadrival A-B vaccine [Fluzone QIV] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 27-Oct-2023, the patient received an unknown dose of suspect influenza quadrival A-B vaccine, Suspension for injection (strength, expiry date: unknown) (lot: UT7680NA) via intramuscular route in unknown administration site for prophylactic vaccination (immunization) and received an expired dose of fluzone qiv np with no reported adverse event (expired product administered) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered the fluzone quad (prefilled) that expired in june 2023 with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who administered the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] that expired in june 2023 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 expired dose of a 0.5 ml of suspect Suspension for injection of INFLUENZA QUADRIVAL A-B VACCINE (prefilled) (strength: standard) (lot UT7744JA, expiry date: 30-Jun-2023) via intramuscular route in the left arm as prophylactic vaccination (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out 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: 16.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: consumer received an extra dose prior to when the dose should have been given with no reported adverse event; consumer received an extra dose prior to when the dose should have been given with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2023SA350940.  This case involves a 16 years old male patient who received an extra dose of IPV (VERO) [IPOL] prior to when the dose should have been given 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 DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TENIVAC); HEPATITIS B VACCINE (HEPATITIS B VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); HPV VACCINE (HPV VACCINE) and VERESELA for prophylactic vaccination (Immunisation).  On 19-Mar-2023, the patient received 0.5 mL dose 1 of suspect IPV (VERO) (Suspension for injection) (Frequency = TWICE), (Strength = standard) (lot W1C751M and expiry date: 18-Nov-2025) via subcutaneous route in the right arm for Immunization. In September 2023, the patient also received 0.5 mL dose 2 of same vaccine.  On 01-Nov-2023 he also received an extra dose prior to when the dose should have been given with no reported adverse event (extra dose administered) and (inappropriate schedule of product administration) 7 months 13 days following the administration of IPV (VERO).  It was reported that "once the extra doses were already given and consumer did not need that second round of immunization, and the dose was given due to timing error."   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 and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received an expired dose of PENTACEL with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA350570.  This case involves a 1 years old female patient who received an expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero) 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 HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 07-Nov-2023, the patient received an expired 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ804AA, Expiry date: 07-Oct-2023 with unknown strength)  via intramuscular route in the right thigh as immunization with no reported adverse event (expired product administered) (Latency: same day).  It was reported "The nurse was asking for guidance on next steps, and she also wanted to know what to tell the patient's parents on what to watch out for in terms of adverse reactions."   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: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was administered to a patient after the expiration date with no reported adverse event; Initial information received on 08-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient  to whom experienced diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was administered after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Nov-2023, the patient received unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, suspension for injection (strength and lot number; not reported) Expiration Date: 30-Sep-2023 via unknown route in unknown administration site for prophylactic vaccination after the expiration date with no reported adverse event (expired product administered) (latency: on same day).  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 and Regulatory Authority 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: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: TENIVAC was administered post expiration with no reported adverse event; Initial information received on 08-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was administered post expiration 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 diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (expired product administered) (unknown 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: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, body aches, fever (100.5 F when measured 9 hours after start of symptoms).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Fever, high temperature, sweating, 12 hours
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Impaired work ability, Malaise, Pain in extremity
Clinical narrative: Symptoms started with chills same evening. Then intermittent sleep with achy joints and pain all the way down the injection arm. In the morning I had a slight fever of 100 and didn't feel well enough to go to work.  Achy joints and vomited after a piece of toast.  Intermittent sleep throughout the day. Nothing to eat.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Vomiting
Clinical narrative: Symptoms started with chills same evening. Then intermittent sleep with achy joints and pain all the way down the injection arm. In the morning I had a slight fever of 100 and didn't feel well enough to go to work.  Achy joints and vomited after a piece of toast.  Intermittent sleep throughout the day. Nothing to eat.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Decreased appetite, Malaise
Clinical narrative: Received his booster ( daughter says he has received all shots and thinks this is #8) at 10 AM on 11/15/23. Did not feel well rest of day. Did not eat. Died at 22:04 at home on 11/15/23
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Feeling hot, Hyperhidrosis
Clinical narrative: Parent reported that child was feeling hot and sweating 10 minutes after receiving vaccine. Parent also stated that patient had a similar reaction after previous influenza vaccination, but she did not disclose that at the check in station when asked.  On assessment, patient had visible perspiration and reported feeling tired, patient's parent also reported that patient had not eat breakfast. Vital signs completed, patient was provided with a lollipop and reported feeling better after eating lollipop. Vital signs were redone, and patient was transported the to facility ER  in wheelchair for observation accompanied by staff and the patient's father.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Muscular weakness, Myalgia, Nausea, Peripheral swelling
Clinical narrative: Arm swelling; muscle pain and weakness. Nausea flash at time of injection. Muscle pain and arm weakness persists
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Respiratory rate increased, Vomiting
Clinical narrative: Dizziness, vomiting, high respiratory rate (24), high heart rate for hours (above 120)
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: "rash" or "hives" on back of legs, under arms, neck/head
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Back pain
Clinical narrative: SEVER BACK PAIN RESULTING IN TRIP TO ER
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunisation reaction, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Swelling in upper left arm and red spots like bumps below vaccination site, extreme itching and almost looked like welps..showed pharmacy staff..went to my local dr and she diagnosed it as adverse reaction to the vaccine,  received steroid shot us antibiotics and triamcinolone medications
Age: 64.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Headache, Nausea, Pain, Seasonal allergy
Clinical narrative: Severe body aches, headache, slight nausea, no treatment
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain and soreness in arm. Patient has described as "tendonitis-like pain" starting shortly after receiving the vaccine and ongoing (until time of this report- 11/18/23)  Patient has not gone to seek treatment.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: PT CALLED AND SAID HER INJECTION SITE IS SORE AND HAS REDNESS THAT EXTENDS OUT FOR 4 INCHES.  I ASKED PATIENT TO PUT HYDROCORTISONE 1 % ON SITE AND REPORT TO DOCTOR IF REDNESS AREA INCREASES.
Age: 74.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Abnormal dreams, Dyspnoea
Clinical narrative: PATIENT COMPLAINED OF SHORTNESS OF BREATH AND DIFFICULTY BREATHING CAUSING RESTLESSNESS AND VIVID DREAMS
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Cardiac monitoring, Computerised tomogram head, Confusional state, Differential white blood cell count, Dysarthria
Clinical narrative: Encephalitis with associated emesis, confusion, slurring of speech
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Electrocardiogram, Encephalitis, Full blood count, Lipids, Magnetic resonance imaging head
Clinical narrative: Encephalitis with associated emesis, confusion, slurring of speech
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Metabolic function test, NIH stroke scale, Vomiting
Clinical narrative: Encephalitis with associated emesis, confusion, slurring of speech
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching and hives over entire arm 10 days after vaccine. vaccine given one week after CoVid booster and flu vaccine