chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Fatigue, Product administered to patient of inappropriate age
Clinical narrative: increased fatigue; administration of FLUZONE HD to a pregnant patient, with no reported adverse event; Initial information received on 19-Nov-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 29 years old female pregnant patient who experienced increased fatigue after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd]. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was reported as 25-Feb-2024. The estimated due date is 01-Dec-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy.  Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix) for Immunisation; and Ferrous sulfate (Iron).  On 13-Nov-2024, the pregnant patient received a 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (strength: unknown, expiry date: 30-Jun-2025 and lot UT8409EA) via intramuscular route in the left deltoid as immunization (exposure during pregnancy) (latency: same day).  On 13-Nov-2024 the patient developed increased fatigue (fatigue) (latency: same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (increased fatigue)  At time of reporting, the outcome was Recovered / Resolved on an unknown date in 2024 for the event (increased fatigue).  Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Lacrimation increased, Nausea
Clinical narrative: Severe body aches and pains, nausea, extreme fatigue and weakness, scratchy throat, watery eyes, no appetite, excessive thirst
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Thirst, Throat irritation
Clinical narrative: Severe body aches and pains, nausea, extreme fatigue and weakness, scratchy throat, watery eyes, no appetite, excessive thirst
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Prostate cancer, Prostatectomy
Clinical narrative: Prostate Cancer; This clinical trial case, initially received on 28-May-2024, was reported by a health professional and concerns an elderly male subject.  Weight: 72 kg; Height: 185 cm  The subject was enrolled in the study  Past medical history included Hernias. At the time of the event the subject had Osteoarthritis.  Administration of company suspect drug: On 08-Dec-2023 10:25, the subject received aQIVc HD  vs QIVr vs aQIV for Prophylaxis of influenza, Dose regimen: .5 ml, Route of administration: Intramuscular. No additional suspect drugs.  Adverse reactions/events and outcomes: On 30-Jan-2024, one month and 23 days after receiving the blinded study vaccine aQIVc HD  vs QIVr vs aQIV, the subject experienced Prostate Cancer (Medically Significant, outcome: Recovered / resolved, stop date: 18-Jun-2024, Intensity: Severe). Subject was told that the cancer did not spread beyond prostate and planned prostatectomy on 18-Jun-2024. No further treatments were given or planned at this time.  Non-drug treatment/Other action taken:  aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable  Reporter's assessment: The Investigator considered the event of prostate cancer as severe and serious due to seriousness criterion of medical significance. The event was assessed as not related to the study vaccine and the alternative cause for the event was reported as other.  The subject remained blinded in the study.  Follow-up (22-Jun-2024) received from Investigator: Alternative cause for the event changed from concomitant disease to other. Narrative amended accordingly.  Follow-up (30-Aug-2024) received from investigator. Event stop date and event outcome updated.  Follow-up (19-Nov-2024) received from investigator. Event stop date updated and narrative updated accordingly.; Reporter's Comments: An elderly subject developed prostate cancer one month and 23 days after receiving the blinded study vaccine aQIVc HD  vs QIVr vs aQIV. In line with Investigator's causality assessment, the reported event assessed as not related to the study vaccine, due to biological implausibility. Listedness was assessed using version.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection, Streptococcus test positive
Clinical narrative: Pneumococcal infection; This spontaneous report has been downloaded from Regulatory Agency and refers to an adult (age group reported as 30-34 years) female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dose, strength, lot #, expiration date, site and route of administration, and indication were not provided).  On an unknown date in 2023, the patient experienced Pneumococcal infection (clinical category reported as no data provided). On an unknown date in 2023, Streptococcus pneumoniae serotyping showed not available. At the time of reporting, the outcome of the event was not known.  The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.   Upon internal review, the event of Pneumococcal infection was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: No data provided; This spontaneous report has been downloaded from Regulatory Authority and refers to an Adult male patient with an unknown exact age (age group was reported as: 30-34). The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), formulation: injection (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis.   On an unknown exact date in 2023, the patient experienced pneumococcal infection (no data provided). On an unknown exact date in 2023, the Streptococcus pneumoniae serotyping was performed but the result was not available. At the time of reporting, the outcome of pneumococcal infection was unknown.  The causal relationship was unknown.   Upon internal review, the event was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: pneumonia; This spontaneous report has been downloaded from Regulatory Authority and refers to male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with 2 doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2023, the patient experienced pneumonia. At the time of reporting, the outcome of the event pneumonia was not known.    The causal relationship between pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown. Upon internal review, the event pneumonia was determined to be medically significant.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Computerised tomogram spine, Contusion, Diarrhoea, Dizziness
Clinical narrative: Diarrhea with nausea started Friday and lasted till Wednesday following week.  10/26/2024 blurred vision, dizziness, seizure, abnormal gate, inability to speak for 30 minutes.  Following day left foot pain near toes.  11/3/2024 bruising in foot with swelling.  No injury.  11/13/2024 pain moved into left leg shooting pain into calf.  Pain moving up leg.  11/23/2024  noticiable breathing isssue.  Appear to be gasping for air.  11/24/2024 both legs hurt woke up screaming from pain.  Pain is worse at night or laying down.  Hurts to walk.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Gait disturbance, Nausea, Pain, Pain in extremity
Clinical narrative: Diarrhea with nausea started Friday and lasted till Wednesday following week.  10/26/2024 blurred vision, dizziness, seizure, abnormal gate, inability to speak for 30 minutes.  Following day left foot pain near toes.  11/3/2024 bruising in foot with swelling.  No injury.  11/13/2024 pain moved into left leg shooting pain into calf.  Pain moving up leg.  11/23/2024  noticiable breathing isssue.  Appear to be gasping for air.  11/24/2024 both legs hurt woke up screaming from pain.  Pain is worse at night or laying down.  Hurts to walk.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Screaming, Seizure, Sleep disorder, Ultrasound Doppler
Clinical narrative: Diarrhea with nausea started Friday and lasted till Wednesday following week.  10/26/2024 blurred vision, dizziness, seizure, abnormal gate, inability to speak for 30 minutes.  Following day left foot pain near toes.  11/3/2024 bruising in foot with swelling.  No injury.  11/13/2024 pain moved into left leg shooting pain into calf.  Pain moving up leg.  11/23/2024  noticiable breathing isssue.  Appear to be gasping for air.  11/24/2024 both legs hurt woke up screaming from pain.  Pain is worse at night or laying down.  Hurts to walk.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred, X-ray limb
Clinical narrative: Diarrhea with nausea started Friday and lasted till Wednesday following week.  10/26/2024 blurred vision, dizziness, seizure, abnormal gate, inability to speak for 30 minutes.  Following day left foot pain near toes.  11/3/2024 bruising in foot with swelling.  No injury.  11/13/2024 pain moved into left leg shooting pain into calf.  Pain moving up leg.  11/23/2024  noticiable breathing isssue.  Appear to be gasping for air.  11/24/2024 both legs hurt woke up screaming from pain.  Pain is worse at night or laying down.  Hurts to walk.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became swollen, red, warm and firm to touch. Dx with Cellulitis. Treated with Amoxicillin.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe vertigo
Age: 76.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: PATIENT HAD A LARGE AREA OF REDNESS AND SWELLING AT VACCINATION SITE WITH ITCHING
Age: 64.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: COVID-19, Laboratory test
Clinical narrative: Contracted covid 6 weeks after vaccination
Age: 81.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 21.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Customer reporting that a dose of VARIVAX was administered on 10/29/2024 after expiring on 10/4/2024. Product also underwent a temperature excursion. No additional AE, no PQC. No additional information.; Customer reporting that a dose of VARIVAX was administered on 10/29/2024 after expiring on 10/4/2024. Product also underwent a temperature excursion. No additional AE, no PQC. No additional information.; Customer reporting that a dose of VARIVAX was administered on 10/29/2024 after expiring on 10/4/2024. Product also underwent a temperature excursion. No additional AE, no PQC. No additional information.; This spontaneous report was received from a medical assistant referring to a 21-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-OCT-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W031816, expiration date: 05-OCT-2024, administered for prophylaxis (strength, dose and route of administration were not provided) after expiring on 04-OCT-2024 (Expired product administered). Product also underwent a temperature excursion (Product storage error). It was reported as 6 degree Fahrenheit to 14 degree Fahrenheit (6.0F) for 1 hour 1 minute 0 seconds; -58 degree Fahrenheit to 5 degree Fahrenheit (5.0F) for 0 hours 46 minutes 0 seconds and 6 degree Fahrenheit to 14 degree Fahrenheit (10.5F) for 0 hours 30 minutes 0 seconds. No additional adverse event (AE) (No adverse event).
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Pediatric dose adminsitered to adult; No reported signs/symptoms of adverse effects; This spontaneous report was received from a medical assistant refers to a 51-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pediatric dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB), formulation: intramuscular injection (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis (underdose). No additional adverse event reported (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: no adverse event; Pharmacist calling to request information on a pediatric dose of RECOMBIVAX HB that was administered to an adult patient on 10/28/2024. No additional information provided by customer. No additional AE, no PQC. No additional information.; This spontaneous report was received from a pharmacist regarding an adult patient (exact age not provided) of unspecified gender.  The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.  On 28-OCT-2024, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 0.5 mL, administered for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional information, adverse events (AE), and or product quality complaints (PQC) were provided by reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise
Clinical narrative: Malaise and generally not feeling well; unable to do activities; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of feeling unwell in number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced feeling unwell (Verbatim: Malaise and generally not feeling well) and activities of daily living impaired (Verbatim: unable to do activities). The outcome of the feeling unwell was resolved and the outcome of the activities of daily living impaired was not reported.   The reporter considered the feeling unwell to be related to Shingrix. It was unknown if the reporter considered the activities of daily living impaired to be related to Shingrix.  The company considered the feeling unwell to be related to Shingrix. It was unknown if the company considered the activities of daily living impaired to be related to Shingrix.   Additional Information: GSK receipt date: 29-OCT-2024 This is a report for multiple patients.  The Healthcare Professional reported hearing about malaise and generally not feeling well a week following Shingrix administration from patients.  When asked if patients reported experiencing malaise for a week, Healthcare Professional clarified that they told her a week later but she did not know how long it lasted.  It was usually resolved by then.  They described the malaise as severe and sometimes they could not do their activities.
Sex: U
Vaccine: RVX
Symptoms: Chest pain, Dysphonia, Fatigue, Oropharyngeal discomfort
Clinical narrative: I was barking like a seal; chest hurts so badly; throat was helped with gargling salt water; tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of voice alteration in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced voice alteration (Verbatim: I was barking like a seal), chest pain (Verbatim: chest hurts so badly), throat discomfort (Verbatim: throat was helped with gargling salt water) and tiredness (Verbatim: tired). The outcome of the voice alteration, chest pain, throat discomfort and tiredness were not reported.   It was unknown if the reporter considered the voice alteration, chest pain, throat discomfort and tiredness to be related to RSV vaccine.     It was unknown if the company considered the voice alteration, chest pain, throat discomfort and tiredness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 13-NOV-2024 This case was reported by a patient via interactive digital media. The patient reported that he/she got a reaction from the RSV vaccine. The patient was barking like a seal and his/her chest hurt so badly throat was helped with the gargling salt water and so very tired too. This was the first for a reaction happened but he/she was fine with Flu and Covid vaccines.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; pretty bad case of shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: pretty bad case of shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 13-NOV-2024  Physician reported that a patient had rheumatoid arthritis which had appeared to be preexisting before he took Shingrix.  The patient completed 2 dose series of Shingrix and came down with a pretty bad case of shingles.  The physician wondered if the patient's medicines for his rheumatoid might have lowered his immunity so that he got shingles even though he was fully immunized.  This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about details regarding  completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1) and Shingrix(Dose 2).
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: received a Men B, MCV4 is what the patient was needed/ incorrect vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number Z39XM, expiry date 31-OCT-2026) for prophylaxis.   Co-suspect products included Meningococcal vaccine conj (Meningococcal conjugate) for prophylaxis.   On 29-OCT-2024, the patient received the 1st dose of Bexsero. On an unknown date, the patient did not receive Meningococcal conjugate. On 29-OCT-2024, immediately after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: received a Men B, MCV4 is what the patient was needed/ incorrect vaccine). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-OCT-2024 The medical assistant reported regarding a vaccine error today (on the day of reporting) during clinic, an 11-year-old patient received a Men B (Bexsero), and wanted a little information about this before calling the patient. Reporter wanted to know if it was side effect to expect regarding this vaccine. The error was that the provider had placed an order for MCV4 immunization. MCV4 was what the patient was needed and he received Men B vaccine, which led to wrong vaccine administered.
Age: 86.0
Sex: F
Vaccine: HEPAB
Symptoms: Blood glucose increased, Condition aggravated, Diabetes mellitus
Clinical narrative: female received her second dose of TWINRIX 28-OCT-2024 in her left arm and her blood glucose level increased to over 400; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of blood glucose increased in a 86-year-old female patient who received HAB (Twinrix adult) (batch number 2553x, expiry date 25-SEP-2026) for prophylaxis.   Concurrent medical conditions included diabetes.   On 28-OCT-2024, the patient received the 2nd dose of Twinrix adult (left arm). In OCT-2024, an unknown time after receiving Twinrix adult, the patient experienced blood glucose increased (Verbatim: female received her second dose of TWINRIX 28-OCT-2024 in her left arm and her blood glucose level increased to over 400). The outcome of the blood glucose increased was unknown.   It was unknown if the reporter considered the blood glucose increased to be related to Twinrix adult and Twinrix Pre-Filled Syringe Device.     It was unknown if the company considered the blood glucose increased to be related to Twinrix adult and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 30-OCT-2024 The reporter called to report a patient received Twinrix in her left arm and her blood glucose level increased to over 400. The reporter stated that patient' s blood glucose was controlled with insulin prior to administration of Twinrix. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: female patient was administered an expired dose of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number M33G4) for prophylaxis.   On 06-OCT-2024, the patient received Shingrix. On 06-OCT-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: female patient was administered an expired dose of Shingrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 30-OCT-2024 Office Supervisor described that a patient was administered an expired dose of Shingrix, which led to expired vaccine used. The reporter asked that which should they advise. Vaccine detail and patient demographics were retrieved from the reporter's end. No further detail were obtained during this call.  The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: and never got the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st done of Shingrix in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: and never got the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 30-OCT-2024 A Healthcare Professional mentioned they were starting a new facility in which several patients got the first dose of Shingrix back in 2021 and never got the second dose.  The reporter asked if the patients had to restart the series or if they had to get an extra dose.  The reporter did not provide information about patients involved in this situation.  Till the time of reporting, the patients did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient has not yet received another dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over 4 years ago, on 30-OCT-2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient has not yet received another dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-NOV-2024 The pharmacist reported that patient had her first dose of Shingrix and has not yet received another dose. The Pharmacist did not have any lot number or expiration date information available for the initial dose. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. Reporter gave permission for follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose of Shingrix only 1 week after the 1st dose; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 11-NOV-2024, the patient received the 2nd dose of Shingrix. On 11-NOV-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose of Shingrix only 1 week after the 1st dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 18-NOV-2024 The reporter was the clinical coordinator.   Reported to field representative that a patient at their clinic received their 2nd dose of Shingrix only 1 week after the 1st dose. No patient information was provided. The reporter consented to follow up. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: FLUX
Symptoms: Asthenia, Chills, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: passed out. Collapsed. Unconscious; sweats; chills; feeling very weak; Initial information received on 22-Nov-2024 regarding an unsolicited valid  serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who had passed out collapsed unconscious, chills, sweats and feeling very weak after receiving influenza USP trival A-B high dose subvirion vaccine.  The patient's past medical history, medical treatment(s), Concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (Unknown strength and expiry date) with lot UT8437AA via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed passed out. collapsed. unconscious (loss of consciousness), chills, sweats (hyperhidrosis) and feeling very weak (asthenia) (approximately a few hours latency) following the administration of influenza USP trival A-B high dose subvirion vaccine.   Reportedly, I noticed nurses in the halfway giving free flu shots. I have not designed to accept flu shots in the past 17 years but, for some unknown reason, this time I did. That night, around midnight I woke up with chills and sweats, feeling very weak. I tottered into the kitchen where I promptly passed out. Collapsed. Unconscious. I dont know how long I was out - I had guess between 5 and 30 minutes. That was the first time I ever passed out from any medication or injury. I ended up going back to bed four times the following day, lost most of the second day, and part of the third. I have been informed that others have had similar reactions. I have learned that you are the manufacturer of the vaccine I was given and that the batch number was UT8437AA. Since collapsing unconscious is not one of the known side-effects of the vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was recovered/ resolved for the event loss of consciousness and  Unknown for the rest of the events.  Seriousness criteria: This event loss of consciousness was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 28-Nov-2024: This case involves an unknown age and unknown gender patient who had passed out collapsed unconscious, after receiving influenza USP trival A-B high dose subvirion vaccine. Further information regarding allergic history, medical history, concomitant medication and tolerance,  laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: FLUA4
Symptoms: Computerised tomogram head normal, Echocardiogram, Electrocardiogram, Facial paralysis, Magnetic resonance imaging head normal
Clinical narrative: Transient ischemic attack; This clinical trial case, initially received on 19-Aug-2024, was reported by a health professional and concerns an elderly female subject. Weight: 68.2 kg; Height: 170.1 cm  The subject was enrolled in the study  Past medical history included Back fusion surgery, Baldder suspension surgery, Hysterectomy. Drug history included duloxetine (Reaction: Allergy), Tramadol (Reaction: Allergy), Hydrocodone (Reaction: allergy). At the time of the event the subject had Dust mites allergy, hypertension, menopause, left hip trochanter bursitis, Type 2 diabetes mellitus, Barretts esophagus, spinal stenosis of lumber region, Lumbar radiculopathy, Osteopenia, pollen allergy.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug: On 28-Nov-2023 14:45, the subject received aQIVc HD  vs QIVr vs aQIV for Prophylaxis of influenza., Route of administration: Intramuscular.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 01-Aug-2024, the subject experienced Transient ischemic attack (Hospitalized, outcome: Recovered / Resolved, stop date: 03-Aug-2024). Hospital stay for Left sided facial droop Worked up for possible stroke like symptoms. echo, EKG, CT scan 2 MRIs performed with no evidence of acute intracranial pathology. On 03-Aug-2024 released from hospital with discharge Diagnosis of transient ischemic attack.  aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable  Reporter's assessment: The reporter considered the event Left-sided facial droop (Serious hospitalization) not related to the administration of the investigational drug. alternative cause of the event was: Other (Hospitalized for Transient Ischemic Attack).  Follow-up (21-Aug-2024) and (24-Aug-2024) received from Investigator. Updated event from Left-sided facial droop to Transient ischemic attack, concomitant stop date added  Follow-up (04-Oct-2024) received from an Investigator. alternative cause of event was added, updated concomitant dose , updated narrative accordingly.  Follow-up (23-Nov-2024) received from an Investigator: Hospitalization start and stop date updated, alternative cause of event updated, narrative updated.; Reporter's Comments: On 28-Nov-2023, the subject was vaccinated with the blinded study vaccine aQIVc HD vs QIVr vs aQIV. On 01-Aug-2024, eight months and 3 days after receiving the blinded study vaccine, the subject was hospitalized due to Transient ischaemic attack. The Sponsor agreed with Investigator's causality assessment and assessed the event as not related due to biological implausibility. The medical history of hypertension, type 2 diabetes mellitus and the back fusion surgery could be contributory factors.  Listedness was assessed using version.
Sex: F
Vaccine: FLUA4
Symptoms: Transient ischaemic attack
Clinical narrative: Transient ischemic attack; This clinical trial case, initially received on 19-Aug-2024, was reported by a health professional and concerns an elderly female subject. Weight: 68.2 kg; Height: 170.1 cm  The subject was enrolled in the study  Past medical history included Back fusion surgery, Baldder suspension surgery, Hysterectomy. Drug history included duloxetine (Reaction: Allergy), Tramadol (Reaction: Allergy), Hydrocodone (Reaction: allergy). At the time of the event the subject had Dust mites allergy, hypertension, menopause, left hip trochanter bursitis, Type 2 diabetes mellitus, Barretts esophagus, spinal stenosis of lumber region, Lumbar radiculopathy, Osteopenia, pollen allergy.  Concomitant medication: refer to appropriate report section.  Administration of company suspect drug: On 28-Nov-2023 14:45, the subject received aQIVc HD  vs QIVr vs aQIV for Prophylaxis of influenza., Route of administration: Intramuscular.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 01-Aug-2024, the subject experienced Transient ischemic attack (Hospitalized, outcome: Recovered / Resolved, stop date: 03-Aug-2024). Hospital stay for Left sided facial droop Worked up for possible stroke like symptoms. echo, EKG, CT scan 2 MRIs performed with no evidence of acute intracranial pathology. On 03-Aug-2024 released from hospital with discharge Diagnosis of transient ischemic attack.  aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable  Reporter's assessment: The reporter considered the event Left-sided facial droop (Serious hospitalization) not related to the administration of the investigational drug. alternative cause of the event was: Other (Hospitalized for Transient Ischemic Attack).  Follow-up (21-Aug-2024) and (24-Aug-2024) received from Investigator. Updated event from Left-sided facial droop to Transient ischemic attack, concomitant stop date added  Follow-up (04-Oct-2024) received from an Investigator. alternative cause of event was added, updated concomitant dose , updated narrative accordingly.  Follow-up (23-Nov-2024) received from an Investigator: Hospitalization start and stop date updated, alternative cause of event updated, narrative updated.; Reporter's Comments: On 28-Nov-2023, the subject was vaccinated with the blinded study vaccine aQIVc HD vs QIVr vs aQIV. On 01-Aug-2024, eight months and 3 days after receiving the blinded study vaccine, the subject was hospitalized due to Transient ischaemic attack. The Sponsor agreed with Investigator's causality assessment and assessed the event as not related due to biological implausibility. The medical history of hypertension, type 2 diabetes mellitus and the back fusion surgery could be contributory factors.  Listedness was assessed using version.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered, Fatigue, Somnolence
Clinical narrative: Some fatigue; Sleepiness; Patient was given two doses of Fluad in the same season; This spontaneous case, initially received on 08-Nov-2024, was reported by a health professional and concerns an elderly female patient.  At the time of the event the patient had memory issues. Concomitant medication: refer to appropriate report section.  Administration of company suspect drug(s): On 23-Oct-2024, the patient received Fluad Quadrivalent for Influenza immunization for 65 plus year old, Dose regimen: 0.5 ml, Administration route: not reported, Anatomical location: not reported, Lot number: No batch number available and will be requested upon follow up.  The patient also received Fluad Quadrivalent on an unknown date, Dose regimen: 0.5 ml, Administration route: not reported, Anatomical location: not reported, Lot number: No batch number available and will be requested upon follow up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 23-Oct-2024, the patient experienced Patient was given two doses of Fluad in the same season (outcome: Not reported)  The patient received accidentally two doses of Fluad, one dose at the reporter's clinic and then she went to the pharmacy and got another one, she has memory issues, so she forgot she'd already taken it She also received two doses of Covid-19 vaccine on the same day.  On an unknown date, the patient experienced Some fatigue (outcome: Not reported), Sleepiness (outcome: Not Reported).  No treatment received for the events.  Fluad Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter considered the events as non-serious and did not provided causality assessment.; Reporter's Comments: The events Some fatigue and Slipness are related and Patient was given two doses of Fluad in the same season are not related.
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Condition aggravated, Dyspnoea, Iron deficiency anaemia, Transfusion
Clinical narrative: Worsening of Iron Deficiency Anemia; This clinical trial case, initially received on 19-Nov-2024, with additional information received on 20-Nov-2024 and 22-Nov-2024 was reported by a health professional and concerns an elderly female subject.  Weight: 67 kg; Height: 184 cm  The subject was enrolled in the study   Past medical history included Coronary artery bypass grafting, Cardiac Medtronic Pacemaker Insertion, Amulet Insertion.  At the time of the event the subject had Recurring Bladder infections, Bilateral Glaucoma, Diabetic Neuropathy, Eczema, Coronary artery disease, Atrial fibrillation, Hyperlipidemia, Postmenopausal, Iron Deficiency Anemia, Bilateral Macular degeneration, Penicillin Allergy, Codeine Allergy, Celebrex Allergy, Latex Allergy, Seasonal Allergies, Irritable Bowel syndrome, Gastroesophageal Reflux Disease, Bilateral Ringing in Ears, Hypertension, Congestive Heart Failure, Type 2 Diabetes Mellitus, Hypothyroidism, Osteoarthritis, Osteopenia.  Concomitant medication: refer to appropriate report section.  The subject's historical vaccine included influenza vaccine (brand not specified) received in Aug-2022 for unreported indication.  Administration of company suspect drug: On 04-Dec-2023 11:55, the subject received aQIVc HD  vs QIVr vs aQIV for Prophylaxis of influenza, Dose regimen: .5 ml, Route of administration: Intramuscular, Lot number: No batch number available.  The study vaccine administered as per protocol.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 11-Nov-2024, the subject experienced Worsening of Iron Deficiency Anemia (Hospitalized, outcome: Not recovered / Not resolved, stop date: 16-Nov-2024).  Subject presented to emergency room on 11-Nov-2024 with SOB and generalized weakness. Subject was admitted to the hospital the same day and was provided blood and iron transfusions during her stay. Subject was discharged on 16-NOV- 2024. Medical records would be requested at the earliest. Pending Medical records.  aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable  Treatment medication: Blood Transfusion (Single)  Reporter's assessment: The investigator assessed the event Worsening of Iron Deficiency Anemia as serious due to the seriousness criterion of Hospitalization and event assess as not related to the administration of the study vaccine. The alternative cause of the event was reported as concomitant disease.  The subject remained blinded in the study.; Reporter's Comments: Causality: Not related based on implausible temporal and biological relationship (11 months 6 days) after administration of study vaccine. Concurrent condition of Iron Deficiency Anemia provides more plausible explanation. Listedness was assessed using version.
Sex: F
Vaccine: UNK
Symptoms: Cough, Gastrointestinal disorder, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, around 101.5 F; Stomach it's not bad just a little bit off; Runny nose; Body aches; Cough; This spontaneous case, initially received on 11-Nov-2024, was reported by a non health professional and concerns an elderly female patient.  Administration of company suspect drug(s): On an unknown date, the patient received Fluad (TIV) for active immunization for the prevention cf influenza disease caused by influenza virus subtypes A and B contained in the vaccine, Dose regimen: .5 ml, Route of administration: Not Reported, Lot number: No batch number available and will be requested upon follow-up   No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Fever, around 101.5 F (outcome: Unknown), Stomach it's not bad just a little bit off (outcome: Unknown), Runny nose (outcome: Unknown), Body aches (outcome: Unknown), Cough (outcome: Unknown). Event description Patient describes: she took Fluad a few days ago. She normally take every year. She is 75 years, and this year she had a lot of side effects. she had fever, around 101.5 F, her Stomach it's not bad just a little bit off, I'm having runny nose, her body aches and cough.  Fluad (TIV) action taken: Not Applicable  Reporter's assessment:  The reporter did not provide seriousness and causality assessment.; Reporter's Comments: Causality: Related for all the events.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache in the front portion of my head.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Injection site reaction, Psoriasis
Clinical narrative: Psoriasis patch at site of injection
Age: 8.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Dyspnoea
Clinical narrative: Short of breath,
Age: 8.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Abdominal pain, Axillary pain, Diarrhoea, Dyspnoea, Erythema
Clinical narrative: Short of breath,
Age: 8.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Oedema peripheral
Clinical narrative: Short of breath,
Age: 8.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Pyrexia
Clinical narrative: Short of breath,
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, Skin abrasion
Clinical narrative: 2 y.o. patient was not restrained properly by mother, and when vaccine was attempted to be administered to left anterolateral thigh, the leg moved, causing needle to dislodge from muscle and graze surface of skin of left leg upper thigh, leaving approximately 1 inch long abrasion. Of note, vaccine did not enter muscle and ended up on pantleg of mother who was attempting to restrain child during vaccine administration.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain, Nervous system disorder, Pain
Clinical narrative: I received a flu shot on Friday, October 25, 2024, at 1:20 PM while at work. By Sunday evening, I began experiencing mild neck pain. On Monday, the pain worsened, feeling like a stiff neck, and I struggled to sit upright for extended periods. By Tuesday, the pain intensified, radiating from my neck to my left shoulder and arm. It was severe enough that I thought it might be a heart issue. I monitored my blood pressure, used ibuprofen, and alternated between hot and cold compresses, but the pain persisted.  On Wednesday, October 30, I visited urgent care. The provider suspected my flu shot caused the pain, possibly by hitting a nerve, but they did not have an MRI machine to confirm this. They advised me to go to the ER. I also saw a chiropractor on October 31, who performed a thermal scan showing nervous system imbalance on my left side, especially in the arm and shoulder region. X-rays were taken and are still under review.  On the evening of October 31, I went to the ER because the pain became unbearable. They recommended I see an orthopedist for further evaluation. I then saw Dr., who prescribed steroids, which provided significant short-term relief.  Unfortunately, the pain returned, prompting me to see Dr. again on November 18. He prescribed another course of steroids for a longer period. However, my symptoms have not improved significantly, and I continue to experience severe pain. I am now filing this report to ensure my experience is documented.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, X-ray
Clinical narrative: I received a flu shot on Friday, October 25, 2024, at 1:20 PM while at work. By Sunday evening, I began experiencing mild neck pain. On Monday, the pain worsened, feeling like a stiff neck, and I struggled to sit upright for extended periods. By Tuesday, the pain intensified, radiating from my neck to my left shoulder and arm. It was severe enough that I thought it might be a heart issue. I monitored my blood pressure, used ibuprofen, and alternated between hot and cold compresses, but the pain persisted.  On Wednesday, October 30, I visited urgent care. The provider suspected my flu shot caused the pain, possibly by hitting a nerve, but they did not have an MRI machine to confirm this. They advised me to go to the ER. I also saw a chiropractor on October 31, who performed a thermal scan showing nervous system imbalance on my left side, especially in the arm and shoulder region. X-rays were taken and are still under review.  On the evening of October 31, I went to the ER because the pain became unbearable. They recommended I see an orthopedist for further evaluation. I then saw Dr., who prescribed steroids, which provided significant short-term relief.  Unfortunately, the pain returned, prompting me to see Dr. again on November 18. He prescribed another course of steroids for a longer period. However, my symptoms have not improved significantly, and I continue to experience severe pain. I am now filing this report to ensure my experience is documented.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Urticaria
Clinical narrative: Hives on legs bilaterally which increased in size and spread to back, shoulders and neck. Hives spread over 2-3 days and then turned to urticaria type spots and bruises.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Fatigue, Hyperhidrosis, Lethargy
Clinical narrative: Severe myalgias, arthralgias, with shivering and episodic diaphoresis lasting for about 16 hours, followed by fatigue, lethargy for the next 2A hours. Treatment was Tylenol, initial dose of Benadryl 50mg, hydration and bed rest.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Severe myalgias, arthralgias, with shivering and episodic diaphoresis lasting for about 16 hours, followed by fatigue, lethargy for the next 2A hours. Treatment was Tylenol, initial dose of Benadryl 50mg, hydration and bed rest.