chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: tingling going up and down my left arm right where I had the shot and my fingers; Pain; Feeling very tired; numbness in my fingers down the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN; ATORVASTATIN; LISINOPRIL; AMLODIPINE; OMEPRAZOLE; SERTRALINE. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, LOT#: GJ2524), administration date: 24Sep2022, for COVID-19 Immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, LOT#: FK9893, Expiry: 20Jun2022), administration date: 03May2022, for COVID-19 Immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, LOT#: FH8027, Expiry:Feb2022), administration date: 23Nov2021, for COVID-19 Immunization; bnt162b2 (DOSE 2, SINGLE, LOT#: EW0150), administration date: 05Apr2021, for COVID-19 Immunization; bnt162b2 (DOSE 1, SINGLE), administration date: 15Mar2021, for COVID-19 Immunization; Rsv vaccine (about 5 weeks before), administration date: Sep2023, for immunization; Flue shot, for immunization. The following information was reported: FATIGUE (non-serious) with onset 15Oct2023, outcome "not recovered", described as "Feeling very tired"; PAIN (non-serious) with onset 15Oct2023, outcome "not recovered", described as "Pain "; HYPOAESTHESIA (non-serious) with onset 15Oct2023, outcome "not recovered", described as "numbness in my fingers down the arm"; PARAESTHESIA (non-serious) with onset 15Oct2023, outcome "not recovered", described as "tingling going up and down my left arm right where I had the shot and my fingers". The events "tingling going up and down my left arm right where i had the shot and my fingers", "pain ", "feeling very tired" and "numbness in my fingers down the arm" required physician office visit. Therapeutic measures were taken as a result of paraesthesia, pain, fatigue, hypoaesthesia.  Additional information: patient was treated with Tylenol 500 milligrams. She stated she went to the Walk-In Clinic because of the pain she was having doctor could not find anything along with her besides the pain so, he suggested she guess it was from the 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.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram head, Musculoskeletal disorder, X-ray limb
Clinical narrative: I no longer have working legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient 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 included: "Open angle glaucoma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown", described as "I no longer have working legs". The event "i no longer have working legs" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Consumer stated that, he got his shot about a week ago and last night, he came in from a day of working outside and sat down on computer, couple of hours he worked there and when he went to got up, his knees were effectively all rubbery. Patient could not support himself. He had to use his arms in order to hold himself up. So, the patient thought it would get better in the morning, it did not. So, Patient went into the urgent care locally, they did a full X-ray of his knees on each side. They also did a CAT scan of his brain. They also took blood samples, and they could not detect anything immediately on the radar. The consumer stated he no longer had working legs. He did not receive vaccine from the previous 9 months or so.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5], has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 17Oct2023 to 21Oct2023. Clinical course: Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300351191 same patient, different drug and AE;
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 55-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 15:15 as dose 1, single (Lot number: HF9299) at the age of 55 years intramuscular, in left arm for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 28Oct2023 at 02:00, outcome "recovering", described as "Body aches"; CHILLS (non-serious) with onset 28Oct2023 at 02:00, outcome "recovering"; PYREXIA (non-serious) with onset 28Oct2023 at 02:00, outcome "recovering", described as "Fever". Therapeutic measures were taken as a result of pyrexia, pain, chills. Additional information: The patient had no other vaccines in four weeks or other medications in two weeks. The events were treated with acetaminophen. The patient has not been tested for COVID post vaccination. He has no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 17:15 as dose 1, single (Lot number: HG4628) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Vitiligo" (unspecified if ongoing); "Suspected celiac" (unspecified if ongoing), notes: uspected celiac-not an allergy but similar/Cannot consume anything with cross-contamination. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (vaccine brand=Pfizer BioNTech, vaccine brand unknown=False,, vaccine administration date=28Sep2022,, vaccine lot number=GJ5342,, vaccine lot unknown=False, vaccine dose number=4,, vaccine dose number unknown=False), administration date: 28Sep2022, when the patient was 35-year-old, for Covid-19 immunization; bnt162b2 (vaccine brand=Pfizer BioNTech,, vaccine brand unknown=False,, vaccine lot number=32030BD,, vaccine lot unknown=False, vaccine dose number=3,, vaccine dose number unknown=False,, vaccine location=Left arm), administration date: 19Nov2021, when the patient was 34-year-old, for Covid-19 immunization; bnt162b2 (vaccine brand=Pfizer BioNTech, vaccine brand unknown=False,, vaccine lot number=EP7534,, vaccine lot unknown=False, vaccine dose number=2,, vaccine dose number unknown=False,, vaccine location=Right arm), administration date: 19Mar2021, when the patient was 34-year-old, for Covid-19 immunization; bnt162b2 (vaccine brand=Pfizer BioNTech, vaccine brand unknown=False,, vaccine administration date=26Feb2021,, vaccine lot number=EN6198,, vaccine lot unknown=False, vaccine dose number=1,, vaccine dose number unknown=False,, vaccine location=Left arm), administration date: 26Feb2021, when the patient was 34-year-old, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2023) Negative, notes: I felt sick starting 19Oct2023 but tested negative using an at-home Binax rapid test; (20Oct2023) Positive, notes: I tested positive with covid on 20Oct2023. On this date a Binax brand at-home rapid test showed a very faint line (nearly invisible), while a Genabio brand at-home rapid test showed a very strong line and showed up positive within 15 seconds; (24Oct2023) Negative; (25Oct2023) Negative; (27Oct2023) Negative; (29Oct2023) Positive; (30Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Sep2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years for COVID-19 immunisation. The patient's relevant medical history included: "LASIK" (unspecified if ongoing); "Dry eyes" (unspecified if ongoing), notes: dry eyes due to botched LASIK and some mild GI issues, but otherwise healthy; "Mild GI issues" (unspecified if ongoing), notes: dry eyes due to botched LASIK and some mild GI issues, but otherwise healthy. The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 4 (booster), single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 3 (booster), single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 2, single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 1, single; manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: UNK
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: still having pain in my arm; have pain; it's shooting up to my elbow; it's shooting up in my shoulder; 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 rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 13Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2023, outcome "not recovered", described as "have pain"; ARTHRALGIA (non-serious) with onset 2023, outcome "not recovered", described as "it's shooting up in my shoulder"; ARTHRALGIA (non-serious) with onset 2023, outcome "not recovered", described as "it's shooting up to my elbow"; PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "not recovered", described as "still having pain in my arm". Additional information: The patient stated "I am still having pain in my arm and it's shooting up to my elbow. It's going on 6 weeks now and it's not getting any better sometimes when I lift up my arm. I have pain and it's shooting up in my shoulder and it hurts. "  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: decrease in inflammation and clearing of the skin, with slow, gradual disappearance of hard patches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): AE-010766 (Biontech).  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 included: "Scleroderma" (ongoing). Concomitant medication(s) included: NEEM taken for supplementation therapy. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "decrease in inflammation and clearing of the skin, with slow, gradual disappearance of hard patches".  Additional information: The reporter (patient) is a scleroderma patient in PRIVACY CITY and wanted to report marked improvement he/she had by taking Neem supplements while getting Pfizer vaccine shots every few weeks. He/she observed decrease in inflammation and clearing of the skin, with slow, gradual disappearance of hard patches. It seems that the vaccine induces some processes which make Neem work on the pathogen causing it. The synergy effect only lasts for 15 days, with sharp drop-off thereafter. His/her rheuma docotor said that it's very interesting and didn't want him/her to take any systemic drugs. Instead, the doctor wants to continue doing this thing, though it's getting harder as no boosters are authorized.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: RSV
Symptoms: Emotional distress
Clinical narrative: I have COPD. Caller later stated on the call. I've got COPD I mean it's even hard for me talk to you right now. I'm sorry I'm just upset it's really hard; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "I have COPD. Caller later stated on the call. I've got COPD I mean it's even hard for me talk to you right now. I'm sorry I'm just upset it's really hard".  Additional information: Caller called in seeking assistance with the Abrysvo vaccine.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site irritation, Vaccination site pain
Clinical narrative: felt like a tiny prick and felt like it did not go all the way in; felt irritated on the injection spot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 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: VACCINATION SITE IRRITATION (non-serious) with onset 25Oct2023, outcome "unknown", described as "felt irritated on the injection spot"; VACCINATION SITE PAIN (non-serious) with onset 25Oct2023, outcome "unknown", described as "felt like a tiny prick and felt like it did not go all the way in".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in May2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID Long Haul symptoms" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant) with onset 2021, 10 days after the suspect product(s) administration, outcome "not recovered", described as "Bells Palsy". The event "bells palsy" required emergency room visit. Therapeutic measures were taken as a result of bell's palsy. Clinical course: In May2021, Patient took our COVID Vaccine, assured by doctors it was safe and would help with patient's COVID Long Haul symptoms. 10 days later patient came down with Bells Palsy. Happening so suddenly he/she feared it was a stroke. After being rushed to the E.R. (Emergency Room) examined by physicians, the diagnosis was made. The Bells Palsy was only supposed to last 2 weeks to 6 months. It was been over 2 years now and it was permanent. Physical therapy, muscle therapy, medications and a surgery. Thousands of dollars and pain caused.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got the 2 COVID shots and still got the COVID Virus; I got the 2 COVID shots and still got the COVID Virus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 71-year-old 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got the 2 COVID shots and still got the COVID Virus". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Pushing multiple shots that were not vaccines against getting the disease at all. She got the 2 COVID shots and still got the COVID Virus and had to take Paxlovid for 5 days. She never had a flu shot and never had the flu of any kind.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Coagulopathy
Clinical narrative: a clotting issue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old 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: COAGULOPATHY (non-serious), outcome "unknown", described as "a clotting issue".  Additioanl information: The reporter stated most elements were relatable, however he developed a clotting issue a few months after receiving (bnt162b2), and considered the event as caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Illness
Clinical narrative: got the flu shot 2x & both times got sick as a dog 1 of the 2x i waz pregnant with my son it caused major problems for me; got the flu shot 2x & both times got sick as a dog 1 of the 2x i waz pregnant with my son it caused major problems for me; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case is linked to case 2023SA328390(CLUSTER).  This case involves Adult female patient who  got the flu shot (Influenza Vaccine) 2 times (2x) and both times got sick as a dog 1 of the 2x she waz pregnant with my son it caused major problems for her.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received a dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. Information on batch number was requested.  On an unknown date the patient who got the flu shot 2x & both times got sick as a dog 1 of the 2x i waz pregnant with my son it caused major problems for me (illness) (exposure during pregnancy) (unknown latency).  Relevant prenatal testing after exposure included not reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently gave expire pentacel to patient with no reported adverse event; Initial information received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves Infant patient of unknown gender who was inadvertently given expired 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.   On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (strength; lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). Information regarding batch number will be requested in this case.  On an unknown date the patient was inadvertently given expired pentacel to patient 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.
Age: 101.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given an expired pentacel with no reported adverse event; 101 year patient received vaccine with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 101-year-old female patient received vaccine with no reported adverse event and patient was given an expired 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 pneumococcal conjugate vaccine for Prophylactic vaccination; measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination; hepatitis A vaccine for prophylactic vaccination; and varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination.  On 25-Sep-2023, the patient received a dose 1 of 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ737AAA, expiry date: 18-Sep-2023) via intramuscular route in the right thigh for Immunization and patient was given an expired pentacel with no reported adverse event (expired product administered) and 101 year patient received vaccine with no reported adverse event (product administered to patient of inappropriate age) (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.
Age: 1.42
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Incorrect route of product administration, No adverse event
Clinical narrative: nurses administered a PENTACEL vaccine that was expired with no reported adverse event; administration of the medication through subcutaneous route with no reported adverse event; Initial information received on 23-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who was administered a Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] that was expired and administration of the medication through subcutaneous route with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Oct-2023, the patient received 0.5 ml total (1 X) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ786AA) (Expiry date: 12-Oct-2023) (Strength: Standard) (Frequency: once) via subcutaneous route in the right thigh (Right Vastus Lateralis) for immunization.  On 20-Oct-2023, the patient was administered a Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine that was expired and administration of the medication through subcutaneous route with no reported adverse event (expired product administered) (incorrect route of product administration) (latency: same day).  It was reported, Caller stated last Friday one of their nurses administered a PENTACEL vaccine that was expired. She said it was only about 8 days past the expiration date and is asking if there is any kind of "grace period" MIA told her that it is not recommended by Sanofi to use any expired products, no matter how far past the expiration date. Nurse supervisor reporting that an expired PENTACEL was administered and is seeking guidance. This situation is reported as a medication error due to the administration of an expired vaccine. This situation is reported as an off-label use as per local labelling due to the administration of the medication through an unapproved route. subcutaneous.  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: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient receiving a double dose of the vaccine with no reported adverse event; Initial information received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 years old male patient who received a double dose of the influenza quadrival A-B vaccine [Fluzone QIV] 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 meningococcal vaccine B RFHBP/NADA/NHBA OMV (Bexsero) for prophylactic vaccination (Immunisation).  On 23-Oct-2023, the patient received double doses of 0.5 ml once of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: UT8144A; expiry date: 30-Jun-2024) via intramuscular route in the left and right arm for prophylactic vaccination (Immunisation) (extra dose 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.
Age: 0.75
Sex: F
Vaccine: YF
Symptoms: Blindness, Brain injury, Loss of consciousness, Paralysis
Clinical narrative: lost consciousness; blindness; complete paralysis; severely brain damaged; Initial information received on 24-Oct-2023 regarding an unsolicited valid serious case received from pharmacist.  This case involves a 9 months old female patient who lost consciousness, blindness, complete paralysis and severely brain damaged after receiving vaccine Yellow Fever vaccine - [YF-VAX].  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 Yellow Fever vaccine-Solution for injection (strength, lot number and expiry: not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested.  On an unknown date, the patient developed lost consciousness (loss of consciousness) (latency: same day) following the administration of Yellow Fever vaccine. This event was assessed as medically significant. The patient was hospitalized for this event.  On an unknown date, the patient developed blindness, complete paralysis (paralysis) and severely brain damaged (brain injury) (unknown latency) following the administration of Yellow Fever vaccine. These events were assessed as medically significant. The patient was hospitalized for these events.  No lab data was reported.  Action taken was not applicable.  An unknown corrective treatment was received for all events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all events.; Sender's Comments: Sanofi company comment dated 01-Nov-2023: This case involves a 9 months old female patient who lost consciousness, blindness, complete paralysis and severely brain damaged after receiving vaccine Yellow Fever vaccine - [YF-VAX]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HD QIV was administered to a patient to 57 years old with no reported adverse event; Initial information was received on 24-Oct-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 57 years old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Oct-2023, the 57 year old patient received 0.7 ml of dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UT8094BA and expiry 30-JUN-2024) (formulation and strength: not reported) (product administered to patient of inappropriate age, latency same day) via intramuscular route in the right deltoid for prophylactic 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 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: 19.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of FLUZONE HD QIV to a 19-year-old patient, with no reported adverse event; Initial information received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 19-years-old female patient who was administered influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant: No Other Vaccines.  On 24-Oct-2023, the 19-years-old patient received 0.7 mL dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (Frequency: Once; batch number: UT8137DA; expiry date: 30-Jun-2024) via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event (product administered to patient of inappropriate age) (same day latency). Treatment: None  No additional information at the time of the report.  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: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event, Poor quality product administered, Product preparation issue
Clinical narrative: patient received 2 doses of DTaP-IPV from the PENTACEL vaccine with no reported adverse event; it was not reconstituted with the powder HIB portion with no reported adverse event; Initial information received on 24-Oct-2023 regarding an unsolicited valid  non-serious case received via Nurse.  This case involves a 4 years old female patient received 2 doses of dtap-ipv from the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] vaccine with no reported adverse event and it was not reconstituted with the powder hib portion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) nd family history were not provided.  On 24-Oct-2023, the patient received a dose 1 of 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ870AA, expiry date: 24-Mar-2024) via intramuscular route in the left deltoid for immunization and patient received 2 doses of dtap-ipv from the pentacel vaccine with no reported adverse event (extra dose administered) and it was not reconstituted with the powder hib portion with no reported adverse event (poor quality 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 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: IPV, UNK
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: patient came into the clinic for PPD tuberculin skin test but their medical assistant drew up 0.1 ML of IPOL and administered it to the patient with no reported adverse event; Initial information was received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient came into the clinic for TUBERCULIN TEST (ppd tuberculin skin test) but their medical assistant drew up 0.1 ml of  IPV (VERO) [IMOVAX POLIO] and administered it to the patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Oct-2023, the patient received a dose of 0.5 ml of suspect IPV (VERO) (Suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization and also received started taking tuberculin ppd (TUBERCULIN TEST) Unknown dosage unknown route unknown (with an unknown formulation, strength, expiry date, batch number) for Skin test. The information on batch number was requested.  On 24-Oct-2023 the patient came into the clinic for ppd tuberculin skin test but their medical assistant drew up 0.1 ml of ipol and administered it to the patient with no reported adverse event (latency : same day) (wrong product administered) following the administration of TUBERCULIN TEST and IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient came into the clinic for ppd tuberculin skin test but their medical assistant drew up 0.1 ml of ipol and administered it to the patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, Device leakage, Exposure via skin contact, No adverse event, Underdose
Clinical narrative: half of the medication leaked out from the part where the needle is attached to the syringe on the patient's arm with no adverse event; leaked on the patient's arm with no adverse event; Initial information was received on 25-Oct-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 23 years old female patient who experienced half of the medication leaked out from the part where the needle is attached to the syringe on the patient's arm and leaked on the patient's arm with no adverse event after receiving influenza quadrival A-B vaccine [Fluzone quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Oct-2023, the patient received a 0.5 ml, once dose of suspect influenza quadrival A-B vaccine Suspension for injection (lot UT8155LA, expiration date: 30-Jun-2024, strength: standard) via Left arm in unknown administration site for Immunization.  On 25-Oct-2023, half of the medication leaked out from the part where the needle is attached to the syringe on the patient's arm with no adverse event (accidental exposure to product) and leaked on the patient's arm with no adverse event (exposure via skin contact) (unknown latency) following the administration of influenza quadrival A-B vaccine.  Reportedly, none of the vaccine was administered to the patient. Caller is requesting for the replacement of the affected FLUZONE QIV pre-filled syringe, she mentions that they have a contract with Vaxcare and they were instructed to reach out to the manufacturer for replacement.   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: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event
Clinical narrative: received a second dose of FLUZONE HD QIV with no reported adverse event; Initial information received on 25-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 69 years old male patient who received a second dose of Influenza Quadrival A-B High dose HV Vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Oct-2023, the patient second dose with dosage 0.7 ml of suspect Influenza Quadrival A-B High dose HV Vaccine (lot U8162CA, expiry date: 30-JUN-2024 with unknown strength)  via intramuscular route in the left deltoid as immunization with no reported adverse event (extra dose administered) (Latency: same day).  It was reported "The patient presented at their pharmacy and requested a flu vaccine. After administration, the patient stated that he meant to ask for a COVID vaccine instead because he had already received his flu vaccine at his HCP (Healthcare professional). Caller requested any safety information available."   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: 12.0
Sex: M
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK inadvertently administered to a 12 year old patient with no adverse event; Initial information received on 26-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves flublok inadvertently administered to a 12 year old patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Oct-2023, the patient received 0.5 ml dose of suspect influenza quadrivalent recombinant vaccine lot QFAA23206, expiry date: 30-Jun-2024 via unknown route in the left arm for prophylactic vaccination (strength, formulation, route: unknown) was inadvertently administered to a 12 year old patient with no adverse event (product administered to patient of inappropriate age) (latency same day).  Action taken: not applicable.   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.