chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; NYQUIL. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE: 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset Dec2023, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Dec2023, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 12Dec2023 to 17Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 61.0
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 Consumer or other non HCP.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 13Dec2023 to 18Dec2023.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Physician.  A 47-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine with aura" (unspecified if ongoing); "mood disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "OSA" (unspecified if ongoing); "Cephalosporin allergy" (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; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Dec2023) Negative; (20Dec2023) Negative; (21Dec2023) Negative; (22Dec2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 14Dec2023 to 18Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported events Vaccination Failure and COVID-19 cannot be ruled out
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Lot number: HG2649) at the age of 37 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pcos" (unspecified if ongoing); "overweight" (unspecified if ongoing); "OCD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (Booster); Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4 (Booster); Manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 13Dec2023 to 18Dec2023.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma moderate" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 17Dec2023 to 21Dec2023. Clinical course: The patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE: 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE: 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE: 2, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE: 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other vaccination in 2 weeks and did not receive other medication in 2 weeks. Paxlovid was given as treatment for COVID-19 from 14Dec2023 to 19Dec2023  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and 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 Nurse.  A 28-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. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER); UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other vaccination and medication in 2 weeks. Paxlovid was given as treatment for COVID-19 from 16Dec2023 to 20Dec2023  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Physician.  A 54-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 as dose 1, single (Lot number: HF9298) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia", stop date: Dec2021, notes: Please note that , the adverse event resolved Dec2021 - this form didn't let , me select that); "migraines", stop date: Dec2021, notes: Please note that , the adverse event resolved Dec2021 - this form didn't let , me select that). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jun2023, stop date: 07Dec2023; VITAMIN D NOS, start date: 01Jun2023, stop date: 07Dec2023; OMEGA 3 [FISH OIL], start date: 01Jun2023, stop date: 07Dec2023; MAGNESIUM MALATE, start date: 01Jun2023, stop date: 07Dec2023; DOXEPIN, start date: 01Jun2023, stop date: 07Dec2023; COQ10 [UBIDECARENONE], start date: 01Jun2023, stop date: 07Dec2023. The patient also took other concomitant therapy. Past drug history included: Relafen, reaction(s): "known allergies: Relafen". Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE  5 (BOOSTER), SINGLE, Batch/Lot No: GH9703), administration date: 08Oct2022, when the patient was 53-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FP7135), administration date: 18Jul2022, when the patient was 52-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (DOSE 3, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 29Oct2021, when the patient was 52-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (DOSE 2, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 01Feb2021, when the patient was 51-year-old, for COVID-19 Immunization; moderna COVID-19 vaccine (DOSE 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 04Jan2021, when the patient was 51-year-old, for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other vaccination and medication in 2 weeks. Paxlovid was taken as treatment for COVID-19 from 08Dec2023 to 12Dec2023; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 43-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 had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other vaccination in 2 weeks and did not receive other medication in 2 weeks. Paxlovid was taken as treatment for COVID-19 from 22Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 02:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative, notes: I tested negative on the 8th day and did so for 3 additional days; (Dec2023) Positive, notes: I am now testing positive again; (Dec2023) Negative, notes: I tested negative on the 8th day and did so for 3 additional days; (Dec2023) Negative, notes: I tested negative on the 8th day and did so for 3 additional days; (Dec2023) Negative, notes: I tested negative on the 8th day and did so for 3 additional days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other vaccination and did not receive other medication in 2 weeks. Paxlovid was taken as treatment for COVID-19 from 18Dec2023 to 22Dec2023. The patient stated that after taking a full 5 days of Paxlovid for covid 19, I tested negative on the 8th day and did so for 3 additional days. My symptoms have returned and I am now testing positive again. At my birth day party which was scheduled on the 4th straight day of negative testing, everyone was exposed-your responsibility.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: The syringe broke after reconstitution at the neck joint while drawing liquid out of vial; This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM7645, Expiration Date: Feb2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "The syringe broke after reconstitution at the neck joint while drawing liquid out of vial". Additional information: reporter stated: "Hi (name withheld) and/or the group, Out site at withheld has experienced a broken syringe in the Abrysvo kit. The syringe broke after reconstitution at the neck joint while drawing liquid out of vial and I'm wondering if I can work directly with you or should we go thru our clinical team? The lot is HM7645 and expiry is Feb2025. Thank you!"  Causality for "the syringe broke after reconstitution at the neck joint while drawing liquid out of vial" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Dizziness, Headache, Malaise, SARS-CoV-2 test
Clinical narrative: Feeling like he was getting sick; Lightheaded foggy feeling in his head, body; Lightheaded foggy feeling in his head, body; Headache; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2 NOS, reported as "Pfizer vaccine", pending clarification), in 2021 as dose number unknon, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Feeling like he was getting sick"; BRAIN FOG (non-serious), DIZZINESS (non-serious), outcome "unknown" and all described as "Lightheaded foggy feeling in his head, body"; HEADACHE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, brain fog, dizziness, headache included Paxlovid.  Additional information: The reporter mentioned that he only got one shot of the Pfizer vaccine (did not specify the name of the vaccine, pending clarification) 2 years ago and has some health issues. He started feeling like he was getting sick (Lightheaded foggy feeling in his head, body, and headache but it has mild symptoms he does not have any fever like his wife and daughter had. The doctor prescribed him Paxlovid even though he was testing negative on the rapid test, he thinks it is because of his vaccination status.
Sex: U
Vaccine: RSV
Symptoms: Cough, Lower respiratory tract infection, Respiratory tract congestion
Clinical narrative: chest cold; chest stuff; coughing; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old patient 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: LOWER RESPIRATORY TRACT INFECTION (medically significant), outcome "unknown", described as "chest cold"; RESPIRATORY TRACT CONGESTION (non-serious), outcome "unknown", described as "chest stuff"; COUGH (non-serious), outcome "unknown", described as "coughing". Clinical courses: the patient kept getting chest stuff, chest cold, and coughing.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I became very ill; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4, manufacturer unknown), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious) with onset 09Dec2023, outcome "unknown", described as "I became very ill".  Additional information: the patient believed he/she had an adverse reaction from this injection. This was the 5th Covid shot the patient received, and the only time that the patient became very ill the next day and lasted for approximately 24 hours.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown". Additional information: it seemed the patient had tinnitus and it started after the Covid shot. The patient was going to a Dr to see what could be done.  Batch/lot number is not provided, and it cannot be obtained.
Age: 61.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Allergy to vaccine, Arthralgia, Product administered at inappropriate site
Clinical narrative: Bad reaction to the flu shot [Allergy to vaccine]; Shoulder pain; Shot was too high on her shoulder [Shoulder pain]; Initial information received on 16-Dec-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves a 61 years old female patient (312 kg) who experienced bad reaction to the flu shot [allergy to vaccine] and shoulder pain; shot was too high on her shoulder [shoulder pain] after receiving Influenza Vaccine and while treated with Treprostinil Sodium [Remodulin].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included Amitriptyline (Amitriptyline); Clonidine (Clonidine); Ketamine (Ketamine); Ketoprofen (Ketoprofen); Lecithin (Lecithin); Lidocaine (Lidocaine); Poloxamer (Poloxamer); Sildenafil (Sildenafil); Vitamin D3 (Vitamin D3); Elasomeran (Moderna Covid-19 Vaccine); Furosemide (Furosemide); Methotrexate (Methotrexate); Folic Acid (Folic Acid); Atorvastatin Calcium (Lipitor); Acetylsalicylic Acid (Aspirine); Carvedilol (Carvedilol); And Potassium Chloride (Potassium Chloride).  On 20-Aug-2012, the patient started taking Remodulin (Treprostinil Sodium) Injection, 10.0 mg/ml via subcutaneous (with an unknown expiry date, batch number) for Pulmonary arterial hypertension. On an unknown date, the patient received a unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for flu vaccination.  On an unknown date the patient developed bad reaction to the flu shot [allergy to vaccine] (allergy to vaccine) and shoulder pain; shot was too high on her shoulder [shoulder pain] (arthralgia) (unknown latency).  Action taken with Treprostinil Sodium (Remodulin) was unknown. Action taken with Influenza Vaccine (Influenza Vaccine) was not applicable.  It was not reported if the patient received a corrective treatment for the events (Bad reaction to the flu shot [Allergy to vaccine], Shoulder pain; Shot was too high on her shoulder [Shoulder pain]).  At time of reporting, the outcome was Unknown for the event bad reaction to the flu shot [allergy to vaccine] and was Unknown for the event shoulder pain; shot was too high on her shoulder [shoulder pain].
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: they have a patient that was inadvertently given a dose of the YF-VAX intramuscularly instead of the recommended subcutaneous route with no reported adverse event; Initial information received on 18-Dec-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender who have a patient that was inadvertently given a dose of the YELLOW FEVER VACCINE - [YF-VAX] intramuscularly instead of the recommended 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 an unknown date, the patient received a unknown dose of suspect YELLOW FEVER VACCINE - (Solution for injection) (strength, expiry date, lot number not reported) via intramuscular route in unknown administration site for Immunization and have a patient that was inadvertently given a dose of the yf-vax intramuscularly instead of the recommended subcutaneous route with no reported adverse event (incorrect route of product administration) (latency: same day) .  Action taken with YELLOW FEVER VACCINE (YF-VAX) was not applicable.  At time of reporting, the outcome was Unknown for the event they have a patient that was inadvertently given a dose of the yf-vax intramuscularly instead of the recommended subcutaneous route 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: 45.0
Sex: F
Vaccine: FLUC3
Symptoms: Hypoaesthesia
Clinical narrative: Numbness on face both sides; This spontaneous case was received on 21-Dec-2023, reported by pharmacist (reference number: SEQW23-04977), and concerned a 45-year-old, female patient.   The patient's medical history and concomitant medications were not reported.  On 21-Dec-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, anatomical location, and route of administration: not reported) as seasonal flu vaccine. The batch number reported was 944480 and expiry date was 30-Jun-2024.  On the same date, 45 minutes after receiving Flucelvax Quadrivalent, the patient called pharmacist and stated that experienced numbness on face on both sides.  At the time of the initial reporting, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 45-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, 45 minutes following vaccination, the patient experienced hypoaesthesia. Information regarding medical history and concomitant drugs was not provided. Causality is assessed as possible, due to suggestive temporal relationship.; Sender's Comments: A 45-year-old patient was vaccinated with Flucelvax Quadrivalent. On the same day, 45 minutes following vaccination, the patient experienced hypoaesthesia. Information regarding medical history and concomitant drugs was not provided. Causality is assessed as possible, due to suggestive temporal relationship.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hives started 2 days after the vaccine booster. They are itchy, red, migratory, large patchy and sometimes targetoid in shape and cover my entire body from head to toe, sometimes including my upper lip. They are worse in the morning and tend to go away in the evening but not always.  I have used antihistamines (Benadryl, hydroxyzine, Claritin, Zyrtec) and a course of steroids. They improved with the steroids and then came back a week or 2 later but a little better than when they first started. However they worsened again to full body and I still wake up with them daily now almost 2 months later.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Dizziness, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: lots of pain swelling at site , muscle pain, achey, light headed. Tired. Loss of appetite,
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Pain
Clinical narrative: lots of pain swelling at site , muscle pain, achey, light headed. Tired. Loss of appetite,
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: underage patient inadvertently received adacel with no reported adverse event; Initial information received on 20-Dec-2023 regarding an unsolicited valid  non-serious case received from nurse.  This case involves a 2 years old male patient who inadvertently received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Dec-2023, the patient received 0.5 ml (Total) of Suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: U7898AA) (Strength: standard) (Frequency: once) (Expiry date: unknown) via intramuscular route in the left thigh for immunization.  On 20-Dec-2023, the patient inadvertently received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported,  The physician wants to know if the dose can be counted as valid and what side effects the child should be monitored. This situation is pre-assessed as a medication error/an inappropriate use due to the product being administered to a patient that is not of age.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Pain in extremity, Rash, Rash macular
Clinical narrative: Red blotch appeared two days after shot; It was now very painful; Overdose; The pain in my arm; This non-serious case was reported by a consumer and described the occurrence of pain in arm in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number Xp24G) for prophylaxis.   Concurrent medical conditions included blood pressure high. Concomitant products included amlodipine and acetylsalicylic acid (Baby Aspirin).   On 14-DEC-2023, the patient received Arexvy 1 ml. On 14-DEC-2023, an unknown time after receiving Arexvy, the patient experienced overdose (Verbatim: Overdose). In DEC-2023, the patient experienced pain in arm (Verbatim: The pain in my arm). On 16-DEC-2023, the patient experienced red blotches (Verbatim: Red blotch appeared two days after shot) and painful rash (Verbatim: It was now very painful). The outcome of the pain in arm, red blotches and painful rash were not resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the pain in arm, red blotches and painful rash to be related to Arexvy.     It was unknown if the company considered the pain in arm, red blotches and painful rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-DEC-2023. The pain in patient arm started a few hours ago. The patient emailed her doctor to see what she would advise. Red blotch appeared two days after shot . It was now very painful. The patient received 1ml Arexvy which led to overdose. The reporter did not consent to follow up.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: chronic DVT's in left arm same as site injection. on blood thinners for life now
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Acute motor-sensory axonal neuropathy, Albumin globulin ratio increased, Albumin globulin ratio normal, Amino acid level, Anion gap
Clinical narrative: That evening (10-24-22) I experienced significant burning in both feet & both hands. It escalated over the next week and the burning spread to hands and face with tingling also in both arms and both legs. Toes, bottom of feet and finger tips became numb. Significant itching and random needle stick pains. Fatigue, insomnia, brain fog, ANXIETY, & some balance issues!!. 10-24 - Dr. visit 10/31 - Dr telephone 11/1 - Dr - office Tried gabapentin - 3 months. 11/1/22 office visit Dr prednisone - 30mg reported symptoms 11/11/ Dr. - Neurology possible acute neuritis due to flu shot 11/21 EMG Tried gabapentin 300mg up to 900mg - too many side effects so stopped.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Antineutrophil cytoplasmic antibody negative, Antineutrophil cytoplasmic antibody positive, Anxiety, Aspartate aminotransferase normal, Balance disorder
Clinical narrative: That evening (10-24-22) I experienced significant burning in both feet & both hands. It escalated over the next week and the burning spread to hands and face with tingling also in both arms and both legs. Toes, bottom of feet and finger tips became numb. Significant itching and random needle stick pains. Fatigue, insomnia, brain fog, ANXIETY, & some balance issues!!. 10-24 - Dr. visit 10/31 - Dr telephone 11/1 - Dr - office Tried gabapentin - 3 months. 11/1/22 office visit Dr prednisone - 30mg reported symptoms 11/11/ Dr. - Neurology possible acute neuritis due to flu shot 11/21 EMG Tried gabapentin 300mg up to 900mg - too many side effects so stopped.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Basophil count decreased, Basophil percentage, Biopsy, Biopsy skin, Blood 25-hydroxycholecalciferol
Clinical narrative: That evening (10-24-22) I experienced significant burning in both feet & both hands. It escalated over the next week and the burning spread to hands and face with tingling also in both arms and both legs. Toes, bottom of feet and finger tips became numb. Significant itching and random needle stick pains. Fatigue, insomnia, brain fog, ANXIETY, & some balance issues!!. 10-24 - Dr. visit 10/31 - Dr telephone 11/1 - Dr - office Tried gabapentin - 3 months. 11/1/22 office visit Dr prednisone - 30mg reported symptoms 11/11/ Dr. - Neurology possible acute neuritis due to flu shot 11/21 EMG Tried gabapentin 300mg up to 900mg - too many side effects so stopped.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood arsenic increased, Blood bilirubin normal, Blood calcium normal
Clinical narrative: That evening (10-24-22) I experienced significant burning in both feet & both hands. It escalated over the next week and the burning spread to hands and face with tingling also in both arms and both legs. Toes, bottom of feet and finger tips became numb. Significant itching and random needle stick pains. Fatigue, insomnia, brain fog, ANXIETY, & some balance issues!!. 10-24 - Dr. visit 10/31 - Dr telephone 11/1 - Dr - office Tried gabapentin - 3 months. 11/1/22 office visit Dr prednisone - 30mg reported symptoms 11/11/ Dr. - Neurology possible acute neuritis due to flu shot 11/21 EMG Tried gabapentin 300mg up to 900mg - too many side effects so stopped.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood chloride normal, Blood copper, Blood creatinine normal, Blood glucose normal, Blood lead normal
Clinical narrative: That evening (10-24-22) I experienced significant burning in both feet & both hands. It escalated over the next week and the burning spread to hands and face with tingling also in both arms and both legs. Toes, bottom of feet and finger tips became numb. Significant itching and random needle stick pains. Fatigue, insomnia, brain fog, ANXIETY, & some balance issues!!. 10-24 - Dr. visit 10/31 - Dr telephone 11/1 - Dr - office Tried gabapentin - 3 months. 11/1/22 office visit Dr prednisone - 30mg reported symptoms 11/11/ Dr. - Neurology possible acute neuritis due to flu shot 11/21 EMG Tried gabapentin 300mg up to 900mg - too many side effects so stopped.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood mercury, Blood osmolarity decreased, Blood potassium normal, Blood sodium decreased, Blood urea normal
Clinical narrative: That evening (10-24-22) I experienced significant burning in both feet & both hands. It escalated over the next week and the burning spread to hands and face with tingling also in both arms and both legs. Toes, bottom of feet and finger tips became numb. Significant itching and random needle stick pains. Fatigue, insomnia, brain fog, ANXIETY, & some balance issues!!. 10-24 - Dr. visit 10/31 - Dr telephone 11/1 - Dr - office Tried gabapentin - 3 months. 11/1/22 office visit Dr prednisone - 30mg reported symptoms 11/11/ Dr. - Neurology possible acute neuritis due to flu shot 11/21 EMG Tried gabapentin 300mg up to 900mg - too many side effects so stopped.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood zinc, Borrelia test, Brain fog, Burning sensation, Carbon dioxide normal
Clinical narrative: That evening (10-24-22) I experienced significant burning in both feet & both hands. It escalated over the next week and the burning spread to hands and face with tingling also in both arms and both legs. Toes, bottom of feet and finger tips became numb. Significant itching and random needle stick pains. Fatigue, insomnia, brain fog, ANXIETY, & some balance issues!!. 10-24 - Dr. visit 10/31 - Dr telephone 11/1 - Dr - office Tried gabapentin - 3 months. 11/1/22 office visit Dr prednisone - 30mg reported symptoms 11/11/ Dr. - Neurology possible acute neuritis due to flu shot 11/21 EMG Tried gabapentin 300mg up to 900mg - too many side effects so stopped.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac electrophysiologic study abnormal, Electromyogram abnormal, Electrophoresis protein normal, Eosinophil count decreased, Fatigue
Clinical narrative: That evening (10-24-22) I experienced significant burning in both feet & both hands. It escalated over the next week and the burning spread to hands and face with tingling also in both arms and both legs. Toes, bottom of feet and finger tips became numb. Significant itching and random needle stick pains. Fatigue, insomnia, brain fog, ANXIETY, & some balance issues!!. 10-24 - Dr. visit 10/31 - Dr telephone 11/1 - Dr - office Tried gabapentin - 3 months. 11/1/22 office visit Dr prednisone - 30mg reported symptoms 11/11/ Dr. - Neurology possible acute neuritis due to flu shot 11/21 EMG Tried gabapentin 300mg up to 900mg - too many side effects so stopped.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Glomerular filtration rate normal, Haematocrit normal, Haemoglobin normal, Hypoaesthesia, Immunology test
Clinical narrative: That evening (10-24-22) I experienced significant burning in both feet & both hands. It escalated over the next week and the burning spread to hands and face with tingling also in both arms and both legs. Toes, bottom of feet and finger tips became numb. Significant itching and random needle stick pains. Fatigue, insomnia, brain fog, ANXIETY, & some balance issues!!. 10-24 - Dr. visit 10/31 - Dr telephone 11/1 - Dr - office Tried gabapentin - 3 months. 11/1/22 office visit Dr prednisone - 30mg reported symptoms 11/11/ Dr. - Neurology possible acute neuritis due to flu shot 11/21 EMG Tried gabapentin 300mg up to 900mg - too many side effects so stopped.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Laboratory test, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: That evening (10-24-22) I experienced significant burning in both feet & both hands. It escalated over the next week and the burning spread to hands and face with tingling also in both arms and both legs. Toes, bottom of feet and finger tips became numb. Significant itching and random needle stick pains. Fatigue, insomnia, brain fog, ANXIETY, & some balance issues!!. 10-24 - Dr. visit 10/31 - Dr telephone 11/1 - Dr - office Tried gabapentin - 3 months. 11/1/22 office visit Dr prednisone - 30mg reported symptoms 11/11/ Dr. - Neurology possible acute neuritis due to flu shot 11/21 EMG Tried gabapentin 300mg up to 900mg - too many side effects so stopped.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Mean cell volume normal, Mean platelet volume normal, Monocyte count, Monocyte percentage, Neutrophil count normal
Clinical narrative: That evening (10-24-22) I experienced significant burning in both feet & both hands. It escalated over the next week and the burning spread to hands and face with tingling also in both arms and both legs. Toes, bottom of feet and finger tips became numb. Significant itching and random needle stick pains. Fatigue, insomnia, brain fog, ANXIETY, & some balance issues!!. 10-24 - Dr. visit 10/31 - Dr telephone 11/1 - Dr - office Tried gabapentin - 3 months. 11/1/22 office visit Dr prednisone - 30mg reported symptoms 11/11/ Dr. - Neurology possible acute neuritis due to flu shot 11/21 EMG Tried gabapentin 300mg up to 900mg - too many side effects so stopped.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Neutrophil percentage increased, Pain, Paraesthesia, Pathology test, Platelet count normal
Clinical narrative: That evening (10-24-22) I experienced significant burning in both feet & both hands. It escalated over the next week and the burning spread to hands and face with tingling also in both arms and both legs. Toes, bottom of feet and finger tips became numb. Significant itching and random needle stick pains. Fatigue, insomnia, brain fog, ANXIETY, & some balance issues!!. 10-24 - Dr. visit 10/31 - Dr telephone 11/1 - Dr - office Tried gabapentin - 3 months. 11/1/22 office visit Dr prednisone - 30mg reported symptoms 11/11/ Dr. - Neurology possible acute neuritis due to flu shot 11/21 EMG Tried gabapentin 300mg up to 900mg - too many side effects so stopped.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Protein total normal, Pruritus, Red blood cell count normal, Red blood cell sedimentation rate normal, Red cell distribution width normal
Clinical narrative: That evening (10-24-22) I experienced significant burning in both feet & both hands. It escalated over the next week and the burning spread to hands and face with tingling also in both arms and both legs. Toes, bottom of feet and finger tips became numb. Significant itching and random needle stick pains. Fatigue, insomnia, brain fog, ANXIETY, & some balance issues!!. 10-24 - Dr. visit 10/31 - Dr telephone 11/1 - Dr - office Tried gabapentin - 3 months. 11/1/22 office visit Dr prednisone - 30mg reported symptoms 11/11/ Dr. - Neurology possible acute neuritis due to flu shot 11/21 EMG Tried gabapentin 300mg up to 900mg - too many side effects so stopped.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Skin burning sensation, Vitamin B1, Vitamin B12 normal, Vitamin B6, Vitamin test
Clinical narrative: That evening (10-24-22) I experienced significant burning in both feet & both hands. It escalated over the next week and the burning spread to hands and face with tingling also in both arms and both legs. Toes, bottom of feet and finger tips became numb. Significant itching and random needle stick pains. Fatigue, insomnia, brain fog, ANXIETY, & some balance issues!!. 10-24 - Dr. visit 10/31 - Dr telephone 11/1 - Dr - office Tried gabapentin - 3 months. 11/1/22 office visit Dr prednisone - 30mg reported symptoms 11/11/ Dr. - Neurology possible acute neuritis due to flu shot 11/21 EMG Tried gabapentin 300mg up to 900mg - too many side effects so stopped.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: White blood cell count normal
Clinical narrative: That evening (10-24-22) I experienced significant burning in both feet & both hands. It escalated over the next week and the burning spread to hands and face with tingling also in both arms and both legs. Toes, bottom of feet and finger tips became numb. Significant itching and random needle stick pains. Fatigue, insomnia, brain fog, ANXIETY, & some balance issues!!. 10-24 - Dr. visit 10/31 - Dr telephone 11/1 - Dr - office Tried gabapentin - 3 months. 11/1/22 office visit Dr prednisone - 30mg reported symptoms 11/11/ Dr. - Neurology possible acute neuritis due to flu shot 11/21 EMG Tried gabapentin 300mg up to 900mg - too many side effects so stopped.
Age: 56.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: -Indicated for patients over 60  was administered to patient at 56 y.o. -Spoke to patient on 12/28/23 - patient didn't experience any side effects besides sore arm -physician was notified
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender.  The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  It was reported that on an unknown date, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live  (recombinant human albumin [rHA]) (PROQUAD) (lot # X011982, expiration date: 22-OCT-2024) underwent a temperature excursion of 6.2 degree Fahrenheit for a time frame of 5 minutes. There was no previous temperature excursion. On 08-NOV-2023, the patient was vaccinated with this improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), injection, 1 dose, (strength, and route of administration were not provided) as prophylaxis (Product storage error). No additional adverse event (AE) was reported.