chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: Fever; had a sore (store) arm and was trembling; had a sore (store) arm and was trembling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETE; UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 05Oct2023, outcome "unknown", described as "Fever"; TREMOR (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 05Oct2023, outcome "unknown" and all described as "had a sore (store) arm and was trembling". Additional information: For about two hours after getting the vaccine, she had a sore (store) arm and was trembling. The patient also said that she had a fever.  The patient would like to know how long the side effects will last, and she also wants to know if she can take aspirin or other medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Vaccination site movement impairment
Clinical narrative: the muscles in his arm become essentially worthless that it affects his lifting capacity; the muscles in his arm become essentially worthless that it affects his lifting capacity; 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 male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious), VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), outcome "unknown" and all described as "the muscles in his arm become essentially worthless that it affects his lifting capacity".  Additional information: The caller mentioned that he called before asking for information about the Pfizer COVID vaccine but wasn't able to get the answer he is looking for. He said he got the COVD vaccine the muscles in his arm become essentially worthless that it affects his lifting capacity and he is asking on how will Pfizer fix this flaw on the vaccine. He added that he's never getting it again because every time he gets the vaccine he needs to plan in advance.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An adult 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (manufacture unknown), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "felt sick".  Additional information: Age reported as 35-49 years old. The reporter consider event as caused by suspect product. The patient stated that having Pfizer was good for him; even though he felt sick after the vaccine shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Tremor
Clinical narrative: I had a reaction to it in my left arm & that night my right hand started trembling; I had a reaction to it in my left arm & that night my right hand started trembling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in Jan2021 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: LIMB DISCOMFORT (non-serious), TREMOR (non-serious), outcome "unknown" and all described as "I had a reaction to it in my left arm & that night my right hand started trembling". The patient received the first round of the double Covid vaccine back in Jan2021 and had a reaction to it in the left arm & that night, the patient's right hand started trembling, so when the patient went for the second, the on-hand pharmacist had the patient receive it in the right arm. In Aug, the patient had the Delta variant and couldn't get out of bed, 2022 Covid, 2023 Covid. The patient stated it's like the patient have no immune system anymore thanks to the vaccine and the patient's body just keeps getting weaker and weaker. Doctors are no help. The patient stated, ''Long Covid is killing me.''  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: Dysgeusia
Clinical narrative: Bad taste in mouth after the covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "Bad taste in mouth after the covid vaccine".  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: U
Vaccine: COVID19
Symptoms: Immune system disorder, Rash
Clinical narrative: developed full body rash; Doctor said it is overactive immune system.; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "developed full body rash"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Doctor said it is overactive immune system.".  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: Arrhythmia
Clinical narrative: cardiac arrhythmia; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant), outcome "unknown", described as "cardiac arrhythmia". Additional information: The reporter stated "Web site to report adverse reactions for covid vaccine was very difficult to use for myself related to cardiac arrhythmia and I am a physician. A non-medical person would give up. Poor information regarding Covid-19 vaccine. ".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event cardiac arrhythmia with BNT162b2 OMI XBB 1.5 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Axillary mass, Chills, Pain in extremity
Clinical narrative: After receiving my Covid vaccine this past Saturday (07Oct2023). I had rap arm soreness.; I've now got a lump under my arm, in the armpit area; Started feeling chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 as dose number unknown (booster), 0.3ml single (Lot number: HF9275, Expiration Date: Dec2023) at the age of 54 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 07Oct2023 as dose number unknown, 1.5 ml single (Lot number: 944463, Expiration Date: Jun2024) for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma. Vaccination history included: COVID-19 vaccine (primary immunization series complete; unknown manufacturer), for COVID-19 immunization; COVID-19 vaccine (dose number unknown (booster), manufacturer unknown), administration date: Oct2022, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Oct2023, outcome "unknown", described as "After receiving my Covid vaccine this past Saturday (07Oct2023). I had rap arm soreness."; AXILLARY MASS (non-serious) with onset 08Oct2023, outcome "not recovered", described as "I've now got a lump under my arm, in the armpit area"; CHILLS (non-serious) with onset 08Oct2023, outcome "unknown", described as "Started feeling chills". Therapeutic measures were taken as a result of pain in extremity, axillary mass, chills. Additional information: the patient specified that It formed a lump under her arms. It was actually a large lump, it's now going down but it's still there. Consumer stated, "I would be going to go the urgent care clinic, but I am figuring is, the shot because I didn't have it and I put a warm compress on it. I have been taking like Ibuprofen, I took Tylenol earlier and I had to put like."
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: opened IPOL was administered to 2 patients with no reported adverse event; temperature excursion for IPOL, highest temperature of 47.5 degrees F for 30 minutes with no reported adverse event; Initial information received on 04-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender 2 patients and reporter reported temperature excursion for IPV (VERO) [IPOL], highest temperature of 47.5 degrees f for 30 minutes with no reported adverse event and opened IPOL was administered to 2 patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Caller reported that IPV (VERO) Suspension for injection (lot number, strength, dosage, expiry date- not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) was exposed to temperature excursion on 14-SEP-2023, highest temperature of 47.5 degrees f for 30 minutes with no reported adverse event (product storage error) (unknown latency) and opened IPOL was administered to 2 patients with no reported adverse event (poor quality product administered) (latency- same day). Batch/lot number requested, not available at the time of call.  Reportedly, Reason of the excursion: unknown Did excursion occur due to a human error: unknown   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Caller refused follow-up. No further information provided by reporter.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given expired tenivac with no reported adverse event; Initial information received on 04-Oct-2023 regarding an unsolicited valid non-serious case received from a Physician.  This case involves an unknown age and unknown gender patient where patient was given expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2023, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot- U7189AA and expiration date- 30-Sep-2023) via unknown route in unknown administration site (dose, strength: not provided) for Immunisation (expired product administered) (latency- 4 days).  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.
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered a dose of expired pentacel had expired on 16Sep2023 with no reported adverse event; Initial information received on 05-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves male patient of an unknown age and administered a dose of expired diphtheria/tetanus/5 hybrid ac pertussis/IPV(Vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] had expired on 16sep2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2023, the patient received a expired dose of 0.5 ml of suspect /tetanus/5 hybrid ac pertussis/IPV(Vero)/HIB(PRP/T) vaccine (strength and lot number: not reported; expiry date: 16-Sep-2023) via unknown route in unknown administration site as immunization (expired product administered) (same day latency). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received 2 doses of fluzone hd with no reported adverse event; Initial information received on 05-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 74-years-old male patient who had received 2 doses 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. concomitant: No other vaccines.  On 04-Oct-2023, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot U8132BA via intramuscular route in the left deltoid.   On 18-Sep-2023 patient received 0.7 mL dose (Dose 1) of the influenza quadrival A-B high dose HV vaccine (unknown formulation) (Batch number: U8132BA; expiry date: 30-Jun-2024) via intramuscular route in the right deltoid for Immunization.  On 04-Oct-2023 the patient again received 0.7 mL Dose 2 of influenza quadrival A-B high dose HV vaccine (unknown formulation) (Batch number: U8132BA; expiry date: 30-Jun-2024) via intramuscular route in the left deltoid for Immunization with no reported adverse event (extra dose administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event received 2 doses of fluzone hd 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: 53.0
Sex: M
Vaccine: YF
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: It was realized after the vaccination that YF-Vax was contraindicated due to the patient takes Revlimid; Initial information received on 05-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 53 years old male patient who realized after the vaccination that yf-vax was contraindicated due to the patient takes revlimid after receiving yellow fever vaccine - [YF-VAX].  The patient's past medical history included Stem cell transplant.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included lenalidomide (Revlimid).  On 05-Oct-2023, the patient received a dose of suspect yellow fever vaccine - Solution for injection (lot- UJ829AA) via subcutaneous route in the back of the left upper arm (dose, strength and expiration date: not provided) for Immunisation.  On 05-Oct-2023, it was realized after the vaccination that yf-vax was contraindicated due to the patient takes revlimid 5 mg qod (with no reported adverse event) (contraindication to vaccination) (latency- same day) following the administration of yellow fever vaccine.  They have a client who was administered a YF-VAX but it turns out the patient is on an immunoregulatory medication called Revlimid. A patient was administered a dose of YF-Vax today around 15:00. Product used: Used First time product used: Yes Still using product: No.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 28.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired tenivac with no reported adverse event; Initial information received on 06-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 28 years old male patient who was administered an expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] 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 expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot U7189AA) (with an unknown strength, dosage, expiry date) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day).  Reportedly, Caller wants to know what to look for and if they need to revaccinate the patient.  Action taken was 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: 78.0
Sex: M
Vaccine: FLUA4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Pain in his left shoulder blade; Pain in his arm; This spontaneous case was received on 30-Sep-2023 from other non-healthcare professional (consumer) via Communications (reference number: SEQW23-02830), with additional information received on 03-Oct-2023 via Communications (being processed together) and concerned a 78-year-old, male patient.   The patient's concurent conditions included diabetes (reported as 'diabetic'). The patient's concomitant medications included unspecified diabetes medication (reported as 'a whole bunch of medication'), used for an unreported indication.  On 24-Sep-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; anatomical location: left deltoid, dose and route of administration: not reported) for flu vaccination. The batch number reported was 370682.  On 27-Sep-2023, three days after receiving Fluad Quadrivalent, the patient began to feel mild pain in his left shoulder blade and arm. The pain progressed to quit intense. The patient described the pain as pulsating pain. The pain intensified with movement and subsided when his arm was immobilized. The pain subsided when the patient would lift arm straight in the air.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 78-year-old patient was vaccinated with Fluad Quadrivalent in the left deltoid. Three days after receiving vaccine, the patient began to feel mild pain in his left shoulder blade and arm. Causal role of Fluad Quadrivalent is assessed as possibly related for pain in arm and shoulder blade pain, based on anatomical and chronological plausibility.; Sender's Comments: A 78-year-old patient was vaccinated with Fluad Quadrivalent in the left deltoid. Three days after receiving vaccine, the patient began to feel mild pain in his left shoulder blade and arm. Causal role of Fluad Quadrivalent is assessed as possibly related for pain in arm and shoulder blade pain, based on anatomical and chronological plausibility.
Sex: F
Vaccine: FLUA4
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: Pregnant woman was inadvertently administered Fluad; Pregnant woman was inadvertently administered Fluad; This spontaneous case was received on 02-Oct-2023 from a health care professional via Communications (reference number: SEQW23-02853) and concerned a pregnant female patient of unreported age.  The patient's medical history included In vitro fertilization (IVF) pregnancy. The patient had no concomitant medications.   The patient's obstetrical history did not include previous pregnancies. The patient's estimated delivery date (EDD) was reported as 09-Dec-2023. The patient's last menstrual period (LMP) date, and corrected estimated date of delivery (CEDD) were not reported. Type of pregnancy was reported as IVF pregnancy (in vitro fertilisation).  On 02-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration, anatomical location: not reported) for active immunization against influenza disease for people 65y and older, as reported (explicitly coded as 'Vaccine exposure during pregnancy' and 'Inappropriate age at vaccine administration'). The batch number reported was 370677, and expiry date: 10-May-2024.  At the time of the initial reporting, the patient did not have any reaction following the vaccination with Fluad Quadrivalent vaccine.  Company comment: A pregnant female patient of unreported age was vaccinated with Fluad Quadrivalent (explicitly coded as: 'Product administered to patient of inappropriate age' and 'Vaccine exposure during pregnancy'). The patient's medical history included in vitro fertilization (IVF). The patient's estimated delivery date (EDD) was reported as 09-Dec-2023, and obstetrical history did not include previous pregnancies. Reportedly, type of the pregnancy is IVF pregnancy. Patient's last menstrual period (LMP) and corrected date of delivery (CEDD) were not reported. The patient did not have any reaction following vaccination. Causality for product administered to patient of inappropriate age and vaccine exposure during pregnancy is assessed as not related as per company's conventions.; Sender's Comments: A pregnant female patient of unreported age was vaccinated with Fluad Quadrivalent (explicitly coded as: 'Product administered to patient of inappropriate age' and 'Vaccine exposure during pregnancy'). The patient's medical history included in vitro fertilization (IVF). The patient's estimated delivery date (EDD) was reported as 09-Dec-2023, and obstetrical history did not include previous pregnancies. Reportedly, type of the pregnancy is IVF pregnancy. Patient's last menstrual period (LMP) and corrected date of delivery (CEDD) were not reported. The patient did not have any reaction following vaccination. Causality for product administered to patient of inappropriate age and vaccine exposure during pregnancy is assessed as not related as per company's conventions.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Heart rate irregular, Myalgia, Pyrexia
Clinical narrative: 1. irregular heartbeat every few minutes with breath difficulties 2. muscle pain 3. Joint pain 4. Fever
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Rash, Rash erythematous, Tenderness
Clinical narrative: SORE TENDER ARM THAT HAD RED RASH AND NOW IS JUST PAINFUL
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Irritability, Pyrexia
Clinical narrative: fever, fussiness
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: got the flu after a flu shot/ suspected vaccination failure; got the flu; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 81-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced vaccination failure (Verbatim: got the flu after a flu shot/ suspected vaccination failure) (serious criteria GSK medically significant) and influenza (Verbatim: got the flu).  The outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine.     It was unknown if the company considered the vaccination failure and influenza to be related to Influenza vaccine.   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter stated that her husband got the flu after a flu shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for flu and laboratory confirmation regarding flu were unknown at the time of reporting. The reporter did not consent to follow up. This case is linked with US2023137024, same reporter.; Sender's Comments:  US-GSK-US2023137024:Same reporter
Sex: U
Vaccine: COVID19, RSV
Symptoms: Atrial fibrillation
Clinical narrative: reoccurrence of A-Fib; This serious case was reported by a nurse via sales rep and described the occurrence of atrial fibrillation in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   The patient's past medical history included atrial fibrillation.   On an unknown date, the patient received Arexvy and COVID VACCINE. On an unknown date, an unknown time after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: reoccurrence of A-Fib) (serious criteria GSK medically significant).  The outcome of the atrial fibrillation was unknown.   It was unknown if the reporter considered the atrial fibrillation to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation to be related to Arexvy.   Additional Information: GSK Receipt date: 05-OCT-2023 GSK field representative reported an adverse event that she heard about it in in a large In-service meeting for nurses. The details were unknown, but she provided the name of the individual who would know who mentioned the adverse event in the meeting. The reporter reported that the patient received their Arexvy vaccine at the same time as a Covid vaccine. The patient experienced a reoccurrence of A-Fib. It was unknown if the reporter considered the atrial fibrillation to be related to Covid vaccine. The reporter consented to follow up.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered an expired act-hib with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old and unknown gender patient who was administered an expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-Oct-2023, the patient received a dose 4 dose 0.5 ml of suspect HIB (PRP/T) Vaccine HIB (PRP/T) VACCINE [ACT-HIB] strength, expiry date, lot number not reported via intramuscular route in unknown administration site for immunization and on the same day administered an expired act-hib with no reported adverse event (expired product administered).Information on the batch number was requested.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired act-hib 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: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Pink rash on face and trunk x 24 hours
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acoustic stimulation tests, Deafness bilateral, Ear tube insertion, Tinnitus
Clinical narrative: Hearing loss both ears.   They tried antibiotics then 10 days steroids, nasal sprays.   Seen by Eye and Ear, Dr. In April 2023.  She pull in ear tubes through the eardrum Both ears in May 2023.   Follow up in November 2023.   Hearing returned with the tubes in place.   Buzzing in both ears still present.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage
Clinical narrative: Immediately after the injection went in, there was a blood trail. I took the bandaid off a couple of hours later and there was no bleeding. The next day I had a bruise at the injection site and it?s still there 4 days later.
Age: 63.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: Sudden cramping diarrhea. Continued cramping hours after bowel emptied.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Urticaria
Clinical narrative: face got red and hives  presented in the trunk area
Age: 10.0
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased, Lymphadenopathy, Neck pain, Pain in extremity
Clinical narrative: Woke up at 3 am due to arm being sore, at 7:15 she had a temp of 101.8 lympthnodes in next are swollen and its hard for her to turn her neck due to pain.
Age: 88.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: The patient came in for a visit and was scheduled to have a flu vaccine. There was no record of a previous flu vaccine in his EMR. When Nursing staff went to administer the vaccine, they noticed there was a band aid on his R upper arm. He was asked if her recently had a vaccine and he replied he didn't know.  His daughter also stated the same. The vaccine was administered. After the fact, the Provider looked in database and found that he had one on 10/2/23 when he was seen in an Urgent Care.
Age: 73.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injection site rash, Injection site swelling, Injection site warmth, Pain
Clinical narrative: She got her vaccine, she was okay, went to another store and went shopping asked that pharmacy to look at it, and she was told that it was ok.   The next day, yesterday she saw a red rash about 3" below the injection site that was hot to the touch and swollen.  She has been icing it every 12 hours.  She took a Benadryl and Tylenol 2 500 mg.  She woke up in the middle of the night her left hand was numb, moved it and it disappeared.  Her temp has been low in the 97.4-97.7 range.  Her neighbor is a NP and she asked her what she thought, and she said it may be due to the injection itself, and told her to take Benadryl and that maybe the Tylenol was too much but to continue taking the Benadryl.  She also called the pharmacy and they told her that it was in the right spot.  The NP told her that it was higher than it should have been.  It looks pretty much the same today as it did yesterday.  The rash is about 2" x 3".  It has not gotten worse, and has not gotten better.  The rest of her body seems ok, it's just her left arm.    When she rotates her arm from the top to the side she feels some pain in the shoulder area, which she did not feel the other day.
Age: 73.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash erythematous
Clinical narrative: She got her vaccine, she was okay, went to another store and went shopping asked that pharmacy to look at it, and she was told that it was ok.   The next day, yesterday she saw a red rash about 3" below the injection site that was hot to the touch and swollen.  She has been icing it every 12 hours.  She took a Benadryl and Tylenol 2 500 mg.  She woke up in the middle of the night her left hand was numb, moved it and it disappeared.  Her temp has been low in the 97.4-97.7 range.  Her neighbor is a NP and she asked her what she thought, and she said it may be due to the injection itself, and told her to take Benadryl and that maybe the Tylenol was too much but to continue taking the Benadryl.  She also called the pharmacy and they told her that it was in the right spot.  The NP told her that it was higher than it should have been.  It looks pretty much the same today as it did yesterday.  The rash is about 2" x 3".  It has not gotten worse, and has not gotten better.  The rest of her body seems ok, it's just her left arm.    When she rotates her arm from the top to the side she feels some pain in the shoulder area, which she did not feel the other day.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: After the pt had left yesterday, 10/10/23 it was found that an error had taken place with the pts COVID vaccine administration. This CMA did not note that the vaccine vial was a multidose vial that needed to be diluted prior to administration. The pt received 0.3ml of the COVID vaccine without dilution. The lead clinic nurse along with our pharmacist were contacted. Per pharmacy the pt should not have any long term effects from this error. The pt may experience an increase in the typical side effects from any COVID vaccine. The pts mother was notified. A safe qual event will be completed. This will also be reported to vaers. Safe guards have been put in place to ensure this does not happen again. This standard procedure was discussed during our nursing huddle this morning, will be reported via email in the nursing huddle minutes and a note was placed in the injection room.    Pts mother had inquired to see if the pt needed to get the additional 2 doses. Per pharmacy it was stated the pt should receive the 2nd and 3rd doses as recommended. The reason being to prolong protection from COVID.    Mother denied any symptoms or adverse reactions.    Pfizer-BioTech COVID-19 vaccine. Lot # HH3252 EXP: 07/2024
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Asthenia, Dizziness, Ear pain, Gait disturbance, Groin pain
Clinical narrative: I also had COVID shot at same time as the Flu shot.   At 11 p.m. while in bed I all of a sudden had searing pain in my ears, groin, dizziness, almost fell several times while attempting to use bathroom.  It was almost like I had to urinate every hour.   and  I had extremely sore arm.  This lasted through the night and had tapered off around 5 a.m.  Still weak in morning and lightheaded.
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Pain in extremity
Clinical narrative: I also had COVID shot at same time as the Flu shot.   At 11 p.m. while in bed I all of a sudden had searing pain in my ears, groin, dizziness, almost fell several times while attempting to use bathroom.  It was almost like I had to urinate every hour.   and  I had extremely sore arm.  This lasted through the night and had tapered off around 5 a.m.  Still weak in morning and lightheaded.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue, Rash, Rash macular
Clinical narrative: After the pt had left yesterday, 10/10/23 it was found that an error had taken place with the pts COVID vaccine administration. This CMA did not note that the vaccine vial was a multidose vial that needed to be diluted prior to administration. The pt received 0.3ml of the COVID vaccine without dilution. The lead clinic nurse along with our pharmacist here at the facility were contacted. Per pharmacy the pt should not have any long term effects from this error. The pt may experience an increase in the typical side effects from any COVID vaccine. The pts mother was notified. A safe qual event will be completed. This will also be reported to vaers.hhs.gov. Safe guards have been put in place to ensure this does not happen again. This standard procedure was discussed during our nursing huddle this morning, will be reported via email in the nursing huddle minutes and a note was placed in the injection room.    Mother states the pt is doing well today other than having a slight blotchy rash on her face.   Pts mother had inquired to see if the pt needed to get the additional 2 doses. Per pharmacy it was stated the pt should receive the 2nd and 3rd doses as recommended. The reason being to prolong protection from COVID.     Pfizer-BioTech COVID-19 vaccine. Lot # HH3252 EXP: 07/2024
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Arthralgia, Asthenia, Cough, Diarrhoea
Clinical narrative: Following yet another annual round of being forced to receive a Flu shot i first started feeling violently ill at approximately 1700, I have severe Diarrhea, Nausea and vomiting and an over all feeling of depleting tiredness. Approximately 1800 i felt so weak, restless and shocked full of anxiety i was incapable of operating my motor vehicle or assisting with my wife managing oir children  who is battling severe heart failure. 1900 i felt deathly ill, coupled with rounds of more fever, diarrhea, congestion, coughing, heart palpitations and extreme fatigue, all the signs and symptoms of a severe flu. Falling asleep early around 2100 i contested rounds of violent nightmares, more diarrhea, night sweats and tremors. 0630 I slept through my alarm, waking up only to feel horrible. Eyes were bloodshot red and extremely painful, my lungs were in pain, i still have a dull headache, nauseous with no appetite, and joint pain in nearly every joint, fatigue and severe congestion.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Eye pain, Fatigue, Feeling abnormal, Headache, Hypersomnia
Clinical narrative: Following yet another annual round of being forced to receive a Flu shot i first started feeling violently ill at approximately 1700, I have severe Diarrhea, Nausea and vomiting and an over all feeling of depleting tiredness. Approximately 1800 i felt so weak, restless and shocked full of anxiety i was incapable of operating my motor vehicle or assisting with my wife managing oir children  who is battling severe heart failure. 1900 i felt deathly ill, coupled with rounds of more fever, diarrhea, congestion, coughing, heart palpitations and extreme fatigue, all the signs and symptoms of a severe flu. Falling asleep early around 2100 i contested rounds of violent nightmares, more diarrhea, night sweats and tremors. 0630 I slept through my alarm, waking up only to feel horrible. Eyes were bloodshot red and extremely painful, my lungs were in pain, i still have a dull headache, nauseous with no appetite, and joint pain in nearly every joint, fatigue and severe congestion.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Impaired driving ability, Influenza, Loss of personal independence in daily activities, Malaise, Nausea
Clinical narrative: Following yet another annual round of being forced to receive a Flu shot i first started feeling violently ill at approximately 1700, I have severe Diarrhea, Nausea and vomiting and an over all feeling of depleting tiredness. Approximately 1800 i felt so weak, restless and shocked full of anxiety i was incapable of operating my motor vehicle or assisting with my wife managing oir children  who is battling severe heart failure. 1900 i felt deathly ill, coupled with rounds of more fever, diarrhea, congestion, coughing, heart palpitations and extreme fatigue, all the signs and symptoms of a severe flu. Falling asleep early around 2100 i contested rounds of violent nightmares, more diarrhea, night sweats and tremors. 0630 I slept through my alarm, waking up only to feel horrible. Eyes were bloodshot red and extremely painful, my lungs were in pain, i still have a dull headache, nauseous with no appetite, and joint pain in nearly every joint, fatigue and severe congestion.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Night sweats, Nightmare, Ocular hyperaemia, Palpitations, Pulmonary pain
Clinical narrative: Following yet another annual round of being forced to receive a Flu shot i first started feeling violently ill at approximately 1700, I have severe Diarrhea, Nausea and vomiting and an over all feeling of depleting tiredness. Approximately 1800 i felt so weak, restless and shocked full of anxiety i was incapable of operating my motor vehicle or assisting with my wife managing oir children  who is battling severe heart failure. 1900 i felt deathly ill, coupled with rounds of more fever, diarrhea, congestion, coughing, heart palpitations and extreme fatigue, all the signs and symptoms of a severe flu. Falling asleep early around 2100 i contested rounds of violent nightmares, more diarrhea, night sweats and tremors. 0630 I slept through my alarm, waking up only to feel horrible. Eyes were bloodshot red and extremely painful, my lungs were in pain, i still have a dull headache, nauseous with no appetite, and joint pain in nearly every joint, fatigue and severe congestion.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Respiratory tract congestion, Restlessness, Tremor, Vomiting
Clinical narrative: Following yet another annual round of being forced to receive a Flu shot i first started feeling violently ill at approximately 1700, I have severe Diarrhea, Nausea and vomiting and an over all feeling of depleting tiredness. Approximately 1800 i felt so weak, restless and shocked full of anxiety i was incapable of operating my motor vehicle or assisting with my wife managing oir children  who is battling severe heart failure. 1900 i felt deathly ill, coupled with rounds of more fever, diarrhea, congestion, coughing, heart palpitations and extreme fatigue, all the signs and symptoms of a severe flu. Falling asleep early around 2100 i contested rounds of violent nightmares, more diarrhea, night sweats and tremors. 0630 I slept through my alarm, waking up only to feel horrible. Eyes were bloodshot red and extremely painful, my lungs were in pain, i still have a dull headache, nauseous with no appetite, and joint pain in nearly every joint, fatigue and severe congestion.
Age: 2.0
Sex: F
Vaccine: DTPPVHBHPB, FLU4, HEPA, MMR, PNC15, VARCEL
Symptoms: Blood culture negative, Computerised tomogram head normal, Electroencephalogram, Full blood count normal, Generalised tonic-clonic seizure
Clinical narrative: Patient overdue for multiple immunizations. Above vaccines due per state registry - given 10/10/2023. Patient with witness approximately 10-minute generalized tonic-clonic seizure on 10/11/2023. EMS call and IM Versed was given.  Upon arrival to emergency department, patient post-ictal. Repeat generalized tonic-clonic seizure activity approximately 15 minutes after resolution of first seizure. Patient febrile upon arrival to 38.4. In ED, Patient was given a total of 4 mg of Ativan (1mg of which was IM and the rest were 1 mg doses IV), Keppra load with 50 mg/kg, and fosphenytoin load of 20pe/kg which ultimately stopped the seizure activity after about 42 minutes.  Patient also received suppository Tylenol and IV Toradol.  She was given 2 normal saline boluses. Patient was admitted to ICU for ongoing management and remains admitted at this time.  Initially NPO on maintenance IV fluids as patient obtunded following multiple AED's. Supplemental oxygen placed - no advanced airway needed. She was weaned to RA overnight 10/11. Diet was advanced as mental status improved and she is tolerating PO intake. Off of IVF. Remains in ICU for observation.