chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "severe sinusitis" (unspecified if ongoing), notes: severe. The patient's concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies: Ceclor. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 20Aug2023 to 24Aug2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose number unknown (booster), single (Lot number: GJ3277) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism (Hashimotos-autoimmune)" (unspecified if ongoing), notes: Hypothyroidism (Hashimotos-autoimmune); "Hypothyroidism (Hashimotos-autoimmune)" (unspecified if ongoing), notes: Hypothyroidism (Hashimotos-autoimmune); "Hypothyroidism (Hashimotos-autoimmune)" (unspecified if ongoing), notes: Hypothyroidism (Hashimotos-autoimmune); "PCOS" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 21Aug2023 to 25Aug2023.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 24May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OMEGA 3 FISH OIL [FISH OIL] as pills. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, 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 had no known allergies, Other medication in 2 weeks product Statins stop date 28Aug2023. Patient received Paxlovid from 29Aug2023 to 02Sep2023 as Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23May2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chron's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Benzoyl peroxide, reaction(s): "Known allergies: Benzoyl peroxide". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 ith Paxlovid from 27Aug2023 to 01Sep2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300294398 same  patient/reporter, different drug/AE;
Sex: U
Vaccine: COVID19
Symptoms: Brain fog, Diarrhoea, Dizziness, Illness, Pyrexia
Clinical narrative: Got very ill; High fever; Dizzy; Diarrhea; Brain fog; 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 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization, reaction(s): "brain fog", "diarrhea", "dizzy", "got very ill", "High fever". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Got very ill"; PYREXIA (non-serious), outcome "unknown", described as "High fever"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; BRAIN FOG (non-serious), outcome "unknown". Additional information: The patient got very ill after the second and third shot. The patient also experienced high fever, dizzy, diarrhea, and brain fog. The patient has avoided getting a fourth shot. The patient would like to know if the vaccines are improved enough that they won't make him/her sick.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300151989 same patient and drug, similar event (separated by time), different dose;
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Lot Number: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Lot Number: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE, Lot Number: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, SINGLE, Lot Number: Unknown), for COVID-19 Immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown".  Clinical course: Consumer stated, "I am doctor in the (city-withheld) area. I have two questions. I currently have Guillain-Barre syndrome following the COVID-19 Pfizer vaccination number 5. RSV virus vaccination, the average dose, is that an mRNA? When paraphrased the concern, Consumer stated, "Guillain-Barre syndrome, it is a known side effect of the COVID-19 vaccine. It is not the question. My question is, whatever studies is mentioned on your website, 3 patients receiving the RSV vaccine got the Guillain-Barre syndrome. My question is, is the RSV vaccine an mRNA product and if already having the Guillain-Barre syndrome from one vaccine is contraindication in getting another vaccine that has the side effect of the Guillain-Barre syndrome." Consumer was informed about the role of the Pfizer Drug Safety and to contact Pfizer Medical Information for the concern and was provided with the contact# as (phone number-withheld), Option #, and was informed that the department is open from Monday to Friday from 8 am to 7 pm. When asked for permission for further probing, Consumer stated, "I don't have the time right now. I am sorry." When probed the LOT# (COVID vaccine), Consumer stated, "No, I don't have the LOT# handy. I am not able to talk to you anymore." Consumer was unwilling to complete the report. Thus, further probing could not be done. Hence, limited information was available over the call.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300295135 Same reporter, patient, different product and events;
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Metastic stage 3C Melanoma survivor" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 70 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "recurrent diverticulitis" (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 25Aug2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2023) Positive; (31Aug2023) Negative; (01Sep2023) Negative; (02Sep2023) Negative; (04Sep2023) Positive; (05Sep2023) Positive; (06Sep2023) Positive; (07Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Full blood count
Clinical narrative: I have had five Pfizer Vaccines for Covid and I didn't have Covid so, I got Covid recently; I have had five Pfizer Vaccines for Covid and I didn't have Covid so, I got Covid recently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 54 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diabetic. Concomitant medication(s) included: LOSARTAN POTASSIUM taken for diabetes mellitus; CENTRUM FOR WOMEN; METFORMIN HCL; ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Aug2023, outcome "unknown" and all described as "I have had five Pfizer Vaccines for Covid and I didn't have Covid so, I got Covid recently". The patient underwent the following laboratory tests and procedures: Full blood count: Normal. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient finished the 5 doses and then five days after that of Paxlovid as covid-19 treatment. Patient is not taking Atorvastatin now, she haven't taken it since she got Covid. She normally takes it but was not taking it while being sick.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown), on 27Mar2021 as dose 2, single (Batch/Lot number: unknown), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 03Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Post thyroidectomy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, including Paxlovid from 22Aug2023 to 26Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: RSV
Symptoms: Injection site pain, Injection site warmth, Pain in extremity, Skin discolouration
Clinical narrative: it might be infected; My arm is black and blue very sore; My arm is black and blue very sore; Burns and warm around shot; Burns and warm around shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received PF-06928316 (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: INJECTION SITE INFECTION (intervention required), outcome "unknown", described as "it might be infected"; PAIN IN EXTREMITY (intervention required), CONTUSION (intervention required), outcome "unknown" and all described as "My arm is black and blue very sore"; INJECTION SITE PAIN (intervention required), INJECTION SITE WARMTH (intervention required), outcome "not recovered" and all described as "Burns and warm around shot". Clinical courses: arm is black and blue very sore. Burns and warm around shot. Been over 2 weeks. Got a doctor watching as it might be infected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart condition; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 25-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart condition". The event "heart condition" required physician office visit.  Additional information: The patient was god child of reporter. The heart condition the patient had that no required surgery was a direct result of her getting the COVID vaccine. She said that 3 separate doctors told her this.   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: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: mild Covid; mild Covid; 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 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "mild Covid".  Clinical course: The patient reported that "I have had 5 Pfizer shots. I just got mild Covid this week . My question is when can I get next booster"  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Brain fog, Diarrhoea, Dizziness, Illness
Clinical narrative: got very ill; High fever; dizzy; diarrhea; brain fog; 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), as dose 2, 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, SINGLE, Lot number: Unknown), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got very ill"; PYREXIA (non-serious), outcome "unknown", described as "High fever"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; BRAIN FOG (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that "I got very ill after my second and third shot. High fever, dizzy, diarrhea, brain fog. I have avoided getting a fourth shot. Are the vaccines improved enough that they won't make me sick?"  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300295013 same patient and drug, similar event (separated by time), different dose;
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: got very ill; High fever; dizzy; diarrhea; brain fog; 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), as dose 2, 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, SINGLE, Lot number: Unknown), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got very ill"; PYREXIA (non-serious), outcome "unknown", described as "High fever"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; BRAIN FOG (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that "I got very ill after my second and third shot. High fever, dizzy, diarrhea, brain fog. I have avoided getting a fourth shot. Are the vaccines improved enough that they won't make me sick?"  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300295013 same patient and drug, similar event (separated by time), different dose;
Age: 1.25
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: they have administered ADACEL to a 15-month-old patient with no reported adverse event; Initial information was received on 01-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA270745(CLUSTER).  This case involves a 15 months old male patient who have administered 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 03-Aug-2023, the patient received a 0.5 ml, once dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: 2CA55D1, expiry date: 21-May-2025, strength: standard) via intramuscular route in the right thigh for Immunization (product administered to patient of inappropriate age) (latency: same day).  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: U
Vaccine: FLUX
Symptoms: Gait inability, Guillain-Barre syndrome, Infection, Spinal cord infection
Clinical narrative: One of one thousand that got Guillain Barre Syndrome; Infection or some kind and got into spine; This spontaneous case was received on 29-Aug-2023 from other non-health professional (consumer) (reference number SEQW23-01908) and concerned an elderly patient of unspecified age and gender. At the time of the reporting, the patient was 85 years old.  The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with the influenza vaccine (brand not specified; dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.  On an unspecified date in 2007, an unknown amount of time after receiving the influenza vaccine, the patient had an infection which got into spine and it came down as Guillain Barre from the waist down and was admitted to the hospital. The patient lost ability to walk.  On an unspecified date in 2007, the patient had recovered from the event of Guillain-Barre syndrome and was discharged from the hospital. The patient stated that after rehab, was sent home in perfect state, and could walk without a cane, with no residual problems.  The reporter did not provide a causality assessment. The patient stated that was one of the 1 hundred thousand to get Guillain-Barre and was wondering to let it go and take the risk and get the flu again or take flu vaccine again this coming season. The patient hasn't had the flu vaccine since Guillain Barre, and before that had the flu shot every year and nothing happened.  The event of Guillain Barre syndrome was considered to be serious due to the seriousness criterion of hospitalization. Additionally, the event of Guillain Barre syndrome was considered to be medically significant by Physician within Seqirus' Pharmacovigilance Department.  Company comment: An 85-year-old patient had an infection that progressed to Guillain-Barre syndrome an unknown amount of time after receiving the influenza vaccine. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the reported events (infection and Guillain-Barre syndrome) is unassessable.; Reporter's Comments: The patient stated that was one of the 1 hundred thousand to get Guillain-Barre and was wondering to let it go and take the risk and get the flu again or take flu vaccine again this coming season. The patient hasn't had the flu vaccine since Guillain Barre, and before that had the flu shot every year and nothing happened.; Sender's Comments: An 85-year-old patient had an infection that progressed to Guillain-Barre syndrome an unknown amount of time after receiving the influenza vaccine. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the reported events (infection and Guillain-Barre syndrome) is unassessable.
Age: 82.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site swelling
Clinical narrative: Arm is swollen / only swollen in the upper portion of the arm, where he had the injection; This spontaneous case was received on 31-Aug-2023 from a other non-healthcare professional (consumer) via Communications (reference number: SEQW23-01955) and concerned a 82-year-old, male patient.  The patient's concurrent condition included pain. The patient's concomitant medication included ibuprofen, used for pain.  On 30-Aug-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, anatomical location: upper arm, route of administration: not reported) for immunization against influenza disease. The batch number reported was 370275 and expiry date: 02-May-2024.  On the same day, reported as six hours after receiving Fluad Quadrivalent, the patient had his arm swollen. It was only swollen in the upper portion of the arm where he had the injection. The patient could move the arm. The patient did not receive any treatment for the event.  At the time of initial reporting on 31-Aug-2023, 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: The event of swollen arm is assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Sender's Comments: The event of swollen arm is assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash erythematous
Clinical narrative: Red, raised generalized rash to face, torso and extremities that appeared approx 3-4 days following vaccination
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given a vaccine beyond use date, incorrect BUD was listed on the vial. BUD: 12/14/22. Contacted Pfizer to determine vaccine viability, no response back yet.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Swelling
Clinical narrative: Patient experience swelling and redness in upper arm, armpit and chest
Age: 23.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: ACCIDENTLY GAVE PT A SHINGRIX SHOT WHEN HER AND HER MOM SWICHTED PLACES.
Age: 73.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and heat (cellulitis) of left upper arm. Diagnosed on 9/7/2023. Treated with Keflex 500 mg tabs 1 tab three times a day and Benadryl 25 mg tabs 1 tab three times daily as needed. Symptoms starting to resolve after 4th dose of antibiotic.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC15
Symptoms: Dermatitis diaper, Diarrhoea
Clinical narrative: Severe diarrhea 10 stools per day,  started 8/18/23, lasted 11 days. Diaper rash. Supportive care, oral hydration OTC topical ointments
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Product administration error, Scratch
Clinical narrative: Administration error: Mother was restraining pt on her lap, as she successfully did for vaccines 3 of 4 patient was receiving this visit. Patient removed her left arm from her mother's grip as needle was being withdrawn from the injection site, full dose was fully injected already. Patient pushed administrator's hand with needle. Patient obtained a superficial scratch on left thigh near injection site. Patient's left hand and arm was assessed no injuries. Vaccine needle was also assessed, it was completely intact. Area was covered with adhesive bandage. Advised mother assess area at home as well.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Patient did not need 3rd dose of HPV, given by mistake due to incorrect forecasting by system.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Induration, Skin warm
Clinical narrative: Redness, warmth, hardening. Went to urgent care and was placed on anti-biotic and topical cream. Doctor called it cellulitis
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Review of medical documentation states erythema noted at the injection site ; mother's verbal report of "grape sized hard bump".
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product preparation error
Clinical narrative: no adverse event.  my clinical coordinator instructed me to fill this out.  abrysvo was reconstituted with fluzone hd and injected.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Hep A and Dtap was given before recommended date. Hep A due 10/18/2023 and Dtap due 11/16/2023. No known adverse events reported. Reporting incident as it was given early.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Injection site rash, Pain in extremity, Rash
Clinical narrative: Patient received vaccine 9/6/23 in the morning then had sore arm by 9/7/23 she noticed rash on arm at the injection site that spread to her whole body. patient went to her primary care doctor who gave her a steroid shot.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Dizziness, Fatigue, Gait disturbance, Influenza like illness
Clinical narrative: Got shot 7:15p Went to bed at 10 P with very sore injection site Woke up at 1a with head spinning, vertigo type symptoms feeling very nauseous.  Stumbled to bathroom, sat for30 minutes, never vomited  Went to bed at 1:30A. Tossed with feeling nauseous until 6:30 A wake-up.  Still mildly nauseous with slight lightheaded ness Generally feeling better but not feeling100%  Around 2p, felt profound weakness, very tired. Went to bed and slept until 6p. Took temperatures -98.8.  Feels like flu type of fatigue without chillls, fever or muscle aches.  Infection site still very sore after 24 hrs.  Nauseous has subsided but still slightly lightheaded 24 hrs after injection.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Injection site pain, Malaise, Nausea, Poor quality sleep, Vertigo
Clinical narrative: Got shot 7:15p Went to bed at 10 P with very sore injection site Woke up at 1a with head spinning, vertigo type symptoms feeling very nauseous.  Stumbled to bathroom, sat for30 minutes, never vomited  Went to bed at 1:30A. Tossed with feeling nauseous until 6:30 A wake-up.  Still mildly nauseous with slight lightheaded ness Generally feeling better but not feeling100%  Around 2p, felt profound weakness, very tired. Went to bed and slept until 6p. Took temperatures -98.8.  Feels like flu type of fatigue without chillls, fever or muscle aches.  Infection site still very sore after 24 hrs.  Nauseous has subsided but still slightly lightheaded 24 hrs after injection.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Neck pain
Clinical narrative: extremely left sore shoulder pain at the site of the vaccination and further up my arm into my shoulder and neck. I'm presently sore in the shoulder near the shoulder blade. I have limited are extension and rotation. I'm limited to some degree of daily function i.e. pulling my shirt off or on. I have problem sleeping. It's been over a month since the vaccination was administered.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Ultrasound scan normal
Clinical narrative: extremely left sore shoulder pain at the site of the vaccination and further up my arm into my shoulder and neck. I'm presently sore in the shoulder near the shoulder blade. I have limited are extension and rotation. I'm limited to some degree of daily function i.e. pulling my shirt off or on. I have problem sleeping. It's been over a month since the vaccination was administered.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Red circlular raised area about 2 inches across in the middle of the upper arm below the deltoid muscle. Itchy areas extend around it and lateral to it 8 inches which worsened at 24 hours. Swollen 3 inches at 48 hours but less itchy.
Age: 2.75
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Provider administered Moderna Bivalent Booster 0.2ML (NDC 80777-0283-99) instead of Moderna Bivalent dose 0.25ML (NDC 00777-282-99) as 2nd dose in primary series. No adverse reaction
Age: 88.0
Sex: F
Vaccine: FLUA4
Symptoms: Joint range of motion decreased, Neuralgia, Pain in extremity
Clinical narrative: Chief complaint  pain in arm, can not lift arm past shoulder, limited range of motion due to pain, nerve pain in RA
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS ASKED HOW OLD HE WAS AND HE SAID HE WAS 18 YRS OLD SO HE WAS GIVEN FLUBLOK. UPON FURTHER CHECKING HIS BIRTHDATE, IT WAS CONFIRMED HE WAS ONLY 16 YRS OLD.
Age: 0.92
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Provider administered covid 19 Bivalent Booster 0.2mL (NDC 80777-0283-99) instead of Moderna Bivalent dose 0.25mL (NDC 80777-282-99) as first dose of primary series. No adverse reaction.
Age: 1.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: Provider administered covid-19 Bivalent Booster 0.2mL (NDC 80777-0283-99) instead on Moderna Bivalent dose 0.25mL (NDC 80777-282-99) as second dose of primary series. No adverse reaction.
Age: 0.5
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Provider administered covid-19 Bivalent Booster 0.2mL (NDC 80777-0283-99) yellow box pink lid instead of Moderna Bivalent dose 0.25mL (NDC 8077-252-99) gray booster dose blue lid as first dose in primary series. No adverse rxn.
Age: 0.58
Sex: F
Vaccine: COVID19-2, DTPPVHBHPB, RV5
Symptoms: No adverse event
Clinical narrative: Provider administered covid-19 Bivalent Booster 0.2mL (NDC 80777-0283-99) yellow box pink lid instead of Moderna Bivalent dose 0.25mL (NDC 80777-282-99) gray border, dark blue lid as second dose in primary series. No adverse reaction.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, PNC15, RV5
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram spine normal, Electromyogram normal, Muscular weakness, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pt reported L sided neck pain, stiffness, weakness w/ neck muscles
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Middle insomnia, Pain in extremity, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: worst headache; Shaking; woke up in the middle of the night; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in 9th June 2023 and experienced Pain in extremity and Diarrhea reference case US2023119268.). Concurrent medical conditions included diarrhea.   On 30-AUG-2023 10:00, the patient received the 2nd dose of Shingrix (right arm). In AUG-2023, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: Fever), tremor (Verbatim: Shaking) and insomnia (Verbatim: woke up in the middle of the night). On 30-AUG-2023 21:00, the patient experienced headache (Verbatim: worst headache).  The patient was treated with paracetamol (Acetaminophen). The outcome of the headache was resolved and the outcome of the fever was not resolved (duration 3 days) and the outcome of the tremor was unknown and the outcome of the insomnia was not reported.   It was unknown if the reporter considered the headache, fever, tremor and insomnia to be related to Shingrix.     It was unknown if the company considered the headache, fever, tremor and insomnia to be related to Shingrix.   Linked case(s) involving the same patient:  US2023119268   Additional Information: GSK Receipt Date: 31-AUG-2023 The patient was self-reported this case. The reporter reported that she received Shingrix vaccine and on same day she experienced arm hurt really bad for 3 days. Patient also reported that she received her 2nd dose of Shingrix and had the worst headache across the top of her skull, and her head still hurt today (on the day of reporting).  Patient reported that she took 2 Acetaminophen 500mg around 11AM this morning and her headache was now (at the time of reporting) gone.  Patient also reported that she woke up in the middle of the night with a fever and shaking. Patient reported she was still shaking when she got up this morning and her fever went from 99.8 degree Fahrenheit when she got up, to 101 degree Fahrenheit at 11AM.  Patient also reported she was having Diarrhea today but this started before she received the 2nd dose of Shingrix.  Patient reported that she did test for Covid as she felt like these were all Covid symptoms, and she did test negative for Covid. The reporter consented to follow up. This case is linked with US2023119268, by same reporter.; Sender's Comments:  US-GSK-US2023119268:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: worst headache; Shaking; woke up in the middle of the night; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in 9th June 2023 and experienced Pain in extremity and Diarrhea reference case US2023119268.). Concurrent medical conditions included diarrhea.   On 30-AUG-2023 10:00, the patient received the 2nd dose of Shingrix (right arm). In AUG-2023, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: Fever), tremor (Verbatim: Shaking) and insomnia (Verbatim: woke up in the middle of the night). On 30-AUG-2023 21:00, the patient experienced headache (Verbatim: worst headache).  The patient was treated with paracetamol (Acetaminophen). The outcome of the headache was resolved and the outcome of the fever was not resolved (duration 3 days) and the outcome of the tremor was unknown and the outcome of the insomnia was not reported.   It was unknown if the reporter considered the headache, fever, tremor and insomnia to be related to Shingrix.     It was unknown if the company considered the headache, fever, tremor and insomnia to be related to Shingrix.   Linked case(s) involving the same patient:  US2023119268   Additional Information: GSK Receipt Date: 31-AUG-2023 The patient was self-reported this case. The reporter reported that she received Shingrix vaccine and on same day she experienced arm hurt really bad for 3 days. Patient also reported that she received her 2nd dose of Shingrix and had the worst headache across the top of her skull, and her head still hurt today (on the day of reporting).  Patient reported that she took 2 Acetaminophen 500mg around 11AM this morning and her headache was now (at the time of reporting) gone.  Patient also reported that she woke up in the middle of the night with a fever and shaking. Patient reported she was still shaking when she got up this morning and her fever went from 99.8 degree Fahrenheit when she got up, to 101 degree Fahrenheit at 11AM.  Patient also reported she was having Diarrhea today but this started before she received the 2nd dose of Shingrix.  Patient reported that she did test for Covid as she felt like these were all Covid symptoms, and she did test negative for Covid. The reporter consented to follow up. This case is linked with US2023119268, by same reporter.; Sender's Comments:  US-GSK-US2023119268:
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Erythema, Fatigue, Gait disturbance
Clinical narrative: -Started with knees becoming tight and painful after a walk in the neighborhood -Swelling moved to fingers, toes, wrists and knees on a weekly basis -Joints would be red, swollen, painful. Feel stiff with limited mobility -Extreme exhaustion and pain in feet and hands -8-9 months of weekly joint swelling and pain. In and out of doctor appointments and no one could tell me why this was happening -Steriod and non steriod medications to control and stop the swelling. -Blood tests and Xrays of joints -2 years of daily foot pain making it hard to walk and be on feet.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint stiffness, Joint swelling, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: -Started with knees becoming tight and painful after a walk in the neighborhood -Swelling moved to fingers, toes, wrists and knees on a weekly basis -Joints would be red, swollen, painful. Feel stiff with limited mobility -Extreme exhaustion and pain in feet and hands -8-9 months of weekly joint swelling and pain. In and out of doctor appointments and no one could tell me why this was happening -Steriod and non steriod medications to control and stop the swelling. -Blood tests and Xrays of joints -2 years of daily foot pain making it hard to walk and be on feet.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: -Started with knees becoming tight and painful after a walk in the neighborhood -Swelling moved to fingers, toes, wrists and knees on a weekly basis -Joints would be red, swollen, painful. Feel stiff with limited mobility -Extreme exhaustion and pain in feet and hands -8-9 months of weekly joint swelling and pain. In and out of doctor appointments and no one could tell me why this was happening -Steriod and non steriod medications to control and stop the swelling. -Blood tests and Xrays of joints -2 years of daily foot pain making it hard to walk and be on feet.