chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: rebound Covid; rebound Covid; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Lot number: HG4680) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Vaccine brand=Pfizer / BioNTech, Vaccine brand unknown=False,, Vaccine administration date=16Jan2021,, Vaccine lot number=EL3249,, Vaccine lot unknown=False,, Vaccine dose number=1,, Vaccine dose number unknown=False,, Vaccine location=Left arm), administration date: 16Jan2021, when the patient was 65-year-old, for Covid-19 Immunization; pfizer / biontech (Vaccine brand=Pfizer / BioNTech, Vaccine brand unknown=False,, Vaccine administration date=06Feb2021,, Vaccine lot number=EL9266,, Vaccine lot unknown=False,, Vaccine lot unknown=False,, Vaccine dose number=2,, Vaccine dose number unknown=False,, Vaccine location=Left arm,), administration date: 06Feb2021, when the patient was 65-year-old, for Covid-19 Immunization; BNT162b2 (Vaccine brand=Pfizer / BioNTech, Vaccine brand unknown=False,, Vaccine administration date=04Nov2021,, Vaccine lot number=32308D,, Vaccine lot unknown=False,, Vaccine dose number=3,, Vaccine dose number unknown=False,, Vaccine location=Left arm,), administration date: 04Nov2021, when the patient was 66-year-old, for Covid-19 Immunization; BNT162b2 (Vaccine brand=Pfizer / BioNTech, Vaccine brand unknown=False,, Vaccine administration date=13May2022,, Vaccine lot unknown=True,, Vaccine lot unknown reason=Not available/provided to reporter at the time of report completion,, Vaccine dose number=4,, Vaccine dose number unknown=False,, Vaccine location=Left arm,), administration date: 13May2022, when the patient was 67-year-old, for Covid-19 Immunization; BNT162b2, BNT162b2 omi ba.4-5 (Vaccine brand=Pfizer / BioNTech, Vaccine brand unknown=False,, Vaccine administration date=16Sep2022,, Vaccine lot number=HG9702,, Vaccine lot unknown=False,, Vaccine dose number=5,, Vaccine dose number unknown=False,, Vaccine location=Left arm,), administration date: 16Sep2022, when the patient was 67-year-old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "rebound Covid". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid from 24Feb2024 to 29Feb2024.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). Concomitant medication(s) included: ANASTROZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Mar2024 at 08:00, outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "sleep apnea" (unspecified if ongoing), notes: sleep apnea; "Known allergies: Penicillen" (unspecified if ongoing), notes: Known allergies: Penicillen. 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". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High; SARS-CoV-2 test: Positive, notes: positive Covid test (5 days after). Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (start date: 27Feb2024, stop date: 02Mar2024).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8732) and on 20Apr2021 as dose 2, single (Lot number: EW0164) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: the patient received Paxlovid treatment from 27Feb2024 to 03Mar2024.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Pharmacist.  A 39-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "NAFLD" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 4 , Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 3 , Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2 , Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid for COVID-19 treatment. The patient also takes an unspecified multivitamin. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose 3 (booster), single (Lot number: GJ3274) at the age of 74 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Oct2023 as dose 4 (booster), single (Lot number: AU393218) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had not known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19,  Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received paxlovid from 28Nov2023 to 02Dec2023.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Interchange of vaccine products
Clinical narrative: Atrial Fibrillation (Afib); /Revaccination with different COVID-19 vaccine/Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2023-735183 (Moderna, Inc.).  This spontaneous case was reported by a patient family member or friend and describes the occurrence of Atrial fibrillation (afib) in a patient who received mRNA-1273 bivalent .222 (Moderna COVID-19 vaccine, bivalent (original and omicron BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below Co-suspect product included non-company product Tozinameran (Pfizer biontech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 bivalent .222 (Moderna COVID-19 vaccine, bivalent (original and omicron BA.4/BA.5)) (unknown route) 1 dosage form and dose of tozinameran (Pfizer biontech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced atrial fibrillation (afib) (seriousness criterion medically significant), COVID-19 immunisation (Revaccination with different COVID-19 vaccine) and Interchange of vaccine products (Interchange of vaccine products). At the time of the report, atrial fibrillation (afib), COVID-19 immunisation (Revaccination with different COVID-19 vaccine) and Interchange of vaccine products (Interchange of vaccine products) outcome was unknown. For mRNA-1273 bivalent .222 (Moderna covid-19 vaccine, bivalent (original and omicron BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. Concomitant medication details not reported by the reporter. Reporter stated that husband has AFib and he was on a blood thinner. Reporter also stated read something about being on a blood thinner. when was speaking about receiving the Moderna COVID19 vaccine.   Company comment: This is a spontaneous case concerning a patient with no medical history reported, who experienced the serious (medically significant) unexpected AESI atrial fibrillation. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as a booster dose of COVID-19 vaccination schedule, was administered. Onset date of the event and vaccination date were not provided hence latency cannot be assessed. Patient also received a dose of tozinameran vaccine (revaccination with different COVID-19 vaccine and interchange of vaccine products). Reporter stated that patient had atrial fibrillation and he was on a blood thinner. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: have spread it down to her joints and swollen and both of her knees; This is a spontaneous report received from a Consumer or other non HCP.  A female patient (unknown if pregnant) received BNT162b2 (BNT162B2 NOS), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "inflammation is very high" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: JOINT SWELLING (non-serious) with onset 2023, outcome "not recovered", described as "have spread it down to her joints and swollen and both of her knees". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: welt; itchiness; Initial information received on 28-Feb-2024 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 43-year-old female patient who had welt and itchiness while receiving vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B vaccine, Suspension for injection (prefilled single dose syringe) (lot number, strength, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination (immunization).  On an unknown date the patient had events welt (urticaria), itchiness (pruritus) (unknown latency) following the administration of influenza quadrival A-B vaccine.  It was unknown if any lab data/test results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown for the events.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: stated that Fluzone High Dose was being used on 1 or 2 patients younger than 65 years of age with no reported adverse event; Initial information received on 29-Feb-2024 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age (younger than 65 years of age) female patient who received influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient (younger than 65 years of age) received unknown dose of suspect influenza quadrival A-B high dose HV vaccine, Suspension for injection (lot number, strength, expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (immunization) with no reported adverse event (product administered to patient of inappropriate age) (same day latency).  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: UNK
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: a 4-year-old patient was administered with only the DTAP-IPV or liquid component of PENTACEL with not reported adverse event.; Initial information received on 01-Mar-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves 4-year-old patient who was administered with only the Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) liquid component of  [Pentacel (VERO)] with not reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Varicella Zoster Vaccine Live (OKA/MERCK) (Varivax [Varicella Zoster Vaccine Live (OKA/MERCK)]) and Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) both for Prophylactic vaccination.  On 23-Feb-2024, the patient received only liquid component of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine, Suspension for injection at dose of  0.5 ml (dose 5) (lot UJ8488AA) (expiry date: 16-Apr-2024) (strength not reported) with not reported adverse event (single component of a two-component product administered) (Latency: same day) via intramuscular route in right deltoid Immunization.  It was reported that patient was administered only DTAP-IPV or liquid component of Pentacel.   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: 25.0
Sex: F
Vaccine: RAB
Symptoms: Incorrect route of product administration, Injection site discomfort, Medication error
Clinical narrative: bit of discomfort from the previous injection site; administered the vaccine at the wrong route of administration (SC); Initial information received on 01-Mar-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 25 years old female patient who experienced bit of discomfort from the previous injection site and was administered the rabies (HDC) vaccine [Imovax Rabies] at the wrong route of administration (SC) (subcutaneous).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Feb-2024, the patient received a dose 2 of suspect rabies (HDC) vaccine (Powder and solvent for suspension for injection) (lot: W1C931M; expiry date: 31-Oct-2025) via subcutaneous route  in unknown administration site (incorrect route of product administration) (latency: same day).  On an unknown date the patient developed bit of discomfort from the previous injection site (vaccination site discomfort) (unknown latency).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (bit of discomfort from the previous injection site).  At time of reporting, the outcome was Unknown for the event bit of discomfort from the previous injection site.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: administered a vaccine that just expired with no reported adverse event; Initial information received on 06-Mar-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient who had administered a Hib (PRP/T) Vaccine [ACT-HIB] that just expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Mar-2024, the patient received a expired unknown dose of suspect Hib (PRP/T) Vaccine Powder and solvent for solution for injection (strength: unknown, expiry date: 01-Mar-2024 and lot UJ8338A) via intramuscular route in the left thigh as immunization (expired product administered) (latency: same day).   Reportedly: Data logger recording issues Low temperature reached: -15.24°C Duration out of labelled range: 4 seconds Human error: No, Does extended stability data cover the excursion: No, Administered to a patient: No, Previous excursion: None   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: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Administered wrong dose of influenza vaccine to patient. 0.7 ml high dose influenza vaccine was administered in R deltoid. No adverse reaction noted at time of administration. Patient denies any adverse reaction since the event.
Age: 0.25
Sex: F
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 3 month xx day old infant was inadvertently administered Rotovirus  #1.  Child is aged out for vaccine.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none will have telephone appointment with provider if needed.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Patient received additional Hep A vaccination, family aware
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given high dose 0.7 ml influenza vaccine in R deltoid. Patient should have received 0.5 ml dose. No adverse reaction noted at that time. Attempted to contact patient to inquire about adverse reaction, unable to contact patient or leave a voicemail.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Redness around upper arm near injection site and below to approximately the elbow. Was seen by his doctor today and prescribed Diphenhydramine and instructed to apply warm compresses.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Injection site induration, Pyrexia
Clinical narrative: Patient explained having low grade fever and arm was hard in the area where vaccine was administered. Her blood pressure was eleveted after the vaccine however she is not sure if it was elevated prior to the vaccine.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Tremor, Visual impairment
Clinical narrative: Roughly 5 minutes after vaccination pt's mother states "my daughter was walking around and she started seeing gray squares so I told her to sit down and then she passed out and started shaking" . Pt was then evaluated by two physicians in clinic and was determined to have recovered from event. Pt was able to accurately tell where she was and able to stand and speak without issue.
Age: 46.0
Sex: F
Vaccine: COVID19, HEP, HEPA, MMR, TDAP, VARCEL
Symptoms: Arthralgia, Burning sensation
Clinical narrative: Left knee pain and burning sensation
Age: 26.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Patient is not having any known adverse reactions, we are just reporting pregnant patient received RSV -Arexvy instead of RSV- Abrysvo.
Age: 1.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine. We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 0.5
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine twice: 1/18/2024 and 2/16/2024 We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 0.5
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine twice: 1/19/2024 and 2/21/2024 We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 1.5
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product administration error, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine twice: 1/18/2024 and 2/16/2024 We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine. We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 1.25
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine. We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 1.08
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine. We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 1.75
Sex: F
Vaccine: COVID19-2, FLU4, HEPA
Symptoms: Product preparation issue
Clinical narrative: Pfizer Covid vaccine, 6 month-4 years, 23-24 formulation, 0.3 ml dose to be given. Vaccine was given to client without incident, IM, Left Thigh,, 0.3 ml, but was not diluted as necessary prior to administration. Child last seen playing near mom, in lobby, about 15 minutes after immunization. Three attempts made to contact parent on 3/8/24, with a message to call agency back to discuss incident, to ascertain child's current status, and to inform parent to observe child closely for any reactions to covid vaccine.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine. We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine. We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine twice on 01/30/2024 and 03/01/2024 We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 43.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired MMR vaccine administered. Pt asymptomatic. No immediate adverse reactions.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Poor quality sleep
Clinical narrative: Very restless/sleepless night
Age: 10.0
Sex: M
Vaccine: COVID19, FLU4, HPV9, MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Spikevax instead of Moderna 6m-11yr formulation
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine. We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine. We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error, Product storage error
Clinical narrative: Administration Error. Gave expired vaccine. We had a recent event where up to 60 patients received an expired batch of Pfizer COVID-19 vaccines (6 months - 4 years) at one of our primary clinics. The vaccines had expired on 12/25/2023 (10 week refrigerated beyond use date) and were administered to the patients past this beyond use date.
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: Evening of vaccine patient felt itching all over body and numbness and tingling in fingers. The itching subsided slowly but the tingling in fingers has taken longer to go away and is still present on 3/8/24 (day 3 post vaccine)
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received vaccine that was 10 days past BUD date.  Moderna was notified and performed quality assessment on lot number and confirmed vaccine was still effective.  No adverse event was reported by the patient
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects noted, but vaccine was given after BUD so may not be as effective
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray
Clinical narrative: Burning sensation of vaccine as it was injected , thebinjection site was on my rightbarem very high up on the top left.By the next day inside of my are in the line of injection site the  inside of my arm  toward the inner elbow bend was very sore and as time went on my range of motion became affect ed as well as discomfort when I tried to reach or bend my arm  in  certain directions.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Post-acute COVID-19 syndrome
Clinical narrative: Long covid; Long covid; Long covid; This is a spontaneous report received from an Other HCP.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 27Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 03Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), POST-ACUTE COVID-19 SYNDROME (medically significant), outcome "unknown" and all described as "Long covid".  Clinical information: Vaccination facility type was pharmacy or drug store. Relevant Tests, List Other Relevant Diagnostic And Confirmatory Test and Specific relevant test for thromboembolic events with thrombocytopenia were reported as None. Patient reported that symptoms began aprox 2-3 weeks after first vaccine started with burning sensation covering entire body. Joints ached could not walk, could not sleep due to pain and burning. Severe pain in stomach, diarrhea, red spot on while of eye appeared causing pain and overtime blindness. Went to the ER multiple times given predisone, pain medicine, vitamins told may be "Long covid". No one has been able to help spoke with someone and Told to try Bariatric chamber. Before the vaccine patient was able to be active pain free and living a good life. Now was mostly bed ridden house bound and in constant pain. Went to the hospital after vaccine multiple times with sever symptoms. She reported the issues began after the third shot, the booster. Some steroid made her sick to the stomach, sometimes when she would eat she would throw up whatever eats. Sometimes she could not eat solid food has to be a liquid, she thinks it was from the steroid, which started taking it the first time she went to the hospital on fire (as reported). She went to the emergency room (ER) multiple times and was given predisone, pain medicine and vitamins and was told it might be "Long COVID".; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine to the drug ineffective (LOE), covid 19 and Long COVID cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300334093 same patient, different dose/AE.;
Age: 24.0
Sex: F
Vaccine: FLU4, HEP, IPV, TDAP, VARCEL
Symptoms: Dizziness, Feeling hot
Clinical narrative: Administered Influenza, Hep B, IPV, Varicella at 11:15. At 11:20 patient stated, "I feel dizzy and hot". Stopped the vaccination. Vital signs: blood pressure 86/65, pulse 64, respirations 18, equal and unlabored, oxygen saturation 99 percent on room air, temperature 97.5. Patient alert and oriented to person, place, and time. At 11:25, provider, on site and assessed patient. Patient stated, "I have not eaten today, but I feel better now." Patient denied dizziness or feeling hot. Provider recommended that patient drink some water and eat a snack. Patient declined snack. Patient was given a bottle of water. Patient was cleared to receive Tdap vaccine. patient received Tdap vaccine at 11:35. At 11:42, Blood pressure 102/75, Pules 69, Respirations 18, equal and unlabored, oxygen saturation was 99 percent on room air, temperature 97.5. Patient was oriented to person, place, and time. Patient stated, "I feel fine now and would like to go eat some lunch." At 11:55, patient was instructed to go t the ER or call EMS if symptoms returned. Patient verbalized understanding and was cleared to go home. Patient discharged to home with no symptoms of distress
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Chills, Diarrhoea, Headache
Clinical narrative: Soreness at injection site, then exactly one week later stomach pain, headache , buttocks aches , soreness lower back, soreness vomiting  6 times and diarrhea.for 3 days 101.3  fever  chills  felt better after three days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Pyrexia, Vomiting
Clinical narrative: Soreness at injection site, then exactly one week later stomach pain, headache , buttocks aches , soreness lower back, soreness vomiting  6 times and diarrhea.for 3 days 101.3  fever  chills  felt better after three days.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Product administered at inappropriate site
Clinical narrative: pt states he has agonizing shoulder pain that the vaccine was given too high in the shoulder.
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity, Sleep disorder, Therapy non-responder
Clinical narrative: The day after administration of Prevnar20 and RSV, the patient's left arm that received Prevnar20 started to have pain. Pt describes pain as muscular pain at the site of injection. The patient took Arnica orally and topically hoping it would go away but it did not, and patient has a cruise tomorrow. Patient reports limited range of motion when lifting arm, and pain disrupts her sleep. The pain has now been persisting for about a month and has not gotten better. Patient was instructed to take ibuprofen, acetaminophen, cold compress and follow up with doctor before her cruise to determine if she needs additional treatment.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient reported of getting rash days later after the vaccination.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthritis, Blood pressure increased, Condition aggravated, Dyspnoea, Heart rate increased
Clinical narrative: At time i believe of the 2nd injection is when i had the elevated BP and HR with swelling in my bottom lip
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling
Clinical narrative: At time i believe of the 2nd injection is when i had the elevated BP and HR with swelling in my bottom lip
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Dysstasia, Similar reaction on previous exposure to drug, Sleep disorder, Tremor
Clinical narrative: Was awakened by shakes and feeling that my nervous system was being attacked. I could not sit up or stand because of the shaking internally and externally. I had a similar reaction after my second Shingrex shot. The adverse reaction lasted about 3 hours for RSV and 6 hours for the Shingrex shot, leaving me feeling weak.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Lymphadenopathy, Musculoskeletal stiffness, Oropharyngeal pain
Clinical narrative: Severe headache for the first two days following vaccination. stiff hands for one day after. sore arm at the shot site, and swollen lymph node under armpit for about 5 days. Sore throat for 5 days. runny nose and phelgm two weeks following.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Rhinorrhoea
Clinical narrative: Severe headache for the first two days following vaccination. stiff hands for one day after. sore arm at the shot site, and swollen lymph node under armpit for about 5 days. Sore throat for 5 days. runny nose and phelgm two weeks following.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspepsia, Headache, Injection site pain, Nausea
Clinical narrative: Dizzy, heartburn, nausea, injection site pain, swelling, body ache, skin tingling, headache, blurry vision
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Swelling, Vision blurred
Clinical narrative: Dizzy, heartburn, nausea, injection site pain, swelling, body ache, skin tingling, headache, blurry vision
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Erythema, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Patient has red arm, swelling , heat and pain at injection site. She states she had scales and red patches on knuckles of hand big toe which have now resolved and were present the day after vaccination. She said she had tingling at end of finger tips/toes like a bug bite. She said her scalp tingled, she had decreased appetite, fatigue, and muscle soreness in back in the area she has scoliosis of back.  All of this was present the day after vaccination, now all that presents is redness, swelling around injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Paraesthesia, Scoliosis
Clinical narrative: Patient has red arm, swelling , heat and pain at injection site. She states she had scales and red patches on knuckles of hand big toe which have now resolved and were present the day after vaccination. She said she had tingling at end of finger tips/toes like a bug bite. She said her scalp tingled, she had decreased appetite, fatigue, and muscle soreness in back in the area she has scoliosis of back.  All of this was present the day after vaccination, now all that presents is redness, swelling around injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Patient has red arm, swelling , heat and pain at injection site. She states she had scales and red patches on knuckles of hand big toe which have now resolved and were present the day after vaccination. She said she had tingling at end of finger tips/toes like a bug bite. She said her scalp tingled, she had decreased appetite, fatigue, and muscle soreness in back in the area she has scoliosis of back.  All of this was present the day after vaccination, now all that presents is redness, swelling around injection site.
Age: 77.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Blood test, Computerised tomogram, Hemiparesis
Clinical narrative: APPROXIMATELY 3 DAYS AFTER VACCINATION, PATIENT COMLPLAINED OF RIGHT SIDED WEAKNESS IN UPPER AND LOWER EXTREMETIES
Age: 61.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Hypoaesthesia, Magnetic resonance imaging normal, Muscular weakness, Pain in extremity, Sleep disorder
Clinical narrative: Severe arm pain started on Wednesday 2/14/24. Tried Advil, Aleve, Tylenol, heat and ice to relieve pain with no success. Pain continued through Thursday 2/15. Went to Urgent Care on 2/16 for the continued pain.  Steroids were prescribed for 10 day period.  Two for 5 days then 1 for 5 days. Steroids were started on 2/16. On 2/19 with severe pain still persistent I visited  Ortho where I saw a PA.  She indicated that it could be Sirva and prescribed physical therapy and cyclobenzaprine, and diclofenac to start after the steroid treatment was completed. Numbness in the thumb and loss of strength in the hand started on 2/20.  Returned to Ortho to see Dr. Based on my symptoms she suggested I may have Parsonage Turner Syndrome.   I had an xray and received a steroid shot in the shoulder.  MRI was scheduled I was told to discontinue the cyclobenzaprine and was prescribed Gabapentin 300 mg 3 times a day.  I had an MRI on 2/29/24 and met with Dr. on 3/1.  Results of MRI were negative.  Prescribed more steroids and increased dosage of Gabapentin to 600 mg three times a day.   I am now waiting to have an EMG which is scheduled for 3/18/2024.  In the meantime I am still experiencing extreme pain at times especially at night.  Sleep has been very difficult.  My thumb is very numb and feels like it may be spreading to my wrist.  My right hand is very weak.  I have started physical therapy but so far my condition has not changed.
Age: 61.0
Sex: M
Vaccine: UNK, UNK
Symptoms: X-ray
Clinical narrative: Severe arm pain started on Wednesday 2/14/24. Tried Advil, Aleve, Tylenol, heat and ice to relieve pain with no success. Pain continued through Thursday 2/15. Went to Urgent Care on 2/16 for the continued pain.  Steroids were prescribed for 10 day period.  Two for 5 days then 1 for 5 days. Steroids were started on 2/16. On 2/19 with severe pain still persistent I visited  Ortho where I saw a PA.  She indicated that it could be Sirva and prescribed physical therapy and cyclobenzaprine, and diclofenac to start after the steroid treatment was completed. Numbness in the thumb and loss of strength in the hand started on 2/20.  Returned to Ortho to see Dr. Based on my symptoms she suggested I may have Parsonage Turner Syndrome.   I had an xray and received a steroid shot in the shoulder.  MRI was scheduled I was told to discontinue the cyclobenzaprine and was prescribed Gabapentin 300 mg 3 times a day.  I had an MRI on 2/29/24 and met with Dr. on 3/1.  Results of MRI were negative.  Prescribed more steroids and increased dosage of Gabapentin to 600 mg three times a day.   I am now waiting to have an EMG which is scheduled for 3/18/2024.  In the meantime I am still experiencing extreme pain at times especially at night.  Sleep has been very difficult.  My thumb is very numb and feels like it may be spreading to my wrist.  My right hand is very weak.  I have started physical therapy but so far my condition has not changed.
Age: 87.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Abnormal behaviour, Agitation, Back pain, Disorientation, Hypertension
Clinical narrative: According to wife, 48 hours later patient acted disoriented, wore clothes backward, agitation increased, complained of excruciating back pain , high BP (200 /120) - usually has normal BP- and had to be taken to the ER and admitted in the hospital for a few days. He was admitted under " rule out encephalopathy". Kept under isolation, tested for covid (negative), no stroke or brain bleed. No silent seizures, but patient was completely "out of it" per wife. Discharged after 1 week in hospital, now normal except BP has stayed up (MD has increased BP meds).  Neurologist feels confident this is a reaction to COVID  shot.
Age: 87.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Immunisation reaction, Laboratory test, SARS-CoV-2 test negative
Clinical narrative: According to wife, 48 hours later patient acted disoriented, wore clothes backward, agitation increased, complained of excruciating back pain , high BP (200 /120) - usually has normal BP- and had to be taken to the ER and admitted in the hospital for a few days. He was admitted under " rule out encephalopathy". Kept under isolation, tested for covid (negative), no stroke or brain bleed. No silent seizures, but patient was completely "out of it" per wife. Discharged after 1 week in hospital, now normal except BP has stayed up (MD has increased BP meds).  Neurologist feels confident this is a reaction to COVID  shot.
Age: 1.67
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: HBP called to report VARIVAX was given after possibly experiencing a temperature excursion.; No adverse event; This spontaneous report was received from health business professional (HBP) and refers to a 20-month-old patient (gender not provided). The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-JAN-2024, (since the excursion) the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, exact dose, lot #, expiry date, and route of administration were not provided) administered for prophylaxis. Varicella virus vaccine live (oka/merck) (VARIVAX) was involved in a temperature excursion (also reported as possibly) (Temperature, time frame and previous temperature excursion were reported as unknown) (Product storage error). No additional information/clarification provided, and no product quality complaint (PQC) was reported.    Lot # is being requested and will be submitted if received.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Carbohydrate antigen 125, Uterine leiomyoma, White blood cell count decreased
Clinical narrative: A fibroid mass grew outside uterus within 30 days of booster. Plus WBC counts have been low since then.
Age: 45.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong product administered
Clinical narrative: Incorrect vaccine given, Patient requested MMR was given Varivax, Varivax was the entered vaccine and was given. MMR was written on the PQCF