chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles on eye; Shingles on forehead; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: shingles on eye) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on forehead). The outcome of the vaccination failure, ophthalmic herpes zoster and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix.     The company considered the vaccination failure to be related to Shingrix. The company considered the ophthalmic herpes zoster to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt date: 29-JUL-2024  This case was reported by patient via interactive digital media. A reporter reported that it isn't 100 percent effective and that there are some bad side effects for some people.  He/she had it on his/her forehead and eye also and he/she heard you should get the vaccine e even if you already had shingles but beware, some have terrible. Side effects from the shot and it's not 100 percent effective, he/she heard many people who still got shingle even after getting the vaccine, bad too.  This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure  is a listed event which is considered related to GSK vaccine Shingrix. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: unintentional administration of Bexsero to a pediatric patient age less than 10 years; Bexsero was not the intended vaccine to be administered; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: unintentional administration of Bexsero to a pediatric patient age less than 10 years) and wrong vaccine administered (Verbatim: Bexsero was not the intended vaccine to be administered). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-JUL-2024 It was reported that incorrect product (Bexsero) retrieved and administered to a pediatric patient less than 10 years of age. Bexsero was not the intended vaccine to be administered which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient was given expired product; This non-serious case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (expiry date 30-JUN-2024) for prophylaxis.   On 30-JUL-2024, the patient received the 1st dose of Bexsero. On 30-JUL-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Patient was given expired product). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-JUL-2024 The office manager reported that in the clinic, the patient was given an expired dose of an Bexsero vaccine, which led to expired vaccine used. The reporter considered the event to be related to the suspect product.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: forgot to have the second dose administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (on an unknown date received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: forgot to have the second dose administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-JUL-2024 The patient reported that she received the first dose of Shingrix vaccine but forget to had the second dose administered with specified time of 2 to 6 Months. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. This case has been linked to the case US2024094868 reported by the same reporter.; Sender's Comments:  US-GSK-US2024094868:Same reporter/Different patient/Wife case
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Incomplete course of vaccination; Shingles at the end of January 2024; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Varicella zoster vaccine (old vaccine initial dose in 2019) and Varicella zoster vaccine (old vaccine booster in 2019).   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. In JAN-2024, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles at the end of January 2024). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the shingles and incomplete course of vaccination were not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 01-AUG-2024 This case was reported the patient via interactive digital media The patient had old vaccine 2 shots. initial and booster in 2019.  In 2020 the patient had the new Shingrix single-shot vaccine. The patient was still got Shingles at the end of January 2024.  The patient's physician told that, for men of their age (early 70s) it was only about 80 percent effective.  The patient was still recommend the vaccine.  No telling how much worse it might have been if had not had the vaccines. Till the time of event onset the patient did not had 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: significant pain in right arm; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Tetanus vaccine.   On an unknown date, the patient received the 1st dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: significant pain in right arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt date: 29-JUL-2024  This case was reported by patient via interactive digital media. The patient reported significant pain in right arm with administration of dose 1 Shingrix and a single dose of Tetnus vaccine in the left arm on the same date and she reported the pain in the right arm was bad enough that it was sore for 2 days and she could not sleep on her right side for 2 nights. She did later go back and get dose 2 of the vaccine. Follow up was not possible, as no contact details were available.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: patient received the first dose of Menveo in 2018 and the 2nd dose in 2022; She states that it appears that the 2nd dose would have been expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA658A) for prophylaxis.   Previously administered products included Menveo (received the 1st dose in 2018).   In 2022, the patient received the 2nd dose of Menveo. In 2022, an unknown time after receiving Menveo, the patient experienced drug dose administration interval too long (Verbatim: patient received the first dose of Menveo in 2018 and the 2nd dose in 2022) and expired vaccine used (Verbatim: She states that it appears that the 2nd dose would have been expired). The outcome of the drug dose administration interval too long and expired vaccine used were unknown.   Additional Information: GSK Receipt Date: 22-JUL-2024 The certified medical assistant (CMA) stated that the patient received the first dose of Menveo in 2018 and the 2nd dose in 2022.  The reporter requested to get a lot number for what she believed was a Menveo vaccine.  The lot number provided did not identified as a GSK vaccine. She states that it appeared that the 2nd dose would had been expired, which led to expired vaccine used. Since the lot number was not identified she thought it may had been transcribed incorrectly since their documentation system had a hard stop if a product was expired. The patient received 2nd dose of Menveo, later than the recommended interval, which led to lengthening of vaccination schedule
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Underage administration/1 year old patient received Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2tp74, expiry date 10-JUN-2024) for prophylaxis.   Previously administered products included DTaP vaccine (previously received 3 dTap doses).   On 15-APR-2024, the patient received Kinrix. On 15-APR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage administration/1 year old patient received Kinrix ). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-JUL-2024 The medical assistant reported that the patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration.  The Vaccine Administration Facility was the same as Primary Reporter. Did not consent to follow-up.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Extra dose administered, Product preparation error
Clinical narrative: nurse administered 3 doses of Havrix to the same patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 12-month-old male patient who received HAV (Havrix) (batch number TF27T, expiry date 05-FEB-2026) for prophylaxis.   Co-suspect products included MMR (MMR vaccine) for prophylaxis and Varicella zoster vaccine live (Oka/Merck) (Varivax) for prophylaxis.   On 25-JUL-2024, the patient received Havrix. On 25-JUL-2024, the patient received MMR vaccine and Varivax. On 25-JUL-2024, an unknown time after receiving Havrix and MMR vaccine, the patient experienced overdose (Verbatim: nurse administered 3 doses of Havrix to the same patient). The outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-JUL-2024 It was reported on July 29th 2024 that a new nurse administered 3 doses of Havrix to the same patient on July 25th 2024. One dose on its own, a dose mixed with Varivax and another dose mixed with MMR vaccine (no brand mentioned) which led to overdose.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the patient was 4 months old when they received the vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 28-MAY-2024, the patient received Kinrix. On 28-MAY-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: the patient was 4 months old when they received the vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-JUL-2024 The nurse reported that, the patient (an infant) who had this Kinrix administered to them. According to nurse, the patient was 4 months old when they received the vaccine which led to inappropriate age at vaccine administration.  The Vaccine Administration Facility was the same as Primary Reporter. This case was linked with US2024041645, reported by same reporter.; Sender's Comments:  US-GSK-US2024041645:Same reporter,Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix + only diluent given; Shingrix + only diluent given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number M5CA9) for prophylaxis.   On 29-JUL-2024, the patient received Shingrix. On 29-JUL-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix + only diluent given) and inappropriate dose of vaccine administered (Verbatim: Shingrix + only diluent given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-JUL-2024 The medical assistant reported that the patient received only diluent portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 1.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient received Menveo 1 vial today instead of a Hib vaccine by a MA; underage; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number LB93L, expiry date 30-JUN-2025) for prophylaxis.   On 29-JUL-2024, the patient received Menveo. On 29-JUL-2024, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: patient received Menveo 1 vial today instead of a Hib vaccine by a MA) and inappropriate age at vaccine administration (Verbatim: underage). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 29-JUL-2024 The practice manager reported that the patient received Menveo 1 vial today (day of reporting) instead of a Hib vaccine by a medical assistant. The 1 year old patient received Menveo instead of Hib vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration.  The reporter consented to follow up
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Inflammation, Peripheral swelling, Pyrexia
Clinical narrative: arm has been swollen, inflamed; arm has been swollen, inflamed; fever; This is a spontaneous report received from a Consumer or other non HCP. A 78-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 01Aug2024 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 78 years, in arm for immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "neuropathy" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "auto immune" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), INFLAMMATION (non-serious) all with onset 01Aug2024 at 21:00, outcome "not recovered" and all described as "arm has been swollen, inflamed"; PYREXIA (non-serious) with onset 01Aug2024 at 21:00, outcome "not recovered", described as "fever". Therapeutic measures were not taken as a result of peripheral swelling, inflammation, pyrexia. Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s) for which you are reporting. The patient was taking any other medications within 2 weeks of the event starting. It was noted that the patient was the reporter's mother. Arm has been swollen, inflamed and mild fever since vaccination.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: heart failure; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure". Therapeutic measures were taken as a result of cardiac failure. Clinical course: Vaccine cost sever heart damage on patient's heart patient had a healthy heart before got the vaccine now patient had a pacemaker and patient was in heart failure, life has totally changed can barely do anything any more, patient would like to know if patient was the only one or were there more people that that has happened.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Dizziness
Clinical narrative: dizziness after taking a dtap booster vaccine; Initial information received on 31-Jul-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 67 years old female patient (84.8 kg) who experienced dizziness after taking a dtap booster vaccine after receiving diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel].  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Asthma and Drug hypersensitivity with morphine sulfate 0.5 mg/ml vial, penicillin v potassium.  Concomitant medications included dupilumab (dupixent); vitamin e nos; carbamazepine (tegretol); montelukast sodium (singulair); hydroxychloroquine sulfate; tramadol hydrochloride; codeine phosphate, guaifenesin (guaifenesin & codeine); anakinra (kineret); telmisartan; metolazone; pantoprazole sodium; potassium chloride; levetiracetam (keppra); levocetirizine dihydrochloride; leflunomide (arava); aciclovir (acyclovir); vitamin k nos (vitamin k); vitamin b12 nos (vitamin b12); azelastine, fluticasone; budesonide, formoterol fumarate, glycopyrronium bromide (breztri aerosphere) and vitamins nos (multivitamin).  On an unknown date, the patient received a Booster dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, frequency, strength and expiration date: not provided) for Immunisation. Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  On an unknown date the patient developed dizziness after taking a dtap booster vaccine (dizziness) (unknown latency).  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event.
Age: 12.0
Sex: F
Vaccine: HPVX, MEN, MENB
Symptoms: Induration, Limb mass
Clinical narrative: hard lump under her skin" on her arm which she does not describe as swelling/that it's been 5 days since she received the vaccines and she had 2 lumps; received both meningitis vaccines in the same arm; received both meningitis vaccines in the same day; Initial information received on 03-Aug-2024 regarding an unsolicited valid non-serious courtesy case received from a consumer/Non-Healthcare Professional.  This case involves a 12 years old female patient who had hard lump under her skin" on her arm which she does not describe as swelling/that it's been 5 days since she received the vaccines and she had 2 lumps, received both MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] in the same arm and received both meningitis vaccines in the same day and also received HPV VACCINE,   It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 01-Aug-2024, the patient received MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection, TRUMENBA and HPV VACCINE not produced by Sanofi Pasteur via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) (strength, dose, batch number and expiry date unknown) both meningitis vaccines in the same arm (vaccination error) and received both meningitis vaccines in the same day (extra dose administered) (latency same day). Information on batch number corresponding to the one at time of event occurrence could not be requested.  On 06-AUG-2024 the patient had hard lump under her skin" on her arm which she does not describe as swelling/that it's been 5 days since she received the vaccines and she had 2 lumps (nodule).  It is unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for nodule.  At time of reporting, the outcome was Unknown for the event nodule.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.25
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MENQUADFI was administered to a 3 month old patient, with no reported adverse event; Initial information received on 30-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old male patient who was administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Jul-2024, the patient of 3 months received a dose 1 with dosage 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (lot U8193AB, Expiry: 30-Sep-2027, Strength: standard) via intramuscular route in the right thigh as Immunization with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day. No treatment and no other vaccines.   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: 7.0
Sex: M
Vaccine: DTP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: the patient has not received their last dtap dose as a booster and is due for this vaccine with no reported adverse event; Initial information received on 05-Aug-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 7-year-old male patient who has not received their last diphtheria, tetanus and NOS pertussis vaccine dose as a booster and is due for this vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the suspect diphtheria, tetanus and Nos pertussis vaccine produced by unknown manufacturer (form, lot number, strength, expiry date: unknown) via unknown route in unknown administration site as Immunization and the patient has not received their last dtap dose as a booster and is due for this vaccine with no reported adverse event (routine immunisation schedule not administered) (unknown latency).  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.     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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Aspiration joint, Blood test, Gait disturbance, Joint swelling
Clinical narrative: Approximately two( 2) hours after  receiving the vaccine, while sitting on the couch, my right knee (status post 8 months RIGHT TKA) with no trauma or other incident,  swelled up and became extremely painful. I could not walk unassisted  and went to the Facility at hospital. X-rays and blood test were WNL, no infecton was suspected and I was issued crutches and a knwe wrap. I was referred bck to my knee sureon who aspirated 100 cc's of bloody fluid, negative for gout or infection. To this day, while the knee has improved, and no further treatment is recommended, no pathopysiology or medically probable cause has been established other than the temporal associaton with the vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Walking aid user, X-ray
Clinical narrative: Approximately two( 2) hours after  receiving the vaccine, while sitting on the couch, my right knee (status post 8 months RIGHT TKA) with no trauma or other incident,  swelled up and became extremely painful. I could not walk unassisted  and went to the Facility at hospital. X-rays and blood test were WNL, no infecton was suspected and I was issued crutches and a knwe wrap. I was referred bck to my knee sureon who aspirated 100 cc's of bloody fluid, negative for gout or infection. To this day, while the knee has improved, and no further treatment is recommended, no pathopysiology or medically probable cause has been established other than the temporal associaton with the vaccine.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Seizure
Clinical narrative: Patient states 9/14/2022 began experiencing new onset seizures. Continued since 9/14 to today. Worsened to tonic clonic seizures.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Contraindication to vaccination, Exposure during pregnancy
Clinical narrative: Nurse administered vaccines that are not recommended in pregnancy.  At time of administration, patient was 15w0d preganant.
Age: 20.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 48.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Mass, Pain, Swelling
Clinical narrative: SWELLING, MASS, PAIN since receiving vaccine
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Malaise
Clinical narrative: Pt. came in to get two vaccines -MMR and Hep B. I gave her both and she started not to feel well, light headed and dizzy and saying like she felt like she was going to pass out but did not. Once we got her stabilized she told me she had a history of syncope with vaccines and blood draw but did not have one in years. We monitored her and no issues she went home and I followed up later she said she got home fine and was feeling fine.
Age: 46.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Dizziness, Erythema, Feeling hot, Injection site pain, Loss of consciousness
Clinical narrative: Patient did report previous events of fainting on blood tests and vaccinations. I counseled the patient extensively prior to preparing and administering vaccines in which I found it reasonable to proceed with vaccination. Patient received first vaccine Typhim with no incident. Patient reacted to Havrix administration. Patient noted pain on injection not experiences on Typhim administration. 10-20 seconds later the patient reported feeling lightheaded and feeling faint. Patient lost consciousness for about 15 seconds and lost control of his bladder, urinating in the chair. Patient remained mostly upright, did slump back wards in the chair. No discernable evidence of seizure. The patient began to turn colored in the face, red, prompting me to quickly exit to have my partner call emergency services in case he was going to lose his airway. I returned to the room immediately after prompting EMS contact. Patient came to within 15 seconds from syncope - remembers last feeling hot that wouldn't pass. Emergency services arrived, the patient obtained permission to leave from an attending physician. I made a follow-up call to check-in, patient reported a productive work day, no other consequences. Advised patient on future vaccination points including option to receive in supine position, and cold compress for future vasovagal response mitigation.
Age: 46.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Posture abnormal, Syncope, Urinary incontinence
Clinical narrative: Patient did report previous events of fainting on blood tests and vaccinations. I counseled the patient extensively prior to preparing and administering vaccines in which I found it reasonable to proceed with vaccination. Patient received first vaccine Typhim with no incident. Patient reacted to Havrix administration. Patient noted pain on injection not experiences on Typhim administration. 10-20 seconds later the patient reported feeling lightheaded and feeling faint. Patient lost consciousness for about 15 seconds and lost control of his bladder, urinating in the chair. Patient remained mostly upright, did slump back wards in the chair. No discernable evidence of seizure. The patient began to turn colored in the face, red, prompting me to quickly exit to have my partner call emergency services in case he was going to lose his airway. I returned to the room immediately after prompting EMS contact. Patient came to within 15 seconds from syncope - remembers last feeling hot that wouldn't pass. Emergency services arrived, the patient obtained permission to leave from an attending physician. I made a follow-up call to check-in, patient reported a productive work day, no other consequences. Advised patient on future vaccination points including option to receive in supine position, and cold compress for future vasovagal response mitigation.
Age: 51.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 35.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse event occurred. The purpose of submitting this report is to document a vaccination administration error not an adverse event per guidelines. Vaccine was administered to this individuals beyond use date of 8 weeks after vaccine had been thawed.  The individual has been notified of this error and offered to be revaccinated per guidelines.  Our local Department of Public Health has been notified of this vaccination administration error.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: Patient reported feeling lightheaded and started having headache 30 mins after the shot and started vomiting 2 times, 1 hour after the shot. Symptoms were not reported to the medical staff. She managed her symptoms by taking ibuprofen, drinking lots of water and taking rest. 1 Day after the shot Patient felt better without any lingering symptoms.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: steroids, antihistamine- rash
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Eyelid rash, Rash, Swelling
Clinical narrative: Patients father called the clinic this morning stating that child had broken out in a rash on the left side of his abdomen, right cheek and right eyelid was red and swollen, no other symptoms were reported.  Father states that they gave child an antihistamine last night, that the rash looked better this morning.  Father called to report the reaction. I discussed with the reaction with Dr and  patients father was told to give child benadryl  every 4-6 hours until rash was resolved and to call if child had any other symptoms.
Age: 76.0
Sex: M
Vaccine: FLUA4, PNC20, TDAP
Symptoms: Arthralgia, Joint swelling
Clinical narrative: The evening of receiving the vaccine his left middle joint in his finger swelled up and was very painful.  When he reported this to us the next day on 8/7/24 he stated the swelling went down and pain had resolved some. He did not using anything at home to manage symptoms.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain oedema
Clinical narrative: her Brain started to swelling, she was then brought to the hospital due to this.; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 (BNT162B2), on 21Apr2022 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: BRAIN OEDEMA (hospitalization), outcome "unknown", described as "her Brain started to swelling, she was then brought to the hospital due to this.". Clinical Course: Patient took pfizer covid 19 shot 21Apr2022 and after this her Brain started to swelling, she was then brought to the hospital due to this.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400231422 same patient, different dose/events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: her Brain started to swelling, she was then brought to the hospital due to this.; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 (BNT162B2), on 21Apr2022 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: BRAIN OEDEMA (hospitalization), outcome "unknown", described as "her Brain started to swelling, she was then brought to the hospital due to this.". Clinical Course: Patient took pfizer covid 19 shot 21Apr2022 and after this her Brain started to swelling, she was then brought to the hospital due to this.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400231422 same patient, different dose/events;
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died since taking your COVID vaccine; Safety information originally reported under manufacturer case 202300047636 has been nullified and re-entered under this new manufacturer report number 202400232403.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Reporter also reported that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail. Upon follow-up on 06Feb2023, reporter stated that I will pass you names of the deceased, their local area and possible doctor that administered your product. Then you need to further investigate what batch, cause of death etc.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (06Feb2023): This is a spontaneous follow-up report received from a contactable consumer. This consumer reported in response to Non-HCP letter sent via email follow-up activity which included that: Updated information included: clinical information was added.  Follow-up attempts are completed. No further information is expected.  Follow-up (07Aug2024): This is a follow-up report to notify that the case 202400232403 and 202300047636 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202400232403.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020087 as same reporter/drug/event, different patient;; Reported Cause(s) of Death: Died since taking your COVID vaccine
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died since taking your COVID vaccine; Safety information originally reported under manufacturer case 202300047640 has been nullified and re-entered under this new manufacturer report number 202400232456.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Reporter also reported that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (06Feb2023): Follow-up attempts are completed. No further information is expected.  Follow-up (07Aug2024): This is a follow-up report to notify that the case 202300047640 and 202400232456 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202400232456.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020087 same reporter/drug/event, different patient.;; Reported Cause(s) of Death: died since taking your COVID vaccine
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died since taking your COVID vaccine; Safety information originally reported under manufacturer case 202300047643 has been nullified and re-entered under this new manufacturer report number 202400232467.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Additional information: Reporter also reported that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail. On 04Feb2023, caller reported that because these events resulted in fatalities he/she will speak with the families and collect relevant information. As this was a sensitive matter it may take a few days. It's not down to the general public to provide data, it needed to be collected yourself as this was your product. He/she will pass names of the deceased, their local area and possible doctor that administered the product. Further investigation was needed to know what batch and cause of death etc. Caller also stated that "looks like you will be very busy with the family for the time being".  Follow-up attempts are completed. No further information is expected.  Follow-up (04Feb2023): This is a spontaneous follow-up report from a contactable Consumer. Updated information included: Additional information updated.  Follow-up attempts are completed. No further information is expected.  Follow-up (07Aug2024): This is a follow-up report to notify that the case 202400232467 and 202300047643 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202400232467.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020087 Same reporter/drug/event, different patient;; Reported Cause(s) of Death: Died since taking your COVID vaccine
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Tinnitus
Clinical narrative: Received ,to date, all Moderna vaccination and boosters. Last year detected a trigger able, louder than normal ring in my left ear ONLY when pressing on the injection location of my upper left arm. Info only. Have not encountered other like issues.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/; HBP reported that PROQUAD has been administered that has been improperly stored. It was stored in the refrigerator for over one year. It was administered to at least 3 patients.; This spontaneous report was received from a healthcare worker and referred to a 4-year-old female patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  From 20-JUN-2023 to 22-JUL-24,, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) has been improperly stored. It was stored in the refrigerator for over one year. On 25-OCT-2023, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot #x009733, expiration date: 02-SEP-2024, administered subcutaneously in right arm for prophylaxis (strength was not provided) (improper storage of product in use); diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP), lot #y4259, expiration date: 03-MAR-2024, administered intramuscularly in left deltoid for prophylaxis (strength and formulation were not provided); and polio vaccine inact (IPV), lot #v1ad21m, expiration date: 17-FEB-2024, administered subcutaneously in right arm for prophylaxis (strength and formulation were not provided). All vaccines were operated by a health professional (trained). The suspect vaccine was quarantined and available for return. The vaccine was used according to the instruction leaflet. No additional adverse event (AE).