chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: had Pfizer covid vaccines/took a home test, positive; had Pfizer covid vaccines/took a home test, positive; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Allergic to penicillin" (unspecified if ongoing), notes: known allergies: Allergic to penicillin. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (Dose 4), administration date: 16Aug2023, when the patient was 55-year-old, for COVID-19 Immunization; Bnt162b2 (Doses 1-3), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "had Pfizer covid vaccines/took a home test, positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Positive, notes: home test. Therapeutic measures were taken as a result of vaccination failure, covid-19 as patient was being treated with Paxlovid.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 47-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years 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), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 59.0
Sex: M
Vaccine: PNC20
Symptoms: Eye pain, Fatigue, Headache, Nausea
Clinical narrative: Severe Headaches; Nausea; eye balls hurt; tired; woozy/dizziness; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 05Mar2024 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM], start date: 19Feb2024, stop date: 04Mar2024. The following information was reported: NAUSEA (non-serious) with onset 05Mar2024 at 13:00, outcome "recovering"; HEADACHE (non-serious) with onset 05Mar2024 at 13:00, outcome "recovering", described as "Severe Headaches"; EYE PAIN (non-serious) with onset 05Mar2024 at 13:00, outcome "recovering", described as "eye balls hurt"; FATIGUE (non-serious) with onset 05Mar2024 at 13:00, outcome "recovering", described as "tired"; DIZZINESS (non-serious) with onset 05Mar2024 at 13:00, outcome "recovering", described as "woozy/dizziness". Therapeutic measures were not taken as a result of headache, nausea, eye pain, fatigue, dizziness. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC20
Symptoms: Expired product administered
Clinical narrative: The patient was given an expired vaccine. Exp date: 2/22/2024
Age: 1.25
Sex: M
Vaccine: HIBV, PNC20
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was given an expired vaccine. Exp date: 2/22/2024
Age: 0.5
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: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm 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: "Htn" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "cancer" (unspecified if ongoing); "Known allergies: Onions" (unspecified if ongoing); "insect venom" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (start date: 24Feb2024, stop date: 29Feb2024).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 3.0
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: 63.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Pt received Covid vaccine HH3252 - 3mcg/0.3mL 6mo-4yrs.  Patient should have received 12+ dose.
Age: 0.58
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: 0.58
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: 0.67
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: 0.83
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: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Patient described lip swelling and hives over body starting that evening of vaccine. She took Benadryl that night and Allegra the next day. She states she is feeling better and less itchy. She reports her arm is still a little sore.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: Soreness started right after vaccine was administered on 2/1/24 and the level of pain has stayed the same (currently 3/7/24). Per patient nothing else occurred around that time that she believes could be responsible for causing the pain.  Patient states that she has a difficult time getting dressed or performing any activities where she must lift her left arm to around shoulder level.  Patient states that the vaccine was administered very low on her arm (a couple of inches above the elbow).  Administering pharmacist does not believe this to be the case and that the vaccine would have been administered 3-4 fingers below the shoulder joint for an intramuscular vaccine.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient given 2 Arexvy vaccines within 5 months.  1st on 10/16/23 and 2nd on 3/7/24.  Spoke with patient and he said he was not experiencing any reactions.
Age: 1.5
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: 0.5
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: 27.0
Sex: M
Vaccine: RAB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: DONOR STATES THAT HE OBSERVED REDNESS AND SWELLING AT THE RT DELTOID ON 3/4/24. DONOR HAD NO OTHER S/S.  DONOR STATES THAT HE DID NOT SEEK ANY TREATMENT.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Computerised tomogram, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: arm swollen, fever, sore arm
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Pain, Product use in unapproved indication
Clinical narrative: arm swollen, fever, sore arm
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWELLING AT SITE OF INJECTION, HER PROVIDER RECOMMENDED NOT TO VACCINATE DOSE 2
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: got the flu; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An elderly patient received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer biontech covid-19 vaccines (Dose 1, single), for COVID-19 immunization; Pfizer biontech covid-19 vaccines (Dose 2, single), for COVID-19 immunization; Pfizer biontech covid-19 vaccines (Dose 3, single), for COVID-19 immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "got the flu".  Additional information: The caller wants to know the newest data of efficacy for adults 65 and older for the Comirnaty. He has got 4 Pfizer Biontech COVID-19 vaccines. He also got the flu from his wife but a mild case.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 0.75
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: 78.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia
Clinical narrative: Patient did not complain about any pain or side effects at the time of vaccination .  2 months later, he came and complained about minor shoulder pain from vaccine. Then on 3/6, he called and complained again that he had to go thru therapy for shoulder pain
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain in extremity
Clinical narrative: his legs has been aching; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "his legs has been aching". The event "his legs has been aching" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional information: patient in regard to the covid shot, patient legs has been aching since last covid shot he got October2023. patient asking how many people complain about it, how long the side effects last. patient stated he had been taking medication for the side effect since he got the vaccine last October2023. States he got all the other shots and nothing bothered him till this shot. Clarifies other shots as all covid shots he received were by Pfizer. Initially states he thinks he had 5 Pfizer covid shots including a booster. Then states he thinks the last one he got was a booster. Then states he thinks he had 6 total covid shots all by Pfizer. Then states he is not sure if his last shot was called a booster shot or it was just called the new covid shot, states did not put anything on his card. After multiple clarification attempts, caller clarifies that he is not sure exactly how many covid shots he has received total, however, he does know that all his covid shots were by Pfizer and confirms today he is reporting on the Pfizer covid shot he received on 22Oct2023, which he states was the last covid shot he received. His back doctor had him do a MRI to see compare it to a c that was done two years ago. The doctor told him there was no difference. Caller states he does not know what the problem is.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: known_allergies: Pfizer vaccine; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 at 12:30 as dose 2 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "drug Allergy"; Amoxicillin, reaction(s): "drug Allergy". Vaccination history included: COVID-19 vaccine janssen (Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 17Sep2021, for Covid-19 immunization. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "known_allergies: Pfizer vaccine".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, COVID-19, Drug ineffective, Red blood cell sedimentation rate
Clinical narrative: COVID-19 in November 2021; COVID-19 in November 2021; This is a literature report.  A 74-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "COVID-19 in November 2021". The patient underwent the following laboratory tests and procedures: C-reactive protein: 73.2 mg/l, notes: elevated; Red blood cell sedimentation rate: 24, notes: Unit: mm/hour. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient 2 is a 74-year-old male who received his primary series through Pfizer-BioNTech in April and May 2021. He also received a monoclonal antibody infusion for COVID-19 in November 2021.   No follow-up attempts are possible.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-PV202400027798 Same article/patient/suspect and different event;
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 30-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: PERICARDITIS (hospitalization, medically significant), outcome "unknown". The event "pericarditis" required physician office visit.  Clinical course: Patient took the first two vaccines and came down with severe perocarditis. He has been hospitalized seven times for this and his physician stated that the cause of this heart condition was likely a reaction to the vaccine. They wanted to report this severe reaction case for a 30 year old athletic male that had no prior health issues before the vaccinations, whatsoever. At the time of report, he was limited on any physical activity for fear of having another cardiac episode. Requesting for recommendation or similar studies information.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Seasonal allergy
Clinical narrative: seasonal allergy; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2023-734900 (MODERNA, INC.).  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: moderna COVID-19 vaccine (2nd booster dose), administration date: 18Apr2022, for COVID-19 immunisation; Covid-19 vaccine (1st dose, unknown manufacturer), for COVID-19 immunisation. The following information was reported: SEASONAL ALLERGY (non-serious), outcome "unknown". Therapeutic measures were taken as a result of seasonal allergy.  Additional information: the patient was treated with fluticasone propionate for hay fever at an unspecified dose and frequency.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19, MNQ
Symptoms: Urticaria
Clinical narrative: urticaria (hives); Initial information received via courtesy From country on 29-Feb-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of an unknown age and gender who experienced urticaria (hives) after receiving Elasomeran [Spikevax] And Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 1 DF (dosage form) dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine Solution for injection via unknown route in unknown administration site as Prophylactic vaccination; also received a 1 DF (dosage form) dose of suspect Spikevax not produced by Sanofi Pasteur (strength, expiry date and lot number not reported for both vaccines) via unknown route in unknown administration site as COVID-19 prophylaxis. Information on the batch number was requested.  On an unknown date the patient developed urticaria (hives) (urticaria) (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 Unknown for the event.
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: PENTACEL was administered inadvertently after expiration with no reported AE; Initial information was received  on 04-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old male patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] was administered inadvertently after expiration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepatitis A Vaccine) for Prophylactic vaccination; and Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad) for Prophylactic vaccination.  On 22-Feb-2024, the patient received a dose 4 of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) (lot UJ806AA ,Expiry date :18-Feb-2024, strength was unknown) via intramuscular route in the right thigh for Prophylactic vaccination (Immunization) and pentacel was administered inadvertently after expiration with no reported adverse event (expired product administered) (latency :same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Malaise
Clinical narrative: he got the flu from his wife.; not feel well; Initial information received on 04-Mar-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to case 2024SA074172.  This case involves Elderly male patient who got the flu from his wife after receiving Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On October 2023, the patient received unknown dose of suspect Influenza Quadrival A-B High Dose HV Vaccine (formulation, lot number, expiry and strength not reported) via unknown route in unknown administration site for Immunization. There will be no information regarding batch number.  On an unknown date the patient developed he got the flu from his wife. (influenza) with symptom  not feel well (malaise) (latency: Unknown) following the administration of Influenza Quadrival A-B High Dose HV Vaccine.  It was reported that patient and his wife got sick with the flu last Sunday. She ended up getting hospitalized and was seriously ill. She had to be put on oxygen, and was high doses of corticosteroids, antibiotics and all kinds of other "unintelligible". It provided no protection no effectiveness whatsoever. His wife is currently out of the hospital but is still on several medications. After that he then got the flu from his wife. He started to not feel well. He said he was in generally in good health prior to him getting the flu.  Action taken: Not applicable.  It was not reported that the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.
Age: 1.25
Sex: F
Vaccine: DTAPIPV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: medication error/an inappropriate use due to administration of QUADRACEL to a patient under 4 years of age with no reported adverse event; inadvertently administered a QUADRACEL to a 2-year old patient instead of the PENTACEL with no reported adverse event; Initial information was received from (Privacy) on 04-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who had medication error/an inappropriate use due to administration of Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine [Quadracel (Vero)] to a patient under 4 years of age with no reported adverse event and inadvertently administered a Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine [Quadracel (Vero)] to a 2-year old patient instead of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza Vaccine and Hepatitis vaccine for Prophylactic vaccination.  In February 2023, the patient received a  dose of 0.5 ml of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine (Solution for injection) (lot U7564AA,Expiry date:08-Nov-2024, strength was unknown) via unknown route in Upper left arm  for Prophylactic vaccination (Immunization). On an unknown date, the patient received a  unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (Suspension for injection) (strength, expiry date, lot number not reported ) via unknown route in unknown administration site for Prophylactic vaccination (Immunization).  On an unknown date in Feb-2023 the patient had medication error/an inappropriate use due to administration of quadracel to a patient under 4 years of age with no reported adverse event (product administered to patient of inappropriate age) and inadvertently administered a quadracel to a 2-year old patient instead of the pentacel with no reported adverse event (wrong product administered) (latency : same day).   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: MEN
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: localized swelling/redness around the injection site; localized swelling/redness around the injection site; Initial information was received on 04-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult and unknown gender patient who experienced localized swelling/redness around the injection site after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, Solution for injection (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious localized swelling/redness around the injection site (vaccination site swelling and vaccination site erythema) (latency 2 days).  Action taken: not applicable.  The patient was treated with  BENADRYL for Vaccination site erythema and Vaccination site swelling.  At time of reporting, the outcome was Unknown for Vaccination site erythema and Vaccination site swelling
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Hepatic cirrhosis, Hepatic failure
Clinical narrative: Reported systems: 10811906: DEATH; Narrative: Patient died at home in home hospice on 2/9/2023. Pt died of hepatic failure due to severely decompensated cirrhosis. Pt had received a covid19 EUA vaccine (J&J) on 7/27/2021. Vaccine is not related to death. Other Relevant HX: Other: death post covid EUA vaccine (j&j)
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Reporter Symptoms: 10011906: DEATH: 10084465: COVID-19 VACCINATION: Narrative: Pt died on 12/24/2022. No information in chart regarding pt's death, cause of death, circumstances of death or place of death. Most recent medical history before death in chart as follow: PMH: BPH post TURP 2016 Bladder cancer 2016 Adenomatous polyp of colon - multiple Thromboembolism, s/p DVT LE x 3 Depression with anxiety Osteoarthritis Hyperlipidemia Diabetes Mellitus Type 2 Hypertension Pt had received a covid19 vaccine (EUA) (J&J) on 4/2/2021. Likely this death is not related to covid vaccine given pt's age and length of time between date of death and date covid vaccine was given. Other Relevant HX: Other: death post covid19 vaccine EUA (J&J)
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10084465: COVID-19 VACCINATION; Narrative: Pt received a covid 19 vaccine EUA (j&j) on 11/17/2021. Pt died on 12/21/2022 at long term care facility. No information available in chart regarding cause of death. Likely this death is not related to covid vaccine given pt's age and length of time between date of death and date covid vaccine was given. Other Relevant HX: Other: death post covid19 EUA (J&J)
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10084268:COVID-19; Narrative: Patient died on 3/23/2023 of unknown cause.. Last chart note in record was 10/27/2022. Pt had received a covid-19 EUA (J&J) on 9/16/2021. Likely this death not related to covid vaccine. Other Relevant HX: Other: death post covid-EUA (j&j)
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder cancer, Death, Prostate cancer
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10084465:COVID-19 VACCINATION; Narrative: Pt died on 1/14/2023 at home in hospice care. Pt was a 75 yo M with hx of Prostate CA and bladder CA. s/p XRT, chronic left hydroureteruenphrosis s/p left ureteral stent, afib s/p ablation, DM, HTN, chronic back pain, and neuropathy. Pt had received a covid vaccine EUA (J&J) on 5/6/2021. This vaccine is unrelated to pt's death. Pt died of prostate & bladder cancer. Other Relevant HX: Other: death post covid vaccine EUA (J&J)
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Acute kidney injury, Atrial fibrillation, COVID-19, Cardiac arrest, Cough
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10011906:DEATH; 10038436:RENAL FAILURE ACUTE; 10038678:RESPIRATORY DEPRESSION; 10084266:COVID-19; Narrative: This patient received 4 doses Pfizer COVID 19 vaccine (Apr, May, Nov 21, and Oct 22) and one dose Moderna (May 22). The patient presented to the ED on 27 Jan 23, after being discharged on 26 Jan 23 from the hospital, with shortness of breath. The patient tested positive for COVID 19 on 27 Jan 23. The patient was admitted with COVID 19 and hypoxia. The patient was treated with remdesivir and dexamethasone. The patient's condition deteriorated, and he experienced afib, required intubation, pulmonary toilet, and died after cardiac arrest on 24 Feb 23. Reported per EUA. Other Relevant HX: Other: covid 19
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Death, Dyspnoea, Endotracheal intubation, General physical health deterioration, Hypoxia
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10011906:DEATH; 10038436:RENAL FAILURE ACUTE; 10038678:RESPIRATORY DEPRESSION; 10084266:COVID-19; Narrative: This patient received 4 doses Pfizer COVID 19 vaccine (Apr, May, Nov 21, and Oct 22) and one dose Moderna (May 22). The patient presented to the ED on 27 Jan 23, after being discharged on 26 Jan 23 from the hospital, with shortness of breath. The patient tested positive for COVID 19 on 27 Jan 23. The patient was admitted with COVID 19 and hypoxia. The patient was treated with remdesivir and dexamethasone. The patient's condition deteriorated, and he experienced afib, required intubation, pulmonary toilet, and died after cardiac arrest on 24 Feb 23. Reported per EUA. Other Relevant HX: Other: covid 19
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Lung disorder, Respiratory depression, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10011906:DEATH; 10038436:RENAL FAILURE ACUTE; 10038678:RESPIRATORY DEPRESSION; 10084266:COVID-19; Narrative: This patient received 4 doses Pfizer COVID 19 vaccine (Apr, May, Nov 21, and Oct 22) and one dose Moderna (May 22). The patient presented to the ED on 27 Jan 23, after being discharged on 26 Jan 23 from the hospital, with shortness of breath. The patient tested positive for COVID 19 on 27 Jan 23. The patient was admitted with COVID 19 and hypoxia. The patient was treated with remdesivir and dexamethasone. The patient's condition deteriorated, and he experienced afib, required intubation, pulmonary toilet, and died after cardiac arrest on 24 Feb 23. Reported per EUA. Other Relevant HX: Other: covid 19
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10084465:COVID-19 VACCINATION; Narrative: Patient died on 2/25/2023. Pt had received a covid vaccine EUA (j&j) on 7/29/2021. Pt is a 73 yo ex-smoker, alcohol abuse, cad ( medically treated ), htn, hld, seizure d.o., copd, s/p left basal ganglia ischemic cva ( transferred to facility on 2/13/20 ), s/p left cea for carotid artery stenosis ( 03/2020 ). No information in facility chart about pt's death other than pt died at home. Likely this death is not related to the vaccine given pt's age, medical history & long length of time btwn VACCINE DATE GIVEN & DEATH DATE. Other Relevant HX: Other: death post covid19 vaccine EUA (j&j)
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10084465:COVID-19 VACCINATION; Narrative: Patient died on 1/23/2023. Pt received a covid vaccine EUA (j&J) on 7/12/2021. Pt left area in May 2022. No further notes in pt's chart since then. Pt moved to another state. No information regarding pt's death available in chart. Likely death not related to vaccine given pt's advanced age and long length of time btwn date of death & date pt received covid vaccine. Other Relevant HX: Other: death post covid 19 EUA(j&j)
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10084465:COVID-19 VACCINATION; Narrative: Patient died on 1/10/2023. Pt had received a covid vaccine (J&J EUA on 6/17/2021. Pt was a 75 yo male with h/o TBI (GSW 1968, s/p lt temporo-parietal craniectomy and cranioplasty), h/o seizure, CKD stg IV, DM2, HTN, suspected CVA 2016, h/o esophageal stricture s/p dilation, hypothyroidism, hyperparathyroidism, GERD, and BPH. Pt died at home in hospice case at time of death. Medical Diagnosis: Age-Related Physical Debility(ICD-10-CM R54.) for hospice admission. Likely death not related to covid vaccine given age, medical history & hospice care. Other Relevant HX: Other: death post covid19 EUA vaccine (j&j)
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Diabetic ketoacidosis, Hyperglycaemia, SARS-CoV-2 test negative, Seizure
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10384465:COVID-19 VACCINATION; Narrative: Pt died on 1/11/23 post EUA covid-19 vaccine (J&J-EUA) received on 6/28/21. Pt had transferred to inpatient hospice on 1/7/23 from community hospital inpatient. Chief Complaint: Seizure, hyperglycemia, DKA Primary Diagnosis: Disposition Admitted Route of Admission: ER Date of Admission: 1/3/2023 Admitting Diagnosis: Seizure, Hyperglycemia, DKA Confirm Level of Care: Acute Inpatient Care Pt was covid negative. Likely this death is not related to the covid vaccine. Other Relevant HX: Other: death1/11/23 post EUA covid vaccine (J&J-EUA) on 6/28/21
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Reported Symptoms:  10011986:DEATH; 10034465:COVID-19 VACCINATION; Narrative:  Patient got a covid-19 (EUA) (J&J) on 9/8/21. Pt died on 2/2/2023 of unknown cause, unknown place, unknown circumstance. NO information in chart of pt's death. Other Relevant HX: Other: death post covid-19 (J&J) (EUA)
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Malignant neoplasm of unknown primary site, Tumour pain
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10084465:COVID-19 VACCINATION; Narrative: Patient died on 1/10/2023 of metastatic malignancy of unknown primary origin at hospital Inpatient. Pt was planning for hospice care. Chief Complaint: G893 - Neoplasm related pain (acute) (chronic) Primary Diagnosis: Disposition Admitted Route of Admission: ER Date of Admission: Jan 4, 2023 Admitting Diagnosis: G893 - Neoplasm related pain (acute) (chronic) Confirm Level of Care: Acute Inpatient Care Pt had received a covid-19 vaccine (J&J) (EUA) on 3/17/2021. This death is not related to this vaccine. Other Relevant HX: Other: death post covid -19 vaccine (J&J) EUA
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Reported Symptoms: 10011986:DEATH; 10084465:COVID-19 VACCINATION; Narrative: Patient died on 1/9/2023. Pt had received a covid19 EUA (j&j) vaccine on 6/14/2021. No information about pt's death in chart. Pt was 59 yo yo M with hx of paroxysmal afib s/p MAZE, CAD s/p stenting and CABG, ischemic heart disease, HTN, HLD, Hypertriglyceridemia, uncontrolled insulin dependent type 2diabetes, chronic pancreatitis, asthma. likely this death not related to this covid vaccine given pt's age & medical history. Other Relevant HX: Other: death post covid19 vaccine (EUA) J&J
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Decubitus ulcer, Femur fracture
Clinical narrative: Reported Symptoms: 10011906:DEATH; 10084465:COVID-19 VACCINATION; Narrative: Patient died on 1/22/2023. Pt had received a covid19 vaccine EUS (j&j) on 3/30/2021. Pt died at community hospital in hospice care. Community Hospital Name: Address: State: Zip Code: Phone: Community Facility Point of Contact: Phone: Chief complaint: LEFT FEMUR FRACTURE Primary Diagnosis: L89300 - Pressure ulcer of unspecified buttock, un Disposition Admitted Route of Admission: ER Date of Admission: Dec, 28, 2022 Admitting Diagnosis: L89300 - Pressure ulcer of unspecified buttock, un Community Care Provider: Confirm Level of Care: Acute Inpatient Care Pt was admitted from this ER visited and remained inpatient until transferred to hospice care, then deceased. Death appears unrelated to the covid vaccine given advanced age and underlying medical condition. Other Relevant HX: Other: death post covid19 EUA (j&j) vaccine
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site swelling, Myalgia
Clinical narrative: aching muscles (full body), swelling at injection site, tiredness
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Urticaria, Vertigo
Clinical narrative: patient experienced large bruise on arm, hives on her back and vertigo. symptoms lasted 5+ days, and was treated at home with benadryl. At time of speaking with patient she had made an appointment with her PCP.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Neuralgia, Neurological symptom, Pain in extremity
Clinical narrative: pt had to go to hospital because of stroke like systems. has been on several antibiotics, has had trouble breathing, nerve pain in both hands. believes it all started after receiving shingrx vaccine
Age: 34.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Hypoaesthesia, Injection site rash
Clinical narrative: Patient stated she had a topical rash and some jaw numbness from her last covid and flu shot, so I asked her to remain for monitoring. After 15 minutes, she said she had a small rash around the varicella injection point, which I said was a possible side effect, but she also had some numbness in her right jaw as well. She said she also received the covid and flu vaccines on her right arm. She reported these to her doctor before and they resolved on their own. I asked her to monitor and report to her doctor if worsens, but I would inform her office as well.
Age: 73.0
Sex: F
Vaccine: HEP
Symptoms: Product administration error, Underdose
Clinical narrative: Patient received 10 mcg (Pediatric dose) of Engerix instead of 20 mcg as ordered due to an administration error.  Patient received an additional dose of 10 mcg to complete the full dose upon the the discovery of the error.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Influenza virus test negative, Pain, Pruritus, Pyrexia
Clinical narrative: Body ache and joint pain (elbow, shoulder, hips) started on 03/03 and lasting through 03/06. Fever on 03/04. Skin rash (red patches) on upper body and face started and 03/05 and fading on 03/07. Itchy on 03/06.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Body ache and joint pain (elbow, shoulder, hips) started on 03/03 and lasting through 03/06. Fever on 03/04. Skin rash (red patches) on upper body and face started and 03/05 and fading on 03/07. Itchy on 03/06.
Age: 1.17
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: As I was documenting the vaccines I gave to pt I noticed I had given her the wrong one. I gave MMRV instead of MMR and A separate dose of Varicella. Pt got two doses of varicella. I let MOC know right after I realized and as well to PCP. MOC is aware of the type of reaction pt might get. Also, PCP went to go talk to MOC to let her know the risk and more information.  PT did not have any symptoms after receiving these vaccines. MOC was provided with a researched article of adverse events, as well with management number if mother is needing to talk to someone about the experience she went through. Per MOC understood about the situation and what to look out for as well with the information we provided to her.  After Provider and I talked to MOC I was able to let my supervisor know about the situation.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pain, Pain in extremity, Swelling
Clinical narrative: Red, swollen and painful to move right arm. Will treat with Benadryl and prednisone times three days. Is to follow up tomorrow if not improving.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Blood test, Chills, Fatigue, Flushing
Clinical narrative: Day one I had flushing, chills, rapid shaking, headache weakness, and very tired.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Tremor
Clinical narrative: Day one I had flushing, chills, rapid shaking, headache weakness, and very tired.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came to pharmacy on 12/15/23 asking for first dose of Shingrix vaccine. He returned to pharmacy on 3/7/24 for second shots. Upon completion, patient asked for vaccine record. Pharmacist checked system and found out patient already completed the series back in 2018.  Thus, patient got dose #3 on 12/15/23 and dose #4 on 3/7/24.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Migraine, Nausea, Vaccine positive rechallenge, Vomiting
Clinical narrative: Migraine 1-2 hours after, nausea 3-4 hours after, lightheadedness 7-8 hours after, vomiting 12 hours after.
Age: 65.0
Sex: M
Vaccine: COVID19-2, COVID19-2, COVID19-2, COVID19-2
Symptoms: Computerised tomogram thorax
Clinical narrative: COVID-19 vaccine (Pfizer-BioNTech 30mcg/0.3mL) 12YO+ BIVALENT PF, MDV x 5
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal erythema, Pharyngeal swelling, Rash, Throat tightness
Clinical narrative: Reported Symptoms: 10037844:RASH; 10038196:RED THROAT: 10043528:THROAT TIGHTNESS; Narrative: Other Relevant HX: Other: REDNESS AND SWELLING/TIGHT THROAT
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Epicondylitis, Joint swelling, Pain in extremity, Tenderness
Clinical narrative: Reported Symptoms: 10042722:SWOLLEN JOINTS;  Narrative: Patient presented to outside provider. Per progress note 6/2/2021: there is acute tenderness in left medial epicondyle with swelling and less so on the left lateral epicondyle, hurts to supinate pronate the arm. pulses in the wrist. no swelling in the hand. no shoulder pain. diagnosis of left medial and lateral epicondylitis. Other Relevant HX: Other: JOINT SWELLING
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Auscultation, Chest X-ray normal, Chest pain, Dyspnoea, Fibrin D dimer normal
Clinical narrative: Reported Symptoms: 10008479:CHEST PAIN; 10013963:DYSPNEA; Narrative: On 10/19. pt received 1st dose of Pfizer COVID-19 vaccine. On 10/22, pt reached out to Nurse with complaints of 7/10 chest pain, SOB, headache, and neck pain. Pt was recommended to go to ER. ER performed several examinations (chest X-ray, troponin, D-dimer, lung auscultation, etc.) which were negative. Pt was recommended to make a follow-up appt with PCP prior to receiving 2nd COVID vaccine. On 11/3, pt spoke with facility care team, who stated that the only contraindications to COVID-19 vaccinations are allergic reactions (e.g. anaphylaxis) to the COVID-19 vaccines or their components. Pt received 2nd dose of Pfizer COVID-19 vaccine on 11/19. F/U testing at PCP appts did not find any condition (ischemia, PE, etc.) that can explain symptoms. Other Relevant HX: Other: DYSPNEA; CHEST PAIN