chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Scan myocardial perfusion, Stress echocardiogram, Ultrasound scan
Clinical narrative: A-Fib; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 23Jul2021 as dose 1, single (Lot number: EW0173) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "She has allergy asthma" (unspecified if ongoing); "She has allergy asthma. Like when get to next to a dog." (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: BREO ELLIPTA oral taken for hypersensitivity. The following information was reported: ATRIAL FIBRILLATION (hospitalization) with onset 15Dec2021, outcome "unknown", described as "A-Fib". The patient was hospitalized for atrial fibrillation (start date: 15Dec2021, discharge date: 16Dec2021, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: Angiocardiogram: Unknown results; Arteriogram: Unknown results; Blood test: Unknown results; Cardiac stress test: Unknown results; Chest X-ray: Unknown results; Computerised tomogram thorax: Unknown results; Echocardiogram: Unknown results; Lab  test: Unknown results; Scan myocardial perfusion: Unknown results; Stress echocardiogram: Unknown results; Ultrasound scan: Unknown results; Electrocardiogram: Unknown results. Therapeutic measures were taken as a result of atrial fibrillation. Clinical course: Reporter on the line called to report side effect Pfizer Covid 19 Vaccine that she got. She did not have an underlying condition before the vaccination. However, she has had A-Fib after the vaccination. She commented she does not know how old she was currently. Thinks she was maybe as clarified 56 years old when event started. It would be 2 years ago from whatever age she is today. Reporter clarified dates of experiencing A-Fib as the: 1st Time: A-Fib occurred on 15Dec2021, 2nd Time: A-Fib occurred on 27Nov2023, 3rd Time: A-Fib occurred on 10May2024. On all three occasions she was hospitalized for 2 days. She was hospitalized on the date the fast heart beat started. The second time she was hospitalized 27Nov2023 to 28Nov2023. The third time she was hospitalized 10May2024 to 11May2024. Treatment/ Intervention: Now, she was on three medications with no underlying conditions. This was why she was so upset. They could not find a point of what she has. Initially stated the first time she was sent home with Diltiazem 120mg capsule to take every night before sleep. She later clarified this was started after the second occurrence. She started this Nov2023. After the third occurrence of A-Fib since this was the third time and had has three episodes they added Eliquis 5mg tablet to take every day during the day. She was also put on Amiodarone 200mg tablet to take every day in the morning with the Eliquis. Had to do exercise where they make you walk on treadmill to make heartbeat accelerate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: took the two original Pfizer vaccines; took the Pfizer booster vaccine in Nov2022/he got COVID-19 in Jan2024; took the two original Pfizer vaccines; took the Pfizer booster vaccine in Nov2022/he got COVID-19 in Jan2024; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and 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 Jan2024, outcome "unknown" and all described as "took the two original Pfizer vaccines; took the Pfizer booster vaccine in Nov2022/he got COVID-19 in Jan2024".  Clinical course: The reporter stated that he took the two original Pfizer vaccines when they originally became available and he didn't have any issues/reactions. However, he took the Pfizer booster vaccine in Nov2022. Three weeks after taking the booster vaccine he started feeling some strange symptoms - his muscles started stiffening. He went to see if PCP who did 40-50 different tests and then he was diagnosed with Polymyalgea Rheumatica. The condition was apparently attributed to the Pfizer booster vaccine and he has not taken any additional booster doses since. His doctor tried various medications, none of which worked, until they tried Prednisone which apparently worked for him. Additionally, he got COVID-19 in Jan2024 (keep in mind the last time he took a booster was in Nov2022).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug Ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant) with onset 2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 03Jun2024 to 07Jun2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis bullous, Herpes gestationis, Immunology test, Maternal exposure during pregnancy, Pathology test
Clinical narrative: New-Onset Pemphigoid Gestationis Following COVID-19 Vaccination; Other Triggers: pregnancy; autoimmune bullous dermatosis; This is a literature report for the following literature source(s).  A 36-year-old female patient (pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunisation. The following information was reported: DERMATITIS BULLOUS (medically significant), 10 days after the suspect product(s) administration, outcome "recovered", described as "autoimmune bullous dermatosis"; HERPES GESTATIONIS (non-serious), outcome "unknown", described as "New-Onset Pemphigoid Gestationis Following COVID-19 Vaccination"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Other Triggers: pregnancy". The patient underwent the following laboratory tests and procedures: Immunology test: C3/IgG (linear); BP180+/BP230-; IgG (linear); Pathology test: spongiotic dermatitis. Therapeutic measures were taken as a result of dermatitis bullous.; Sender's Comments: Based on the temporal relationship, the association between the event autoimmune bullous dermatosis and Herpes gestationis with BNT162b2 can not be fully excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A patient in their 40's received BNT162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), in Jan2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ill" (unspecified if ongoing), notes: um about a little over 20 years ago um unfortunately I was very ill; "Pancreatitis" (ongoing), notes: I still had pancreatitis; "Gallstones" (unspecified if ongoing), notes: I had gallstones and had my gallbladder removed; "Cyst" (unspecified if ongoing), notes: they found a cyst in my pancreas and um removed the cyst as well; "Surgery on my pancreas" (unspecified if ongoing), notes: because of the surgery on my pancreas I was basically automatically pre-diabetic; "pre-diabetic" (unspecified if ongoing), notes: because of the surgery on my pancreas I was basically automatically pre-diabetic; "asthma" (unspecified if ongoing), notes: I also have asthma, allergies; "allergies" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: I actually have had COVID-19 twice. The patient's family history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure and high cholesterol; "high cholesterol" (unspecified if ongoing), notes: high cholesterol. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (I was a vaccinated., Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (I had every booster that vaccination), for COVID-19 immunization; Flu vaccine (I get my flu vaccine every year as well). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient stated, "I actually have had COVID-19 twice and I think because I was a vaccinated, I had very few symptoms the first time and the second time I took anti-virals and had few symptoms and I feel like I got through the illness faster and recovered faster.  I got my most recent COVID-19 vaccine in Jan2024. And Pfizer, BioNTech, and BioNTech made my vaccine. And when I first heard there was a new formula, I knew I wanted to get it right away. I had every booster that vaccination and booster for COVID-19 that has been recommended".   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The is fully vaccinated with the Pfizer COVID vaccine, but unfortunately she tested positive today; The is fully vaccinated with the Pfizer COVID vaccine, but unfortunately she tested positive today; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jun2024, outcome "unknown" and all described as "The is fully vaccinated with the Pfizer COVID vaccine, but unfortunately she tested positive today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2024) Positive, notes: tested positive today for COVID.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Blood glucose increased, General physical health deterioration, Haemorrhoids, Hepatic steatosis
Clinical narrative: high blood pressure; tinnitus; hemorrhoids; high cholesterol; high glucose; fatty liver; my health has deteriorated; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure"; TINNITUS (non-serious), outcome "unknown"; HAEMORRHOIDS (non-serious), outcome "unknown", described as "hemorrhoids"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "high cholesterol"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "high glucose"; HEPATIC STEATOSIS (non-serious), outcome "unknown", described as "fatty liver"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "my health has deteriorated".  Additional information: The reporter always been a pretty healthy person. But ever since he/she got the covid vaccine, his/her health has deteriorated. The patient experienced high blood pressure, tinnitus, hemorrhoids, high cholesterol, high glucose, fatty liver, etc. It's no coincidence that his/her health started diminishing not long after the vaccine was administered. The reporter stated, "You owe me my health back".
Sex: U
Vaccine: COVID19
Symptoms: Hypertension, Tinnitus
Clinical narrative: high blood pressure; tinnitus; hemorrhoids; high cholesterol; high glucose; fatty liver; my health has deteriorated; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure"; TINNITUS (non-serious), outcome "unknown"; HAEMORRHOIDS (non-serious), outcome "unknown", described as "hemorrhoids"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "high cholesterol"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "high glucose"; HEPATIC STEATOSIS (non-serious), outcome "unknown", described as "fatty liver"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "my health has deteriorated".  Additional information: The reporter always been a pretty healthy person. But ever since he/she got the covid vaccine, his/her health has deteriorated. The patient experienced high blood pressure, tinnitus, hemorrhoids, high cholesterol, high glucose, fatty liver, etc. It's no coincidence that his/her health started diminishing not long after the vaccine was administered. The reporter stated, "You owe me my health back".
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Polymyalgia rheumatica
Clinical narrative: muscles started stiffening/ Polymyalgea Rheumatica; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), 3 weeks after the suspect product(s) administration, outcome "unknown", described as "muscles started stiffening/ Polymyalgea Rheumatica". The event "muscles started stiffening/ polymyalgea rheumatica" required physician office visit. The patient underwent the following laboratory tests and procedures: tests: Polymyalgea Rheumatica, notes: He went to see if PCP who did 40-50 different tests. Therapeutic measures were taken as a result of polymyalgia rheumatica. Clinical course:It was reported that patient took two original Pfizer vaccines when it originally became available and he didn't have any issues/reactions. However, he took the Pfizer booster vaccine in Nov2022. Three weeks after taking the booster vaccine he started feeling some strange symptoms - his muscles started stiffening. The condition was apparently attributed to the Pfizer booster vaccine and he has not taken any additional booster doses since. His doctor tried various medications, none of which worked, until they tried Prednisone which apparently worked for him.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400191756 same patient/reporter; different vaccine dose/AE;
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Irritability
Clinical narrative: fussiness; Initial information was received on 05-Jun-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 2 months old female patient who experienced fussiness after receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)], pneumococcal vaccine CONJ 7V (CRM197) [Prevenar] and rotavirus vaccine live reassort oral 5V [Rotateq].  The patient had no medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 21-Mar-2024, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UK015AA, expiry date unknown) via intramuscular route, unknown dose of suspect Rotateq and Prevanar not produced by Sanofi Pasteur (unknown formulation, Lot number, expiry date, strength, route, administration site)  for Prophylactic vaccination (Immunisation). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.  On 21-Mar-2024 the patient had fussiness (irritability) (Latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Prevenar and Rotateq.  There were no lab data/results available.  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 22-Mar-2024 (Duration: 1 day) for the event.
Age: 0.33
Sex: U
Vaccine: DTAP, DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was supposed to receive pentacel yesterday, but the patient was given a different vaccine called infanrix with no reported adverse event; Initial information received on 04-Jun-2024 regarding an unsolicited valid non-serious case received via Nurse.  This case involves a 4-month-old and unknown gender patient was supposed to receive diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] yesterday, but the patient was given a different vaccine called diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Infanrix) 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 28-May-2024 the patient developed a non-serious patient was supposed to receive diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection yesterday, but the patient was given a different vaccine called infanrix not produced by Sanofi Pasteur (strength, lot number, expiry date: unknown) via unknown route in unknown administration site as prophylactic vaccination (immunization) 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.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: Max/Low Temperature reached: 1.0 C or 34.3 F for less than an hour due to human error with no reported adverse event; menquadfi was administered post excursion with no reported adverse event; Initial information received on 07-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to 2024SA174753 (Master case)  This case involves a 18 years old male patient who had administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] after it was exposed to max/low temperature reached: 1.0 Celsius or 34.3 Fahrenheit for less than an hour due to human error 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 MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for Prophylactic vaccination.  On 30-May-2024, the patient received a 0.5 ml (millimeter) dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (strength: standard, frequency: once, expiry date: 30-Mar-2026 and lot U7945BB) via intramuscular route in the right arm as immunization and was administered post excursion with no reported adverse event (poor quality product administered) (same day latency).  On an unknown date the max/low temperature reached: 1.0 ccelsus or 34.3 f for less than an hour due to human error with no reported adverse event (product storage error) (unknown latency) Human Error: Yes, the extended stability data does not cover the excursion.   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: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Products were administered post excursion with no reported adverse event; Initial information received on 10-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to 2024SA175682 (Cluster case).  This case involves 5 patients and reporter reported that IPV (VERO) [IPOL] were administered after post excursion with no reported adverse event.  On an unknown date, the patient's received a unknown dose of suspect IPV (VERO) Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization and administered post excursion (poor quality product administered) (same day latency).  Reportedly: "Max/Low Temperature reached: 46.65 F for 45 minutes 46.08 F for 56 minutes Duration out of labelled range: as stated above Human Error: Unknown, the extended stability data does not cover the excursion for punctured IPOL"   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: 5.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: they gave the patient the wrong vaccine, which was adacel, when she should have daptacel with no reported adverse event; Initial information received on 10-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient to whom they gave the wrong vaccine, which was  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], when she should have DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] 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 MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) both for prophylactic vaccination (immunization).  On 10-May-2024, the patient received 0.5 ml, total of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, Suspension for injection (lot U7671AA and expiry 18-Mar-25) via intramuscular route when she should have DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, Suspension for injection (wrong vaccine administered) (latency same day) in unknown administration site for prophylactic vaccination (immunization).  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: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient receiving a dose of PENTACEL in which only the diluent was administered, the dose was not reconstituted with the HIB portion of the vaccine (with no reported adverse event); patient receiving a dose of PENTACEL in which only the diluent was administered, the dose was not reconstituted with the HIB portion of the vaccine (with no reported adverse event); Initial information received on 10-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender of patient receiving a dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] in which only the diluent was administered, the dose was not reconstituted with the hib portion of the vaccine (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 13-May-2024, 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) and patient receiving a dose of pentacel in which only the diluent was administered, the dose was not reconstituted with the hib portion of the vaccine (with no reported adverse event) (product preparation error) and (product administration error) (latency: same day). The information on 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: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: she administered PENTACEL that had expired with no reported adverse event; Initial information received on 11-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient who was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] that had expired 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 pneumococcal vaccine conj 7v (crm197) (prevnar; hepatitis b vaccine (hepatitis b [hepatitis b vaccine]); and rotavirus vaccine (rotavirus vaccine) for Prophylactic vaccination.  On 04-Jun-2024, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ958AB) (Expiry date: 02-Jun-2024) (Strength: standard) (Frequency: once) via intramuscular route in the left vastus lateralis for immunization.  On 04-Jun-2024, the patient was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine that had expired 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: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: HCP reported PROQUAD was administered to a patient on an unspecified date during a temperature excursion; No additional AE; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  Concomitant medication included combination with sterile diluent (MERCK STERILE DILUENT).  On an unspecified date, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, as prophylaxis (lot number: X024655, which was determined to be valid, with an expiration date on 09-APR-2024. Therapy type: rHA) (strength, dose, scheme, route and anatomical location of administration were not reported) (Product storage error), administered in combination with sterile diluent (MERCK STERILE DILUENT) Solution for injection/infusion.  The administered dose underwent a temperature excursion of 12 degrees Fahrenheit for 1 hour. No previous temperature excursion was reported.  No additional information was provided.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: Patient called pharmacy on 06/13 to report a "blister-like" leg rash on right leg (opposite leg to the injection site.) The rash started on 06/11, one day post-injection. She reports to slight itching but no severe pain or swelling. The rash is contained to the leg and has not spread since. Pharmacist advised patient to contact doctor if rash persists, becomes bothersome, or the skin breaks. Ruled out various other causes of rash (insect bites, contact dermatitis, etc.)
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: donor reports feeling nausea and having one episode of vomiting 24 hours after receiving the immunization. Nausea resolved after the one vomiting episode and no further adverse events.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given two early in series
Age: 17.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Erythema, Pruritus, Rash
Clinical narrative: Client reports stomach cramps, abdominal itching, and redness and rash localized to abdomen.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given expired vaccine. expired 5/9/24, given on 6/7/24. patient did not have any adverse effects.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: Patient was itching all over and had blisters.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Myalgia, Rash, Type III immune complex mediated reaction
Clinical narrative: Deep bone and muscle pain, started the day of vaccine and continued developed and a facial rash started on 06/12/2024 same day seen at Urgent Care and treated by what turned out to be a third grade reaction.
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness
Clinical narrative: pt felt dizzy, after relaxing felt ok in 10 minutes
Age: 18.0
Sex: U
Vaccine: UNK
Symptoms: Dizziness, Tremor
Clinical narrative: Patient felt dizzy , was shaking, pharmacy called paramedics, they checked the vitals , pt felt finej in 15  - 20 minutes
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient came on 4-27 to get both Boostrix and 1st dose of Shingrix vaccine. Boostrix was adminstered on the left arm and Shingrix was adminstered on the left arm. Patient came to pharmacy to pick up prescription on 6-10-2024 informed us that she has pain on her right arm since getting the shingles shot in April. Pt says there is pain present when she moves her right arm up and down but there is no pain while trying to pick up or hold things. She just wondered if she should get the second shinlges shot when its due cause of concerns she might still have the same effect. We inquired if she did anything to try to reduce the pain or try any otc meds in the meantime. She states that she had not tried anything the pain was decreasing but it was still present at the time.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Received second dose of Spikevax (2023-2024) COVID vaccine under the age of 65 years old. Patient does not have immunocompromising condition, but has family member with an immunocompromising condition.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Received second dose of Spikevax (2023-2024) COVID vaccine under the age of 65 years old. Patient does not have immunocompromising condition, but has family member with an immunocompromising condition.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: Patient reported that 48 hours after first dose of Shingrix, she developed palpitations and had a recorded BP of 217/91. She went to the ER but they found no cause for the event. Patient is currently feeling fine, has a BP range of 120-130/80 and normal pulse. Patient will still get the second dose, but wanted to report this event.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient with persistent swelling and pain to right upper arm/deltoid since receiving immunization back on 4-25-24.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Immunisation reaction
Clinical narrative: Caller reports patient had a "severe" reaction to MMR II and VARIVAX in 2021.  Patient also has an egg allergy.  Caller unable to provide any additional information.  No additional AEs or PQC reported.; This spontaneous report was received from an advanced nurse practitioner (also reported as office manager) concerning a male patient of unknown age (age group between infant and child). The patient's medical history and concomitant medications were not reported. The patient's concurrent conditions included egg allergy.   On an unknown date in 2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, lot #, expiry date, route and site of administration were not provided); and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, dose, lot #, expiry date, route and site of administration were not provided).Both vaccines were administered as prophylaxis.  On an unknown day in 2021, the patient had a reaction to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (immunisation reaction) (Severe); he sought medical attention. On an unspecified date, the patient had recovered from the event. Caller unable to provide any additional information.  The action taken with the suspect vaccines regarding the event was considered as not applicable.  The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  and varicella virus vaccine live (oka/merck) (VARIVAX) and the event of immunisation reaction (Severe) was considered as related.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Twinrix - Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received in JUN-2022, batch number-4F3YY,Expiry date-01-JAN-2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Twinrix - Late second dose). The outcome of the incomplete course of vaccination 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: 07-JUN-2024 Till the time of reporting the patient had not received the second dose of Twinrix, which led to incomplete course of vaccination. The reporter asked if it was necessary to re-start the series.  The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Menveo (1 vial formulation) went out of range for 13 hours 30 minutes, with a maximum temperature of  50 degree F; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) (batch number BL3ES, expiry date 31-DEC-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Menveo (1 vial formulation) went out of range for 13 hours 30 minutes, with a maximum temperature of  50 degree F). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 07-JUN-2024 The medical assistant called in to report Menveo (1 vial formulation) went out of range for 13 hours 30 minutes, with a maximum temperature of 50 degrees Fahrenheit, which led incorrect storage of drug. The vaccines have had two prior excursions and were now at a total time above range of 40 hours 30 minute. Prior to the current 13 hours 30-minute excursion that she was calling about, the vaccines would have been at 27 hours above range, which exceeds the maximum limit for Menveo 1 vial formulation. Reporter states she would have to go back and audit records, but she believes the Menveo likely was administered. She did not have any dates or patient details available at the time of the call. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: DEVELOPED PSORIASIS AFTER COVID VACCINE; This spontaneous report received from a patient via a company representative concerned a 38 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for covid-19 prophylaxis. No concomitant medications were reported. Patient developed psoriasis after covid vaccine. Covid vaccine was received on March 2021 , 2 weeks after injection patient developed psoriasis and its been an ongoing battle ever since. He never had any medical conditions with his skin until the vaccine was administered. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient had not recovered from developed psoriasis after covid vaccine. This report was non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had them on my face; Worst pain ever; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Had them on my face) and pain (Verbatim: Worst pain ever). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   The company considered the vaccination failure to be related to Shingles vaccine. The company considered the shingles to be unrelated to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-JUN-2024 This case was reported by a patient via interactive digital media. The patient reported that it was terrible. The patient had them on face. The patient did not know he/she could get when he/she had been vaccinated. The patient had worst pain ever. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingles vaccine.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: we gave her the HepB pediatric; patient that is 21 years-old and we gave her the HepB pediatric; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 21-year-old female patient who received HBV (Engerix B pediatric) (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis.   On 28-MAY-2024, the patient received the 1st dose of Engerix B pediatric. On 28-MAY-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: we gave her the HepB pediatric) and adult use of a child product (Verbatim: patient that is 21 years-old and we gave her the HepB pediatric). The outcome of the underdose and adult use of a child product 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: 06-JUN-2024 The patient that was 21 years old and gave her the HepB pediatric, which led to underdose and adult use of child product. The reporter confirmed that the brand was Engerix-B, and that such dose was the 1st dose of the series and also, reporter mentioned that the vaccine was administered because the patient did a titer for HepB and she didn't have any immunity, and school required that.  The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: did not received the third dose/Vaccine schedule is incomplete; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on November 2021) and Twinrix (received 2nd dose on December 2021).   On an unknown date, the patient did not receive the 3rd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: did not received the third dose/Vaccine schedule is incomplete). The outcome of the incomplete course of vaccination 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: 06-JUN-2024 The reporter/patient stated he received Twinrix first and second dose con. According to customer he did not received the third dose, which led to vaccine schedule was incomplete. Customer was referred to Healthcare provider. Did not consent to follow-up.
Age: 40.0
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient had not received the third dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 40-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included twinrix (received 1st dose on November 2021) and Twinrix (received 2nd dose on December 2021).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient had not received the third dose yet). The outcome of the incomplete course of vaccination 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: 06-JUN-2024 The pharmacist reported that a patient received the first and second dose of Twinrix in November and December 2021, respectively. The patient had not received the third dose yet, which led to incomplete course of vaccination. The HCP asked if it was necessary to re start the series. The HCP did not provide any information about the two previous Twinrix doses. Consented to follow up.