chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Near death experience
Clinical narrative: ended up almost dead; heart attack; 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. The following information was reported: NEAR DEATH EXPERIENCE (medically significant, life threatening), outcome "unknown", described as "ended up almost dead"; MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack". The events "ended up almost dead" and "heart attack" required emergency room visit.  Clinical course: It was unknown if the reporter was a healthcare professional. The reporter reported that My step mother just had a reaction to the last shot she got. Lets put it this way we don't know if it was a reaction but she got her shot that day and ended up in the emergency room and ended up almost dead and ended up having a heart attack  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 1.33
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently administered ADACEL instead of DAPTACEL to a 16-month-old patient with no reported adverse event; Initial information was received on 13-Dec-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 16 months old female patient to whom inadvertently diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administered instead of 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 hepatitis A vaccine inact (VAQTA) for Immunisation; and HIB vaccine CONJ (TET TOX) (ACTHIB) for Immunisation.  On 12-Dec-2023, the patient received a 0.5 ml, once (total) dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot U7928AA, expiry date: unknown, strength: standard) via intramuscular route in the left deltoid for Immunisation and inadvertently administered adacel instead of daptacel to a 16-month-old patient 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 and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Quadracel was given to a 3 and 1/2 year old patient with no reported adverse event; Initial information received on 15-Dec-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 42 months old female patient where diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel] was given to a 3 and 1/2 year old patient 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 for Prophylactic vaccination.  On 13-Dec-2023, the patient received 0.5 ml dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine Suspension for injection lot U7908AB via intramuscular route in the left deltoid (strength and expiration date: not provided) for Immunisation (product administered to patient of inappropriate age) (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. 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: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: has been injected with adacel that is almost a month expired with no reported adverse event; Initial information received on 15-Dec-2023 from RA regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 28-year-old male patient who had been injected with diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] that is almost a month 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 influenza vaccine inact split 4V (Fluarix Quadrivalent) for Prophylactic vaccination.  On 13-Dec-2023, the patient received 0.5 mL expired dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (Frequency: once; Strength: standard; lot number: C5855AA; expiry date: 12-Nov-2023) via intramuscular route in the left deltoid for Immunization that is almost a month expired with no reported adverse event (expired product administered) (same day latency).  Treatment: No   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: 83.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Blood potassium increased, Fatigue, Myalgia, Renal impairment
Clinical narrative: Abnormal kidney function; Elevated potassium; Feeling fatigue / Tiredness; Arthralgia; Myalgia; This spontaneous case from the country was received on 13-Dec-2023 from a non-healthcare professional via agency (reference number: SEQW23-04825) and concerned an 83-year-old, female patient.  The patient had no relevant medical history. The patient's concomitant medications included unspecified blood pressure medications.  On 01-Dec-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) as every year shot, as reported. The batch number was not reported.  On 02-Dec-2023, one day after receiving Fluad Quadrivalent, the patient experienced tiredness, arthralgia, myalgia and was feeling fatigue.  On 12-Dec-2023, the patient had blood analysis that showed elevated potassium and abnormal kidney function.  At a time of initial reporting, on 13-Dec-2023, the patient had not recovered from events. As reported, symptoms continued.   The reporter did not provide causality assessment.   The event of kidney function abnormal was considered to be medically significant by a Physician within Seqirus's Department.  Company comment: A patient was vaccinated with Fluad Quadrivalent. One day after vaccination, the patient experienced tiredness, arthralgia, myalgia and was feeling fatigue. Ten days later, the patient had blood analysis that showed elevated potassium and abnormal kidney function. Information regarding laboratory findings and diagnostic data was not provided. The patient had no relevant medical history. The patient's concomitant medications included unspecified blood pressure medications. Causal role of the suspect vaccine is unassessable for the events blood potassium increased and renal impairment, due to lack of additional information. Causal role of the suspect vaccine is assessed as possibly related for the events arthralgia, myalgia and fatigue, due to biological and chronological plausibility.; Sender's Comments: A patient was vaccinated with Fluad Quadrivalent. One day after vaccination, the patient experienced tiredness, arthralgia, myalgia and was feeling fatigue. Ten days later, the patient had blood analysis that showed elevated potassium and abnormal kidney function. Information regarding laboratory findings and diagnostic data was not provided. The patient had no relevant medical history. The patient's concomitant medications included unspecified blood pressure medications. Causal role of the suspect vaccine is unassessable for the events blood potassium increased and renal impairment, due to lack of additional information. Causal role of the suspect vaccine is assessed as possibly related for the events arthralgia, myalgia and fatigue, due to biological and chronological plausibility.
Sex: M
Vaccine: FLUA4
Symptoms: Muscular weakness
Clinical narrative: Muscle weakness; This spontaneous case was received on 20-Dec-2023 from other non-healthcare professional (consumer) (reference number SEQW23-04958) and concerned an elderly male patient.  The patient's concurrent conditions included glaucoma and high blood pressure. The patient's medical history was not reported. The patient's concomitant medications included eye drops for glaucoma and blood pressure pills. The patient underwent physical therapy in past for another unspecified event.  On 22-Sep-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 millilitres, route of administration and anatomical location: not reported) as every year shot, as reported. The batch number reported was 370682.  On 23-Sep-2023, one day after receiving Fluad Quadrivalent vaccine, the patient developed extreme muscle weakness. The patient went to see a doctor and the doctor told him that it had nothing to do with the flu shot. The patient wanted to know if there was anything that his doctor needs to know about the vaccine.  On an unspecified date in 2023, the patient's physical therapy was resumed.  At the time of initial reporting, on 20-Dec-2023, the patient had not recovered from the event of 'muscle weakness'.  The reporter assessed event of 'muscle weakness' as not related to Fluad Quadrivalent. As reported, the patient attended his physician and the doctor told him that it had nothing to do with the flu shot. .  The case was assessed as non-serious.  Company comment: The event of muscle weakness was assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Reporter's Comments: The patient attended his physician and the doctor told him that it had nothing to do with the flu shot.; Sender's Comments: The event of muscle weakness was assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Age: 0.25
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Rash
Clinical narrative: Bilateral localized rash/ reaction noted on cheeks, arms, and feet twenty- minutes after vaccine administration. No distress noted.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Magnetic resonance imaging abnormal, Mobility decreased, Muscle injury, X-ray limb normal
Clinical narrative: Patient describes he cannot lift arm at the shoulder, has extreme weakness, but no pain. States he followed up with PCP, who sent patient for xray and mri - mri showed muscle tissue damage but nothing that would cause inability of patient to lift arm. Can curl bicep, but cannot raise arm at shoulder. When arm is manually raised by another individual patient describes no pain in any direction, but when that person lets go, patient cannot hold arm up on his own. He states he has no control or strength in the shoulder whatsoever. Per patient, he has been in physical therapy for 5 weeks with no results or progress.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Swelling
Clinical narrative: Patient had localized redness, swelling, heat, and pain at the arm, lasted for 4 days still present but has improved since.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient developed a bruise at injection site.  Same day, developed a baseball sized flat red spot that felt warm and was tender to the touch.  This developed about 2 inches below the injection site.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD was given instead of Fluzone Quad, patient is under 65.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU4, PNC20
Symptoms: Wrong product administered
Clinical narrative: Fluzone HD was administered instead of Fluzone Quad
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Patient developed full body hives 4-5 days after receiving the Moderna COVID 19 vaccination. It had not occurred after previous vaccinations. Mild difficulty breathing also developed.  Symptoms improved within 24 hours. Patient took 2 doses of Zyrtec.  No emergency intervention was required.  This is the 5th time patient received Moderna vaccination since the pandemic. Patient had COVID in September 2023.
Age: 66.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient received a second flu shot
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Vaccine was given too early. No signs and symptoms of anyphylaxis, no excessive redness or swelling, no hospitalization.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Full blood count, International normalised ratio, Liver function test
Clinical narrative: bruising along arms and legs
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: PT REPORTED RASH AROUND VACCINATION AREA THE FOLLOWING DAY POST-IMMUNIZATION.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills, fever, headache starting about 4.5 hours after vaccine. Lasted through the night and into the next morning. Tylenol helped somewhat.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: I now  have new dermatographism and urticaria. This occured 2.5 weeks after the pfizer booster. This has occurred once before, a few weeks after receiving the moderna booster last year, and it lasted for 3 months then resolved.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Depression, Drug hypersensitivity, Psychotic disorder, Thyroid function test abnormal, Tinnitus
Clinical narrative: Became very sensitive to Amlodipine Besylate. Had been on that prescription since 2011 with no problems until this 3rd Covid-19 vaccination.  Second shot 12/07/21 mild sensitivity to hbp med, but after 10/07/22 shot increased unbearably.  Depression with a couple psychotic episodes. Also tinnitus started and has continued until now. Doctor is continuing to try different hbp meds.  None have been without adverse side effects that reduce my quality of life as not before.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Blood pressure increased, Blood test, Brain fog, Cardiac stress test
Clinical narrative: Erratic heart rate, elevated blood pressure, brain fog, muscle spasms, chest pressure, inability to focus and retain information, nausea, constipation and diarrhea, altered sense of smell, migraine headaches, change in tinnitus, cyst on clavicle, arthritis, internal tremors, heat and cold intolerance, fatigue, pins and needles/numbness in arms, hands, feet, and legs. Multiple MRIs, CT, X-rays, multiple trips to the ER and to doctor appointments, changes in medications, blood work. This has all been since the vaccine and is ongoing as symptoms are ongoing.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Constipation, Cyst, Diarrhoea, Disturbance in attention
Clinical narrative: Erratic heart rate, elevated blood pressure, brain fog, muscle spasms, chest pressure, inability to focus and retain information, nausea, constipation and diarrhea, altered sense of smell, migraine headaches, change in tinnitus, cyst on clavicle, arthritis, internal tremors, heat and cold intolerance, fatigue, pins and needles/numbness in arms, hands, feet, and legs. Multiple MRIs, CT, X-rays, multiple trips to the ER and to doctor appointments, changes in medications, blood work. This has all been since the vaccine and is ongoing as symptoms are ongoing.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Fatigue, Heart rate irregular, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Erratic heart rate, elevated blood pressure, brain fog, muscle spasms, chest pressure, inability to focus and retain information, nausea, constipation and diarrhea, altered sense of smell, migraine headaches, change in tinnitus, cyst on clavicle, arthritis, internal tremors, heat and cold intolerance, fatigue, pins and needles/numbness in arms, hands, feet, and legs. Multiple MRIs, CT, X-rays, multiple trips to the ER and to doctor appointments, changes in medications, blood work. This has all been since the vaccine and is ongoing as symptoms are ongoing.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Migraine, Muscle spasms, Nausea, Paraesthesia
Clinical narrative: Erratic heart rate, elevated blood pressure, brain fog, muscle spasms, chest pressure, inability to focus and retain information, nausea, constipation and diarrhea, altered sense of smell, migraine headaches, change in tinnitus, cyst on clavicle, arthritis, internal tremors, heat and cold intolerance, fatigue, pins and needles/numbness in arms, hands, feet, and legs. Multiple MRIs, CT, X-rays, multiple trips to the ER and to doctor appointments, changes in medications, blood work. This has all been since the vaccine and is ongoing as symptoms are ongoing.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Parosmia, Temperature intolerance, Tinnitus, Tremor, Ultrasound Doppler
Clinical narrative: Erratic heart rate, elevated blood pressure, brain fog, muscle spasms, chest pressure, inability to focus and retain information, nausea, constipation and diarrhea, altered sense of smell, migraine headaches, change in tinnitus, cyst on clavicle, arthritis, internal tremors, heat and cold intolerance, fatigue, pins and needles/numbness in arms, hands, feet, and legs. Multiple MRIs, CT, X-rays, multiple trips to the ER and to doctor appointments, changes in medications, blood work. This has all been since the vaccine and is ongoing as symptoms are ongoing.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Erratic heart rate, elevated blood pressure, brain fog, muscle spasms, chest pressure, inability to focus and retain information, nausea, constipation and diarrhea, altered sense of smell, migraine headaches, change in tinnitus, cyst on clavicle, arthritis, internal tremors, heat and cold intolerance, fatigue, pins and needles/numbness in arms, hands, feet, and legs. Multiple MRIs, CT, X-rays, multiple trips to the ER and to doctor appointments, changes in medications, blood work. This has all been since the vaccine and is ongoing as symptoms are ongoing.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: On 12/1, pt was given Moderna Covid vaccine 2023-2024 for 12y+. Date moved to refrigeration: October 31, 2023, manufacturer expiration date: March 31, 2024, date of administration: December 1, 2023, lot: 8057658. Per Moderna Medication Information: "Analysis of the vaccine associated with your storage excursion is complete. The vaccine administered on December 1, 2023 from lot number 8057658 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration." No adverse event occurred. This is reported as a vaccination administration error (possible product expiration based on storage temperature), but per Moderna vaccine is still viable.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: The victim's teenage son shared this information via an online video. He dictated the dates, lot numbers and manufacturer of the COVID-19 EUA Countermeasure marketed as a vaccine. The son stated his father was inoculated as result of the attempted Mandate for employers with 100 employees or more. Other information was obtained through publicly available sources online. DOSE1 DATE 12/7/21 DOSE2 DATE 12/28/21
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Headache, Pyrexia
Clinical narrative: Fevers. Headaches
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Productive cough
Clinical narrative: Reported Symptoms:  10011232:COUGHING; 10042772:SYNCOPE;  Narrative: Patient reported to ED on 11/26/222 with complaints of SOB and cough with phlegm and dx with COPD exacerbation as patient has had several admissions previously very similar to this. Follows with pulmonary and was started on prednisone 60mg taper, but symptoms did not improve so patient came to ED. Upon admission had incidental COVID19 positive screening. Patient denied loss of smell, diarrhea, or generalized aches/pains.  It was not able to be determined if positive screening contributed to COPD exacerbation.  COPD exacerbation was treated with corticosteroids, bronchodilators, and mucolytic. COVID was treated with symptomatic care.  Other Relevant HX:  PMH significant for CAD, GAD, severe COPD (not on home O2), pAfib, adrenal insufficiency d/2 chronic prednisone use.  Other:
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Syncope
Clinical narrative: Reported Symptoms:  10011232:COUGHING; 10042772:SYNCOPE;  Narrative: Patient reported to ED on 11/26/222 with complaints of SOB and cough with phlegm and dx with COPD exacerbation as patient has had several admissions previously very similar to this. Follows with pulmonary and was started on prednisone 60mg taper, but symptoms did not improve so patient came to ED. Upon admission had incidental COVID19 positive screening. Patient denied loss of smell, diarrhea, or generalized aches/pains.  It was not able to be determined if positive screening contributed to COPD exacerbation.  COPD exacerbation was treated with corticosteroids, bronchodilators, and mucolytic. COVID was treated with symptomatic care.  Other Relevant HX:  PMH significant for CAD, GAD, severe COPD (not on home O2), pAfib, adrenal insufficiency d/2 chronic prednisone use.  Other:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10004355:COVID-19 VIRUS TEST POSITIVE; Narrative: 76 y/o male presented to Emergency Department on 8/27/23 with c/o dizziness, nasal drainage, and + COVID test. Admitted for overnight observation and then discharged home on 8/28/23. Other Relevant HX: Other: COVID +
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arrhythmia, COVID-19, Cardiac failure acute, Chills, Hypogeusia
Clinical narrative: Reported Symptoms:  10033556:PALPITATION;   Narrative: Patient was transferred to the facility from an outside facility for arrhythmias. Patient was tested at outside facility for COVID-19 and test was negative, but when transferred to facility, facility's COVID screen was positive. Patient reported mild symptoms (decreased taste, cough with phlegm, and chills). Remdesivir was contraindicated due to renal function. Per shared decision with patient and his family, treatment was deferred and symptoms were monitored. Patient was admitted for acute decompensated heart systolic/diastolic failure requiring milrinone and sustained Vtach.  Other Relevant HX:  Other:
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Left ventricular failure, Palpitations, Productive cough, Renal impairment, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms:  10033556:PALPITATION;   Narrative: Patient was transferred to the facility from an outside facility for arrhythmias. Patient was tested at outside facility for COVID-19 and test was negative, but when transferred to facility, facility's COVID screen was positive. Patient reported mild symptoms (decreased taste, cough with phlegm, and chills). Remdesivir was contraindicated due to renal function. Per shared decision with patient and his family, treatment was deferred and symptoms were monitored. Patient was admitted for acute decompensated heart systolic/diastolic failure requiring milrinone and sustained Vtach.  Other Relevant HX:  Other:
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ventricular tachycardia
Clinical narrative: Reported Symptoms:  10033556:PALPITATION;   Narrative: Patient was transferred to the facility from an outside facility for arrhythmias. Patient was tested at outside facility for COVID-19 and test was negative, but when transferred to facility, facility's COVID screen was positive. Patient reported mild symptoms (decreased taste, cough with phlegm, and chills). Remdesivir was contraindicated due to renal function. Per shared decision with patient and his family, treatment was deferred and symptoms were monitored. Patient was admitted for acute decompensated heart systolic/diastolic failure requiring milrinone and sustained Vtach.  Other Relevant HX:  Other:
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC20
Symptoms: Rash maculo-papular
Clinical narrative: maculopapular rash - SYMPTOMATIC TREATMENT AND RECHECK WITH PROVIDER NEXT WEEK
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received Arexvy; Underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 04-DEC-2023, the patient received Arexvy. On 04-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received Arexvy). The action taken with Arexvy was unknown. The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178358:2nd  patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178431:7th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023173296:1st patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178585:21st patient US-GSK-US2023AMR178450:10th patient
Age: 27.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received Arexvy; underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 26-OCT-2023, the patient received Arexvy. On 26-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received Arexvy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The reporter consented to follow up. The patient received Arexvy vaccine below the recommended age schedule, which led to inappropriate age at vaccine administration. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR178358:2nd  PATIENT US-GSK-US2023AMR178395:3rd  PATIENT US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178431:7th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21st patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178594:23rd patient
Age: 31.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received AREXVY; underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 31-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 13-NOV-2023, the patient received Arexvy. On 13-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received AREXVY). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178358:2nd patient US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178431:7th patient US-GSK-US2023173296:1st patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21th patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178594:23rd patient
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received Arexvy; Underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 30-NOV-2023, the patient received Arexvy. On 30-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received Arexvy). The action taken with Arexvy was unknown. The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023173296:1st patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178358:2nd patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178431:7th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178588:22 nd patient US-GSK-US2023AMR178594:23rd patient
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received AREXVY; Underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 13-NOV-2023, the patient received Arexvy. On 13-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received AREXVY). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR178431:7th patient US-GSK-US2023173296:1st  patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178358:2nd patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21st patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178594:23rd patient US-GSK-US2023AMR178567:
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received Arexvy; Underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 02-NOV-2023, the patient received Arexvy. On 02-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received Arexvy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023173296:1st patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178358:2nd patient US-GSK-US2023AMR178395:3rd  patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178431:7th patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178444:9th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21th patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178594:23rd patient US-GSK-US2023AMR178469:5th patient
Age: 27.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received Arexvy; Underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 30-NOV-2023, the patient received Arexvy. On 30-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received Arexvy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR178431:7th patient US-GSK-US2023173296:1st patient US-GSK-US2023AMR178424:4th patient US-GSK-US2023AMR178358:2nd patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178444:9 th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21st patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178594:23 rd patient US-GSK-US2023AMR178567:
Age: 31.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received AREXVY; Underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 31-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 09-NOV-2023, the patient received Arexvy. On 09-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received AREXVY). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR178431:7th patient US-GSK-US2023173296:1st patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178358:2nd patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178466:12th patient US-GSK-US2023AMR178469:13th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178578:19 th patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178585:21st patient US-GSK-US2023AMR178588:22nd patient US-GSK-US2023AMR178594:23rd patient
Age: 29.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received Arexvy; Underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 29-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2023) for prophylaxis.   On 01-DEC-2023, the patient received Arexvy. On 01-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received Arexvy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The pregnant patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. This was 1 of 23 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR178431:7th  patient US-GSK-US2023173296:1st  patient US-GSK-US2023AMR178424:6th patient US-GSK-US2023AMR178358:2nd patient US-GSK-US2023AMR178415:5th patient US-GSK-US2023AMR178412:4th patient US-GSK-US2023AMR178395:3rd patient US-GSK-US2023AMR178435:8th patient US-GSK-US2023AMR178565:17th patient US-GSK-US2023AMR178567:18th patient US-GSK-US2023AMR178578:19th patient US-GSK-US2023AMR178444:9th  patient US-GSK-US2023AMR178583:20th patient US-GSK-US2023AMR178489:15th patient US-GSK-US2023AMR178469:13 patient US-GSK-US2023AMR178458:11th patient US-GSK-US2023AMR178513:16th patient US-GSK-US2023AMR178481:14th patient US-GSK-US2023AMR178466:12th  patient US-GSK-US2023AMR178585:21st patient US-GSK-US2023AMR178450:10th patient US-GSK-US2023AMR178594:23rd patient
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received Arexvy; underage; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2025) for prophylaxis.   On 21-NOV-2023, the patient received Arexvy. On 21-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 23 pregnant women received Arexvy). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was CMA (clinic account manager). The reporter reported that pregnant women received Arexvy. The reporter consented to follow up. The patient received Arexvy below the recommended age schedule, which led to inappropriate age at vaccine administration. This was 1 of 23 linked cases, reported by the same reporter; Sender's Comments:  US-GSK-US2023AMR178395:18th patient US-GSK-US2023173296:18th patient US-GSK-US2023AMR178424:18th patient US-GSK-US2023AMR178358:18th patient US-GSK-US2023AMR178412:18th patient US-GSK-US2023AMR178431:18th patient US-GSK-US2023AMR178435:18th patient US-GSK-US2023AMR178565: US-GSK-US2023AMR178444:18th patient US-GSK-US2023AMR178469:18th patient US-GSK-US2023AMR178466:18th patient US-GSK-US2023AMR178458:18th patient US-GSK-US2023AMR178458: US-GSK-US2023AMR178450: US-GSK-US2023AMR178489: US-GSK-US2023AMR178513:18th patient US-GSK-US2023AMR178583: US-GSK-US2023AMR178585: US-GSK-US2023AMR178588: US-GSK-US2023AMR178594: