chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Dyspnoea, Dyspnoea exertional, Echocardiogram, Echocardiogram abnormal
Clinical narrative: Patient is a 40 y.o. F with hx of anxiety/depression and ADHD. Recent admit (10/11-10/13/23) for new onset A fib with RVR. EP followed and pt was placed on Eliquis, Flecainide and Cardizem. Pt re-presented on 10/23/23 with CC of palpitations and episodes of A fib (noted on smart watch) with associated chest pain and SOB. Noted to be in A fib with RVR in ED but converted back to NSR and fluid bolus. Per ED, pt uncomfortable about returning home. As such admit to OBS for EP evaluation. S/p ablation 10/23/23. Hospital course complicated by dyspnea with unclear etiology, possibly related to OSA/OHS deconditioning in the setting COVID. Repeat ECHO unchanged, only trivial pericardial effusion, likley reactive to ablation. EP followed. Pulmonology followed, trial prednisone and breathing inhalers for possible asthma exacerbation. Stress test unremarkable. Sniff test negative. CTPA 10/23/23 unremarkable but suboptimal, Q scan with low probability of PE. RT performed NIF which was normal with VC 1950 ml. Pt notes continued shortness of breath on exertion, typically after 5 min. CM to order nurses aid, family called previous day to ensure coverage.    1. A fib: Noted last admit. TSH normal. CHADS2-VASC 1. TTE on 10/13/2023 normal LVEF, no WMA. EP followed and pt initiated Eliquis, Flecainide, and Cardizem. Now presented as above. S/p ablation 10/23/23. Continued home meds. In sinus during admission. EP followed 2. Dyspnea: ongoing with questionable worsening after ablation. Patient notes conversational and exertional dyspnea. No hypoxia. No wheezing; did not improve with prednisone/breathing tx. ECHO 10/13/23 as above. BNP 10/24/23 normal. Unclear etiology, possibly related to OSA/OHS deconditioning in the setting COVID. Repeat ECHO unchanged, only trivial pericardial effusion, likley reactive to ablation. EP followed. Pulmonology followed, trial prednisone and breathing inhalers for possible asthma exacerbation. Stress test unremarkable. Sniff test negative. CTPA 10/23/23 unremarkable but suboptimal, Q scan with low probability of PE. RT performed NIF which was normal with VC 1950 ml. Pt notes continued shortness of breath on exertion, typically after 5 min. CM to order nurses aid, family called previous day to ensure coverage.  3. COVID +:  Not a candidate for paxlovid due to drug interaction. ID followed, remdesivir completed.  4. ADHD/Anxiety/Depression: Continued home Wellbutrin. Vyvanse discontinued on last admit.  5. Mild intermittent Asthma exacerbation: Xopenex scheduled as home med. Ipatroprium neb ordered. Prednisone thru 10/30/23. Ordered xopenex inhaler and neb, ipatropium neb for discharge.  6. Suspected OSA: Suspected on last admit. Often feel tired, fatigued, or sleepy during the daytime? + 1, Observed you stop breathing during sleep? + 1, BMI > 35 +1, Neck circumference > 40 cm + 1, and Patient's score is > 3 implying high risk for OSA. Referral was made for sleep study on last admit.  7. Morbid Obesity:  BMI 46. Recommend lifestyle modification and weight loss.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ejection fraction, Fatigue, Laboratory test normal, Palpitations, Pericardial effusion
Clinical narrative: Patient is a 40 y.o. F with hx of anxiety/depression and ADHD. Recent admit (10/11-10/13/23) for new onset A fib with RVR. EP followed and pt was placed on Eliquis, Flecainide and Cardizem. Pt re-presented on 10/23/23 with CC of palpitations and episodes of A fib (noted on smart watch) with associated chest pain and SOB. Noted to be in A fib with RVR in ED but converted back to NSR and fluid bolus. Per ED, pt uncomfortable about returning home. As such admit to OBS for EP evaluation. S/p ablation 10/23/23. Hospital course complicated by dyspnea with unclear etiology, possibly related to OSA/OHS deconditioning in the setting COVID. Repeat ECHO unchanged, only trivial pericardial effusion, likley reactive to ablation. EP followed. Pulmonology followed, trial prednisone and breathing inhalers for possible asthma exacerbation. Stress test unremarkable. Sniff test negative. CTPA 10/23/23 unremarkable but suboptimal, Q scan with low probability of PE. RT performed NIF which was normal with VC 1950 ml. Pt notes continued shortness of breath on exertion, typically after 5 min. CM to order nurses aid, family called previous day to ensure coverage.    1. A fib: Noted last admit. TSH normal. CHADS2-VASC 1. TTE on 10/13/2023 normal LVEF, no WMA. EP followed and pt initiated Eliquis, Flecainide, and Cardizem. Now presented as above. S/p ablation 10/23/23. Continued home meds. In sinus during admission. EP followed 2. Dyspnea: ongoing with questionable worsening after ablation. Patient notes conversational and exertional dyspnea. No hypoxia. No wheezing; did not improve with prednisone/breathing tx. ECHO 10/13/23 as above. BNP 10/24/23 normal. Unclear etiology, possibly related to OSA/OHS deconditioning in the setting COVID. Repeat ECHO unchanged, only trivial pericardial effusion, likley reactive to ablation. EP followed. Pulmonology followed, trial prednisone and breathing inhalers for possible asthma exacerbation. Stress test unremarkable. Sniff test negative. CTPA 10/23/23 unremarkable but suboptimal, Q scan with low probability of PE. RT performed NIF which was normal with VC 1950 ml. Pt notes continued shortness of breath on exertion, typically after 5 min. CM to order nurses aid, family called previous day to ensure coverage.  3. COVID +:  Not a candidate for paxlovid due to drug interaction. ID followed, remdesivir completed.  4. ADHD/Anxiety/Depression: Continued home Wellbutrin. Vyvanse discontinued on last admit.  5. Mild intermittent Asthma exacerbation: Xopenex scheduled as home med. Ipatroprium neb ordered. Prednisone thru 10/30/23. Ordered xopenex inhaler and neb, ipatropium neb for discharge.  6. Suspected OSA: Suspected on last admit. Often feel tired, fatigued, or sleepy during the daytime? + 1, Observed you stop breathing during sleep? + 1, BMI > 35 +1, Neck circumference > 40 cm + 1, and Patient's score is > 3 implying high risk for OSA. Referral was made for sleep study on last admit.  7. Morbid Obesity:  BMI 46. Recommend lifestyle modification and weight loss.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Physical deconditioning, Sleep apnoea syndrome, Somnolence, Ventilation/perfusion scan abnormal
Clinical narrative: Patient is a 40 y.o. F with hx of anxiety/depression and ADHD. Recent admit (10/11-10/13/23) for new onset A fib with RVR. EP followed and pt was placed on Eliquis, Flecainide and Cardizem. Pt re-presented on 10/23/23 with CC of palpitations and episodes of A fib (noted on smart watch) with associated chest pain and SOB. Noted to be in A fib with RVR in ED but converted back to NSR and fluid bolus. Per ED, pt uncomfortable about returning home. As such admit to OBS for EP evaluation. S/p ablation 10/23/23. Hospital course complicated by dyspnea with unclear etiology, possibly related to OSA/OHS deconditioning in the setting COVID. Repeat ECHO unchanged, only trivial pericardial effusion, likley reactive to ablation. EP followed. Pulmonology followed, trial prednisone and breathing inhalers for possible asthma exacerbation. Stress test unremarkable. Sniff test negative. CTPA 10/23/23 unremarkable but suboptimal, Q scan with low probability of PE. RT performed NIF which was normal with VC 1950 ml. Pt notes continued shortness of breath on exertion, typically after 5 min. CM to order nurses aid, family called previous day to ensure coverage.    1. A fib: Noted last admit. TSH normal. CHADS2-VASC 1. TTE on 10/13/2023 normal LVEF, no WMA. EP followed and pt initiated Eliquis, Flecainide, and Cardizem. Now presented as above. S/p ablation 10/23/23. Continued home meds. In sinus during admission. EP followed 2. Dyspnea: ongoing with questionable worsening after ablation. Patient notes conversational and exertional dyspnea. No hypoxia. No wheezing; did not improve with prednisone/breathing tx. ECHO 10/13/23 as above. BNP 10/24/23 normal. Unclear etiology, possibly related to OSA/OHS deconditioning in the setting COVID. Repeat ECHO unchanged, only trivial pericardial effusion, likley reactive to ablation. EP followed. Pulmonology followed, trial prednisone and breathing inhalers for possible asthma exacerbation. Stress test unremarkable. Sniff test negative. CTPA 10/23/23 unremarkable but suboptimal, Q scan with low probability of PE. RT performed NIF which was normal with VC 1950 ml. Pt notes continued shortness of breath on exertion, typically after 5 min. CM to order nurses aid, family called previous day to ensure coverage.  3. COVID +:  Not a candidate for paxlovid due to drug interaction. ID followed, remdesivir completed.  4. ADHD/Anxiety/Depression: Continued home Wellbutrin. Vyvanse discontinued on last admit.  5. Mild intermittent Asthma exacerbation: Xopenex scheduled as home med. Ipatroprium neb ordered. Prednisone thru 10/30/23. Ordered xopenex inhaler and neb, ipatropium neb for discharge.  6. Suspected OSA: Suspected on last admit. Often feel tired, fatigued, or sleepy during the daytime? + 1, Observed you stop breathing during sleep? + 1, BMI > 35 +1, Neck circumference > 40 cm + 1, and Patient's score is > 3 implying high risk for OSA. Referral was made for sleep study on last admit.  7. Morbid Obesity:  BMI 46. Recommend lifestyle modification and weight loss.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling at site of injection and immediately adjacent to it. About a week our so after, my left shoulder and arm (injection arm) became extremely sore in the infraspinatus and down the exterior side of my left upper arm. It's still very sore and tender two months later, and I have limited movement.
Age: 72.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Haemorrhage subcutaneous, Injection site bruising, Injection site reaction, Injection site swelling
Clinical narrative: The patient says that when she received the vaccine she had a bleed out while shopping in the store.  She then came back to the pharmacy and was given a new bandage.  After going home a few hours later the patient noticed a bruise over the injection site and the skin is puffy with blood under the skin.  It does not radiate and it localized.  I informed the patient to use an ice pack and if she had any bruising cream that will assist with that.  I will follow up in the morning with the patient.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Confusional state, Immediate post-injection reaction, Loss of consciousness, Presyncope
Clinical narrative: Administered menquadfi and HPV to left upper arm to pt. Pt immediately had vasovagal episode, then woke up after 5 seconds. Mom and I were right next to patient, patient did not fall. Pt was on table and was supported by mom and myself. Vaccine had been fully administered at this point. Pt placed in lying position immediately once alert. Confused initially but then alert to location and place.  MD notified immediately. Ice packs placed on pt and water given to pt. BP at 12:35 was 103/68, pulse 81. After 10 minutes pt sat up and we were able to provide pt some cookies and more water. Upon departure at 1pm pt supported by myself and mom while getting up, no dizziness or blurry vision noted. Pt feeling well and left with parent.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine had a beyond use date of 12/18/23 and was given on 12/19/23.  The supplier verified that the vaccine was still proven effective and would not need an additional dose.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no side effects, adverse outcomes, or unexpected reactions expienced by the patient; A HBP called to report a TE for GARDASIL 9 (Lot #1957405 expiration: 11/11/2025) that had been administered to a patient on 11/20/2023. The TE details were a low temp of 33.15F for 1 hour 8 minutes and 0 seconds on 11/18/2023 with zero previous excu; This spontaneous report was received from an office manager and refers to a 13-year-old.  The patient's medical history , concurrent conditions and concomitant therapies were not reported.  On 20-NOV-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1957405, expiration date: 11-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in 33.15 Farenheit for 1 hour 8 minutes on 18-NOV-2023 with no previous excursions (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called and reported that 1 dose of PROQUAD was administered to a patient after the product was involved in a temperature excursion. Caller stated the patient has not had any symptoms. Caller also reported a dose of VARIVAX involved in the same; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender.   Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On an unspecified date, there was a temperature excursion, temperature was 8.89 F for 1 hour 33 minutes 45 seconds for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number reported as W039841 and expiration date 12-JUN-2024. No previous temperature excursion had been reported.    On 04-DEC-2023, the patient received the improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (product storage error) which was administered as prophylaxis (strength, dose, and route of administration were not provided). The patient did not have any symptoms, no additional adverse event (AE) (no adverse event) or product quality complaint (PQC) reported.        This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2312USA002330:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called and reported that 1 dose of VARIVAX was administered to a patient after the product was involved in a temperature excursion. Caller stated the patient has not had any symptoms. Caller also reported a dose of PROQUAD involved in the same; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender.   Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On an unspecified date, there was a temperature excursion, temperature was 8.89 F for 1 hour 33 minutes 45 seconds for varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number reported as W006412 and expiration date 23-FEB-2024. No previous temperature excursion had been reported.    On 01-DEC-2023, the patient received the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (product storage error) which was administered as prophylaxis (strength, dose, and route of administration were not provided). The patient did not have any symptoms, no additional adverse event (AE) (no adverse event) or product quality complaint (PQC) reported.        This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2312USA002304:
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On 29-AUG-2003 vaccination with Hepatitis A; This spontaneous report has been received from a lawyer, via Medical Records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (2310USA011688), concerning a currently 32-year-old female patient. Her historical vaccines included: diphtheria vaccine toxoid, pertussis vaccine, tetanus vaccine toxoid (reported as DTP), measles vaccine, mumps vaccine, rubella vaccine (reported as MMR) and hepatitis B. Concomitant vaccine included hepatitis B. There was no information about the patient's concurrent conditions or medical history provided.  On 07-DEC-2001, the patient was vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown) (reported as Hepatitis A) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis.  On 29-AUG-2003, she was vaccinated with the next dose of hepatitis a vaccine, inactivated (manufacturer unknown) (reported as Hepatitis A) (formulation, dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). Other vaccinations included: diphtheria vaccine toxoid, tetanus vaccine toxoid (reported as Td); quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL); meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA); "PPD" and influenza vaccine inact split (reported as influenza (split)).  This is one of the few reports concerning the same patient.; Sender's Comments:  US-009507513-2312USA005492:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse issues or side effects were reported with the administered dose; Current excursion:-14.1°C / (-14°C to -10°C) for 0 hours 10 minutes 0 seconds; This spontaneous report was received from a registered nurse referring to a 4-year-old patient of unknown gender. The patient's medical history, and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 22-SEP-2023, the suspect vaccine, measles, mumps, rubella, and varicella (oka-merck) live virus vaccine (rHA recombinant human albumin) (PROQUAD), experienced a temperature excursion of -0.5 degrees Celsius (C) (-10C to 8C) for 0 hours 40 minutes and 0 seconds. On 27-SEP-2023, there was another temperature excursion of -2.6C (-10C to 8C) for 1 hour 12 minutes and 0 seconds. Furthermore, on 28-SEP-2023, the temperature excursion was -1.1C (-10C to 8C) for 1 hour 2 minutes and 0 seconds.   On 09-DEC-2023, the patient was vaccinated with a dose of measles, mumps, rubella, and varicella (oka-merck) live virus vaccine (PROQUAD) injection, at a dosage of 0.5 milliliters (ml), once (lot #X018584 with an expiration date on 05-JAN-2025), administered for prophylaxis (route of administration was not reported) which experienced a temperature excursion of -14.1C (-14C to -10C) for 0 hours 10 minutes and 0 seconds (product storage error).  The temperature excursion stability evaluation resulted in a "supported" outcome. No adverse issues or side effects were reported with the administered dose.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HBP called to report TE where product was administered to one patient. TE case number: 02525489. No additional AE/PQC. Operator of device = HCP.    ?    VARIVAX;  LOT: w031816   EXP: 10/05/2024         ?    -11.82C for 3 hours 0 minutes 0 seconds; This spontaneous report was received from other and refers to a 39-year-old female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-DEC-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #w031816, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided). Thisvaccine underwent temperature excursion in -11.82 degree Celsius for 3 hours (Product storage error). No additional adverse events were reported.
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Injection site pruritus, Injection site swelling, Oropharyngeal pain
Clinical narrative: injection site itchy & swollen; injection site itchy; 1st reaction could not breathe via my throat; 1st reaction could not breathe via my throat, so sore; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number C9GB5, expiry date 30-MAR-2025) and (batch number Z9R9Y, expiry date 29-JUN-2026) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis, blood pressure high, rash, muscular back pain, yeast infection, type iib hyperlipidemia and allergic reaction. Concomitant products included hydroxychloroquine, leflunomide, tocilizumab (Actemra), losartan, nystatin (Nyamyc), diclofenac, cyclobenzaprine hydrochloride (Flexeril), fluconazole, eicosapentaenoic acid ethyl ester (Icosapent Ethyl), ezetimibe, evolocumab (Repatha) and triamcinolone.   On 25-NOV-2023, the patient received Arexvy. On 25-NOV-2023, less than a day after receiving Arexvy, the patient experienced difficulty breathing (Verbatim: 1st reaction could not breathe via my throat) and sore throat (Verbatim: 1st reaction could not breathe via my throat, so sore). On 26-NOV-2023, the patient experienced injection site swelling (Verbatim: injection site itchy & swollen) and injection site itching (Verbatim: injection site itchy). The patient was treated with cortisone, paracetamol (Tylenol) and acrivastine (Benadryl). The outcome of the injection site swelling, injection site itching and sore throat were not resolved and the outcome of the difficulty breathing was resolved.   It was unknown if the reporter considered the injection site swelling, injection site itching, difficulty breathing and sore throat to be related to Arexvy.     It was unknown if the company considered the injection site swelling, injection site itching, difficulty breathing and sore throat to be related to Arexvy.   Additional Information: GSK Receipt date: 12-DEC-2023 The patient was self-reported. She could not breathe via her throat, so sore, drank water she was able to breathe.  Next morning, Sunday injection site itchy & swollen and put Cortisone 10 on it & took Tylenol & Benadryl. Patient received other product Actemra Infusion get every 28 days based on her weight, Nyamyc 100,000 units per gram powder use as needed, Repatha Srclk 140 mg/ml Prefilled auto Inject, given to herself every other week and Triamcinolone 0.025 percent Cream 80 gram, apply small film 1-2 times per day.
Sex: F
Vaccine: RSV
Symptoms: Pain, Pruritus, Sensitive skin, Skin exfoliation, Swelling
Clinical narrative: redness; swelling; itching; aching; sensitivity to touch; peeling skin; This non-serious case was reported by a consumer and described the occurrence of erythema in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included chronic lymphocytic leukemia (since five years), fungal infection (chronic susceptibility to fungal infections) and drug hypersensitivity (patient was sensitive to a wide array of medications). Concomitant products included fluconazole.   On 29-NOV-2023, the patient received Arexvy. On 05-DEC-2023, 6 days after receiving Arexvy, the patient experienced erythema (Verbatim: redness), swelling (Verbatim: swelling), pruritus (Verbatim: itching), pain (Verbatim: aching), abnormal touch sensation (Verbatim: sensitivity to touch) and skin peeling (Verbatim: peeling skin). The outcome of the erythema, swelling, pruritus, pain, abnormal touch sensation and skin peeling were not resolved.   It was unknown if the reporter considered the erythema, swelling, pruritus, pain, abnormal touch sensation and skin peeling to be related to Arexvy.     It was unknown if the company considered the erythema, swelling, pruritus, pain, abnormal touch sensation and skin peeling to be related to Arexvy.   Additional Information: GSK Receipt date: 12-DEC-2023 The patient was self-reported this case. The patient had redness, swelling, itching, aching, sensitivity to touch, peeling skin. Not sure if it's relevant but she had chronic lymphocytic leukemia for five years and it had not required treatment up to this point.  The patient states that she also sensitive to a wide array of medications.  The symptoms were not treated.
Sex: U
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infant receiving Arexvy instead of nirsevimab; Inappropriate age at vaccine administration; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of wrong vaccine administered in a infant patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 13-DEC-2023, the patient received the 1st dose of Arexvy. On 13-DEC-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Infant receiving Arexvy instead of nirsevimab) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 13-DEC-2023 It was reported that Arexvy was given to an unknown infant at an unknown time on 13-DEC-2023, which led to  wrong vaccine administered and inappropriate age at vaccine administration. Its intended was to give nirsevimab. The report was provided to author by a pharmacist in a large health care system of an infant receiving Arexvy instead of nirsevimab. Reporter asked for next best steps and this author referred the reported to contact. The reporter did not know/declined to provide additional detail of patient gender at birth, initials, etc. There were no known serious event from the vaccine at the time of this report. The reporter did not consented to follow up.
Sex: F
Vaccine: RVX
Symptoms: Erythema, Feeling hot, Injection site swelling, Pain
Clinical narrative: red expanding site specific skin reaction; soreness; swelling at site; heat; This non-serious case was reported by a consumer via patient support programs and described the occurrence of localized erythema in a 68-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included blood pressure high. Concomitant products included amlodipine mesilate (Amlodipine).   On 29-NOV-2023, the patient received RSV vaccine. On 01-DEC-2023, 2 days after receiving RSV vaccine, the patient experienced localized erythema (Verbatim: red expanding site specific skin reaction), pain (Verbatim: soreness), local swelling (Verbatim: swelling at site) and feeling hot (Verbatim: heat). On 09-DEC-2023, the outcome of the localized erythema, pain, local swelling and feeling hot were resolved (duration 8 days).   It was unknown if the reporter considered the localized erythema, pain, local swelling and feeling hot to be related to RSV vaccine.     It was unknown if the company considered the localized erythema, pain, local swelling and feeling hot to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 13-DEC-2023 The patient reported that she received rsv vaccine. The patient stated that she had it treated with an antibiotic. The patient had red expanding site specific skin reaction, heat and soreness, swelling at site.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Had an allergic reaction to Shingrix; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included drug hypersensitivity (sensitive to medications).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: Had an allergic reaction to Shingrix). The outcome of the allergic reaction was not reported.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     It was unknown if the company considered the allergic reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-DEC-2023 The reporter was asking about RSV (respiratory syncytial virus) vaccine as was pretty sensitive to medications and had an allergic reaction to Shingrix and apparently the product for RSV had a component in it so pharmacist said to that she wants to get Pfizer and said that like to check with Pfizer first and made sure would not had an issue that there's anything that was in the Shingrix.  The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: injected a patient with the diluent without the powder; injected a patient with the diluent without the powder; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: injected a patient with the diluent without the powder) and inappropriate dose of vaccine administered (Verbatim: injected a patient with the diluent without the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-DEC-2023 The reported stated that one of there nurses injected a patient with the diluent without the powder of Shingrix which led to which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter question if be able to send  just 1 vial of diluent.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: patient received only the adjuvant; patient received only the adjuvant; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the adjuvant) and inappropriate dose of vaccine administered (Verbatim: patient received only the adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-DEC-2023 The patient received only adjuvant suspension component of shingrix without being mixed with the antigen component powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Arexvy was administered to a pregnant woman in error; vaccine exposure during pregnancy; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of wrong vaccine administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy .5 ml. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Arexvy was administered to a pregnant woman in error) and vaccine exposure during pregnancy (Verbatim: vaccine exposure during pregnancy). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date:12-DEC-2023 The reporter reported that Arexvy was administered to a pregnant woman in error. The patient was supposed to receive Abrysvo during pregnancy, which led to wrong vaccine administered and vaccine exposure during pregnancy. The reporter consented to follow up.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test, Incorrect dose administered
Clinical narrative: 19year old received an adult dose of Engerix-B/Patientreceived a childhood series of hepatitis; Overdose; This non-serious case was reported by a consumer via call center representative and described the occurrence of adult product administered to child in a 19-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Hepatitis b vaccine (received a childhood series of hepatitis B vaccine).   On 11-DEC-2023, the patient received Engerix B adult. On 11-DEC-2023, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: 19year old received an adult dose of Engerix-B/Patientreceived a childhood series of hepatitis) and overdose (Verbatim: Overdose). The outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK Receipt Date: 13-DEC-2023. Pharmacy technician stated that a 19-year-old received an adult dose of Engerix-B which led to adult product administered to child and overdose. Patient received a childhood series of hepatitis B vaccine and was receiving a booster series due to titer levels. The reporter did not consented to follow up.
Age: 73.0
Sex: F
Vaccine: RVX
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: RSV vaccine she had muscle weakness; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 73-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of muscular weakness (in august 2023 patient received Shingrix and experienced muscle weakness and had difficulty walking, reference case US2023173311).   On an unknown date, the patient received RSV vaccine. On an unknown date, 24 hrs after receiving RSV vaccine, the patient experienced muscle weakness (Verbatim: RSV vaccine she had muscle weakness ). The outcome of the muscle weakness was resolved (duration 4 days).   It was unknown if the reporter considered the muscle weakness to be related to RSV vaccine.     It was unknown if the company considered the muscle weakness to be related to RSV vaccine.   Linked case(s) involving the same patient:  US2023173311   Additional Information: GSK Receipt Date: 11-DEC-2023. Reporter was a consumer who had a Shingrix vaccine in August of 2023.   Reporter had a RSV vaccine 30 days after the Shingrix vaccine but did not knew which manufacturing brand was  administered and stated that 24 hours after the RSV vaccine she had muscle weakness that resolved 4 days post RSV vaccine administration.     Reporter then had a Flu vaccine 30 days after the RSV vaccine but again did not knew which manufacturing brand was administered and stated that 12 hours after flu vaccine administration she developed fever and muscle weakness that resolved 3 days post Flu vaccine administration. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023173311:same patient,Different suspect
Sex: U
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: very tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced tiredness (Verbatim: very tired). The outcome of the tiredness was not reported.   It was unknown if the reporter considered the tiredness to be related to Arexvy.     It was unknown if the company considered the tiredness to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-DEC-2023 This case was reported by a patient via interactive digital media. The patient stated that he/she had been very tired and was glad to know it was a side effect and questioned how long does it usually last. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact
Clinical narrative: When they injected the diluent into the antigen vial it sprayed back in their face; it sprayed back in their face; This non-serious case was reported by a nurse via sales rep and described the occurrence of occupational exposure while preparing product for administration in a patient who received Herpes zoster (Shingrix) (batch number 22TX7, expiry date 06-DEC-2025) and (batch number 5SG54, expiry date 06-DEC-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration (Verbatim: When they injected the diluent into the antigen vial it sprayed back in their face) and exposure via skin contact (Verbatim: it sprayed back in their face). The outcome of the occupational exposure while preparing product for administration and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was nurse. The reporter reported that two very experienced nurses had trouble preparing Shingrix vaccine. They injected the diluent into the antigen vial, it sprayed back in their face around the needle insertion site which led to occupational exposure while preparing product for administration and exposure via skin contact. The reporter consented to follow up granted.
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 23 pregnant women received Arexvy; Underdose; 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 30-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4l5m7, expiry date 29-MAR-2023) 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: Underdose). 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-US2023173296:17th patient US-GSK-US2023AMR178424:17th patient US-GSK-US2023AMR178395:17th patient US-GSK-US2023AMR178415:17th patient US-GSK-US2023AMR178412:17th patient US-GSK-US2023AMR178431:17th patient US-GSK-US2023AMR178358:17th patient US-GSK-US2023AMR178458:17th patient US-GSK-US2023AMR178444:17th patient US-GSK-US2023AMR178435:17th patient US-GSK-US2023AMR178466:17th patient US-GSK-US2023AMR178450: US-GSK-US2023AMR178469: US-GSK-US2023AMR178481: US-GSK-US2023AMR178489: US-GSK-US2023AMR178513: US-GSK-US2023AMR178567: US-GSK-US2023AMR178578: US-GSK-US2023AMR178583: US-GSK-US2023AMR178585: US-GSK-US2023AMR178588: US-GSK-US2023AMR178594:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Dizziness, Feeling cold, Headache
Clinical narrative: Headache; Shivering; Lightheaded; Cold feet; Cold nose; Blood pressure 207/104; Soreness; Pressure behind the eye balls; Pounding Severe Migraine; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-NOV-2023, the patient received the 1st dose of Shingrix. On 13-NOV-2023, less than a day after receiving Shingrix, the patient experienced pain (Verbatim: Soreness) and sensation of pressure in eye (Verbatim: Pressure behind the eye balls). In NOV-2023, the patient experienced migraine (Verbatim: Pounding Severe Migraine). On an unknown date, the patient experienced headache (Verbatim: Headache), shivering (Verbatim: Shivering), light headedness (Verbatim: Lightheaded), cold feet (Verbatim: Cold feet), coldness local (Verbatim: Cold nose) and hypertension (Verbatim: Blood pressure 207/104). In NOV-2023, the outcome of the migraine was resolved (duration 2 days).  On 16-NOV-2023, the outcome of the pain and sensation of pressure in eye were resolved (duration 3 days). The outcome of the headache, shivering, light headedness, cold feet, coldness local and hypertension were unknown.   It was unknown if the reporter considered the pain, sensation of pressure in eye, migraine, headache, shivering, light headedness, cold feet, coldness local and hypertension to be related to Shingrix.     It was unknown if the company considered the pain, sensation of pressure in eye, migraine, headache, shivering, light headedness, cold feet, coldness local and hypertension to be related to Shingrix.   Additional Information: GSK receipt date: 12-DEC-2023 The patient reported this case for herself. The patient received shingrix 1st dose, same day she developed soreness, pressure behind the eye balls that lasted about 3 days. In November 2023, then a week later, patient developed a pounding migraine so severe that lasted for 2 days. The patient took some medications for headache, then 6 days later the patient went to emergency room, she was not admitted but treated for a few hours for the migraine. The patient also had shivering, and went to the bathroom like 26 times that night she went to emergency room. The patient also reported lightheadedness and cold with her nose and feet. According to the patient the blood pressure was high 207/104. The reporter did not consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Ocular discomfort, Pain, Peripheral coldness
Clinical narrative: Headache; Shivering; Lightheaded; Cold feet; Cold nose; Blood pressure 207/104; Soreness; Pressure behind the eye balls; Pounding Severe Migraine; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-NOV-2023, the patient received the 1st dose of Shingrix. On 13-NOV-2023, less than a day after receiving Shingrix, the patient experienced pain (Verbatim: Soreness) and sensation of pressure in eye (Verbatim: Pressure behind the eye balls). In NOV-2023, the patient experienced migraine (Verbatim: Pounding Severe Migraine). On an unknown date, the patient experienced headache (Verbatim: Headache), shivering (Verbatim: Shivering), light headedness (Verbatim: Lightheaded), cold feet (Verbatim: Cold feet), coldness local (Verbatim: Cold nose) and hypertension (Verbatim: Blood pressure 207/104). In NOV-2023, the outcome of the migraine was resolved (duration 2 days).  On 16-NOV-2023, the outcome of the pain and sensation of pressure in eye were resolved (duration 3 days). The outcome of the headache, shivering, light headedness, cold feet, coldness local and hypertension were unknown.   It was unknown if the reporter considered the pain, sensation of pressure in eye, migraine, headache, shivering, light headedness, cold feet, coldness local and hypertension to be related to Shingrix.     It was unknown if the company considered the pain, sensation of pressure in eye, migraine, headache, shivering, light headedness, cold feet, coldness local and hypertension to be related to Shingrix.   Additional Information: GSK receipt date: 12-DEC-2023 The patient reported this case for herself. The patient received shingrix 1st dose, same day she developed soreness, pressure behind the eye balls that lasted about 3 days. In November 2023, then a week later, patient developed a pounding migraine so severe that lasted for 2 days. The patient took some medications for headache, then 6 days later the patient went to emergency room, she was not admitted but treated for a few hours for the migraine. The patient also had shivering, and went to the bathroom like 26 times that night she went to emergency room. The patient also reported lightheadedness and cold with her nose and feet. According to the patient the blood pressure was high 207/104. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Sleep disorder
Clinical narrative: Severe Headache; barely slept; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-FEB-2022, the patient received the 1st dose of Shingrix (left arm). In FEB-2022, less than a day after receiving Shingrix, the patient experienced sleeplessness (Verbatim: barely slept). On 16-FEB-2022, the patient experienced headache (Verbatim: Severe Headache). The patient was treated with acetaminophen and ketorolac. On 17-FEB-2022, the outcome of the headache was resolved (duration 1 day). The outcome of the sleeplessness was not reported.   It was unknown if the reporter considered the headache and sleeplessness to be related to Shingrix.     It was unknown if the company considered the headache and sleeplessness to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-DEC-2023. The patient stated that last year patient had a bad reaction to 2-part shingles vaccine and after the 1st vaccination, patient suffered severe headache.  It was so bad that patient went to emergency room thinking that she might even have a brain aneurysm.  The headache started a few hours after vaccine.  The patient treated with frozen eye mask and took 2 acetaminophen.  A couple of hours later the headache was getting more severe, so patient took a 3rd acetaminophen.  The headache got increasingly worse, and patient barely slept that night.  The patient went to emergency room the following morning.  The headache began to subside after they gave patient a pain medicine ketorolac 10mg.  The headache resolved that evening on 17-Feb-2022. Due to this reaction, the patient did not receive a second dose. The reporter consented to follow up.
Age: 8.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 8 year old received one dose of Pediarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old patient who received DTPa-HBV-IPV (Pediarix) (batch number A32BB, expiry date 10-AUG-2025) for prophylaxis.   On 11-DEC-2023, the patient received Pediarix. On 11-DEC-2023, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: 8 year old received one dose of Pediarix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 12-DEC-2023 A nurse reported that a 8 year old patient received one dose of Pediarix on 11th December 2023 which led to Inappropriate age at vaccine administration.  This was the second dose in Dtap and IPV series. The reporter consent to follow up.