chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome, Oropharyngeal pain, Pneumonitis, Positive airway pressure therapy, Procalcitonin
Clinical narrative: Patient is a 67 y.o. female patient ofl, DO with history of arthritis, CKD, GERD, essential HN, HLD, hypothyroidism, COPD, and OSA  presented to General Hospital with SOB and  worsening breathing.   Acute hypoxic respiratory failure d/t Sepsis was present on admission s/t COVID-19 pneumonia NSTEMI, suspected type 2 due to demand Suspected acute PE with elevated D-dimer -ruled out on VQ scan P/w 10 day history of cough, nasal congestion, and sore throat. Pt fully vaccinated with 1 booster shot Afebrile on arrival, HR 84, RR 18, BP 120/73, satting >92% on 2L by NC (no home O2 needs) CBC unremarkable. BMP with AKI as below CXR: Slight area of inflammation or small infiltrate in the lateral aspect in the right midlung field Cont supplemental O2 to maintain goal SpO2 >90%, wean off to room air as tolerated Decadron 6mg daily for 10 days CRP 16.9, Pro-Cal 0.07 Albuterol, robitussin-DM, tylenol PRN; encourage IS use Contact precautions PT/OT/SW VQ scan negative for PE.  Lovenox changed to prophylactic dose Home O2 evaluation prior to discharge.  Case management consulted for discharge needs   Acute kidney injury Initial Cr 2.09 (baseline ~1).  Likely pre-renal given poor PO intake secondary to above  Improved with IVF   Essential HTN HLD Normotensive on admission Continue home amlodipine and statin Hold hyzaar pending improvement of kidney function    Hypothyroidism Continue home synthroid    GERD Continue home protonix PRN tums   Chronic arthritic pain Continue home tramadol and gabapentin   Obesity  OSA Body mass index is 37.12 kg/m². Discussed dietary and lifestyle modifications Continue home CPAP   Nicotine dependence Current 1 PPD smoker Discussed and encouraged smoking cessation, >3min total time spent Nicotine replacement ordered
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Sepsis, Ventilation/perfusion scan
Clinical narrative: Patient is a 67 y.o. female patient ofl, DO with history of arthritis, CKD, GERD, essential HN, HLD, hypothyroidism, COPD, and OSA  presented to General Hospital with SOB and  worsening breathing.   Acute hypoxic respiratory failure d/t Sepsis was present on admission s/t COVID-19 pneumonia NSTEMI, suspected type 2 due to demand Suspected acute PE with elevated D-dimer -ruled out on VQ scan P/w 10 day history of cough, nasal congestion, and sore throat. Pt fully vaccinated with 1 booster shot Afebrile on arrival, HR 84, RR 18, BP 120/73, satting >92% on 2L by NC (no home O2 needs) CBC unremarkable. BMP with AKI as below CXR: Slight area of inflammation or small infiltrate in the lateral aspect in the right midlung field Cont supplemental O2 to maintain goal SpO2 >90%, wean off to room air as tolerated Decadron 6mg daily for 10 days CRP 16.9, Pro-Cal 0.07 Albuterol, robitussin-DM, tylenol PRN; encourage IS use Contact precautions PT/OT/SW VQ scan negative for PE.  Lovenox changed to prophylactic dose Home O2 evaluation prior to discharge.  Case management consulted for discharge needs   Acute kidney injury Initial Cr 2.09 (baseline ~1).  Likely pre-renal given poor PO intake secondary to above  Improved with IVF   Essential HTN HLD Normotensive on admission Continue home amlodipine and statin Hold hyzaar pending improvement of kidney function    Hypothyroidism Continue home synthroid    GERD Continue home protonix PRN tums   Chronic arthritic pain Continue home tramadol and gabapentin   Obesity  OSA Body mass index is 37.12 kg/m². Discussed dietary and lifestyle modifications Continue home CPAP   Nicotine dependence Current 1 PPD smoker Discussed and encouraged smoking cessation, >3min total time spent Nicotine replacement ordered
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product label issue
Clinical narrative: No adverse effect.  Patient potentially received Moderna COVAX 0.5 mL versus the correct dosage of Moderna COVAX 0.25 mL. The Moderna COVAX 6mos to 4yrs old is clearly labeled as ?0.25 mL single dose vial? however I did the investigation and found that the single dose vials we have on hand indeed have 0.5 mL inside of it.
Age: 29.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Arthralgia, Arthritis
Clinical narrative: Systemic arthritis, joint pain. Occurred 3 days after vaccination with Flu/Moderna at same time. Has been persistent for 5 days now requiring medical attention.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Covid 19 Pfizer 6 month-4 year vaccine given 0.3 ml dose, however, vial was not diluted with 1.1 cc normal saline as recommended by vaccine manufacturer
Age: 11.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient was 11 years & 5 months old and received 12 year old dose. No side effects or adverse reactions.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effect.  Patient potentially received Moderna COVAX 0.5 mL versus the correct dosage of Moderna COVAX 0.25 mL. The Moderna COVAX 6mos to 4yrs old is clearly labeled as ?0.25 mL single dose vial? however I did the investigation and found that the single dose vials we have on hand indeed have 0.5 mL inside of it.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: When administering covid-19 vaccine to patient, staff accidentally took the pre-filled syringe and administered entire syringe to patient instead of the pediatric dose. Patient was given 0.5mL instead of 0.25mL of vaccine.
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Dyspepsia
Clinical narrative: patient claims to have self diagnosed pancreatitis after developing a burning sensation in her stomach. diagnosed via online research.
Age: 50.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Condition aggravated, Seizure
Clinical narrative: AS REPORTED BY FACILITY DIRECTOR: SEIZURE 24 HOURS POST INJECTION
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Pancreatitis
Clinical narrative: Pancreatitis three nights in hospital
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient received, Moderna covid19 vaccine lot:3030592 exp:03/29/2024 @ 11/6/2023 at 12:15PM. Pt reached out to me @12:55PM. letting me know that her arm was feeling itchy and hives appearing. no SOB or difficulty breathing. We both went to CT to speak with a provider for advice, CT provider NP advised that reaction not concerning, but to take 25mg of Benadryl and if any worsening symptoms to report to ER. Pt was given 1 Benadryl 25mg tablet at 1:00PM. Advised of reaction. checked in the Pt at 1:30pm and reported to feel itchy but not as much. VEARS report also submitted.
Age: 66.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Blister, Skin lesion
Clinical narrative: Pt had bulla appear on L wrist  hours after having vaccines. These have multiplied in teh course of week to 2 lesions (L wrist and hand).
Age: 49.0
Sex: F
Vaccine: PNC20
Symptoms: Induration, Loss of personal independence in daily activities, Pain in extremity, Swelling
Clinical narrative: Large swollen indurated area. Significant pain in arm, limited ADLs
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Gait inability, Influenza like illness, Renal pain, Rhinorrhoea
Clinical narrative: A few hours after getting a flu shot starting getting runny nose and flu like symptoms.  By the next day was significantly worse and said was causing kidney pain and joint pain that prevented from walking.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, X-ray limb
Clinical narrative: PATIENT DESCRIBED PAIN IN ARMAT SITE AND ABOVE FOLLOWING THE INJECTION. THIS PAIN CONTINUES HER TO NOT BE ABLE TO LIFT RIGHT ARM WITHOUT PAIN . WENT TO URGENT CARE ON 11/2/23 AS HER PRIMARY DOCTOR COULD NOT  SEE HER. AT THE URGENT CARE SHE HAD AN XRAY DONE, WAS GIVEN PRED PACK AND MOTRIN RX.  AT THE TIME OF THIS REPORT SEH DOES NOT KNOW THE RESULTS OF THE X-RAY AND FEEL  A SLIGHT IMPROVEMENT BUT STILL IS PAINFUL.
Age: 10.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pt did NOT have any type of adverse event.  After giving the vaccine, it was realized that vaccine was only approved for 12 years and older.  pt received a full dose of the spikevax (0.5ml) instead of 0.25ml, which is the recommended dose.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Cough, Injection site swelling, Nasal congestion, Tonsillar disorder
Clinical narrative: Administration error: Pt received Men B vaccine on 10/30/23 when pt should have received MCV4.  Per parents, pt noted for the following symptoms post vaccination: nasal congestion, cough, tonsil irritation, severe redness and swelling around injection site.
Age: 68.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Fatigue, Headache, Mobility decreased, Renal pain
Clinical narrative: Patient said her and her husband both got side effects.  Hers was mostly pain where her kidneys where which moved more to the right side as time progressed.  She also was very tired and had a bad headache.  Pain was bad enough didn't want to walk or get out of bed.  Still has symptoms but getting better.
Age: 16.0
Sex: M
Vaccine: FLU4, HEPA, MNQ
Symptoms: Dizziness, Electrocardiogram normal, Fall, Full blood count normal, Head injury
Clinical narrative: Night that shots given presented to ED Got up,  felt nausea, then recalls feeling lightheaded and as if he was about to pass out. Next recalls being on the ground, mother witnessed that he hit his head, was briefly shaking, then regained consciousness and acting normal soon after this
Age: 16.0
Sex: M
Vaccine: FLU4, HEPA, MNQ
Symptoms: Laboratory test normal, Loss of consciousness, Nausea, Tremor
Clinical narrative: Night that shots given presented to ED Got up,  felt nausea, then recalls feeling lightheaded and as if he was about to pass out. Next recalls being on the ground, mother witnessed that he hit his head, was briefly shaking, then regained consciousness and acting normal soon after this
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product label issue, Product packaging quantity issue
Clinical narrative: No adverse effect.  Patient potentially received Moderna COVAX 0.5 mL versus the correct dosage of Moderna COVAX 0.25 mL. The Moderna COVAX 6mos to 4yrs old is clearly labeled as ?0.25 mL single dose vial? however I did the investigation and found that the single dose vials we have on hand indeed have 0.5 mL inside of it.
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dry skin, Insomnia, Loss of personal independence in daily activities, Pruritus, Urticaria
Clinical narrative: Developed chronic urticaria with the same symptoms after taking the first Moderna booster. Intense itching at random parts of the body all day and night. Itching was severe enough to prevent normal daily functions and sleep. Hives and itching would crop up at multiple parts of the entire body and last for approximately 30 minutes to 2 hours at each spot. Also accompanied by dry skin.
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Urticaria chronic
Clinical narrative: Developed chronic urticaria with the same symptoms after taking the first Moderna booster. Intense itching at random parts of the body all day and night. Itching was severe enough to prevent normal daily functions and sleep. Hives and itching would crop up at multiple parts of the entire body and last for approximately 30 minutes to 2 hours at each spot. Also accompanied by dry skin.
Age: 13.0
Sex: M
Vaccine: FLU4, HEP, TD, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Extra dose of Varivax administered. Vaccine was not necessary, no symptoms reported
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Blood pressure increased, Chills, Diabetes mellitus inadequate control, Extra dose administered, Malaise
Clinical narrative: This patient received her prevnar 20 on 10/23/2023 due to her doctor recommending her to make an appointment here to receive the vaccine.    It was discovered today that she already received the prevnar 20 at this pharmacy on 07/20/2022.  Patient's daughter called and raised concerns of her mother receiving too many doses and stated that a week after getting the vaccine her mother started "not feeling well".. She stated that her blood pressure went up, her blood sugars were not in control, and that her mother had the chills.  These symptoms caused the patient to have to visit the doctor.   It is unknown if these symptoms are related to the vaccine since they did not start until a whole week after receiving the vaccine.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Cardiac arrest, Death
Clinical narrative: PATIENT PRESENTED TO HOSPITAL EMERGENCY DEPARTMENT 10/20 @ 0927 IN CARDIAC ARREST AND EXPIRED.
Age: 89.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia
Clinical narrative: numbness in left arm and left side of face for 10 minutes
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient was supposed to get the Moderna Covid vaccine for patients ages 6 months - 11 years of 0.25ml.  Medical assistant administering vaccine grabbed wrong vial and administered 0.25ml Monovalent Spikevax (intended for 12 years and older). Physician notified, patient observed in clinic for 20 minutes with no adverse events.  Patient followed up via phone call 2 days later with no adverse effects.
Age: 53.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 53 y/o pt received Fluad 65+ yrs and older vaccine. No noted adverse side effects.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pruritus, Urticaria
Clinical narrative: Body ache, head ache, itching, whelps to wrist, stomach,  back, buttocks, shoulders and arms. Patient states she too zyrtec with some relief. Went to ER on 11/03/2023 and was treated and told to take Benadryl. Patient states ER Dr. was unable to tell whether the Spikevax caused the whelps/itching.  Patient states she has appointment with PMD.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Employee reported to Occupational Health for a flu vaccine.  Received notification that he had participated in the COVID vaccination program.  Review of the sign in sheet and electronic record reveals that he signed in on the COVID Vaccination Consent/Sign-in.  Unable to identify with 100% accuracy which vaccine has been administered.
Age: 40.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Vaccine is formulated for patients 60+ and pt was given the vaccine being under 60 years of age. Pt experienced no adverse reaction. Pt reports only a sore arm that resolved yesterday. Pt doing well. Pt was made aware of error.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills for @5 hours; Low-grade fever (99.1) @12 hours
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse effect.  Patient potentially received Moderna COVAX 0.5 mL versus the correct dosage of Moderna COVAX 0.25 mL. The Moderna COVAX 6mos to 4yrs old is clearly labeled as ?0.25 mL single dose vial? however I did the investigation and found that the single dose vials we have on hand indeed have 0.5 mL inside of it.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Musculoskeletal stiffness
Clinical narrative: Leg stiffness right leg near knee joint
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse effect.  Patient potentially received Moderna COVAX 0.5 mL versus the correct dosage of Moderna COVAX 0.25 mL. The Moderna COVAX 6mos to 4yrs old is clearly labeled as ?0.25 mL single dose vial? however I did the investigation and found that the single dose vials we have on hand indeed have 0.5 mL inside of it.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pityriasis rosea
Clinical narrative: Developed a spot of pyterisis rosea on left side of face near chin.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse effect.  Patient potentially received Moderna COVAX 0.5 mL versus the correct dosage of Moderna COVAX 0.25 mL. The Moderna COVAX 6mos to 4yrs old is clearly labeled as ?0.25 mL single dose vial? however I did the investigation and found that the single dose vials we have on hand indeed have 0.5 mL inside of it.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Feeling abnormal, Rash, Rash erythematous, Rash pruritic
Clinical narrative: "I seem to have broken out in hives after my vaccination yesterday.   Also it  hit hard and fast. Body felt miserable last night.  With dizzy spell."  ".....NURSING NOTE...... Patient noticed a rash on saturday after getting a covid vaccination. There are  red bumps to bilateral arms and legs. They appear to be in line formation.  Patient reports these bumps are itchy."  Patient also noted to have current incomplete root canal
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: "I seem to have broken out in hives after my vaccination yesterday.   Also it  hit hard and fast. Body felt miserable last night.  With dizzy spell."  ".....NURSING NOTE...... Patient noticed a rash on saturday after getting a covid vaccination. There are  red bumps to bilateral arms and legs. They appear to be in line formation.  Patient reports these bumps are itchy."  Patient also noted to have current incomplete root canal
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Dizziness, Dyspnoea, Feeling abnormal, Musculoskeletal stiffness
Clinical narrative: administered flu shot then walked patient out to the waiting area. a customer asked me a question while the patient sat down. then the patient said she doesn't feel right, said she was lightheaded and seeing stars. she then proceeded to stiffen and convulse and I yelled for the other pharmacist to call 911. patient convulsed for approximately 15-20 seconds. During this time she also lost control of her bladder. said she was having difficulty breathing so an epipen was administered. ems arrived at approximately 405pm. they took her by ambulance to er to monitor her and also bc her pulse ox was only 89 and she was feeling very weak and shaky.
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Photopsia, Seizure, Tremor, Urinary incontinence
Clinical narrative: administered flu shot then walked patient out to the waiting area. a customer asked me a question while the patient sat down. then the patient said she doesn't feel right, said she was lightheaded and seeing stars. she then proceeded to stiffen and convulse and I yelled for the other pharmacist to call 911. patient convulsed for approximately 15-20 seconds. During this time she also lost control of her bladder. said she was having difficulty breathing so an epipen was administered. ems arrived at approximately 405pm. they took her by ambulance to er to monitor her and also bc her pulse ox was only 89 and she was feeling very weak and shaky.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Patient experienced hives and red swelling around injection site-was seen in the ER and got IV Benadryl and steroids
Age: 0.25
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 3-month-old was given a flu shot too early.  Called father to inform and he said patient is doing well and has no complaints. They will reschedule for 6-month-old shots.
Age: 59.0
Sex: F
Vaccine: COVID19, FLU4, PNC13
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: The evening after getting the vaccines I left arm started to hurt and get red. By the next day it has swelled up. After about a week the swelling went down yet I am no longer able to raise My left arm up two my shoulder like doing a jumping jack nor can I rose it behind that. I can slowly raise it forward over my head
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: PT IN HOUSE BED.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product label issue
Clinical narrative: No adverse effect.  Patient potentially received Moderna COVAX 0.5 mL versus the correct dosage of Moderna COVAX 0.25 mL. The Moderna COVAX 6mos to 4yrs old is clearly labeled as ?0.25 mL single dose vial? however I did the investigation and found that the single dose vials we have on hand indeed have 0.5 mL inside of it.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: PATIENT STATED THAT MD DIAGNOSED HER WITH SIRVA
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Bed sharing, Death, Unresponsive to stimuli
Clinical narrative: Found down by mother at home while sleeping the next morning after well visit. Was dead on arrival to ER. Last known normal about 2-3 hours prior to being found unresponsive. Was reportedly found in unsafe sleeping position (co-sleeping with another caregiver with blanket covering the infant).
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Mobility decreased, Pain
Clinical narrative: Patient received vaccination 3pm on 11/4 and shopped in the store until 10pm.  She fell asleep in her car after shopping and did not wake up until 4:30am on 11/5.  When she went to start her car, her arm was so sore she had trouble starting the car and her hand was wrapped up tightly in a ball.  She has pain at the injection site, forearm, and wrist.  Most of the pain is in her forearm and wrist and complains of numbness/pain in her fingers as she is having trouble using them.  She also complains of a shooting pain that travels back up her arm at times.  Patient says there has been some improvement since evening of 11/5 and has gained some function in her hand.   She is able to move her entire arm above her head now as well.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Patient received vaccination 3pm on 11/4 and shopped in the store until 10pm.  She fell asleep in her car after shopping and did not wake up until 4:30am on 11/5.  When she went to start her car, her arm was so sore she had trouble starting the car and her hand was wrapped up tightly in a ball.  She has pain at the injection site, forearm, and wrist.  Most of the pain is in her forearm and wrist and complains of numbness/pain in her fingers as she is having trouble using them.  She also complains of a shooting pain that travels back up her arm at times.  Patient says there has been some improvement since evening of 11/5 and has gained some function in her hand.   She is able to move her entire arm above her head now as well.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No Adverse Event; HCP called to report a TE with PROQUAD.  Improperly stored. TE case reference 02490108.  No adverse effects reported.  Consent to contact is no. No additional AE/No PQC. AE cross reference cases 02490153, 02490133, 02490163, 02490160, 02490148, 02490; This spontaneous report was received from an other health care professional refers to a 4-year-old patient of unknown gender.     The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-AUG-2023, the patient was vaccinated with the dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin)(PROQUAD) lot #W029555, expiration date: 14-MAR-2024, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis.         Administered dose of vaccine experienced the temperature excursion (product storage error). The information about previous temperature excursion were not provided. There were no additional adverse events reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no adverse event; Inbound call from physician calling to report TE for GARDASIL-9.  Caller reports that vaccine was administered to patient following excursion.  Confirmed no symptoms or other adverse events were reported.  No other information at this time.  Permissi; This spontaneous report was received from a physician, referring to a patient of unknown age and gender.  The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 10-OCT-2023, the patient was vaccinated with improperly stored vaccine of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter/once, product quantity: 1, lot #W014513, expiration date: 26-JAN-2025 (strength, and route of administration were not provided) administered for prophylaxis (Product storage error). The vaccine was exposed to 0 degree Celsius (C) for 15 minutes and the data logger was involved on an unspecified date. There was no previous temperature excursion. It was confirmed no symptoms or other adverse events were reported.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; Physician calling to report a TE VARIVAX. HCP stated that the vaccines were administered to a patient on date of administration in July 2023.; This spontaneous report was received from a physician and referred to a 13-year-old patient of unknown gender.   The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On an unspecified date in July 2023, the patient was vaccinated with improperly stored vaccine of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # X006981, expiry date: 07-MAR-2025), the second dose for the series (dose, strength and route of administration were not provided) for prophylaxis (Product storage error). The vaccine was exposed to 28 Fahrenheit (F)/14 F to 46 F for 15 minutes 0 seconds. There was no previous temperature excursion. No additional adverse event (AE) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2309USA007382:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to an unknown age and gender patient. The patient's concurrent condition, medical history, and concomitant medications were not reported.   Varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# W032370 [reported as w032370], expiry date was reported as 19-APR-2025, but upon internal validation established as 10-OCT-2024) was stored at temperature of 37.2 degree Fahrenheit (F) for 18 hours. There was no previous temperature excursion. On 06-SEP-2023, after temperature excursion, the patient was vaccinated with 1 dose of the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (exact dose, route of administration, and anatomical location not provided) as prophylaxis (product storage error). No additional adverse events (AEs) were reported (no adverse event). No further information was provided.  This is one of 4 reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No additional AEs were reported; Medical assistant reported that a patient received an expired PNEUMOVAX 23.   No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-OCT-2023, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, lot #w007035, expiration date: 20-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Age: 1.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE/PQC; HCP called to report an inadvertent administration of GARDASIL 9 to an infant instead of PREVNAR 20.  Administered today 11/1/2023 to a 1 yr old male. No adverse effects were reported. Request case reference 02501053. Consent to contact is yes.  No a; To a 1 yr old male; This spontaneous report has been received from a physician, regarding a 12-month-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 01-NOV-2023, the patient was erroneously vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliters as prophylaxis (lot number: W026152, which was determined to be valid as syringe formulation, with an expiration date reported as 24-JAN-2025, but confirmed to be on 29-JAN-205), instead of pneumococcal vaccine CONJ 20V (CRM197) (PREVNAR 20) (wrong vaccine administered, Product administered to patient of inappropriate age).   No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PROQUAD was administered to a 16 year old patient; No additional AE; This spontaneous report was received from a registered nurse and refers to a 16-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with one dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration). There was no additional adverse event reported.
Sex: F
Vaccine: RSV
Symptoms: Cellulitis, Contusion, Injection site erythema, Injection site swelling, Skin disorder
Clinical narrative: localized cellulitis; redness at injection site; Sweeling at injection site; bruising; Skin Breakdown; This serious case was reported by a physician via sales rep and described the occurrence of cellulitis in a 61-year-old female 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 cellulitis (Verbatim: localized cellulitis) (serious criteria GSK medically significant), injection site erythema (Verbatim: redness at injection site), injection site swelling (Verbatim: Sweeling at injection site), contusion (Verbatim: bruising) and skin breakdown (Verbatim: Skin Breakdown). The outcome of the cellulitis, injection site erythema, injection site swelling, contusion and skin breakdown were not reported.   It was unknown if the reporter considered the cellulitis, injection site erythema, injection site swelling, contusion and skin breakdown to be related to Arexvy.     It was unknown if the company considered the cellulitis, injection site erythema, injection site swelling, contusion and skin breakdown to be related to Arexvy.   Additional Information: GSK receipt date: 28-OCT-2023 The physician reported a patient returned within 2 weeks with bruising, redness, and swelling at injection site. Within 4 weeks, skin breakdown had occurred, and physician was concerned about localized cellulitis. The reporter did not consent to follow up.
Sex: F
Vaccine: RVX
Symptoms: Lymphadenopathy, Mammogram
Clinical narrative: Had mammogram the next week and got false reading because of swollen lymph node; This non-serious case was reported by a consumer and described the occurrence of swollen lymph nodes in a 72-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 08-SEP-2023, the patient received RSV vaccine. On 12-SEP-2023, 4 days after receiving RSV vaccine, the patient experienced swollen lymph nodes (Verbatim: Had mammogram the next week and got false reading because of swollen lymph node). On 04-OCT-2023, the outcome of the swollen lymph nodes was resolved (duration 22 days).   It was unknown if the reporter considered the swollen lymph nodes to be related to RSV vaccine.     It was unknown if the company considered the swollen lymph nodes to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 27-OCT-2023 The patient self-reported this case. This report was submitted via the online direct entry reporting system.  The patient received RSV vaccine and had mammogram the next week after vaccination and got false reading because of swollen lymph node. The symptoms were treated. The reporter gave permission to contact her.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Malaise
Clinical narrative: Diarrhea; ill; This non-serious case was reported by a consumer and described the occurrence of diarrhea in a 78-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included atrial fibrillation. Concomitant products included metoprolol, tramadol, rosuvastatin and cyclobenzaprine hydrochloride (Flexeril Tablet (Cyclobenzaprine)).   On 26-OCT-2023, the patient received Shingles vaccine. On 26-OCT-2023, less than a day after receiving Shingles vaccine, the patient experienced diarrhea (Verbatim: Diarrhea) and unwell (Verbatim: ill). The outcome of the diarrhea was resolved and the outcome of the unwell was not reported.   It was unknown if the reporter considered the diarrhea and unwell to be related to Shingles vaccine.     It was unknown if the company considered the diarrhea and unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-OCT-2023 The patient reported that she received the Shingles injection and became very ill after 30 minute shopping. Her daughter brought her home to bed and bathroom where she suffered from diarrhea for several days. The patient  called the pharmacist and told her that they know the side effects included the gastrointestinal issues. The patient was not informed before the procedure.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). 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 : 27-OCT-2023 The reporter called to get information on Kinrix, that was administered to an inappropriate age patient which led to inappropriate age at vaccine administration. After collecting demographic information, the reporter realized she was calling the wrong company and abandoned the call. Very limited information known before call was abandoned. No other information was provided by reporter. NO PQC reported.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 3rd dose administered by accident; This non-serious case was reported by a physician via sales rep and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-OCT-2023, the patient received the 3rd dose of Shingrix. On 27-OCT-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose administered by accident). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 27-OCT-2023 It was reported that 3rd dose of Shingrix was administered by accident which led to extra dose administered. No events reported yet.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Oral herpes, Rash, Rash pruritic
Clinical narrative: itchy rash on lower back; herpes on her lip; This non-serious case was reported by a physician via sales rep and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced itchy rash (Verbatim: itchy rash on lower back) and herpes on lip (Verbatim: herpes on her lip). The outcome of the itchy rash and herpes on lip were not reported.   It was unknown if the reporter considered the itchy rash and herpes on lip to be related to Shingrix.     It was unknown if the company considered the itchy rash and herpes on lip to be related to Shingrix.   Additional Information: GSK receipt date: 27-OCT-2023 The reporter reported that right after the vaccine the patient developed an itchy rash on lower back and a herpes on her lip. The reporter did not consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Cough, Fatigue, Oropharyngeal pain
Clinical narrative: Sore throat; Cough; Feel exhausted; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sore throat 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 sore throat (Verbatim: Sore throat), cough (Verbatim: Cough) and exhaustion (Verbatim: Feel exhausted). The outcome of the sore throat, cough and exhaustion were not reported.   It was unknown if the reporter considered the sore throat, cough and exhaustion to be related to Arexvy.   It was unknown if the company considered the sore throat, cough and exhaustion to be related to Arexvy.   Additional Information: GSK Receipt Date: 27-OCT-2023 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Skin burning sensation
Clinical narrative: I have a burn on my arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin burning sensation 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 skin burning sensation (Verbatim: I have a burn on my arm). The outcome of the skin burning sensation was not reported.   It was unknown if the reporter considered the skin burning sensation to be related to Arexvy.     It was unknown if the company considered the skin burning sensation to be related to Arexvy.  Additional Information: GSK Receipt Date: 28-OCT-2023 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient had burn on his/her arm after RSV vaccine. The follow-up could not be possible as no contact details were available. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR151221:Same reporter US-GSK-US2023AMR151214:Same reporter
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hit her like a ton of bricks; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included intestinal resection (In 2015), peridiverticular abscess (on colon) and diverticulitis. Previously administered products included Proton pump inhibitors (for years). Concurrent medical conditions included renal disease (3rd stage kidney disease in 2016) and hypothyroidism. Concomitant products included famotidine (Pepcid).   In JUL-2018, the patient received the 1st dose of Shingrix. On an unknown date, 18 hrs after receiving Shingrix, the patient experienced pain (Verbatim: hit her like a ton of bricks).The outcome of the pain was resolved (duration 1 day).   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Linked case(s) involving the same patient:US2023149435, US2023AMR149797   Additional Information: GSK Receipt Date: 27-OCT-2023 The patient also mentioned having received the Shingrix and that shot hit her like a ton of bricks. This started about 18 hours after receiving Shingrix, and lasted for about a day.  No further information was provided about these events. A diverticulitis abscess on her colon all pre-existing. The Shingrix was being monitored for all of this. The patient was on proton pump Inhibitors for years but no longer took these medications (no drug information provided).  The patient currently took Pepcid the smallest dose (no product information provided). The reporter consented to follow up. The case had been linked to US2023AMR149797 and US2023149435, reported by the same reporter, for a different product.; Sender's Comments:  US-GSK-US2023AMR149797:Shingrix Dose 2 US-GSK-US2023AMR149797:same patient US-GSK-US2023149435:same patient
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Product administration error, Wrong patient received product
Clinical narrative: 20 months old was administered with Kinrix; 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 20-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 27-OCT-2023, the patient received Kinrix (intramuscular, unknown thigh). On 27-OCT-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 20 months old was administered with Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date : 27-OCT-2023 The reporter reported that a Kinrix vaccine intended for a 4 year old patient was administered by error to his 20 months old brother which led to inappropriate age at vaccine administration. The vaccine was administered on day of reporting and it was injected in the thigh. It was unknown if it was the left thigh or the right thigh.  No additional information was provided. The reporter consented to follow up
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Kinrix to a 4 month old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On 26-OCT-2023, the patient received Kinrix. On 26-OCT-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Kinrix to a 4 month old patient). 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: 27-OCT-2023 The medical assistant reported the administration of Kinrix to a 4 month old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Hcp reported a 4 month old baby received Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Hcp reported a 4 month old baby received Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-OCT-2023 The HCP (health care professional) reported a 4 month old baby received Kinrix, which led to inappropriate age at vaccine administration. This would be the 2nd shot of DTap and IPV. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received 1st dose of Shingrix in Sept 2019 and is late for the 2nd dose/ did not receive; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in SEP-2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received 1st dose of Shingrix in Sept 2019 and is late for the 2nd dose/ did not receive). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-OCT-2023 The pharmacist reported that a patient received 1st dose of Shingrix and was late for the 2nd dose. 1st dose was given at different clinic, HCP (health care professional) did not have lot/expiry date. The reporter consented to follow up.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has only had 1 dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 8th March 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has only had 1 dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-OCT-2023 The pharmacist reported a 72 year old male patient states insisted he had only had 1st dose of Shingrix, but his pharmacy had record of 2 doses being administered.  The doses were on record as being given on 08th March 2023 and 20 July 2023.  The patient was disputing that he received the 2nd dose and wanted to receive another dose, but this had not been administered at the time of call. The consumer reported only received 1st dose, which led to incomplete course of vaccination. The reporter consented to follow up.