chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test abnormal
Clinical narrative: showed a low titer; This spontaneous report was received from a licensed practical nurse and refers to a 20-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported.  On 20-JUN-2005, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5  milliliters (ml) / two dose series, administered intramuscularly for varicella prevention (prophylaxis) and on 30-APR-2009, he was vaccinated with the second dose (anatomical location, lot number, and expiry date were not provided for both doses) within the recommended age parameters.  On 16-AUG-2024, the reporter stated that blood work recently taken prior to the patient going to college showed a low titer result against Varicella in the patient's results (antibody test abnormal), he has not had any medical concerns or any reported Varicella infections and his immunity to Varicella was low based on lab results after being fully vaccinated as stated in the recommended guidelines of the prescribing information. No additional information provided.  At the time of reporting, the outcome of the event was not provided.   The causal relationship between antibody test abnormal  and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Cardiomyopathy, Costochondritis
Clinical narrative: Cardiomyopathy; when to ER and admitted with MI/Eventual diagnosis: costochrondritis; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 25-year-old male patient received BNT162b2 (COMIRNATY), on 17Jun2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CARDIOMYOPATHY (hospitalization, medically significant), outcome "recovered with sequelae"; COSTOCHONDRITIS (hospitalization), outcome "recovered with sequelae", described as "when to ER and admitted with MI/Eventual diagnosis: costochrondritis". The events "when to er and admitted with mi/eventual diagnosis: costochrondritis" required emergency room visit. It was unknown if therapeutic measures were taken as a result of cardiomyopathy, costochondritis. It was unknown if the patient received other vaccine in four weeks. It was unknown if the patient received other medications in two weeks.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Respiratory syncytial virus infection, Treatment failure
Clinical narrative: Treatment failure; Treatment failure; This is a spontaneous report received from a consumer from product quality group.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HN3801, Expiration Date: 31Mar2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (medically significant), outcome "unknown" and all described as "Treatment failure".  Product Quality Group provided investigational results on 30Aug2024 for RSV Vaccine: Per investigation summary and conclusion, the complaint (Treatment failure) for of Abrysvo was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the involved scope. A complaint sample was not returned. The complaint is not confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. The Issue Escalation (NTM) process determined that no regulatory notification was required. The final scope was determined to be the associated lots of the reported lot HN3801. The reported defect is not representative of the quality of the batch, and reported lot remains acceptable for further distribution.   No follow-up attempts are possible.
Age: 57.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: chills; myalgia in the legs; a low grade fever; This is a spontaneous report received from a Pharmacist.  A 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Aug2024 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 02Aug2024 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing); "thyroid cancer" (unspecified if ongoing); "Sulfa Allergy" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; SYNTHROID. The following information was reported: PYREXIA (non-serious) with onset 30Aug2024 at 23:30, outcome "recovered" (01Sep2024), described as "a low grade fever"; CHILLS (non-serious) with onset 30Aug2024 at 23:30, outcome "recovered" (01Sep2024); MYALGIA (non-serious) with onset 30Aug2024 at 23:30, outcome "recovered" (01Sep2024), described as "myalgia in the legs". Therapeutic measures were taken as a result of chills, myalgia, pyrexia.  Additional information: The batch/lot was unknown as not available/provided to reporter at the time of report completion. The patient have not received any other vaccines within 4 weeks prior to the vaccine(s) for which they are reporting. The patient taking other medications within 2 weeks of the event starting. On 30Aug2024, at 11:30 pm, she awoke with chills, myalgia in the legs, and a low grade fever. The treatment received for the adverse event included 2 Tylenol extra strength.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Presyncope
Clinical narrative: After the vaccines when I was about leaving the room, I saw him almost fainting. At 2:30pm we followed up with the patient to make sure he was doing okay.
Age: 2.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient was mistakenly given MenQuadfi instead of PCV 20. Parents were notified. Provider was notified. Parent had no questions or concerns at this time. She understands that her child will need to get the proper PCV 20 dose and that the MCV does not count as a proper dose.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chest pain, Chills, Dyspnoea, Erythema
Clinical narrative: 8/29/24-6p vaccine admin.9pm-L deltoid red ,warm to touch 1" diameter.4am- woke up because both arms n legs were tremoring,S.O.B, felt pressure on mid chest level 8 pain duration of episode 2 minutes.Later in the morning  I had difficulty completing complete thoughts intermittently for 2 days.On.8/30/2024- chills ,body aches took  2 325mg tabs of Tylenol.Left arm remains red raised, itchy and warm to touch. Contacted Neuro. ,this was not MS,contacted R.Jaffe,APN,she didn't know what the reaction was caused by.Contacted cardiologist for appt, I was unable  to get an appt.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Mental impairment, Pain, Peripheral swelling
Clinical narrative: 8/29/24-6p vaccine admin.9pm-L deltoid red ,warm to touch 1" diameter.4am- woke up because both arms n legs were tremoring,S.O.B, felt pressure on mid chest level 8 pain duration of episode 2 minutes.Later in the morning  I had difficulty completing complete thoughts intermittently for 2 days.On.8/30/2024- chills ,body aches took  2 325mg tabs of Tylenol.Left arm remains red raised, itchy and warm to touch. Contacted Neuro. ,this was not MS,contacted R.Jaffe,APN,she didn't know what the reaction was caused by.Contacted cardiologist for appt, I was unable  to get an appt.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm, Tremor
Clinical narrative: 8/29/24-6p vaccine admin.9pm-L deltoid red ,warm to touch 1" diameter.4am- woke up because both arms n legs were tremoring,S.O.B, felt pressure on mid chest level 8 pain duration of episode 2 minutes.Later in the morning  I had difficulty completing complete thoughts intermittently for 2 days.On.8/30/2024- chills ,body aches took  2 325mg tabs of Tylenol.Left arm remains red raised, itchy and warm to touch. Contacted Neuro. ,this was not MS,contacted R.Jaffe,APN,she didn't know what the reaction was caused by.Contacted cardiologist for appt, I was unable  to get an appt.
Age: 24.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Fall, Loss of consciousness
Clinical narrative: After the vaccination, asked patient to stay near the pharmacy for 15 minutes.  Patient lost consciousness & fell about 1-2 minutes later. Partner then grabbed the pharmacist.  Pharmacy then called EMS and was on the operater while paramedics were on the way.  He was sitting upright. Took blood pressure immediately (3:08pm) 78/46 pulse 49.  At 3:13pm 96/60 pulse 69.  At 3:18pm 106/70 pulse 77.  Started to feel better as time progressed.   Paramedics then was called off by patient.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylaxis treatment, Dyspnoea, Speech disorder
Clinical narrative: Patient had difficulty speaking and breathing. Gave 1 dose of epinephrine 0.3mg in left thigh. She started to do better after 2 minutes. Ems arrived and evaluated her.  They did take her to the ER for further evaluation.
Age: 73.0
Sex: F
Vaccine: PPV, COVID19, FLU4, PPV
Symptoms: Mobility decreased
Clinical narrative: Patient is unable to move right upper arm.
Age: 73.0
Sex: F
Vaccine: PPV, COVID19, FLU4, PPV
Symptoms: Arthralgia, Asthenia, Cough, Decreased appetite, Feeling abnormal
Clinical narrative: Patient is unable to move right upper arm.
Age: 73.0
Sex: F
Vaccine: PPV, COVID19, FLU4, PPV
Symptoms: Gait disturbance, Mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: Patient is unable to move right upper arm.
Age: 73.0
Sex: F
Vaccine: PPV, COVID19, FLU4, PPV
Symptoms: Pyrexia, Rash macular, Skin warm, Swelling
Clinical narrative: Patient is unable to move right upper arm.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Headache, Hypertension, Hypertensive crisis, Immediate post-injection reaction
Clinical narrative: Adverse Effect:  headaches, high pitched hissing / ringing in ears, along with resistant high blood pressure (hypertensive crisis level) started after the 2nd vaccine shot given on 05/03/2021. Went to primary care on 5/17/2021 and blood pressure was 210/108. It took from  May 2021 to October 2021 requiring trialing multiple combinations of high blood pressure medications  to bring it down to 126/78 range taking 100mg losartan, 5mg Bystolic, and 12.5mg hydrochlorothiazide.  Still taking blood pressure medications 10mg Bystolic  and 12.5 hydrochlorothiazide to keep blood pressure in normal range.  The hissing / ringing in ears, and headaches remain and live with it.  Going on three years and believe requiring blood pressure medications, headaches, and hissing / ringing in the years are permanent. Still hopeful a way to resolve.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Adverse Effect:  headaches, high pitched hissing / ringing in ears, along with resistant high blood pressure (hypertensive crisis level) started after the 2nd vaccine shot given on 05/03/2021. Went to primary care on 5/17/2021 and blood pressure was 210/108. It took from  May 2021 to October 2021 requiring trialing multiple combinations of high blood pressure medications  to bring it down to 126/78 range taking 100mg losartan, 5mg Bystolic, and 12.5mg hydrochlorothiazide.  Still taking blood pressure medications 10mg Bystolic  and 12.5 hydrochlorothiazide to keep blood pressure in normal range.  The hissing / ringing in ears, and headaches remain and live with it.  Going on three years and believe requiring blood pressure medications, headaches, and hissing / ringing in the years are permanent. Still hopeful a way to resolve.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at injection site - ER treated as infection and prescribed doxycycline
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Periarthritis, Product administered at inappropriate site
Clinical narrative: Frozen shoulder within four hours. Ortho thinks it was injected subacromial bursa.  Upon administration it was too high, too deep, and felt like it entered joint space
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Pain
Clinical narrative: Pain at the injection site with minimal pressure to area and simple movements since date of injection
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered, Fatigue, Feeling abnormal, Pyrexia, Respiratory disorder
Clinical narrative: Medical error. Instead of pulling individual DTaP and inactivated Polio vaccine, clinic personnel pulled the combined Pediarix DTaP-HepB-IPV and the IPV vaccines and administered on the same day. Mom describes that the next day, child was "out of it", more tired than her usual. She has not reacted like this to a vaccine in the past. She recovered within 1 day. Mom notes that today, 12 days later, she has a fever and respiratory illness when no one else at home is sick.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Wrong product administered
Clinical narrative: Medical error. Instead of pulling individual DTaP and inactivated Polio vaccine, clinic personnel pulled the combined Pediarix DTaP-HepB-IPV and the IPV vaccines and administered on the same day. Mom describes that the next day, child was "out of it", more tired than her usual. She has not reacted like this to a vaccine in the past. She recovered within 1 day. Mom notes that today, 12 days later, she has a fever and respiratory illness when no one else at home is sick.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: 2023-2024 MODERNA was administered and is no longer authorized to be administered as of 08/22/2024
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Lip erythema, Lip swelling
Clinical narrative: Per patient/parent report approx three months after the event: Redness/swelling around lips and sores in the mouth starting approx 2-3 days after vaccine administration. No other symptoms reported. Symptoms resolved within a few days.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Injection site erythema, Muscle spasms
Clinical narrative: Her both hips and knees were hurting, and she had two red spots on two injection sites. Also she had leg cramps around her knee area and tight armpit.
Age: 64.0
Sex: F
Vaccine: FLU4, HEP, HEPA, PPV
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: PT reported pain, swelling, redness/hives and warm to the touch at the injection site starting when they woke up on 9/2/24(morning after vaccination ~14 hrs after vaccination) .  Diphenhydramine cream was applied at that time with some relief, but the irritation had come back on 9/3/24 when they reported the reaction to the pharmacy.  Recommended they contact their physician for evaluation of the injection site.
Age: 64.0
Sex: F
Vaccine: FLU4, HEP, HEPA, PPV
Symptoms: Injection site warmth
Clinical narrative: PT reported pain, swelling, redness/hives and warm to the touch at the injection site starting when they woke up on 9/2/24(morning after vaccination ~14 hrs after vaccination) .  Diphenhydramine cream was applied at that time with some relief, but the irritation had come back on 9/3/24 when they reported the reaction to the pharmacy.  Recommended they contact their physician for evaluation of the injection site.
Age: 71.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Fatigue
Clinical narrative: Extreme fatigue in evening on Sat & Mon 9/2
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Fall, Syncope
Clinical narrative: After receiving vaccines patient had vasovagal syncope within a few minutes, Medical assistant was still in the room with patient when she fell back on to the bed, Medical Assistant called Dr who then evaluated patient and reported to me a vasovagal reaction. Patient was monitored for 30minutes and had no further symptoms.
Age: 67.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Blister, Lip swelling, Rash, Swelling face
Clinical narrative: Pt had rash on face the next day after receiving vaccine, and then rash turned into fluid-filled blisters, and then had swollen right face and lip, pt went to see doctor 1 week later, and his doctor prescribed prednisone for treatment.
Age: 67.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Scar, Skin lesion, Swelling face
Clinical narrative: Pt had rash on face the next day after receiving vaccine, and then rash turned into fluid-filled blisters, and then had swollen right face and lip, pt went to see doctor 1 week later, and his doctor prescribed prednisone for treatment.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chills, Cough, Rhinorrhoea
Clinical narrative: Cough, chills, runny nose
Age: 3.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Body temperature increased, Diagnostic procedure, Febrile convulsion, Lethargy, Rash
Clinical narrative: Febril seizure, high fever, rash on leg
Age: 3.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Rash vesicular, SARS-CoV-2 test negative
Clinical narrative: Febril seizure, high fever, rash on leg
Age: 3.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Febrile convulsion, Pyrexia, Rash
Clinical narrative: Febril seizure, high fever, rash on leg
Age: 73.0
Sex: F
Vaccine: PPV, COVID19, FLU4, PPV
Symptoms: Mobility decreased
Clinical narrative: About an hour an half later I had shooting pain from shoulder to fingers, and still can't move my arm. I had low grade fever, felt terrible, I had no appetite all day, muscle aches, dry cough, weak and bumbing into things, my arms was hot with a big bloch on it. I tool a lot of over the counter naproxin, and the next day it was down 10%, but only from my elbow down. The rest is still 100%.  I have an appointment for physical therapy consultation, I am waiting on a MRI and a steriod sho, .At Health DOS: 9/3/24 Dortor/NP said the shoulder is really swallon.
Age: 73.0
Sex: F
Vaccine: PPV, COVID19, FLU4, PPV
Symptoms: Arthralgia, Asthenia, Cough, Decreased appetite, Feeling abnormal
Clinical narrative: About an hour an half later I had shooting pain from shoulder to fingers, and still can't move my arm. I had low grade fever, felt terrible, I had no appetite all day, muscle aches, dry cough, weak and bumbing into things, my arms was hot with a big bloch on it. I tool a lot of over the counter naproxin, and the next day it was down 10%, but only from my elbow down. The rest is still 100%.  I have an appointment for physical therapy consultation, I am waiting on a MRI and a steriod sho, .At Health DOS: 9/3/24 Dortor/NP said the shoulder is really swallon.
Age: 73.0
Sex: F
Vaccine: PPV, COVID19, FLU4, PPV
Symptoms: Gait disturbance, Mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: About an hour an half later I had shooting pain from shoulder to fingers, and still can't move my arm. I had low grade fever, felt terrible, I had no appetite all day, muscle aches, dry cough, weak and bumbing into things, my arms was hot with a big bloch on it. I tool a lot of over the counter naproxin, and the next day it was down 10%, but only from my elbow down. The rest is still 100%.  I have an appointment for physical therapy consultation, I am waiting on a MRI and a steriod sho, .At Health DOS: 9/3/24 Dortor/NP said the shoulder is really swallon.
Age: 73.0
Sex: F
Vaccine: PPV, COVID19, FLU4, PPV
Symptoms: Pyrexia, Rash macular, Skin warm, Swelling
Clinical narrative: About an hour an half later I had shooting pain from shoulder to fingers, and still can't move my arm. I had low grade fever, felt terrible, I had no appetite all day, muscle aches, dry cough, weak and bumbing into things, my arms was hot with a big bloch on it. I tool a lot of over the counter naproxin, and the next day it was down 10%, but only from my elbow down. The rest is still 100%.  I have an appointment for physical therapy consultation, I am waiting on a MRI and a steriod sho, .At Health DOS: 9/3/24 Dortor/NP said the shoulder is really swallon.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Additional AE; patient received MMR II the evening of 08/13/2024 - Patient DOB: - 23-year-old; This spontaneous report was received from a pharmacist referring to a 23-year-old male patient. The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.   On 13-AUG 2024, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (Strength, exact dose, lot number, expiration date, route of administration and anatomical site of administration were not reported) for prophylaxis (Inappropriate age at vaccine administration). Furthermore, it was reported that the patient needed to receive their first dose of varicella virus vaccine live (Oka/Merck)( VARIVAX) as well but was unable to receive the vaccine due to the other facility (where reporting reporter resided closing and consumer was asked to come back the next day). The patient returned on 14-AUG-2024 to receive the varicella virus vaccine live (Oka/Merck)( VARIVAX) vaccine but was told he could not receive the varicella virus vaccine live (Oka/Merck)( VARIVAX) vaccine and there would need to be a 4-week interval before varicella virus vaccine live (Oka/Merck)( VARIVAX) could be administered. No further information provided. No additional adverse event (AE)(no adverse event).
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Inbound call from HCP calling to report a temperature excursion in which one dose of PROQUAD was administered.; This spontaneous report was received from a Certified medical assistant (CMA), referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On 02-AUG-2024, the patient was vaccinated with improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, 1 dose, lot #Y006771, expiration date: 24-SEP-2025, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). The vaccine was exposed to a temperature excursion (temperature: 14.9 degrees Fahrenheit [F]; time frame: 10 minutes) on the same date. It was confirmed no symptomatic adverse events reported (no adverse event). There was no previous temperature excursion.  Follow up information has been received on 22-AUG-2024 by the CMA referring a female patient of 4 years old.  No further information was available. The C.M.A shared that no untoward effects have been reported by family of child.  Additional information is not expected.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; HCP reports that a patient received her first dose of GARDASIL 9 in 2018 (exact date is unknown). The HCP states that the patient didn't receive their second dose until today 08/15/2024. No additional information was provided. No additional AE/no PQ; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.   On an unknown date in 2018, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (Strength, exact dose, lot number, expiration date, route of administration and anatomical site of administration were not reported) for prophylaxis.  On 15-AUG-2024, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (mL) series (Strength, lot number, expiration date, route of administration and anatomical site of administration were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). No additional adverse event (AE)(no adverse event).
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Confirmed no symptoms or side effects. No additional AE/no PQC.; on behalf of unknown HCP office to report expired MMRII was administered to an 18 year old female; This spontaneous report was received from a Nurse on behalf of unknown HCP office and refers to an 18-year-old female patient.  The patient's medical history, concurrent conditions, drug allergies and reactions and concomitant therapies were not reported.  On 27-AUG-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human Albumin) (M-M-R II) injection, 0.5ml/once, lot #W026512, expiration date was reported and confirmed as 22-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). The vaccine was stored appropriately. Patient needed a booster dose for her college. Confirmed no symptoms or side effects. Expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human Albumin) (M-M-R II) dose was supported by memo, disclaimer provided. No additional adverse event no product quality complaint.
Age: 36.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Received their second dose of MMR II.; received their second dose 18 days later; Pharmacist stating that a 36 year old patient received their first dose of MMR II.; This spontaneous report was received from a pharmacist referring to a 36-year-old patient, gender was not provided.  Information regarding the patient's pertinent medical history, drug allergies reactions, or concomitant medications was not provided.  On 09-AUG-2024, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) at a dose of 0.5 mL, for prophylaxis (route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number X027903, with expiration date of 02-DEC-2025, but upon internal validations established as 04-DEC-2025; albumin status: rHA) (product administered to patient of inappropriate age). On 27-AUG-2024 (also reported as 18 days later ), the patient received the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) at a dose of 0.5 ml, for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number X027903, with expiration date on 02-DEC-2025, but upon internal validations established as 04-DEC-2025; albumin status: rHA) (product administered to patient of inappropriate age, inappropriate schedule of vaccine administered). The pharmacist confirmed the patient has not reported any medical concerns or symptoms after the administrations of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) doses (no adverse event).
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects; HCP calling to report that patient received expired dose of MMR II.  Per HCP, MMR II expired on 8/22/2024 and was administered on 8/29/2024.  No adverse effects reported. No additional AE. No PQC.; This spontaneous report was received from physician concerning a 16-month-old female.  The patient's medical, concurrent conditions and concomitant therapies were not reported.   On 29-AUG-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, single dose, (lot #X023322, expiration date: 22-AUG-2024) (albumin status: recombinant human albumin rHa)), administered for prophylaxis (strength, and route of administration were not provided). The operator of device health professional. No adverse effects reported.
Sex: U
Vaccine: MENB
Symptoms: Off label use
Clinical narrative: Bexsero used to prevent gonorrhea; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of off label use in unapproved indication in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced off label use in unapproved indication (Verbatim: gonorrhea). The outcome of the off label use in unapproved indication was not reported.   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: 28-AUG-2024 The doctors giving Bexsero off label to adolescent patients to prevent gonorrhea which led to Off label use in unapproved indication.
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Oropharyngeal pain
Clinical narrative: Severe ear pain; severe sore throat; This non-serious case was reported by a consumer and described the occurrence of ear pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included naproxen sodium (Aleve) and lidocaine hydrochloride (Lidocaine Viscous).   On 20-AUG-2024, the patient received Shingrix. On 21-AUG-2024, 1 days after receiving Shingrix, the patient experienced ear pain (Verbatim: Severe ear pain) and sore throat (Verbatim: severe sore throat). The patient was treated with dexamethasone phosphate (Decadron). The outcome of the ear pain and sore throat were not resolved.   It was unknown if the reporter considered the ear pain and sore throat to be related to Shingrix.     It was unknown if the company considered the ear pain and sore throat to be related to Shingrix.   Additional Information: GSK Receipt date: 25-AUG-2024 This report was submitted via the online reporting system.  The patient had severe ear pain and severe sore throat. The patient had injection of Dexamethasone (Decadron) dose 1mg.
Sex: M
Vaccine: VARZOS
Symptoms: Antiviral treatment, Herpes zoster, Therapeutic product ineffective
Clinical narrative: After the vaccine shingles came back; This non-serious case was reported by a physician via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (several weeks ago).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: After the vaccine shingles came back). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Linked case(s) involving the same patient:US2024106714   Additional Information: GSK Receipt Date: 26-AUG-2024 The reporter called on behalf of himself to report had a case of shingles several weeks ago and 4 weeks later received the first dose of Shingrix.  After the vaccine shingles came back.  The reporter stated to have a bad case or something and Valtrex and antivirals had not been effective. No consent to follow up asked since decision to make adverse event was made after the call. It was confirmed with reporter no Shingrix vaccine was given before the first shingles case. The case had been linked to US2024106714, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024106714:2 of 2 report
Age: 17.0
Sex: F
Vaccine: FLUC3, MENB
Symptoms: Injection site erythema, Pain
Clinical narrative: 9 cm x 6 cm redness at injection site.  - pain to raise arm up - Tx: ATB- Cephalexin
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Scar, Urticaria
Clinical narrative: Around 2pm 8/22 (day of vaccine) noticed hives on back.  Total of 8 hives.   8/23 hives continued to get redder and larger.  8/24 hives turned into blotches filled with tiny pin-tip sized blisters.  Visit back to provider on 8/26 which I was prescribed 40mg prednisone for 5 days.  Beginning on day 2 of prednisone the sites began to dry up and eventually were gone around day 7 but have left scars.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Pain in extremity, Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: ?Covid arm?: painful swelling, red rash, itchy, warm to the touch.; symptoms worsening each day.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: ?Covid arm?: painful swelling, red rash, itchy, warm to the touch.; symptoms worsening each day.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nausea, Pain
Clinical narrative: Pain at injection site, pain when I try to raise my arm, headache at both temples, nauseus.  Symptoms are worse on 9/4 (day following injection.   I didn't finish listing medications - when I hit return the form went to another page and I couldn't get back. I also take, D3, multivitamin and a generic Tums antacid.
Age: 65.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Influenza like illness, Malaise, Pain in extremity
Clinical narrative: Patient describes having  pain in her arm and feeling sick with malaise flu like symptoms.  I ask the patient to put ice on the injection site today and take some acetaminophen for the pain. Patient will report with me  this afternoon to see if her symptoms have improved.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip pain, Lip swelling, Migraine
Clinical narrative: Bottom lip started to swell within a few hours.  By morning her lip was completely swollen and had soars on it.  She also got a migraine
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chest X-ray, Chest pain, Cough, Electrocardiogram normal
Clinical narrative: Local reactions, weakness, and fever every year after flu vaccination. 2023 immunization was accompanied by prolonged cough, and chest pain. chest pain is still present.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Local reaction, Pyrexia
Clinical narrative: Local reactions, weakness, and fever every year after flu vaccination. 2023 immunization was accompanied by prolonged cough, and chest pain. chest pain is still present.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling hot, Injection site erythema, Injection site pruritus, Malaise
Clinical narrative: "I was really sick, hot, big red  injection site, and now 5 days post, it's itching like crazy. "
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was administered the Menquadfi vaccine before the earliest date to be given (determined by immunization registry).  After administration of the vaccine, the NP was notified immediately, and she determined that the patient would not suffer any adverse side effects, especially none that would cause serious harm or injury. The mother was notified at that point.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Product administered at inappropriate site, Swelling
Clinical narrative: LOCAL REDNESS/SWELLING... NO PAIN OR SYMPTOMS. WAS GIVEN A LITTLE TOO FAR DOWN.
Age: 12.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMRV
Symptoms: Wrong product administered
Clinical narrative: The 12 year old patient received the following vaccines incorrectly MMRV HEP B Pentacel  The 12 year old patient should have been administered  Menquadfi
Age: 55.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: on 8/14/24, pt got RSV shot (arexvy). Beginning the next day, it began to hurt at the injection site and was sore to touch. Today on 9/4/24, pt has shown us that the spot is still tender and has a red patch/streak on arm. Has had no pus or redness around injection site (no sign of infection). Pt had spoken to the prescriber as well and they believe a capillary was hit on injection (not uncommon). Pt wanted to make us aware so that if future patients had reaction we would know what it had looked like. Will report to VAERS as well.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA
Symptoms: Extra dose administered
Clinical narrative: Patient was administered duplicate vaccines on 8/30/24 that were given on 8/23/24.  MA notified the physician of the mistake and the physician spoke with the family and a incident report was filed at the office.
Age: 46.0
Sex: F
Vaccine: HEPAB, UNK
Symptoms: Immediate post-injection reaction, Mobility decreased, Motor dysfunction, Pain, Pain in extremity
Clinical narrative: Patient called pharmacy this morning to report side effect of vaccination. Patient reports pain and loss in motor function in arm started immediately after immunization. The pain is characterized as shooting down to her fingertips and loss in motor function has progressively gotten worse to now where she cannot lift her arm more than halfway away from her body. Patient is currently self treating with ice packs, APAP, and IBU. She also has RA medications she uses and states nothing is touching the pain. RPh advised her to continue to use these interventions and to seek medical help if she feels the need.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Perioral dermatitis, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Seven days after the vaccination patient presented with fever, cough and macular papular rash on torso/face/extremities. Mom stated that the first day of the fever the rash was strictly around her mouth and then it went away. It came back starting on her face/head and then has slowly been spreading down her body. Patient received her first MMR, Varicella and Pneumococcal vaccine on 7/25/2024
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired vaccine from last season. Patient suffered no side effects and was advised he would still need one from this season for protection.
Age: 12.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient to receive Meningitis A vaccine, instead received Hepatitis A vaccine
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient was to have separate MMR and Varicella, MMRV was given instead of Varicella alone. MMR had already been given seperately. No adverse reaction or symptoms
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash starting day 5
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Peripheral swelling, Swelling of eyelid, Urticaria
Clinical narrative: Around 11 pm yesterday (day of vaccine), she got hives all over her arms, legs, feet, hands, stomach, buttocks that kept getting worse. Swollen hands and mild swelling of eyelids.
Age: 13.0
Sex: M
Vaccine: FLUR4
Symptoms: Fatigue, Product administered to patient of inappropriate age, Pyrexia, Wrong product administered
Clinical narrative: PATIENT RECEIVED FLUBLOK INSTEAD OF FLUZONE. PER DAD HAVE LOW GRADE FEVER AND FEEL FATIGUE FOR 1 DAY
Age: 11.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT RECEIVED FLUBLOK INSTEAD OF FLUZONE FOR PATIENT AGE.
Age: 20.0
Sex: M
Vaccine: HEP, HEPA, HPV9
Symptoms: Chest pain, Dizziness, Syncope, Tremor
Clinical narrative: Patient started to complain of chest pain and dizziness. Patient LOC variable. Patient shaking. EMS called, Oxygen at 2L initiated, monitoring of vital signs until EMS arrived. Patient transported to ED for evaluation.  Patient evaluated in ED, diagnosed with syncopal event, discharged home in stable condition same day. ED follow up OV at PCP office 8/21/24.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: SWOLLEN, RED AND WARM
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Syncope
Clinical narrative: Pt fainted shortly after injection
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Non of the Above
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was mistakenly given second flu shot of the season 3 weeks after already receiving first dose. He denied getting a flu shot this season but after giving this dose it was discovered that he had received a dose already.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: NO TREATMENT NEEDED PT WAS ADVISED BY PROVIDER AND INFORMED VACCINES MUST BE REPEATED WHEN CHILD IS 4 YEARS OF AGE.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Malaise, Pallor
Clinical narrative: The patient received MCV4 and Tdap vaccines, one in each arm.  The patient tolerated both vaccines well.  The patient had been sitting in the waiting area with his mother for 10 mins when his mother told the office manager he wasn't feeling well.  I went to the waiting area and asked the patient to tell me how he was feeling.  His only complaint at that time was dizziness.  I asked if he thought he could walk with me to the patient exam room to lie down.  He said yes and with my hands supporting him, we began to walk down the hallway.  His knees began to give out and I guided him to the floor and laid him down.  I yelled for my office manager to call EMS.  I propped his feet up and we put a pillow under his head along with a cold pack under his neck.  He was pale and sweaty, but never lost consciousness.  I took his vitals, and he remained on the floor until EMS arrived.  EMS arrived, spoke with him and his mother and took his vitals.  They checked his vitals numerous times lying on the floor, sitting up, and standing until they were convinced that the episode was over.  At that point, he was released home with his mother.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: The patient received MCV4 and Tdap vaccines, one in each arm.  The patient tolerated both vaccines well.  The patient had been sitting in the waiting area with his mother for 10 mins when his mother told the office manager he wasn't feeling well.  I went to the waiting area and asked the patient to tell me how he was feeling.  His only complaint at that time was dizziness.  I asked if he thought he could walk with me to the patient exam room to lie down.  He said yes and with my hands supporting him, we began to walk down the hallway.  His knees began to give out and I guided him to the floor and laid him down.  I yelled for my office manager to call EMS.  I propped his feet up and we put a pillow under his head along with a cold pack under his neck.  He was pale and sweaty, but never lost consciousness.  I took his vitals, and he remained on the floor until EMS arrived.  EMS arrived, spoke with him and his mother and took his vitals.  They checked his vitals numerous times lying on the floor, sitting up, and standing until they were convinced that the episode was over.  At that point, he was released home with his mother.
Age: 1.33
Sex: F
Vaccine: HEPA, MMRV, PNC20
Symptoms: Facial paralysis, Magnetic resonance imaging head normal, Otitis media, Scan with contrast
Clinical narrative: Patient is a previously healthy full-term female of 16 months who presents with left facial droop. Parents noted right sided eye and mild twitching on 08/21 (1 day prior). On the day of presentation noticed that her left face was not moving. Took her to ED. She had her 12-months vaccines,  include ProQuad (MMR, Varivax), Hepatitis A, Prevnar 20 on 8/19 (4days ago). Also had a bilateral Otitis Media about 2 weeks ago and completed a 10 day treatment with Amoxicillin. Normal gait, no other weakness, no abnormal movements. Has had sparsa intermittent cough. No sick exposures. Not in daycare. No recent fevers, vomiting, diarrhea, congestion, runny nose, change in level of alertness, abnormal movements, new rash. She is eating less but is her usual active self per parents.  At ED, the following labs (CBC, CMP,CRP) grossly reassure except for bicarb of 16. Neurology consulted who recommended admission for MRI imaging.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Feeling abnormal, Feeling drunk, Gait disturbance, Injection site pain
Clinical narrative: She got her vaccine, and did not really bother her yesterday.  Before she went to bed she had some tenderness at the injection site and a little feverish in that area.  During the night sometime she got up to go to the bathroom and she went to get out of bed and could not hardly sit up, did not have the strength to sit up, and rolled sideway to get up and fell against her night stand and then started walking and it was like somebody that was stone drunk.  She got to the bathroom, and got back to bed but was not able to get into bed as she did not have enough strength in her arms or legs to get back into bed, and it took 15-20 minutes to get back into bed.  She got up twice during the night and had the same rubber band legs and bumping into walls to get to the bathroom, and both times had trouble getting into bed taking 15-20 minute each time to get back to bed.  She did not get up until noon today as she felt yucky, but her legs are still rubbery feeling.  Her arm is still tender and warm to touch.  She is not running any fever.  She did not take anything for her symptoms.  She has not called her doctor.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pyrexia, Skin warm
Clinical narrative: She got her vaccine, and did not really bother her yesterday.  Before she went to bed she had some tenderness at the injection site and a little feverish in that area.  During the night sometime she got up to go to the bathroom and she went to get out of bed and could not hardly sit up, did not have the strength to sit up, and rolled sideway to get up and fell against her night stand and then started walking and it was like somebody that was stone drunk.  She got to the bathroom, and got back to bed but was not able to get into bed as she did not have enough strength in her arms or legs to get back into bed, and it took 15-20 minutes to get back into bed.  She got up twice during the night and had the same rubber band legs and bumping into walls to get to the bathroom, and both times had trouble getting into bed taking 15-20 minute each time to get back to bed.  She did not get up until noon today as she felt yucky, but her legs are still rubbery feeling.  Her arm is still tender and warm to touch.  She is not running any fever.  She did not take anything for her symptoms.  She has not called her doctor.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and pain at injection site. Swelling is approx. 5 inches by 4 inches. Very hot and raised
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose decreased, Condition aggravated, Influenza
Clinical narrative: Severe Flu weakeness for 36 hours. No temp. Blood sugar crashed for 12 hours...could not keep above 40-50 with 15-30 carbs, kept going down.
Age: 1.0
Sex: M
Vaccine: FLU4, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received influenza, MMRV, and Varicella vaccine. Spoke to mother in evening and following evening and she reported no adverse events. Will follow up as needed.