chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of Pfizer-BioTech COVID-19 vaccine 2023-2024 formula for ages 6m-<5yr that was diluted with an expired diluent. Upon reconciling vaccine inventory for the end of the day Inventory Specialist and RN Nurse Manager discovered that an expired diluent was used to reconstitute the vaccine. The diluent used was 0.9% Sodium Chloride Injection, USP Lot number 35-035-DK, expiration date 11/01/2023. The vaccine itself was not expired. Patient's mother was contacted and made aware of error and that we would be reaching out to the vaccine manufacturer for guidance on if the child needs to be re-vaccinated. RN Nurse Manager contacted  the Pfizer manufacturer and they did not have any recommendations on if the patient should be re-vaccinated. Pfizer then advised RN to reach out for guidance of re-vaccination. Vaccine authority did not have an answer and referred RN to the emergency number. When RN spoke with them they referred RN to the County Board Of Health. When RN spoke to clinician there they did not have an answer and said RN should reach out to Pfizer or the vaccine authority. Due to the manufacture and vaccine authority not having any recommendations RN reached out to Immunization Coordinator and District 10 Clinical and Nursing Director for guidance. RN Nurse Manager/RN advised that the patient does not need to be re-vaccinated due to the vaccine not being expired and Pfizer and vaccine authority providing no recommendation to re-vaccinate. Patient's parent was then contacted and informed that her child did not need to be re-vaccinated. The patients mother verbalized understanding.
Age: 73.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: patient stated that Saturday night ( same day she get the shoots ) she said her arm started to swell . it started in the inner side of her arm and spread to the outer part.  today there is still some redness left and still a bit red but she said it was worse before and now it looks a bit better.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Eye pain, Ophthalmic herpes zoster, Pain in extremity, Vision blurred
Clinical narrative: Might be unrelated. From Oct 31 had only minor soreness in arm for about a week and a half.  On Nov 6 I had eye pain & blurriness - --prescribed Neomycin and Polymyxin B Sulfate. After one week little improvement. On Nov 13 Ophthalmologist exam revealed a Herpes Zoster Ophthalmicus on cornea. Prescribed Valacyclovir & Prednisolone Acetate. Improving.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site mass, Vomiting
Clinical narrative: VOMITTING, DIARRHEA, HEADACHE, HUGE LUMP AND REDNESS AT INJECTION SITE
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: EXPIRED PPSV23 ADMINISTERED TO PATIENT.  VACCINE EXPIRED ON 10/31/2023. NO REACTION OCCURED. NO SIDE EFFECTS.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Generalised oedema, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: red, swollen, itch y at injection site and body, tender to touch
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pruritus
Clinical narrative: red, swollen, itch y at injection site and body, tender to touch
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: HEADACHE AND DIARRHEA
Age: 35.0
Sex: M
Vaccine: FLUR4
Symptoms: Device connection issue, Syringe issue
Clinical narrative: This was a problem with administration not an adverse event.  When the vaccine was injected it came out the side of the syringe where the piece that holds the needle connects to the syringe.  So instead of being injected into the patients arm the vaccine leaked out of the syringe.
Age: 0.08
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: I gave a newborn RSV vaccine meant for pregnant moms. Reported to Dr and Dr. Spoke to infectious disease doctor regarding adverse symptoms to watch for.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Candida infection, Ear pain, Lymphadenopathy, Oral candidiasis
Clinical narrative: Developed thrush on left side of tongue, down left side of throat. Caused lymph nodes to swell in left neck  below left mandible joint  and pain in Eustachian tube  and inside ear.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Atrial fibrillation
Clinical narrative: Atrial Fibrillation- Transient (lasted 1.5 hours).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: PATIENT HAD PAIN EVERYWHERE DURING THE NIGHT AND THE FOLLOWING DAY. FELT VERY TIRED THE FOLLOWING DAY. FELT MUCH BETTER BY THE TIME HE CALLED ON 11/13/23.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Pain
Clinical narrative: Patient reports pain in shoulder, pain upon certain movements or articulations of shoulder joint. Patient does NOT report decreased range of motion.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Pt says,  she has itching & bumps on right arm for last 4 weeks since she got shot
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Per Employee's Incident report:  Five minutes later, while I was in the elevator, I started to experience burning sensation in my abdomen along with SOB, chest pain and tightness, unable to breath properly, nausea and dizziness. Episode lasted about 10 minutes with a very slight relief enough to walk back to my desk. However, once I reached my desk in the clinic, the chest tightness and SOB worsened and I also started to experience stiffness in my neck that radiated to my lower back, I was unable to move my neck due to the stiffness. I immediately notified my manager and was instructed to go to ED.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal stiffness, Nausea, Respiration abnormal
Clinical narrative: Per Employee's Incident report:  Five minutes later, while I was in the elevator, I started to experience burning sensation in my abdomen along with SOB, chest pain and tightness, unable to breath properly, nausea and dizziness. Episode lasted about 10 minutes with a very slight relief enough to walk back to my desk. However, once I reached my desk in the clinic, the chest tightness and SOB worsened and I also started to experience stiffness in my neck that radiated to my lower back, I was unable to move my neck due to the stiffness. I immediately notified my manager and was instructed to go to ED.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient presented to the office for well child visit. Kinrix, Proquad and Influenza vaccines were administered with permission of patient's father. Patient's mother, who was not present at the visit, called the office to confirm vaccines received at the visit. Mother was given information about vaccines given, and she reports that patient received Kinrix and Proquad on 10/02/2023 with Health Department. Patient received duplicate vaccines. No known adverse event due to this duplication.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Brain fog, Depression, Exercise tolerance decreased, Fatigue
Clinical narrative: Extreme fatigue, depression, loss of stamina, brain fog, lost stamina and it never came back, loss of ability to exercise
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Laboratory test
Clinical narrative: Extreme fatigue, depression, loss of stamina, brain fog, lost stamina and it never came back, loss of ability to exercise
Age: 17.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Vaccines were adminstered high in left shoulder. The second injection caused immediate significant pain.  Pain in arm continued with minimal improvement for ~ 10 days with difficulty fully moving shoulder despite regular ibuprofen use. Discussed with pediatrician around day 5 who recommended continuing ibuprofen. When pain continued we discussed again with pediatrician who prescribed decadron x 5 days. Pain improved by day 4. One ~ day 3 following decadron course, pain in left shoulder returned and worsened over next 3 days with limitation in movement. Seen by PCP office on 11/14 and shoulder MRI, ortho referral and repeat course of decadron for pain management were recommended.   Vaccines were covid spikevax moderna and fluzone quad -  I don't know which was administered 2nd - both were in a similar location.
Age: 68.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: redness, swelling, tenderness, itching
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1, RV1
Symptoms: Extra dose administered, Product preparation issue
Clinical narrative: Rotarix (do not reconstitute) was mixed as a diluent with the Rotarix powder (reconstitution required) and patient received a double dose.
Age: 59.0
Sex: M
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was provided the influenza vaccine meant for individuals 65 years and older.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Essential tremor, Migraine, Muscle spasms, Nerve conduction studies
Clinical narrative: I received the Covid vaccination on 03/01/2022 and nerve conduction testing on 03/09/2022.  A week later I began to experience severe migraines and Tinnitus along with painful muscle spasm along my right leg and right arm.  Days later, I was burdened with a painful right shoulder, painful right elbow, extreme tremors at my right leg, right foot, right arm, and right hand.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Parkinson's disease, Tinnitus, Tremor
Clinical narrative: I received the Covid vaccination on 03/01/2022 and nerve conduction testing on 03/09/2022.  A week later I began to experience severe migraines and Tinnitus along with painful muscle spasm along my right leg and right arm.  Days later, I was burdened with a painful right shoulder, painful right elbow, extreme tremors at my right leg, right foot, right arm, and right hand.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Arthralgia, Deep vein thrombosis, Fibrin D dimer increased, Joint swelling
Clinical narrative: Mid October, 2023, pt started having left leg/knee pain and swelling.  Was diagnosed with left DVT after office visit 2 weeks later and started on Eliquis for treatment
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Ultrasound Doppler abnormal
Clinical narrative: Mid October, 2023, pt started having left leg/knee pain and swelling.  Was diagnosed with left DVT after office visit 2 weeks later and started on Eliquis for treatment
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Covid 19 2023-24 age 12 years and old vaccine was ordered. Vaccine given was the Covid 19 2023-24 age 5-11 year dose. Patient currently 14 years old. Patient received smaller dose(10 mcg), should have received larger dose (30 mcg).  Vial for ages 5years to 11 year old was given. Informed MA who administered dose, informed supervisor. MA had recorded the lot number for age 5-11 year old, the vaccine count did not match, mistake was discovered. Contacted Pfizer regarding under dose of vaccine. Informed we can give the full dose of 12 year and older Covid vaccine, no wait time needed. Will contact parent to inform them of under dose and schedule appointment to get the 12 year and older Pfizer covid 19 2023-24 vaccine. Added additional age label to each Conid 19 box. Reviewed location of vaccines in refrigerator with staff. Reviewed need to have another clinical staff check all vaccines before administration to verify vaccines prepared match vaccines provider has ordered.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: HOSPITALIZED INPATIENT FOR COVID 11/11/23-11/14/23
Age: 43.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Back pain, Gait inability, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Patient stated she had intense lower back pain that spread to her legs.  She then noticed her left leg started tingling and became numb.  This then spread to her right leg and she became unable to walk.  This lasted until the next day and then began improving.  She did not seek any medical attention.  By 48 hours all symptoms had improved.  By 96 hours she said she was back to 100%.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain
Clinical narrative: Severe pain under right breast
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: One year Hep A and varicella were given in left thigh. She had a hives like reaction, worse on left thigh that was documented and shown to pediatrician. No other symptoms and no other new exposures. Resolved with steroids and has no other issues
Age: 1.33
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2ND DOSE WAS ADMINISTERED TOO SOON - PRIOR TO 6 MONTH MINIMUM INTERVAL. PER CHILD'S MOTHER NO ADVERSE REACTION OCCURRED FOLLOWING THIS DOSE OR THE DOSE HE RECEIVED AFTER.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Bladder hypertrophy, Computerised tomogram abdomen abnormal, Dizziness, Fatigue
Clinical narrative: Intense pain in L deltoid from the medial/lateral side down to hand beginning at time of injection.  Throughout rest of evening continued to have intense pain and "tired muscle" that became less severe and continued to have pain in fingertips that rotated into "all of my extremities and in fingertips and toes in the last year that comes and goes."  Sept 2023 began having tingling in extremities with "near syncope."  October 2023 began experiencing numbness and tingling in legs and arms bilaterally, this is "the first time I went to see a doctor.  Continue to have dizziness and easily fatigue with rapid heartbeat and pain that "feels like peripheral neuropathy."  I've had 2 ER admission and missed alot of work.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Hypoaesthesia, Immunology test abnormal, Impaired work ability, Injection site pain
Clinical narrative: Intense pain in L deltoid from the medial/lateral side down to hand beginning at time of injection.  Throughout rest of evening continued to have intense pain and "tired muscle" that became less severe and continued to have pain in fingertips that rotated into "all of my extremities and in fingertips and toes in the last year that comes and goes."  Sept 2023 began having tingling in extremities with "near syncope."  October 2023 began experiencing numbness and tingling in legs and arms bilaterally, this is "the first time I went to see a doctor.  Continue to have dizziness and easily fatigue with rapid heartbeat and pain that "feels like peripheral neuropathy."  I've had 2 ER admission and missed alot of work.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test normal, Magnetic resonance imaging head normal, Muscle fatigue, Myalgia, Pain
Clinical narrative: Intense pain in L deltoid from the medial/lateral side down to hand beginning at time of injection.  Throughout rest of evening continued to have intense pain and "tired muscle" that became less severe and continued to have pain in fingertips that rotated into "all of my extremities and in fingertips and toes in the last year that comes and goes."  Sept 2023 began having tingling in extremities with "near syncope."  October 2023 began experiencing numbness and tingling in legs and arms bilaterally, this is "the first time I went to see a doctor.  Continue to have dizziness and easily fatigue with rapid heartbeat and pain that "feels like peripheral neuropathy."  I've had 2 ER admission and missed alot of work.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia, Presyncope
Clinical narrative: Intense pain in L deltoid from the medial/lateral side down to hand beginning at time of injection.  Throughout rest of evening continued to have intense pain and "tired muscle" that became less severe and continued to have pain in fingertips that rotated into "all of my extremities and in fingertips and toes in the last year that comes and goes."  Sept 2023 began having tingling in extremities with "near syncope."  October 2023 began experiencing numbness and tingling in legs and arms bilaterally, this is "the first time I went to see a doctor.  Continue to have dizziness and easily fatigue with rapid heartbeat and pain that "feels like peripheral neuropathy."  I've had 2 ER admission and missed alot of work.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Feeling hot, Lethargy
Clinical narrative: lethargy, hot, claminess,
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Limb discomfort, Pain in extremity
Clinical narrative: 2 days post vaccination the patient was experiencing arm pain and chest tightness. He has a history of heart failure and 2 bipass heart surgeries. He grew concerned so went to the ER. They cleared him of any cardiac issues. He continued to feel uncomfortable in his chest and arm for approximately 2 days. He is unsure what caused this
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red area up to 6 cm and warm to touch noted around injection site of varicella (RUE) after 20 minutes. Area marked and receded after an additional 5 minutes. No difficulty breathing or rash. Pt then able to be DCd home. Refer to allergist
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Hypoaesthesia, Paralysis
Clinical narrative: Pt's daughter called and stated her mother had been hospitalized with numbness in her legs that had progressed to her being paralyzed.  She is currently in the hospital intubated and the doctors are saying she developed GBS
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Headache, body aches, sore arm (injection site), extreme fatigue
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired vaccine
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: fatigue, fever, body aches
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Tinnitus
Clinical narrative: Tinnitus both ears, saw ENT, cut back on sugar, caffeine, salt, sound therapy with Widex Zen tinnitus management. Still have tinnitus in both ears.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain, Injection site rash
Clinical narrative: 11/03/23: Rash developed at injection site 11/04: Pain developed at injection site 11/05: Shoulder pain developed 11/08: Pain in shoulder area, described by patient as a 10/10   Treatment: Tylenol with codeine, muscle relaxor, injection for pain and inflammation  Patient is feeling better now after the treatment was initiated by prescriber.
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Chest pain, Vertigo
Clinical narrative: After 36 hours chest pain was experienced. After 48 hours of vaccination vertigo was experienced.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Pain, Pyrexia
Clinical narrative: Pt states that it started being sore and painful the night after receiving the vaccine. High fever, Soreness, redness and itchiness spread away from the injection site and we went to her Dr. Dr informed her that it's cellulitis from the Prevnar shot and will require antibiotics. she also had to take Benadryl because it was severely itchy.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: Hives fully covering abdomen, back, chest, neck, and partial upper thigh
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Inflammation
Clinical narrative: redness and inflamation in the arm the vaccine was administered
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Tremor
Clinical narrative: Headache, nausea, shanking. enough to go to emergency room
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Antiphospholipid syndrome, Chest pain, Deep vein thrombosis, Dyspnoea, Intensive care
Clinical narrative: shortly after getting the covid vaccine, I developed intermittent shortness of breath with chest pain. I had a cardiac workup that was negative. But I have just gotten diagnosed with antiphospholipid syndrome with DVT and bilateral, multiple PEs. The pain that I had with the PEs is the same pain that I have been having intermittently with activity, but the previous pains were not as serious as this recent PE which required ICU admission and Heparin infusion and now daily Warfarin.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test normal, Pain
Clinical narrative: shortly after getting the covid vaccine, I developed intermittent shortness of breath with chest pain. I had a cardiac workup that was negative. But I have just gotten diagnosed with antiphospholipid syndrome with DVT and bilateral, multiple PEs. The pain that I had with the PEs is the same pain that I have been having intermittently with activity, but the previous pains were not as serious as this recent PE which required ICU admission and Heparin infusion and now daily Warfarin.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Inadvertently gave adult dose to 9 year 11 month old
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold
Clinical narrative: 85 y.o male pt came for the covid booster vaccine. pt was A&Ox3, responsive, in wheelchair, attended by home attendant and sister. pt reported no symptoms of cold, flu, fever. no prior reaction to vaccines. after the administration, pt was moved to a waiting area for 15 mins observation time. 15 mins into the vaccine administration, pt started feeling cold and chills. VS=151/65 (L arm, sitting position), O2=95%, HR=88, BS=106 mg/dL.  Pt was observed by PA as well and it was decided to send him to the ER for further monitoring. Hx of CAD, stents.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Electrocardiogram abnormal, Headache, Hypoaesthesia, Muscular weakness
Clinical narrative: I woke up the next day with a numb face and heart palpitations and chills with no fever. I had muscle aches as well. Urgent care did an EKG they saw PVC but I have no heart issues in my history so they were not too concerned. I also have headaches and muscle weakness and my extremities are intermittently numb.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myalgia, Palpitations, Ventricular extrasystoles
Clinical narrative: I woke up the next day with a numb face and heart palpitations and chills with no fever. I had muscle aches as well. Urgent care did an EKG they saw PVC but I have no heart issues in my history so they were not too concerned. I also have headaches and muscle weakness and my extremities are intermittently numb.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported AE on behalf of patient who was administered improperly stored VARIVAX. TE Filed (Case #02506183). No symptoms reported. Obtained consent to contact HCP. Additional AE Filed (Case #02506185). No additional AE/PQC.  Product Name: VARIV; 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 10-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X010534, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in 27.3/ 14 degree Farenheit up to 46 degree Farenheit for 1 hour 59 minutes and no previous excursions. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported AE on behalf of patient who was administered improperly stored VARIVAX. TE Filed (Case #02506183). No symptoms reported. Obtained consent to contact HCP. Additional AE Filed (Case #02506186). No additional AE/PQC.  Product Name: VARIV; 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 10-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X010534, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in 27.3/ 14 degree Farenheit up to 46 degree Farenheit for 1 hour 59 minutes with no previous excursion (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product packaging confusion, Wrong product administered
Clinical narrative: No further AE; MMRII and PROQUAD look too similiar; Wrong vaccine administered; Medical assistant calls to report PROQUAD w026326 2/18/2024 and VARIVAX x010535 4/11/2025 administered to a  12 month old patient on the same day.  No further AE.  request  02506115.  No PQC; This spontaneous report was received from a medical assistant and refers to a 12-month-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-NOV-2023, the patient was vaccinted with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, one time, lot #W026326, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, one time, lot #X010535, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided) (Overdose). On that day, the patient should be vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) but measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) packaging was too similar (Product packaging confusion and Wrong product administered).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC; expired dose of PNEUMOVAX 23 was administered.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 04-NOV-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe lot #U035117, expiration date: 18-AUG-2023 (strength, anatomical location, and route of administration were not provided) as prophylaxis. No adverse event was reported.
Age: 11.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Caller reported patient received GARDASIL 9 doses on 10/8/2019 (at 11 years old), 10/15/2020 and on 11/6/2023.; No additional AEs or PQC; This spontaneous report was received from a medical assistant and refers to a patient of approximately 15-year-old of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-OCT-2019 (also reported as "at 11-year-old"), the patient was vaccinated with the first dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (strength, lot #, expiry date, anatomical location, and route of administration were not provided). On 15-OCT-2020, the patient was vaccinated with the second dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (strength, lot #, expiry date, anatomical location, and route of administration were not provided). On 06-NOV-2023, the patient was vaccinated with the third dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) pre-filled syringe, lot #1965044, expiration date: 07-JAN-2026 (strength, anatomical location, and route of administration were not provided) (inappropriate schedule of product administration). All given as prophylaxis. No adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Received transfer from specialist. HCP reported expired PNEUMOVAX 23 was administered to a patient on 11/07/2023. The product has been stored appropriately and has not had any TEs. The operator of the device was a healthcare professional. HCP request; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age an gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-NOV-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23 SYRINGE (DEVICE)) injection, administered for prophylaxis (lot #W007035, expiration date: 20-OCT-2023) (strength, dose description, and route of administration were not provided) (Expired product administered). No additional adverse events were reported.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Immediate post-injection reaction, Pain, Pulmonary embolism
Clinical narrative: Pulmonary embolism; severe body aching; Chills all over.; This serious case was reported by a physician via sales rep and described the occurrence of pulmonary embolism in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid vaccine (patient had been vaccinated for Covid).   On 02-NOV-2023, the patient received the 2nd dose of Shingrix. In NOV-2023, immediately after receiving Shingrix, the patient experienced pulmonary embolism (Verbatim: Pulmonary embolism) (serious criteria hospitalization and GSK medically significant), general body pain (Verbatim: severe body aching) and chills (Verbatim: Chills all over.). The outcome of the pulmonary embolism and chills were not reported and the outcome of the general body pain was not resolved.   It was unknown if the reporter considered the pulmonary embolism, general body pain and chills to be related to Shingrix.     It was unknown if the company considered the pulmonary embolism, general body pain and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-Nov-2023 The reporter reported that the patient received Shingrix vaccine and experienced severe body aching and chills all over, this was started immediately.  The patient thought maybe he was sore from working in the yard but they did not improve.  The patient was admitted to the hospital on 6th November 2023 with pulmonary embolism.  The patient finds it odd that it started immediately after getting the vaccine. The reporter did consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Atrial fibrillation, Heart rate irregular
Clinical narrative: Atrial fibrillation; irregular heart beats; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a elderly patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation) (serious criteria GSK medically significant) and heartbeats irregular (Verbatim: irregular heart beats). The outcome of the atrial fibrillation and heartbeats irregular were resolved.   It was unknown if the reporter considered the atrial fibrillation and heartbeats irregular to be related to Arexvy.   It was unknown if the company considered the atrial fibrillation and heartbeats irregular to be related to Arexvy.   Additional Information: GSK receipt Date:09-NOV-2023 The patient self-reported this case. The patient age was in between 65-79 years old. The patient had no prior vaccinations for this reported event. The patient did not have any current illness. The follow up would not possible as no contact details were available.
Sex: M
Vaccine: RSV
Symptoms: Atrial fibrillation, Brain natriuretic peptide increased, Chest X-ray abnormal, Echocardiogram abnormal, Electrocardiogram abnormal
Clinical narrative: Atrial fibrillation with rapid ventricular response; Felt loopy; 64 percentage Left ventricular hypertrophy; Hepatomegaly; BNP 137 slightly high; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation with rapid ventricular response) (serious criteria hospitalization and GSK medically significant), feeling drunk (Verbatim: Felt loopy) (serious criteria hospitalization), left ventricular hypertrophy (Verbatim: 64 percentage Left ventricular hypertrophy) (serious criteria hospitalization), hepatomegaly (Verbatim: Hepatomegaly) (serious criteria hospitalization) and brain natriuretic peptide increased (Verbatim: BNP 137 slightly high) (serious criteria hospitalization). The patient was treated with diltiazem. The outcome of the atrial fibrillation was not resolved and the outcome of the feeling drunk, left ventricular hypertrophy, hepatomegaly and brain natriuretic peptide increased were not reported.   It was unknown if the reporter considered the atrial fibrillation, feeling drunk, left ventricular hypertrophy, hepatomegaly and brain natriuretic peptide increased to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation, feeling drunk, left ventricular hypertrophy, hepatomegaly and brain natriuretic peptide increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-Nov-2023 The reporter reported that atrial fibrillation with rapid ventricular response new onset rate now controlled on Diltiazem however A fib persists.  Only symptoms felt loopy Wife was a physician and heard A fib upon auscultation hospitalized for 2 days at hospital. Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: RSV
Symptoms: Feeling drunk, Full blood count normal, Hepatomegaly, International normalised ratio increased, Left ventricular hypertrophy
Clinical narrative: Atrial fibrillation with rapid ventricular response; Felt loopy; 64 percentage Left ventricular hypertrophy; Hepatomegaly; BNP 137 slightly high; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation with rapid ventricular response) (serious criteria hospitalization and GSK medically significant), feeling drunk (Verbatim: Felt loopy) (serious criteria hospitalization), left ventricular hypertrophy (Verbatim: 64 percentage Left ventricular hypertrophy) (serious criteria hospitalization), hepatomegaly (Verbatim: Hepatomegaly) (serious criteria hospitalization) and brain natriuretic peptide increased (Verbatim: BNP 137 slightly high) (serious criteria hospitalization). The patient was treated with diltiazem. The outcome of the atrial fibrillation was not resolved and the outcome of the feeling drunk, left ventricular hypertrophy, hepatomegaly and brain natriuretic peptide increased were not reported.   It was unknown if the reporter considered the atrial fibrillation, feeling drunk, left ventricular hypertrophy, hepatomegaly and brain natriuretic peptide increased to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation, feeling drunk, left ventricular hypertrophy, hepatomegaly and brain natriuretic peptide increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-Nov-2023 The reporter reported that atrial fibrillation with rapid ventricular response new onset rate now controlled on Diltiazem however A fib persists.  Only symptoms felt loopy Wife was a physician and heard A fib upon auscultation hospitalized for 2 days at hospital. Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: RSV
Symptoms: Prothrombin time, Troponin normal
Clinical narrative: Atrial fibrillation with rapid ventricular response; Felt loopy; 64 percentage Left ventricular hypertrophy; Hepatomegaly; BNP 137 slightly high; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation with rapid ventricular response) (serious criteria hospitalization and GSK medically significant), feeling drunk (Verbatim: Felt loopy) (serious criteria hospitalization), left ventricular hypertrophy (Verbatim: 64 percentage Left ventricular hypertrophy) (serious criteria hospitalization), hepatomegaly (Verbatim: Hepatomegaly) (serious criteria hospitalization) and brain natriuretic peptide increased (Verbatim: BNP 137 slightly high) (serious criteria hospitalization). The patient was treated with diltiazem. The outcome of the atrial fibrillation was not resolved and the outcome of the feeling drunk, left ventricular hypertrophy, hepatomegaly and brain natriuretic peptide increased were not reported.   It was unknown if the reporter considered the atrial fibrillation, feeling drunk, left ventricular hypertrophy, hepatomegaly and brain natriuretic peptide increased to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation, feeling drunk, left ventricular hypertrophy, hepatomegaly and brain natriuretic peptide increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-Nov-2023 The reporter reported that atrial fibrillation with rapid ventricular response new onset rate now controlled on Diltiazem however A fib persists.  Only symptoms felt loopy Wife was a physician and heard A fib upon auscultation hospitalized for 2 days at hospital. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, less than a day after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation) (serious criteria GSK medically significant). The outcome of the atrial fibrillation was resolved.   It was unknown if the reporter considered the atrial fibrillation to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-Nov-2023 The patient reported that she was diagnosed with atrial fibrillation in emergency department. The patient was observed at the hospital and does not recall the medications she was given. The patient reported that she felt well today. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Atrial fibrillation, Condition aggravated, Heart rate increased
Clinical narrative: Atrial fibrillation; Heart rate increased; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included atrial fibrillation. Concurrent medical conditions included blood pressure high. Concomitant products included apixaban (Eliquis), dofetilide, metoprolol, losartan, amlodipine and atorvastatin.   On 03-NOV-2023, the patient received Arexvy. On 03-NOV-2023, several hours after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation) (serious criteria GSK medically significant) and heart rate increased (Verbatim: Heart rate increased). The outcome of the atrial fibrillation and heart rate increased were not resolved.   It was unknown if the reporter considered the atrial fibrillation and heart rate increased to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation and heart rate increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 9-NOV-2023 The patient went into atrial fibrillation, it happened on Friday a few hours after patient got the vaccine.  Then it happened again at 5:15 am on the morning of reporting day, and patient was still in atrial fibrillation at the time of reporting. The patient checked and the heart rate was at 117, when checked on Friday, it was about 120.  Normally the medication controls that, but it was not doing it now. It just seemed odd that patient had the vaccine on Friday and then was getting atrial fibrillation. The patient had no prior vaccinations for those events. Follow-up would not be possible, as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Asthenia, Atrial fibrillation, Cardiac pacemaker insertion, Chills, Condition aggravated
Clinical narrative: Afib; had a pace maker put in; Fever; terrible chills; Very weak; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a elderly patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included atrial fibrillation (occasional atrial fibrillation). Concurrent medical conditions included sulfonamide allergy. Concomitant products included metoprolol (Metoprolol Er), clonidine, dabigatran etexilate mesilate (Pradaxa) and flecainide.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Afib) (serious criteria GSK medically significant), cardiac pacemaker insertion (Verbatim: had a pace maker put in) (serious criteria clinically significant/intervention required), fever (Verbatim: Fever), chills (Verbatim: terrible chills) and weakness (Verbatim: Very weak). The outcome of the atrial fibrillation, cardiac pacemaker insertion, fever, chills and weakness were not reported.   It was unknown if the reporter considered the atrial fibrillation, cardiac pacemaker insertion, fever, chills and weakness to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation, cardiac pacemaker insertion, fever, chills and weakness to be related to Arexvy.   Additional Information: GSK Receipt Date: 9-NOV-2023 The patient had terrible chills, fever, was very weak so called an ambulance and went into atrial fibrillation and had a pace maker put in. The patient received metoprolol er, flecainide er, clonidine and Pradaxa as treatment. The patient had no prior vaccinations for those events. The patient had no current illness. Follow-up would not be possible, as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: Afib; had a pace maker put in; Fever; terrible chills; Very weak; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a elderly patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included atrial fibrillation (occasional atrial fibrillation). Concurrent medical conditions included sulfonamide allergy. Concomitant products included metoprolol (Metoprolol Er), clonidine, dabigatran etexilate mesilate (Pradaxa) and flecainide.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Afib) (serious criteria GSK medically significant), cardiac pacemaker insertion (Verbatim: had a pace maker put in) (serious criteria clinically significant/intervention required), fever (Verbatim: Fever), chills (Verbatim: terrible chills) and weakness (Verbatim: Very weak). The outcome of the atrial fibrillation, cardiac pacemaker insertion, fever, chills and weakness were not reported.   It was unknown if the reporter considered the atrial fibrillation, cardiac pacemaker insertion, fever, chills and weakness to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation, cardiac pacemaker insertion, fever, chills and weakness to be related to Arexvy.   Additional Information: GSK Receipt Date: 9-NOV-2023 The patient had terrible chills, fever, was very weak so called an ambulance and went into atrial fibrillation and had a pace maker put in. The patient received metoprolol er, flecainide er, clonidine and Pradaxa as treatment. The patient had no prior vaccinations for those events. The patient had no current illness. Follow-up would not be possible, as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Atrial fibrillation, Electrocardiogram abnormal
Clinical narrative: atrial fibrillation; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a elderly patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included blood pressure high (back high blood pressure) and drug allergy (Tetracycline, sulfa allergy). Concomitant products included atenolol, atorvastatin, desmopressin, estradiol vaginal and rimegepant sulfate (Nurtec).   On 05-SEP-2023, the patient received Arexvy. On 12-SEP-2023, 7 days after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: atrial fibrillation) (serious criteria GSK medically significant). The outcome of the atrial fibrillation was resolved.   It was unknown if the reporter considered the atrial fibrillation to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-NOV-2023 The patient self-reported this case. The patient received Arexvy shot and with 7 days interval he/she watched him/her and had atrial fibrillation.  The patient watch continued to give him/her daily's.  The patient was on a vacation and went to him/her doctor when he/she got home on 13th September 2023. The patient had no prior vaccinations for this reported event. The patient did not have any current illness. The follow-up could not be possible as no contact details were available.