chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Headache, Malaise, Myalgia, Pain in extremity, Tenderness
Clinical narrative: arm is hurting/ arm tender; not feeling well/ hate how it make me feel right after shot; headache; muscles hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date and experienced not feeling well).   On 02-APR-2025, the patient received the 2nd dose of Shingles vaccine. On 02-APR-2025, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm is hurting/ arm tender) and feeling unwell (Verbatim: not feeling well/ hate how it make me feel right after shot). In APR-2025, the patient experienced headache (Verbatim: headache) and muscle pain (Verbatim: muscles hurt). The outcome of the pain in arm was not resolved and the outcome of the feeling unwell was not reported and the outcome of the headache and muscle pain were resolved.   It was unknown if the reporter considered the pain in arm, feeling unwell, headache and muscle pain to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, feeling unwell, headache and muscle pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-APR-2025 and 04-APR-2025 This case was reported by a patient via interactive digital media. The patient just got 2nd shot of Shingles and arm was hurting and not feeling well just like the first Shingles shot but would be ok tomorrow. The patient get headache and muscles hurt but it's better than shingles. The patient stated ok now(at the time of reporting) arm still tender and he/she hate how it makes felt right after Shingles shot.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Myalgia, Pyrexia
Clinical narrative: sick for a couple days; like ran a fever; muscle aches and pains; muscle aches and pains; felt like she had the flu and stuff like; did not feel good; This is a spontaneous report and received from Nurses from medical information team, Program ID:.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2021 as dose 2, single (Lot number: ER8735) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, batch/lot number ER8727), administration date: 24Mar2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "was just sick for a couple days", "ran a fever", "muscle aches", "pains", "felt like she had the flu and stuff like". The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "sick for a couple days"; PYREXIA (non-serious), outcome "unknown", described as "like ran a fever"; MYALGIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "muscle aches and pains"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "felt like she had the flu and stuff like"; MALAISE (non-serious), outcome "unknown", described as "did not feel good".  Additional information: The patient informed that she had the first two lot number both at Hospital. The first dose she had of the vaccine was covid19 and the Pfizer purple and that was the only thing they gave her. The first one she had was lot ER8727 and on this website that was the one that was really highly toxic; her 2nd one was lot number ER8735 and that was toxic but not as bad as the first and both she had probably 3 weeks apart. She informed that this website was saying on all the ER series it was probably maybe 25 of them that were 100 percent more toxic than other batches in the ER series and the ones she got were really high like 200125 and the other ER series got to 8 or 9 and 7 and 6. The patient informed that the first two lot numbers of the Pfizer BioNTech covid vaccine were in the ER series and on a website she looked up called (redacted). She had received her 2 doses weeks apart and the website said they were highly toxic and when she looked through the ER series it looked like they were highly contaminated but some were not and the first batches were highly toxic but got better after that and they were all sent to the same city for the 1st and 2nd ER series lot numbers which was (redacted). She got both doses for the first two doses and she was just sick for a couple days like ran a fever and on the (redacted) thing she reported that and thinks she had a fever, muscle aches and pains, and felt like she had the flu and stuff like on both of the doses and probably like for 5 days, did not feel good. She wanted to know if she got something toxic that was all. She wanted to know if Pfizer has had any problems with these two batches.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021417458 same patient/product, different dose/events;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I was one of the first people to get your immunization/got sick on the cruise and fortunately I had Paxlovid with me; I was one of the first people to get your immunization/got sick on the cruise and fortunately I had Paxlovid with me; This is a spontaneous report received from an Other HCP, Program ID.  A 71-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I was one of the first people to get your immunization/got sick on the cruise and fortunately I had Paxlovid with me". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: During an inbound call for financial assistance, the representative mentioned there are cases where patients need to use financial assistance if they're sick twice in a year, the patient replied that it had happened to her. Representative asked if patient was on Paxlovid, they replied, "Well not now, but I was at one point. I got sick on a cruise, I'm not sick at the moment." Representative clarified that patient was prescribed Paxlovid, they replied, "Yeah, to take with me. I want to be honest, I went on a cruise in August and got sick on the cruise and fortunately I had Paxlovid with me and  I really don't want this to happen to me again." Later in the call the representative asked if the patient would speak with DSU, they stated, "Yes, I'd be happy to because I was one of the first people to get your immunization." The representative asked when Paxlovid was taken, they stated, "It was January."
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of ACTHIB was administered to a patient with no reported adverse event; Initial information received on 08-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient whom  administered expired dose of hib (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Apr-2025, the patient received a expired unknown dose of suspect hib (PRP/T) vaccine, Powder and solvent for solution for injection (strength: unknown, lot UK042AA,expiry date:31-mar-2025) via unknown route in unknown administration site  as immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. .
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Fall
Clinical narrative: Patient was administered Gardasil on left deltoid, M.A. then turned to give the sibling vaccines. After administering the sibling's vaccines, the patient fell over, and M.A. noticed the patient on the floor. The M.A. immediately called for the Dr. Dr. entered and assessed the patient. 911 was called and Dr. took over the call and it was determined; emergency services were no longer needed by Dr. and the dispatcher.  The patient's head was stabilized with a cushion and legs were elevated. The provider and M.A. remained in the room until the patient stabilized, patient's vitals were rechecked and vitals returned to baseline.
Age: 21.0
Sex: F
Vaccine: PNC20
Symptoms: Anxiety, Dehydration, Epistaxis, Hyperventilation, Nausea
Clinical narrative: 04/10/25 @ 10:40 AM PATIENT WAS SITTING ON FLOOR WITH BLOODY NOSE WHEN PROVIDER ENTERED EXAM ROOM. PATIENT WAS ALONE, DIDN'T KNOW HOW SHE GOT BLOODY NOSE. PATIENT RECALLED SHE TRIED TO GET UP FROM CHAIR TO VOMIT AFTER SHE GOT THE PCV 20 VACCINE AND ACKNOWLEDGED SHE DIDN'T KNOW HOW SHE ENDED UP ON THE FLOOR.  SYMPTOMS: NAUSEA,VOMITING,FAINT,BLOODY NOSE,APPEARED PALE. VASOVAGAL SYNCOPE AFTER IMMUNIZATION REPORT WILL BE MADE ANXIETY MOST LIKELY TRIGGERED HER TO HAVE TACHYCARDIA, WHICH MAY HAVE LEAD TO LOW BLOOD PRESSURE, WHICH WAS MADE WORSE BY DEHYDRATION (POOR PO INTAKE PRIOR TO VISIT) OR HYPERVENTILATION DURING THE ANXIETY EPISODE.  I RECOMMENDED 911 TO BE CALLED EARLY DURING VISIT AND PT DECLINED (AMA FORM WAS SIGNED). SHE REMAINED IN CLINIC FOR A TOTAL OF 2 HRS AND FELT BETTER AFTER ORAL HYDRATION. HER BP IMPROVED AND LOOKED BETTER. SHE PREFERRED TO GO HOME AND HER MOM AGREED TO TAKE HER HOME TO CONT W/ ORAL HYDRATION W/ PEDIALYTE / GATORADE OR SIMILAR FLUIDS. STRICT ED PRECAUTIONS REVIEWED.
Age: 21.0
Sex: F
Vaccine: PNC20
Symptoms: Pallor, Syncope, Tachycardia, Vomiting
Clinical narrative: 04/10/25 @ 10:40 AM PATIENT WAS SITTING ON FLOOR WITH BLOODY NOSE WHEN PROVIDER ENTERED EXAM ROOM. PATIENT WAS ALONE, DIDN'T KNOW HOW SHE GOT BLOODY NOSE. PATIENT RECALLED SHE TRIED TO GET UP FROM CHAIR TO VOMIT AFTER SHE GOT THE PCV 20 VACCINE AND ACKNOWLEDGED SHE DIDN'T KNOW HOW SHE ENDED UP ON THE FLOOR.  SYMPTOMS: NAUSEA,VOMITING,FAINT,BLOODY NOSE,APPEARED PALE. VASOVAGAL SYNCOPE AFTER IMMUNIZATION REPORT WILL BE MADE ANXIETY MOST LIKELY TRIGGERED HER TO HAVE TACHYCARDIA, WHICH MAY HAVE LEAD TO LOW BLOOD PRESSURE, WHICH WAS MADE WORSE BY DEHYDRATION (POOR PO INTAKE PRIOR TO VISIT) OR HYPERVENTILATION DURING THE ANXIETY EPISODE.  I RECOMMENDED 911 TO BE CALLED EARLY DURING VISIT AND PT DECLINED (AMA FORM WAS SIGNED). SHE REMAINED IN CLINIC FOR A TOTAL OF 2 HRS AND FELT BETTER AFTER ORAL HYDRATION. HER BP IMPROVED AND LOOKED BETTER. SHE PREFERRED TO GO HOME AND HER MOM AGREED TO TAKE HER HOME TO CONT W/ ORAL HYDRATION W/ PEDIALYTE / GATORADE OR SIMILAR FLUIDS. STRICT ED PRECAUTIONS REVIEWED.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Giant cell arteritis, Influenza like illness, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Feeling flu sickness and sore arm, recoved. Rheumatoid arthritis and giant cell arteritis, ongoing
Age: 10.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered had beyond use date of 11/7/24, but was administered 11/9/24.  Parent was contacted when this was discovered. No adverse effects reported.
Age: 62.0
Sex: F
Vaccine: HEPAB, PNC21, RSV, TDAP, VARZOS
Symptoms: Chills, Dizziness, Eye pain, Pain, Pyrexia
Clinical narrative: Patient received twinrix, shingrix, adacel, capvaxive and arexvy on 4/9/25 and started experiencing symptoms about 20 minutes after leaving the pharmacy which included body aches and pains, eye pain, chills, fever, vomiting and dizziness. Patient tried Tylenol and Ginger ale and saw no relief so she was advised to go to the ER.
Age: 62.0
Sex: F
Vaccine: HEPAB, PNC21, RSV, TDAP, VARZOS
Symptoms: Vomiting
Clinical narrative: Patient received twinrix, shingrix, adacel, capvaxive and arexvy on 4/9/25 and started experiencing symptoms about 20 minutes after leaving the pharmacy which included body aches and pains, eye pain, chills, fever, vomiting and dizziness. Patient tried Tylenol and Ginger ale and saw no relief so she was advised to go to the ER.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 9.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered had beyond use date of 11/7/24, but was administered 11/9/24.  Parent was contacted when this was discovered. No adverse effects reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dementia Alzheimer's type, Fall, Mobility decreased
Clinical narrative: Movement problems, frequent falls, Alzheimer disease on going
Age: 68.0
Sex: F
Vaccine: PNC21
Symptoms: Extra dose administered
Clinical narrative: Patient was given one dose of pneumo shot on 4/3 and given another shot on 4/10.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 41.0
Sex: M
Vaccine: COVID19, FLU3, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Autism spectrum disorder, Depressed level of consciousness, Foaming at mouth, Magnetic resonance imaging head normal
Clinical narrative: Foaming at the mouth, difficult to arouse lasting minutes.  EMS called.  Told did not need to go to the hospital as was recovering during time of their eval. Within 2 weeks of the event described, he lost the ability to speak.  He was previous speaking in sentences, describing sea animals and saying his ABC's.  2 weeks after the event, he stopped talking.  He has been diagnosed with autism and no longer has any words.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT HAD SWELLING, REDNESS AND ITCHING IN AREA  ON BACKSIDE OF RIGHT ARM WHERE VARIVAX VACCINE WAS ADMINISTERED SUBCUTANEOUSLY.  NO SWELLING, REDNESS OR PAIN IN AREA WHERE OTHER IM INJECTIONS WERE GIVEN IN SAME ARM. ADVISED PATIENT TO APPLY COLD COMPRESS/ICE TO AREA 2-3 TIMES PER DAY FOR THE NEXT SEVERAL DAYS, ALERT PHARMACY OF ANY WORSENING OF SYMPTOMS OR FEVER AS IT MAY BE A SIGN OF CELLULITIS. ADVISED SYMPTOMS SHOULD RESOLVE AFTER A FEW DAYS OR UP TO A WEEK
Age: 86.0
Sex: M
Vaccine: RSV
Symptoms: Atrial fibrillation, Chest X-ray normal, Dyspnoea, Electrocardiogram abnormal, Fibrin D dimer normal
Clinical narrative: The day after receiving the vaccine, patient presented to local Emergency Department with chief complaint of shortness of breath. He reports that he went to go for a walk that afternoon with his walker. He normally is able to walk about 1/4 mile but was only able to make it about 10 feet before he got very short of breath. Denied recent fever, chills, abdominal pain, chest pain, or other complaints. Patient was treated with acetaminophen while in the ED.
Age: 86.0
Sex: M
Vaccine: RSV
Symptoms: Full blood count, Respiratory viral panel, Troponin normal
Clinical narrative: The day after receiving the vaccine, patient presented to local Emergency Department with chief complaint of shortness of breath. He reports that he went to go for a walk that afternoon with his walker. He normally is able to walk about 1/4 mile but was only able to make it about 10 feet before he got very short of breath. Denied recent fever, chills, abdominal pain, chest pain, or other complaints. Patient was treated with acetaminophen while in the ED.
Age: 65.0
Sex: F
Vaccine: MMR
Symptoms: Blood test, Full blood count, Malaise, Pyrexia
Clinical narrative: PATIENT STATED THAT NOT LONG AFTER RECEIVING THE LIVE MMRII VACCINE THAT HE DEVELOPED MALAISE AND A LOW GRADE FEVER. THE LOW GRADE FEVER HAS NOT SUBSIDED AS OF 4/10/25 EVEN WITH USING ACETAMINOPHEN OTC. PHYSICIAN IS AWARE AND IS DOING ONGOING BLOODWORK TO RULE OUT VACCINE INVOLVEMENT OR OTHER HEALTH CONDITIONS.
Age: 78.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Abrysvo given 4/8/2025 should not have been given as patient already had this vaccine on 1/29/2025. Patient reports no ill effects.
Age: 38.0
Sex: M
Vaccine: COVID19, HEP, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: The patient stated that after she got home from receiving the Prevnar vaccine, her arm was hot, itchy and red at the inject site. She also stated that she was dizzy. She did not mention it to the pharmacy until she came to pick up her prescriptions on 4/10/25.
Age: 59.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 67.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 56.0
Sex: F
Vaccine: PNC21
Symptoms: Pyrexia
Clinical narrative: 102 fever
Age: 61.0
Sex: F
Vaccine: COVID19, FLU3, HEPA, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Heart rate increased, Nausea
Clinical narrative: Employee reported to be  symptomatic at 1900 with symptoms of increase heart rate (105BPM) and nausea. No treatment due to symptoms decreasing after sitting and drinking water. Symptoms resolved at 1942.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Pruritus
Clinical narrative: PATIENT CAME TO PHARMACY TODAY (4/10/25) TO REPORT TO PHARMACIST SHE HAD A REACTION TO AREXVY THAT SHE RECEIVED ON 2/11/25. STATED SHE GOT REALLY ITCHY AFTER RECEIVING THE VACCINE AND SAW HER DOCTOR. DOCTOR RECOMMENDED OVER THE COUNTER REMEDIES AND PATIENT WAS ASKING IF SHE WOULD HAVE TO CONTINUE TO TAKE THESE FOR LIFETIME. SHE REPORTS IT HAS GOTTEN BETTER BUT SHE DOES NOT WANT TO CONTINUE TO TAKE MEDICATIONS.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Abscess drainage, Abscess limb, Erythema, Peripheral swelling
Clinical narrative: Patient stated that it began with swelling and redness on her left arm after the vaccination. She kept an eye on it and as it got redder and did not heal I advised the patient to go the the doctor to have it checked out. Upon seeing a doctor she was given antibiotics and she reported that it eventually abcessed and had to be drained. That information was given to me today, 4/10/2025.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Cough, Pneumonia, Rash, Wheezing
Clinical narrative: Resident developed rash, wheezing, cough, and CXR (+) for PNA
Age: 1.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 75.0
Sex: M
Vaccine: PNC21
Symptoms: Chills, Erythema, Feeling hot, Pruritus, Pyrexia
Clinical narrative: Pt received IMZ and developed local redness, swelling, itching, and heat starting day of vaccine.  Also developed fever and shivering.  Pt states that as of today (5 days after receiving IMZ), fever and shivering is gone.  Local symptoms are slowly improving.  Denies any other symptoms.
Age: 75.0
Sex: M
Vaccine: PNC21
Symptoms: Swelling
Clinical narrative: Pt received IMZ and developed local redness, swelling, itching, and heat starting day of vaccine.  Also developed fever and shivering.  Pt states that as of today (5 days after receiving IMZ), fever and shivering is gone.  Local symptoms are slowly improving.  Denies any other symptoms.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Device connection issue
Clinical narrative: Caller stated a patient was stuck twice while vaccinating with VARVAX; No adverse side effects were reported; leaky diluent syringes; YES, DURING ADMINISTRSTION- BECAUSE THE NEEDLE WAS NOT ATTACHING TO THE LUER LOCK CORRECTLY.; LUER LOCK SEEMS LIKE IT WON'T GET A  TIGHT FIT, WHEN YOU GET TOO TIGHT IT KIND OF PULLS SIDEWAYS  o Is there difficulty attaching the Syringe Needle to the Syringe? YES- BUT NOT SECURLEY; YES, DURING ADMINISTRSTION- BECAUSE THE NEEDLE WAS NOT  ATTACHING TO THE LUER LOCK CORRECTLY.; This spontaneous report was received from a nurse via field base employee (FBE) and refers to a 1-year-old male patient.   The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. The reporter stated that she had a complaint regarding sterile diluent (BAXTER STERILE DILUENT) solution for injection, as "leaky diluent syringes" were reported by several nurses at the health department", she also stated that luer lock seemed like it wouldn't get a tight fit, when they got it too tight it kind of pulled sideways, they could attach the needle to the syringe but not securely, so leaking occurred while attaching the needle to the syringe. The reporter informed that this occurred with 3 syringes from the same lot#1973253 (expiration date: 22-Feb-2026), but came from different boxes. Then on an unspecified date a patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), solution for injection as prophylaxis (dose, route of administration, lot # and expiration date were not reported) reconstituted with one of these sterile diluent (BAXTER STERILE DILUENT) syringes, and stated that the patient was stuck twice while being vaccinated, but no adverse side effects were reported. The reporter stated that the syringe leaked during this administration since the needle was not attaching to the luer lock correctly. Caller did say it happened more than once with this lot (not clarified). Only one of the involved syringes could be returned.   Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: PNC21
Symptoms: Upper respiratory tract infection
Clinical narrative: Upper Respiratory Infection; This spontaneous report was received from a physician assistant via company representative regarding to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 15-JAN-2025, the patient was vaccinated with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) via intramuscular, (strength, dose, frequency, anatomical injection site, lot number and expiration date were not reported), for the treatment of immunization/prevention of pneumonia caused by strep pneumoniae.  On 18-FEB-2025, the patient experienced upper respiratory infection. At the reporting time, the patient had not recovered from the event.   The reporter considered the event to be related to pneumococcal 21-valent conjugate vaccine (CAPVAXIVE).   Lot # is being requested and will be submitted if received.
Age: 66.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Computerised tomogram thorax normal, Contusion, Gait disturbance, Joint swelling, Magnetic resonance imaging abnormal
Clinical narrative: 12/27/24 ORTHOPEDIC DR and XRAY -right knee swollen and bruised 12/30/24 MRI 1/03/25 MRI reviewed. Thigh and lower leg now swollen and bruised. ORTHOPEDIC DR Instructed me to go to hospital emergency. 1/04/25 ER - Ultrasound. Difficulty walking. Severe leg pain. Knee and leg  continue to swell. 1/07/25 PRIMARY CARE PHYSICIAN exam. Oxygen low, back to ER 1/07/25 ER - Cat Scan lungs. Lungs clear. 1/13/25 different ORTHOPEDIC DR - more x-rays. Surgery scheduled for torn meniscus. 1/14/25 VASCULAR TEST completed 1/14/25 PRIMARY CARE DR for pre-op exam -In office blood draw. High platelets. Surgery not recommended 1/15/25 ORTHOPEDIC DR - reviewed blood results. Surgery cancelled. 1/21/25 HEMATOLOGIST DR - blood draw 1/22/25 HEMATOL DR - another blood draw  1/30/25 HEMATOLOGIST DR - follow up blood. Leg swelling and bruising diminishing. No explanation offered. 02/03/25 ORTHOPEDIC DR switch. Review MRI from 12/30. No surgery needed 03/03/25 ENDOCRINOLOGIST no new abnormalities in thyroid condition 3/13/25 - LAB - blood draw 3/27/25 - HEMATOLOGIST blood review. Platelets getting back to normal. No explanation offered.
Age: 66.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Meniscus injury, Oxygen saturation decreased, Peripheral swelling, Platelet count increased, Ultrasound scan abnormal
Clinical narrative: 12/27/24 ORTHOPEDIC DR and XRAY -right knee swollen and bruised 12/30/24 MRI 1/03/25 MRI reviewed. Thigh and lower leg now swollen and bruised. ORTHOPEDIC DR Instructed me to go to hospital emergency. 1/04/25 ER - Ultrasound. Difficulty walking. Severe leg pain. Knee and leg  continue to swell. 1/07/25 PRIMARY CARE PHYSICIAN exam. Oxygen low, back to ER 1/07/25 ER - Cat Scan lungs. Lungs clear. 1/13/25 different ORTHOPEDIC DR - more x-rays. Surgery scheduled for torn meniscus. 1/14/25 VASCULAR TEST completed 1/14/25 PRIMARY CARE DR for pre-op exam -In office blood draw. High platelets. Surgery not recommended 1/15/25 ORTHOPEDIC DR - reviewed blood results. Surgery cancelled. 1/21/25 HEMATOLOGIST DR - blood draw 1/22/25 HEMATOL DR - another blood draw  1/30/25 HEMATOLOGIST DR - follow up blood. Leg swelling and bruising diminishing. No explanation offered. 02/03/25 ORTHOPEDIC DR switch. Review MRI from 12/30. No surgery needed 03/03/25 ENDOCRINOLOGIST no new abnormalities in thyroid condition 3/13/25 - LAB - blood draw 3/27/25 - HEMATOLOGIST blood review. Platelets getting back to normal. No explanation offered.
Age: 66.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Vascular test, X-ray
Clinical narrative: 12/27/24 ORTHOPEDIC DR and XRAY -right knee swollen and bruised 12/30/24 MRI 1/03/25 MRI reviewed. Thigh and lower leg now swollen and bruised. ORTHOPEDIC DR Instructed me to go to hospital emergency. 1/04/25 ER - Ultrasound. Difficulty walking. Severe leg pain. Knee and leg  continue to swell. 1/07/25 PRIMARY CARE PHYSICIAN exam. Oxygen low, back to ER 1/07/25 ER - Cat Scan lungs. Lungs clear. 1/13/25 different ORTHOPEDIC DR - more x-rays. Surgery scheduled for torn meniscus. 1/14/25 VASCULAR TEST completed 1/14/25 PRIMARY CARE DR for pre-op exam -In office blood draw. High platelets. Surgery not recommended 1/15/25 ORTHOPEDIC DR - reviewed blood results. Surgery cancelled. 1/21/25 HEMATOLOGIST DR - blood draw 1/22/25 HEMATOL DR - another blood draw  1/30/25 HEMATOLOGIST DR - follow up blood. Leg swelling and bruising diminishing. No explanation offered. 02/03/25 ORTHOPEDIC DR switch. Review MRI from 12/30. No surgery needed 03/03/25 ENDOCRINOLOGIST no new abnormalities in thyroid condition 3/13/25 - LAB - blood draw 3/27/25 - HEMATOLOGIST blood review. Platelets getting back to normal. No explanation offered.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, MENB, PNC20, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Healthy 6mo male presenting for WCC & vaccines. Bexsero was ordered in error and administered along with other vaccines. No side effects or bad outcomes.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site discharge, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site. Site oozing - antibiotic given for treatment Cephalexin 750 mg 1 capsule twice a day for 7 days
Age: 47.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms.; one dose of GARDASIL 9 was administered to a patient who is 47 years old; This spontaneous report was received from a nurse concerning to a 47-year-old female patient.   Her medical history, concurrent conditions and concomitant therapies were not reported.   On 26-DEC-2024, the patient was vaccinated with one dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) pre-filled syringe, lot #Y014510, expiration date: 01-Nov-2026, 0.5 mL (dosage regimen, anatomical location and route of administration were not reported) administered as prophylaxis (product administered to patient of inappropriate age.)  On 26-Dec-2024, the patient experienced one dose of GARDASIL 9 was administered to a patient who is 47 years old.  There were no symptoms (no adverse event.)
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Nausea, Vertigo
Clinical narrative: chills; sweat; vertigo; nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular). On 27-MAR-2025, 1 days after receiving Shingrix, the patient experienced chills (Verbatim: chills), sweating (Verbatim: sweat), vertigo (Verbatim: vertigo) and nausea (Verbatim: nausea). On 28-MAR-2025, the outcome of the chills, sweating, vertigo and nausea were resolved (duration 1 day).   It was unknown if the reporter considered the chills, sweating, vertigo and nausea to be related to Shingrix.     It was unknown if the company considered the chills, sweating, vertigo and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-MAR-2025 Reporter called and stated she received her 1st of 2 vaccines for Shingrix on 26-MAR-2025 and within 24 hours the reporter started having chills, sweat, vertigo and nausea that lasted around 24 hours before completely resolving.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix administered IM instead of subcutaneously; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of subcutaneous injection formulation administered by other route in a female patient who received MMR (Priorix) (batch number 4N222) for prophylaxis.   On 31-MAR-2025, the patient received Priorix (intramuscular, right arm). On 31-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix administered IM instead of subcutaneously). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   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 : 05-APR-2025 Priorix administered intramuscularly instead of subcutaneously which led to Subcutaneous injection formulation administered by other route.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: I took your vaccine and about a week later I got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: I took your vaccine and about a week later I got shingles). The outcome of the shingles was resolved.   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.   Additional Information: GSK Receipt Date: 04-APR-2025 The reporter reported that the patient received the vaccine and about a week later he got shingles.  He had never had shingles.  He was never warned he might get shingles after he took the shingles shot.  He was not very happy about this. It was the most painful of anything he ever experienced.  The shingles attack occurred on his right butt cheek.  He was in pain for 3 days. The doctor gave him a cream to use.  It helped a little. He asked, why was not he warned.  He was pretty old and had pain like that was a surprise. He could believe, he was the first to get shingles from vaccine. He did not care whether vaccine was live or dead.  No one would ever convince him those two events were not connected. If he was going to get shingles it would had happened during one of his decades.  It would not had happened one-week after taking a vaccine. He had already talked to 3 of his doctors and they were puzzled.  That did not mean he was wrong.  It happened to him, on his butt.  It was painful.  If he had not taken the vaccine he seriously doubt he would ever had heard the word shingles. 2024 was a bad medical year. He was fine now.  It was been a few months.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-APR-2025 The case was received from the patient via interactive digital media. The patient asked he/she had the vaccine so why did he/she get shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue, Underdose
Clinical narrative: patient was given an incomplete dose of PENTACEL that was not mixed together correctly, it was missing HIB with no reported adverse event; Initial information received on 08-Apr-2025 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced patient was given an incomplete dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] that was not mixed together correctly, it was missing hib with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an incomplete 1ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine Suspension for injection frequency -once (strength-unknown) (lot UK043AA, expiry date- 31-Aug-2025) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) that was not mixed together correctly, it was missing hib with no reported adverse event (single component of a two-component product administered) (latency- same day).  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Feeling abnormal
Clinical narrative: Patient was confused and dazed.
Age: 60.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Symptoms.
Age: 7.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product preparation error
Clinical narrative: No adverse event; HCP called to report a patient received an expired dose of PROQUAD.  caller states the product expired 03/12/2025 and was administered to one patient 03/14/2025.; This spontaneous report was received from a Nurse and refers to a 7-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 14-Mar-2025, the patient was vaccinated with an expiry dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #X022919, expiration date: 12-Mar-2025), 0.5 mL (strength, dose, and anatomical location not provided) for prophylaxis, diluted in sterile diluent (MERCK STERILE DILUENT) 0.5 mL (indication, expiration date, and lot # were not reported). No side effects or symptoms have been reported.
Sex: F
Vaccine: PNC21
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: HCP diagnosed as cellulitis; Patient came back to clinic 03/18/2025 with complaint of  injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand  to 14 by 11 centimeters, area is tender to touch.; Patient came back to clinic 03/18/2025 with complaint of  injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand  to 14 by 11 centimeters, area is tender to touch.; Patient came back to clinic 03/18/2025 with complaint of  injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand  to 14 by 11 centimeters, area is tender to touch.; Patient came back to clinic 03/18/2025 with complaint of  injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand  to 14 by 11 centimeters, area is tender to touch.; This spontaneous report was received from a Nurse and refers to a(n) 49-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 12-Mar-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), formulation: injection (lot #, expiration date, exact dose, route of administration, anatomical location and indication were not provided).   On an unknown exact date in March 2025, the patient experienced cellulitis, vaccination site erythema, vaccination site induration, vaccination site pain, vaccination site swelling. Patient came back to clinic 10-Mar-2025 with complaint of injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand to 14 by 11 centimeters, area is tender to touch. Patient was prescribed Benadryl and topical cortisone cream for symptoms as well as CEPHALEXIN. HCP diagnosed as cellulitis. On the same date, body temperature was 97.8 F, oxygen saturation was 99 %, heart rate showed 71 (units not provided), blood pressure showed 126/75 (units not provided). At the reporting time, the outcome of the events was unknown.   The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown/not reported/not provided.
Sex: F
Vaccine: PNC21
Symptoms: Pyrexia
Clinical narrative: HCP diagnosed as cellulitis; Patient came back to clinic 03/18/2025 with complaint of  injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand  to 14 by 11 centimeters, area is tender to touch.; Patient came back to clinic 03/18/2025 with complaint of  injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand  to 14 by 11 centimeters, area is tender to touch.; Patient came back to clinic 03/18/2025 with complaint of  injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand  to 14 by 11 centimeters, area is tender to touch.; Patient came back to clinic 03/18/2025 with complaint of  injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand  to 14 by 11 centimeters, area is tender to touch.; This spontaneous report was received from a Nurse and refers to a(n) 49-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 12-Mar-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), formulation: injection (lot #, expiration date, exact dose, route of administration, anatomical location and indication were not provided).   On an unknown exact date in March 2025, the patient experienced cellulitis, vaccination site erythema, vaccination site induration, vaccination site pain, vaccination site swelling. Patient came back to clinic 10-Mar-2025 with complaint of injection site pain, fever, redness that increased around injection site as well as swelling and induration. Redness continued to expand to 14 by 11 centimeters, area is tender to touch. Patient was prescribed Benadryl and topical cortisone cream for symptoms as well as CEPHALEXIN. HCP diagnosed as cellulitis. On the same date, body temperature was 97.8 F, oxygen saturation was 99 %, heart rate showed 71 (units not provided), blood pressure showed 126/75 (units not provided). At the reporting time, the outcome of the events was unknown.   The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown/not reported/not provided.
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema
Clinical narrative: Received from the AE Self-Service Portal: Report submitted by Merck Employee  Provider stated today that this patient experienced 7-10 days of redness at the injection site after receiving a dose of Capvaxive.   "Case assigned/processed; This spontaneous report was received from a physical assistant and refers to a(n) 50-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown exact day in January 2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis.   On an unknown exact day in January 2025, the patient experienced vaccination site erythema (experienced 7-10 days of redness at the injection site after receiving a dose of vaccine).  At the reporting time, the outcome of the event was unknown.   The causal relationship between the event of vaccination site erythema and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown/not reported/not provided.
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: HCP called to report a female patient received third dose of GARDASIL 9 late according to vaccination schedule. Caller did not have exact dates but states the first and second dose were administered appropriately according to the vaccination schedule; No additional AE; This spontaneous report was received from a nurse and refers to a female patient of unknown age.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (expiration date, and lot # were not reported) for prophylaxis. According to the reporter, the first and second dose were administered appropriately according to the vaccination schedule, but the third dose was administered later than the recommended 6 months (the nurse did not have exact dates) (Inappropriate schedule of product administration). No adverse events were reported.   Lot is being requested and will be submitted if received.
Vaccine: PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: No adverse event; Poor quality device used; LPN calling to report increased pressure irregularity of VAXNEUVNACE prefilled syringe while administering vaccine to a 15-month-old patient. Caller stated vaccine was being given to a 15-month-old patient in the thigh when the injection experienced; Device leakage; This spontaneous report was received from a nurse and refers to a(n) 15-month-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 09-Apr-2025, the patient was vaccinated with the dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE), formulation: injection, lot #Y010035, expiration date: 17-Feb-2027, 0.5 mL, administered in thigh (route of administration and site of administration were not provided) for prophylaxis.  The reporter stated that vaccine was being given to a 15-month-old patient in the thigh when the injection experienced resistance to the point that nurse "couldn't push anymore". Reporter stated that the needle was removed from patient at that point the rest of the medication squirted out of the syringe with no force (poor quality device used, device leakage). Patient was given vaccine however did not receive full dose (vaccine underdose). No additional adverse event reported (no adverse event).