chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Walking aid user
Clinical narrative: I had 2 Pfizer vaccines in 2021. One in March and then another in April. I almost immediately started having pain in my hip. Within a month of the 2nd dose I had to go to the dr. I was having trouble walking. I was scheduled with an orthopedic surgeon and they began to run tests thinking I had an autoimmune disease because my inflammatory levels were so high. I was tested by a rheumatologist and they ruled out autoimmune diseases. I had an MRI which showed that I had a lot of inflammation around my hip joint that had caused the cartilage to breakdown. It was an unexplained issue that had caused me to be on a walker. The surgeon did not specify vaccine injury but said that it was an unexplainable very aggressive arthritis he guessed. He told me I had no other choice but to have a hip replacement. I had not had any hip pain or hip problems before that vaccine so it was very confusing to all of us to have this happen to me so fast out of nowhere. I had the hip replacement by September 2021 (which was just a few months after my 2nd vaccine dose). I unfortunately developed sepsis from a staph infection from that hip replacement and almost died. I was hospitalized for weeks and had to be treated by infectious disease dr for the next year. I still have a lot of health issues today. I have researched and talked with many people and have come to realize that all of that happened immediately after the 2 covid vaccines that I had. I had one in March 2021 and 2nd in April 2021. I was at drs office in may and having hip replacement surgery by September. My surgeon never implied that it was caused by the vaccines. I had a dr in the hospital that suggested it might be a covid vaccine injury but nothing documented. I am convinced that it was caused by the 2 vaccines within a month of each other. Thank you for your time
Age: 81.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Pt was given 2nd shot of Prevnar by mistke today. Pt already had receive this shot in Nov 2024.
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Pain
Clinical narrative: Two days after the injection, a 3-inch by 3-inch red splotch has developed approximately 1-inch below and slightly left of the injection site. It is warm to the touch. It began smaller and has gotten larger over several days. It is itchy. It is still present on day 7; Before that, on day 2 I felt achy and extremely fatigued. The aches and fatigue had resolved by the time the splotch developed.
Age: 73.0
Sex: U
Vaccine: UNK
Symptoms: Computerised tomogram head abnormal, Magnetic resonance imaging head abnormal, Muscular weakness, Peripheral swelling, Transient ischaemic attack
Clinical narrative: pt had a tia, and has left foot weakness and right arm swelling
Age: 73.0
Sex: U
Vaccine: UNK
Symptoms: Ultrasound scan
Clinical narrative: pt had a tia, and has left foot weakness and right arm swelling
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient came to consultation window 2-12-25  in the evening stating his arm is still sore from the flu shot on 1-19-25. I brought him into the consultation room and looked at right and did not notice any redness or swelling. I palpated the deltoid area and he did not complain of any pain, numbness or tingling. He stated it hurts when he raises his arm upward, outward and above head. Also states, he cannot sleep on that side. I asked him if he injured arm/shoulder at work or fell . He stated no and his job is a nail technician. I recommended he follow-up with his PCP. Today, 2-14-25, I left him a message to  follow up with him to see if arm/shoulder is still sore and if he went to his PCP.
Age: 5.0
Sex: M
Vaccine: COVID19, DTAPIPV, FLU3
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Pruritic generalized erythematous rash excluding the face; started as small area per mother and slowly worsened, came to the clinic on 02/13/2025 (pictures taken of the rash), no medications were administered since the rash started; afebrile, no respiratory of GI symptoms
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Dehydration, Diarrhoea, Erythema, Flushing
Clinical narrative: Over a few weeks pt had a full body rash. Cheecks were very blush and dry and rashy looking.  Lack of appetite diarrhea, dehydration. Low grade fever.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Over a few weeks pt had a full body rash. Cheecks were very blush and dry and rashy looking.  Lack of appetite diarrhea, dehydration. Low grade fever.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given vaccine that was beyond Best Use by Date.  Patient has no symptoms.  Vaccine was noticed after being given.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the child is 10 years old and i gave him the covid shot that is for 12 years and older and did not realize till after
Age: 70.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Headache, Knee operation, Musculoskeletal stiffness, Myalgia
Clinical narrative: VACCINES 9/30. ABOUT 1 WEEK LATER SORE MUSCLES/JOINTS, STIFF NECK, HEADACHE, SWOLLEN HANDS. DEALTH WITH IT UNTIL (12/16) FOLLOW UP APPT WITH SURGEON FROM KNEE SURGERY (11/23) GAVE MEDROL DOSEPACK. HELPED UNTIL FINISHED PACK. GAVE ANOTHER MEDROL PACK (12/23). AGAIN HELPED UNTIL FINISHED. SAW PCP AND RECEIVED ANOTHER PACK (12/30). PCP REFERRED HIM TO RHEUMATOLOGIST (1/14).  PCP PRESCRIBED NAPROXEN (1/10). RHEUMATOLOGIST, PCP, AND SURGEON AGREED THEY BELIEVE FROM VACCINE AND NOT ARTHRITIS.
Age: 70.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Peripheral swelling
Clinical narrative: VACCINES 9/30. ABOUT 1 WEEK LATER SORE MUSCLES/JOINTS, STIFF NECK, HEADACHE, SWOLLEN HANDS. DEALTH WITH IT UNTIL (12/16) FOLLOW UP APPT WITH SURGEON FROM KNEE SURGERY (11/23) GAVE MEDROL DOSEPACK. HELPED UNTIL FINISHED PACK. GAVE ANOTHER MEDROL PACK (12/23). AGAIN HELPED UNTIL FINISHED. SAW PCP AND RECEIVED ANOTHER PACK (12/30). PCP REFERRED HIM TO RHEUMATOLOGIST (1/14).  PCP PRESCRIBED NAPROXEN (1/10). RHEUMATOLOGIST, PCP, AND SURGEON AGREED THEY BELIEVE FROM VACCINE AND NOT ARTHRITIS.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: The day after the booster vaccine I have suffered from tinnitus in both ears.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC20
Symptoms: Rash, Rash macular
Clinical narrative: Scattered macular rash across trunk and back - onset 7 days after receiving MMRV vaccine; Diagnoses at visit on 02/14/25 Varicella without complication - B01.9 (Primary), Adverse effect of other viral vaccines, initial encounter - T50.B95A , Infection following immunization, initial encounter - T88.0XXA
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain and erythema at the site of injection
Age: 1.08
Sex: M
Vaccine: FLU3, HEPA, MMRV
Symptoms: Product use issue
Clinical narrative: I asked a peer for help with vaccines for a well child check as I am a new MA and did not know exactly what I needed to do. The insurance part of the vaccinations made it more complicated, my peer said that when she does vaccines for her provider instead of doing multiple vaccines and having the child get poked more, they do a combo vaccine. She helped me draw up the vaccinations and instead of doing MMR and Varicella separately, she drew up MMRV.  My provider has since talked to the parent of the patient.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC15, VARCEL
Symptoms: Injection site bruising, Injection site cellulitis, Injection site inflammation, Injection site swelling
Clinical narrative: PATIENT WENT TO THE COUNTY HEALTH DEPARTMENT ON 2/12/2025 TO RECEIVE THEIR ONE YEAR OLD SET OF VACCINES. ON 2/12/2025 PENTACEL, VARIVAX, MMR II, AND VAXNEUVANCE WAS ADMINISTERED TO THE PATIENT. THE MOTHER OF THE PATIENT NOTIFED US VIA PORTAL MESSAGE ON THE MORNING OF 2/14/2025 WITH A PICTURE AND CONCERN ON THE BABY'S RIGHT THIGH WHICH IN THE PICTURE LOOKED TO BE VERY VERY BRUISED WITH LOCALIZED SWELLING AND INFLAMMATION AND THE START OF CELLULITIS BASED OFF THE PICTURE. THE BABY WAS BROUGHT INTO OUR OFFICE TO BE ASSESSED THE SAME DAY AND WAS DIAGNOSED WITH CELLULITUS AND PRESCRIBED CEPHALEXIN ANTIBIOTICS TO TREAT THE CELLULITIS.
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema
Clinical narrative: Area where the vaccine was administered has redness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Circumoral oedema, Lip oedema, Streptococcus test negative
Clinical narrative: Mild to moderate perioral edema with edema of upper and lower lip
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site oedema, Large intestine polyp, Lipoma, Magnetic resonance imaging, Pain
Clinical narrative: Incident onset: about two weeks ago; had covid booster in that arm about three weeks ago. There was no injury mechanism. The quality of the pain is described as aching. The pain radiates to the right arm and right hand. The pain has been Worsening since the incident. Right upper arm: Edema (area of localizing edema to right tricep area; about baseball sized) present.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Ultrasound Doppler, Ultrasound scan, X-ray limb
Clinical narrative: Incident onset: about two weeks ago; had covid booster in that arm about three weeks ago. There was no injury mechanism. The quality of the pain is described as aching. The pain radiates to the right arm and right hand. The pain has been Worsening since the incident. Right upper arm: Edema (area of localizing edema to right tricep area; about baseball sized) present.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, COVID-19, Hypersomnia, Malaise, Pain
Clinical narrative: From each of 5 covid 19 shots I have received I was very sick for all of them. This last one in December was the worse of all.  I had 102 temp for 3 days, everything hurt and all I did was sleep.  I addition, since 2022 I have had covid 6 times.
Age: 60.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Urticaria
Clinical narrative: pt exerienced hives 2 weeks after receiving vaccines
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Injected limb mobility decreased, Sleep disorder
Clinical narrative: Patient reports pain in shoulder where vaccine was administered, still persisting nearly 4 months later. Painful to sleep on arm. Reports it "feels frozen" when doing routine activities like applying deodorant under her arm.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Mobility decreased, Sleep disorder
Clinical narrative: Patient reports pain in shoulder where vaccine was administered, still persisting nearly 4 months later. Painful to sleep on arm. Reports it "feels frozen" when doing routine activities like applying deodorant under his arm.
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Diarrhoea, Dizziness, Headache, Injection site erythema
Clinical narrative: itching, aching, redness, swelling of injection area, fever, headache, nausea, diarrhea on days 2 and 3 after.   Day 2:  ache extended up into neck on that side as well as shoulder and down to elbow.  Day 3 awoke with dizziness and nausea.   All reactions very unusual for me.
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Nausea, Neck pain
Clinical narrative: itching, aching, redness, swelling of injection area, fever, headache, nausea, diarrhea on days 2 and 3 after.   Day 2:  ache extended up into neck on that side as well as shoulder and down to elbow.  Day 3 awoke with dizziness and nausea.   All reactions very unusual for me.
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: itching, aching, redness, swelling of injection area, fever, headache, nausea, diarrhea on days 2 and 3 after.   Day 2:  ache extended up into neck on that side as well as shoulder and down to elbow.  Day 3 awoke with dizziness and nausea.   All reactions very unusual for me.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: shingles on eye; shingles on my face and nose; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 6 days after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (Verbatim: shingles on eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: shingles on my face and nose). The outcome of the ophthalmic herpes zoster and facial herpes zoster were resolved (duration 8 weeks).   It was unknown if the reporter considered the ophthalmic herpes zoster and facial herpes zoster to be related to Shingles vaccine.     The company considered the ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-JAN-2025 The case was received from the patient via interactive digital media. The patient got the shingle shot and about 6 days later, had shingles on his/her face, eye and nose. The patient got medications and it clear up again in his/her face and other spots . The patient reported that finally after 8 weeks, things cleared up. The patient did not get the second dose of the shot.; Sender's Comments: Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Meningitis, Nervous system disorder
Clinical narrative: shingles diagnosis developed into Meningitis; Neurological complications; contracted shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of meningitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAR-2024, the patient received Shingrix. On 05-MAR-2024, 2 days after receiving Shingrix, the patient experienced shingles (Verbatim: contracted shingles). On an unknown date, the patient experienced meningitis (Verbatim: shingles diagnosis developed into Meningitis) (serious criteria GSK medically significant) and nervous system disorder (Verbatim: Neurological complications). The outcome of the meningitis was not reported and the outcome of the shingles and nervous system disorder were resolved.   It was unknown if the reporter considered the meningitis, shingles and nervous system disorder to be related to Shingrix.     The company considered the meningitis to be unrelated to Shingrix. It was unknown if the company considered the shingles and nervous system disorder to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-JAN-2025 This case was reported by a patient via interactive digital media. The patient received Shingrix vaccine and got shingles that was turned in to a Meningitis and put in the hospital.  GlaxoSmithKline would not help with any of the medical bills and are immune from any lawsuits from this vaccine.  The patient now have neurological complications nine months out.  They did not tell this could happen, but it could, it did and people should know.  The patient did not had anti vaccine, but advised to think twice before get this vaccine.; Sender's Comments: Meningitis is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine was inadvertently administered sooner than recommended timeframe; This non-serious case was reported by a nurse via sales rep and described the occurrence of drug administration duration too short in a 10-year-old patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (Received first dose on unknown date).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced drug administration duration too short (Verbatim: vaccine was inadvertently administered sooner than recommended timeframe). The outcome of the drug administration duration too short was unknown.   Additional Information: GSK Receipt Date: 16-JAN-2025 The reporter reported that a patient received Havrix booster dose given less than 6 months which led to drug administration duration too short. A vaccine was inadvertently administered sooner than recommended timeframe, specifically for the Havrix (hepatitis A). Reporter was waiting for nurse manager to get back with more information.
Sex: U
Vaccine: HIBV
Symptoms: Incomplete course of vaccination
Clinical narrative: potential for missed dose of Hiberix at 6 months; This non-serious case was reported by a nurse via patient support programs and described the occurrence of incomplete course of vaccination in a 6-month-old patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient did not receive Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced incomplete course of vaccination (Verbatim: potential for missed dose of Hiberix at 6 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-FEB-2025 The reporter reported that the patient received Hiberix but had confusion with transition among nursing staff.  Unsure of actual missed doses and currently investigating but potential for missed dose of Hiberix at 6 months due to misunderstanding of transition guidelines. Till the time of reporting, the patient did not receive 2nd dose of Hiberix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got shingles most likely a mild case but it was very painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got shingles most likely a mild case but it was very painful). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by a patient via interactive digital media. The patient had the first vaccine and later got shingles and most likely a mild case but it was very painful.  The patient when had the 2nd vaccine became available  got it but no problems.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; had the two doses of shots and still get 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the two doses of shots and still get shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 31-JAN-2025 This case was reported by a patient via interactive digital media. The patient received two doses of shots and still get shingles. It was nerve wracking pain. Patient was currently (on the day of reporting) on his/her 6th episode after the shots. Apparently, the 99 percent effective results did not happen to be saw patient results. Patient reported he/she was the rare 1 percent. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine dose 1 and Shingles vaccine dose 2.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test positive, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles on his face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Family history included shingles (patient's wife had shingles before Shingrix was available) and pain (patient's wife still had to hurt for a while).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: got shingles on his face). The patient was treated with gabapentin. The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was resolving.   It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the facial herpes zoster to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 01-FEB-2025 This case was reported by a patient's wife via interactive digital media. The reporter reported that sorry but the only way to avoid getting shingles in later life was to have the chickenpox vaccine as a child. Most of the adult's had chickenpox as children, and that virus, herpes zoster, never goes away. It hides out at the base of the spine, and when we were older it comes back as shingles. The reporter had shingles before Shingrix was available. Her doctor gave her an antiviral, but still had to hurt for a while. Better believe got the 2 shot Shingrix vaccine as soon as it was available. The patient got it too. He got shingles late last year, but it was a mild case. It was on his face, but he had no pain and no permanent damage. He had an antiviral which helped him heal faster. He was given Gabapentin for pain, but never needed it. He believes in vaccines. Even if they did not totally stop the infection, they make it milder. It was proved that husband had shingles, by an antibody test. He had antibodies to herpes zoster, but not to herpes simplex which causes cold sores and genital herpes. This case was considered as suspected vaccination failure as details regarding time to onset for 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 time to onset and laboratory confirmation of herpes zoster) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Sex: U
Vaccine: VARZOS
Symptoms: Muscle spasms, Neck pain, Tremor
Clinical narrative: Shakes; leg cramps; pain up my neck; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tremor in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (twice).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced tremor (Verbatim: Shakes), leg cramps (Verbatim: leg cramps) and neck pain (Verbatim: pain up my neck). The outcome of the tremor, leg cramps and neck pain were not reported.   It was unknown if the reporter considered the tremor, leg cramps and neck pain to be related to Shingles vaccine.     It was unknown if the company considered the tremor, leg cramps and neck pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that a patient received a Shingles vaccine and had day one the side effects of shakes, leg cramps and pain up in neck were terrible.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: fever; itching; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 06-FEB-2025, the patient received Shingles vaccine. In FEB-2025, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: fever) and pruritus (Verbatim: itching). The outcome of the fever and pruritus were not reported.   It was unknown if the reporter considered the fever and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the fever and pruritus to be related to Shingles vaccine.   Additional Information: GSK receipt date: 07-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had received Shingles vaccine day before reporting and wanted to know why it was itching with a fever around it.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; diagnosed with shingles and my symptoms are different.Will I  have a lighter case, it's  in my eye; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, more than a year after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: diagnosed with shingles and my symptoms are different. Will I  have a lighter case, it's  in my eye) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 09-FEB-2025 This case was reported by a patient via interactive digital media. The patient had vaccine 2 years ago and now had been diagnosed with shingles with the symptoms was different.  He/she had a lighter case, it was in the eye. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 vaccine Shingrix. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got both shots and I've had them off and on for like 7 months; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got both shots and I've had them off and on for like 7 months). 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 and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 06-FEB-2025 This case was reported by a patient via interactive digital media. It was reported that the patient got both shots and have had them off and on for like 7 months. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; 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 dose 1 and Shingles vaccine dose 2.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got the vax and did not help, she still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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: got the vax and did not help, she still got 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: 07-FEB-2025 This case was reported by a patient's sibling via interactive digital media. The patient got the vax and did not help, she still got shingles. This case was considered as suspected vaccination failure since the details regarding primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The case was linked with case US2025AMR017914, reported by the same reporter for friend's brother.; 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 vaccine Shingles vaccine. US-GSK-US2025AMR017914:same reporter different patinet
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; My friends brother got the vaccine, he still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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: My friends brother got the vaccine, he still got 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: 07-FEB-2025 This case was reported by a consumer interactive digital media. The reporter reported that his/her friend's brother got the shingles vaccine and he still got shingles. This case was considered as suspected vaccination failure since the details regarding primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The case was linked with case US2025AMR017906, reported by the same reporter for his/her sister.; 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 vaccine Shingles vaccine. US-GSK-US2025AMR017906:same reporter different patient
Sex: U
Vaccine: HIBV
Symptoms: Device connection issue, Underdose
Clinical narrative: Defective vaccine potentially administered; getting leakage between the needle and the luer lock on the Prefilled Syringe; getting leakage between the needle and the luer lock on the Prefilled Syringe; Product Complaint; This non-serious case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received Hib (Hiberix) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental underdose (Verbatim: Defective vaccine potentially administered), syringe leak (Verbatim: getting leakage between the needle and the luer lock on the Prefilled Syringe), syringe connection issue (Verbatim: getting leakage between the needle and the luer lock on the Prefilled Syringe) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental underdose, syringe leak, syringe connection issue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the syringe leak and syringe connection issue to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device.     It was unknown if the company considered the syringe leak and syringe connection issue to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device.   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: 17-MAY-2024 GlaxoSmithKline Representative stated he was calling on behalf of an Office Administrator who reported a Product Quality Complaint this morning, mentioning that their clinic was having issues with Hiberix, when they put the needle onto the Prefilled Syringe and then try to draw they were getting leakage between the needle and the luer lock on the Prefilled Syringe. The Healthcare Provider mentioned it was 2 incidents out of this box, but understanding of the caller is that several kids were administered that morning which led to accidental underdose, syringe leak, syringe connection issue and pharmaceutical product complaint. Patient demographics, lot number or expiration date were unknown.   Upon internal review case was updated on 14-FEB-2024 The suspect product was recoded.
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had a dose of boostrix approximately 6 months earlier; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Boostrix (Patient received a dose approximately six months ago).   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced drug dose administration interval too short (Verbatim: had a dose of boostrix approximately 6 months earlier). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-JAN-2025 The Health Care Professional was the reporter.  The patient received a dose of Boostrix after having had a dose of Boostrix approximately 6 months earlier which drug dose administration interval too short.    No further information is known including date vaccine was administered
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 57 year old patient received Bexsero; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 57-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included neoplasm (part of her pancreas was removed due to a tumor) and splenectomy.   In OCT-2024, the patient received the 1st dose of Bexsero. In OCT-2024, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: 57 year old patient received Bexsero). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-JAN-2025 Patient reported that she received first shot of Bexsero in early October 2024, her physician has ordered this vaccine for her due to her pre-existing medical condition. Patient received Bexsero at the age of 57 years which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: administered with a second dose on January 16th 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 39-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 33G3M, expiry date 30-JUN-2025) for prophylaxis.   Previously administered products included Flulaval (received 1st dose on 8th October 2024, batch number 33G3M, expiry date 30th June 2025.).   On 16-JAN-2025, the patient received the 2nd dose of FluLaval 2024-2025 season. On 16-JAN-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced extra dose administered (Verbatim: administered with a second dose on January 16th 2025). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-JAN-2025 Nurse mentioned that a patient who received a prior dose of FluLaval back on October 8th 2024 was administered with a second dose on January 16th 2025 which led to Extra dose administered. Lot number and expiration date were the same for both doses.
Age: 1.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Menveo was administered instead of MMR; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number X4T99, expiry date 30-SEP-2025) for prophylaxis.   Co-suspect products included MMR (MMR vaccine) for prophylaxis.   On 16-JAN-2025, the patient received Menveo. On an unknown date, the patient received MMR vaccine. On 16-JAN-2025, an unknown time after receiving Menveo and not applicable after receiving MMR vaccine, the patient experienced wrong vaccine administered (Verbatim: Menveo was administered instead of MMR). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 16-JAN-2025 The reporter reported that a patient received Menveo 1 vial was administered to a baby who was 12 months, 5 days old instead of measles vaccine, mumps vaccine, rubella vaccine which led to wrong vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Fear, Nausea
Clinical narrative: feeling very ill; feeling nauseous; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JAN-2025, the patient received the 1st dose of Shingrix. On 03-JAN-2025, less than a day after receiving Shingrix, the patient experienced nausea (Verbatim: feeling nauseous). On 07-JAN-2025, the patient experienced feeling unwell (Verbatim: feeling very ill). The outcome of the feeling unwell and nausea were not reported.   It was unknown if the reporter considered the feeling unwell and nausea to be related to Shingrix.     It was unknown if the company considered the feeling unwell and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-JAN-2025 The reporter reported that she was feeling very ill 4 days afterwards she received a first dose of Shingrix.  She was feeling nauseous 4 hours after the shot, woke up in the middle of the night.  Also said her physician was concerned of whether or not to receive the second shot, need some guidance on this topic.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Immediate post-injection reaction, Underdose, Vomiting projectile
Clinical narrative: patient projectile vomited immediately after giving it to her; Accidental underdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of vomiting projectile in a 2-month-old female patient who received Rota (Rotarix liquid formulation) (batch number HP495, expiry date 17-MAY-2026) for prophylaxis.   On 17-JAN-2025, the patient received Rotarix liquid formulation. On 17-JAN-2025, immediately after receiving Rotarix liquid formulation, the patient experienced vomiting projectile (Verbatim: patient projectile vomited immediately after giving it to her) and accidental underdose (Verbatim: Accidental underdose). The outcome of the vomiting projectile and accidental underdose were unknown.   It was unknown if the reporter considered the vomiting projectile to be related to Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator Device.     It was unknown if the company considered the vomiting projectile to be related to Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator Device.   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: 17-JAN-2025 The registered nurse stated they attempted to administer Rotarix to 2 month old and the patient projectile vomited immediately after giving it to her which led to Accidental underdose. The vaccine administration facility is the same as primary reporter.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: patient administered a second dose of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 14-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number X4T99, expiry date 30-SEP-2025) for prophylaxis.   Previously administered products included Menveo (received 1st dose on 20-SEP-2022).   On 31-JAN-2025, the patient received the 2nd dose of Menveo. On 31-JAN-2025, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: patient administered a second dose of Menveo). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 31-JAN-2025 The medical assistant reported that they administered a second dose of Menveo which led to, extra dose administered. The reporter wanted to know advise/safety concerns about this situation.  The vaccination date, vaccine detail and patient demographics were obtained from the medical assistant´s end. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Asthenia, Blood pressure increased, Pruritus
Clinical narrative: severe weakness; Anxiety; she experienced increased blood pressure; pressure in her head; itching on her left arm and left leg; This non-serious case was reported by a consumer via call center representative and described the occurrence of weakness in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In FEB-2025, the patient received the 1st dose of Shingrix. In FEB-2025, an unknown time after receiving Shingrix, the patient experienced weakness (Verbatim: severe weakness), anxiety (Verbatim: Anxiety), increased blood pressure (Verbatim: she experienced increased blood pressure), head pressure (Verbatim: pressure in her head) and pruritus (Verbatim: itching on her left arm and left leg). The outcome of the weakness, anxiety, increased blood pressure, head pressure and pruritus were unknown.   It was unknown if the reporter considered the weakness, anxiety, increased blood pressure, head pressure and pruritus to be related to Shingrix.     It was unknown if the company considered the weakness, anxiety, increased blood pressure, head pressure and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-FEB-2025 The patient who received her first dose of Shingrix vaccine 2 days prior to the reporting date and after the dose, she experienced increased blood pressure, anxiety, itching on her left arm and left leg, pressure in her head and severe weakness.