chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Electric shock sensation, Loss of personal independence in daily activities, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: She reports persistent arm pain following a vaccination, which has improved with steroid treatment. Initially, she experienced limited range of motion, necessitating support from the counter to perform tasks such as drying her hair. The pain was initially localized but has since spread to both arms and down to her fingers. She had a tingling/electric shock pain to her fingers. She also reports tingling in her fingers, reminiscent of a previous shoulder injury. She describes the sensation as similar to a rotator cuff injury, with associated tingling in her fingers. She has been using red light therapy and over-the-counter analgesics, but these have caused gastrointestinal upset. She has no history of shoulder issues, except for occasional soreness. She has received annual influenza vaccines without complications, but did not receive one this year due to illness. She was unable to lift objects above her head for weeks, and felt like she lost all strength in that arm for about one week.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: She reports persistent arm pain following a vaccination, which has improved with steroid treatment. Initially, she experienced limited range of motion, necessitating support from the counter to perform tasks such as drying her hair. The pain was initially localized but has since spread to both arms and down to her fingers. She had a tingling/electric shock pain to her fingers. She also reports tingling in her fingers, reminiscent of a previous shoulder injury. She describes the sensation as similar to a rotator cuff injury, with associated tingling in her fingers. She has been using red light therapy and over-the-counter analgesics, but these have caused gastrointestinal upset. She has no history of shoulder issues, except for occasional soreness. She has received annual influenza vaccines without complications, but did not receive one this year due to illness. She was unable to lift objects above her head for weeks, and felt like she lost all strength in that arm for about one week.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Injection site pain, Injection site reaction, Nausea
Clinical narrative: Patient returned to the pharmacy the morning after her vaccination.  She complained of a welt and soreness at the site of the injection as well as nausea/vomiting, dizziness, and fatigue.  I looked at the arm and told her that it looked within normal limits.  I asked her if she had been around any sick people and she said no, that she hadn't left the house in weeks.  I told her to rest and and if her symptoms did not improve, to see her physician.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria, Vomiting
Clinical narrative: Patient returned to the pharmacy the morning after her vaccination.  She complained of a welt and soreness at the site of the injection as well as nausea/vomiting, dizziness, and fatigue.  I looked at the arm and told her that it looked within normal limits.  I asked her if she had been around any sick people and she said no, that she hadn't left the house in weeks.  I told her to rest and and if her symptoms did not improve, to see her physician.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Urticaria
Clinical narrative: Infant developed small hives over most of her body surface area approximately 4 minutes after she was vaccinated. She was observed for 30 minutes without progression of reaction and was sent home. Mother reports the rash resolved by 2/19/25
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Decreased appetite, Immediate post-injection reaction, Lethargy, Mobility decreased
Clinical narrative: Patient's mother, reported to this RN that she is concerned about the HPV vaccination and vaccinating her son a 2nd time as the first time he was vaccinated with the vaccine it immediately took a lot out of him. His continence changed, he became lethargic and did not eat or get out of bed for several days over the entire weekend. She had never noticed this severe of a reaction in him with any other vaccine.
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Crying, Dizziness, Eye pain, Headache, Hyperacusis
Clinical narrative: Day 9 after vaccine: swollen occipital lymph node (associated with rubella) which caused a headache so bad, she was crying from the pain.  eye pain dizziness lightheadedness slight nasal congestion  noise and light sensitivity Day 10 after vaccine: a temperature of about 100 In the evening (Day 12 after vaccine) red splotches on her chest and hairline, progressed to tummy, arms, hands.  Looks like a measles rash.  Worse in the sun or with heat.  Very itchy.   Then, on 03/21/24 pain under her jaw,  She got the MMR shot just over 3 weeks ago.  about 10 days after the shot she had swollen occipital lymph node, fever and a migraine that lasted about 3 days.  the next day she had a measles looking rash that lasted 3 days.  Now swelling of salivary glands from the vaccine.  She still gets headaches to this day, never had one before the vaccine.
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Photophobia, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Day 9 after vaccine: swollen occipital lymph node (associated with rubella) which caused a headache so bad, she was crying from the pain.  eye pain dizziness lightheadedness slight nasal congestion  noise and light sensitivity Day 10 after vaccine: a temperature of about 100 In the evening (Day 12 after vaccine) red splotches on her chest and hairline, progressed to tummy, arms, hands.  Looks like a measles rash.  Worse in the sun or with heat.  Very itchy.   Then, on 03/21/24 pain under her jaw,  She got the MMR shot just over 3 weeks ago.  about 10 days after the shot she had swollen occipital lymph node, fever and a migraine that lasted about 3 days.  the next day she had a measles looking rash that lasted 3 days.  Now swelling of salivary glands from the vaccine.  She still gets headaches to this day, never had one before the vaccine.
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Salivary gland enlargement
Clinical narrative: Day 9 after vaccine: swollen occipital lymph node (associated with rubella) which caused a headache so bad, she was crying from the pain.  eye pain dizziness lightheadedness slight nasal congestion  noise and light sensitivity Day 10 after vaccine: a temperature of about 100 In the evening (Day 12 after vaccine) red splotches on her chest and hairline, progressed to tummy, arms, hands.  Looks like a measles rash.  Worse in the sun or with heat.  Very itchy.   Then, on 03/21/24 pain under her jaw,  She got the MMR shot just over 3 weeks ago.  about 10 days after the shot she had swollen occipital lymph node, fever and a migraine that lasted about 3 days.  the next day she had a measles looking rash that lasted 3 days.  Now swelling of salivary glands from the vaccine.  She still gets headaches to this day, never had one before the vaccine.
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: Patient was seen by PCP yesterday 02/18/2025. Patient reported extreme pain right after from the HPV vaccine received 01/27/2025. Provider asked why patient did not seek help immediately, per patient about to go to ER that day but eventually went after few days and arm pain still experiencing. During PCP visit yesterday 02/18/2025, presenting for sudden onset pain, numbness, and weakness in right arm. Reports had HPV vaccine #2 placed in her right arm on 1/27/25 (although per documentation by LVN, vaccine was placed in left arm). Patient verbalized vaccine was given on right arm, not on left arm.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: 10 minutes after receiving Heplisav B vaccine at OH Clinic client reported feelings of itching on bilateral arms from shoulders to wrists. Itching progressed to front of neck, upper chest, lower back and bilateral upper portion of legs.   0940 administered 25mg Benadryl one time dose with improvement after dose.  Vital signs stable
Age: 1.25
Sex: M
Vaccine: MMRV, PNC20, VARCEL
Symptoms: Wrong product administered
Clinical narrative: MMRV given instead of MMR
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Eye swelling, Nausea, Ocular hyperaemia, Vomiting
Clinical narrative: Pt reports varicella vaccination at 0950, started eye redness, swelling approx 1030. now reports SOB and trouble breathing, intermittent nasuea, no vomiting maintaining airway in triage. denies taking anything prior to arrival  Patient is a 19-year-old male otherwise healthy presented to the emergency department for concerns of difficulty breathing, swollen left eye, nausea and vomiting that started this morning.  Patient states that this morning he took the fitness test, afterwards he presented to clinic to receive his varicella vaccine shortly after that time patient went home and began experiencing 2 episodes of nausea and vomiting.  1 of his friends noticed that his left eyelid looked swollen. patient was not aware of this at that time.  Additionally he endorsed feeling short of breath.  So he came to the emergency department.  He is not aware of any allergies, has not had an allergic reaction in the past.  Denies any new medications.  Denies any issues/illness prior to the fitness test this morning.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given a pediatric dose of recombivax instead of adult dose. No current symptoms being reported.
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site reaction
Clinical narrative: PT CALLED REPORTING INJECTION SITE REACTION ON 2/19/2025 AT AROUND 10:18 AM AND TOLD ME THERE IS A DEFINED RED BORDER WHERE SHE WAS INJECTED. SHE NOTICED IT LAST NIGHT AND TOOK AN ANTIHISTAMINE (DID NOT REPORT WHICH ONE) AND IT WAS SPLOCHY AND EXTENDED AT LEAST 1 INCH AWAY FROM INJECTION POINT. PT REPORTS NO FEVER OR PAIN DURING OUR CALL. I SUGGESTED FOR HER TO GO TO URGENT CARE AFTER WORK IF THINGS DO NOT GET BETTER.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis, Pain in extremity, Ultrasound scan, X-ray limb
Clinical narrative: Patient received injection of Tdap to right arm and later that night it begin to get sore. Came and saw a provider a few days later and she was dx with bursitis.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: dizziness after vaccine
Age: 37.0
Sex: M
Vaccine: HPV9
Symptoms: Condition aggravated, Injection site pain, Joint dislocation
Clinical narrative: Patient described the vaccine as extremely painful when administered, unlike the first dose and felt like it contributed to her shoulder popping out of her socket. Patient reported swelling, and inflammation, but I observed no abnormalities when I compared her right and left arm in person on 2/19/2025 at 11 AM, but vaccine was administered on 2/11/2025. She reported her shoulder being partially dislocated during this time. Her physical therapist recommended patient reach to the pharmacy to inform us in which I has patient present to the pharmacy to observe.
Age: 64.0
Sex: F
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED 2 TDAP VACCINES WITHIN 9 MONTH PERIOD (MAY 2024 AND FEB 2025)
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Pyrexia, Swelling
Clinical narrative: Fever and Chills for 24 hours, Swelling and redness for 6 days
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Induration, Swelling, Urticaria, Vomiting
Clinical narrative: 11:35am MMR vaccine given. 11:36am tennis ball sized area of redness with induration and swelling. 11:55 vomiting. 12:00, hives began to form on the other arm. Vitals and respiratory status stable on room air. Epinephrine given and 911 contacted to transport to the hospital for monitoring.
Age: 57.0
Sex: M
Vaccine: PNC21
Symptoms: Chills, Confusional state, Fatigue, Poor quality sleep, Speech disorder
Clinical narrative: Chills, confusion, babbling approx 13 hours after vaccination. Poor sleep that night. Lingering intermittent confusion and fatigue the following day
Age: 1.58
Sex: F
Vaccine: COVID19, HEPA
Symptoms: Urticaria
Clinical narrative: Hives, administered 1.5mL of Benadryl orally in office
Age: 70.0
Sex: F
Vaccine: CHIK
Symptoms: Arthralgia, Chikungunya virus infection, Chills, Myalgia, Night sweats
Clinical narrative: Worsening signs/symptoms of chikungunya - chills, night sweats, severe muscle and joint pain that has worsened;
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: PATIENT REPORTED EXPERIENCING TINNITUS 6-8 WEEKS AFTER INJECTION. HE HAD A FOLLOW UP WITH AN AUDIOLOGIST AND IT WAS CONFIRMED ON 01/2022. PATIENT STATED HE NEVER HAD TINNITUS PRIOR.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear pain, Pain, Pyrexia, SARS-CoV-2 test, Sinus congestion
Clinical narrative: Fever, head congestion, left ear pain, body aches
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: Sudden onset tinnitus/dizziness 6 months after injection. No prior hearing issues before injection.  Tinnitus has continued to present day. GP and ENT tried treatment with oral and nasal steroids but nothing has made it subside.
Age: 77.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: big red reaction around injection site with inflamation and pain down to elbow -- now gone
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: none from this vaccine
Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV, FLU3, MMRV
Symptoms: No adverse event
Clinical narrative: no other symptoms noted after vaccination other than the ones patient initially arrived to the clinic with.
Age: 0.58
Sex: M
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: NO ADVERSE REACTION- The HIB vaccine was ordered and administered too early for the patient. Dr spoke to parent on phone and had child follow up in office 2 days later. No adverse reaction, child was cleared.
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient states that by the end of the day on 2/4/25 after receiving the vaccine she developed swelling, itching, redness, and pain around the injection site. She also stated that the swelling and redness spread to her underarm area at some point. She called me on 2/28/25 to report the symptoms and stated that the symptoms are still persisting at 2 weeks post vaccination. She also told me that she had an adverse reaction to a different vaccine in the past but it did not last for 2 weeks.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, FLU3, PNC20, RV5
Symptoms: Crying, Erythema, Rash, Rash erythematous
Clinical narrative: After the patient received the vaccines she broke out on her face, she had red spots just on her face. The rest of her body was free of any signs. The patient was crying after vaccines and skin turned red but after patient calmed down red spots remained.
Age: 54.0
Sex: F
Vaccine: RSV
Symptoms: Unevaluable event
Clinical narrative: pt at skilled nursing home under 60 immunocompromised got the RSV vaccine
Age: 1.0
Sex: M
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Acute haemorrhagic oedema of infancy, Autism spectrum disorder, Blister, Erythema, Laboratory test
Clinical narrative: We went to a friends house and he was okay for an hour, Then he went with my mom and he started getting red blisters all over his body. And she took him hospital and i met them there around 5. We were there all night and he was admitted for 5 days and he had acute hemporric edmea of infancy. In 2017 there were only 5 cases reported. It took 21 days for it to go away and it took 5 docs to diagnose him. And he is now autistic.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: arm pain to right side injection site
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Received the Arexvy vaccine on 10/24/2023.  Patient did not remember getting the vaccine and the Pharmacist inappropriately gave another dose of Arexvy on 02/16/2025.   Spoke with patient on 02/19/2025.  He is not experiencing any side effects from the vaccine .
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site reaction, Injection site urticaria, Urticaria
Clinical narrative: Local hive/urticarial rash at site of injections on right arm.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 doses of Beyfortus vaccine about 4 weeks apart. (1/4/25 & 2/3/25). No adverse outcomes noted to date. Parent notified of the vaccine administration on 2/3/25
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Patient with area of confluent erythema along right upper arm, overlying the deltoid area. Spanning approximately 10cm in length x 7.5cm in width. Area was marked with surgical marker. -most distal area of induration is slightly tender to touch and warmer than surrounding  area -denes fever, chills -states that initially area was very itchy and then redness spread to larger area  Patient was in clinic today for flu immunization. After immunization patient notified this RN that she had a question. She notified this RN she was given the pneumonia vaccine last week and now has a reddened area. Patient proceeded to take how other arm out of her sleeve of her jacket and pull up the sleeve of her shirt. The deltoid region of her left arm was exposed where there was a red circle that covered most of her deltoid region. This RN touched patients arm where reddened area was and felt area was warm to touch. There was no other abnormalities and patient denies chills, fever, n/v/d, light headed or dizziness. She notes mild arm discomfort when moving. This RN notified patients PCP who provided this RN with supportive measures for patient and strict instruction to return to clinic if not better in 48 hours.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site warmth, Limb discomfort, Skin warm
Clinical narrative: Patient with area of confluent erythema along right upper arm, overlying the deltoid area. Spanning approximately 10cm in length x 7.5cm in width. Area was marked with surgical marker. -most distal area of induration is slightly tender to touch and warmer than surrounding  area -denes fever, chills -states that initially area was very itchy and then redness spread to larger area  Patient was in clinic today for flu immunization. After immunization patient notified this RN that she had a question. She notified this RN she was given the pneumonia vaccine last week and now has a reddened area. Patient proceeded to take how other arm out of her sleeve of her jacket and pull up the sleeve of her shirt. The deltoid region of her left arm was exposed where there was a red circle that covered most of her deltoid region. This RN touched patients arm where reddened area was and felt area was warm to touch. There was no other abnormalities and patient denies chills, fever, n/v/d, light headed or dizziness. She notes mild arm discomfort when moving. This RN notified patients PCP who provided this RN with supportive measures for patient and strict instruction to return to clinic if not better in 48 hours.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Dermatitis atopic
Clinical narrative: Patient reported that  the 1st time they started developing skin issues (atopic dermatitis) was within about two months after receiving their 2nd dose of the Moderna COVID-19 vaccination.  They now require use of over the counter and prescription medications to manage atopic dermatitis. The vaccinations were received at a local pharmacy (not the pharmacy of the reporting RPH) on an unknown date. Patient unable to provide additional specifics on the vaccine details at time of reporting. Any follow-up on this report should be completed by calling the patient directly.
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Gave three does in one with no diluent
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Pain, Rash
Clinical narrative: Patient developed a rash on the R abdomen, nausea, dizziness, and R sided pain. Symptoms occurred the day after she was vaccinated with dose #1 of the Shingrix vaccine series.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness, vertigo
Sex: F
Vaccine: COVID19
Symptoms: Biopsy colon abnormal, Colitis microscopic, Colonoscopy abnormal, Diarrhoea, Laboratory test abnormal
Clinical narrative: On Feb 20, 2021, I received my first Covid vaccine (Pfizer). 15 days later, after 2 weeks of watery diarrhea and a 15-pound weight loss, I was admitted to the hospital for 6 days. A colonoscopy biopsy revealed microscopic colitis (MC). Pervious routine colonoscopies were normal with 1-2 benign polyps. IV steroids immediately stopped the diarrhea and I was discharged on Budesonide. I never made the association of the vaccine and MC until recently when I came across an article noting the several such cases had been reported. July 28, 2024, I was hospitalized again for 5 days for a recurrence of MC. I was treated with IV steroids and discharged on Prednisone. As soon as I tapered to 5 mg a day, the watery diarrhea returned. I was readmitted 6 weeks later for 12 days. A complete GI workup was done, only positive finding was MC. I am currently tapering off Budesonide.
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: On Feb 20, 2021, I received my first Covid vaccine (Pfizer). 15 days later, after 2 weeks of watery diarrhea and a 15-pound weight loss, I was admitted to the hospital for 6 days. A colonoscopy biopsy revealed microscopic colitis (MC). Pervious routine colonoscopies were normal with 1-2 benign polyps. IV steroids immediately stopped the diarrhea and I was discharged on Budesonide. I never made the association of the vaccine and MC until recently when I came across an article noting the several such cases had been reported. July 28, 2024, I was hospitalized again for 5 days for a recurrence of MC. I was treated with IV steroids and discharged on Prednisone. As soon as I tapered to 5 mg a day, the watery diarrhea returned. I was readmitted 6 weeks later for 12 days. A complete GI workup was done, only positive finding was MC. I am currently tapering off Budesonide.
Sex: U
Vaccine: MENB
Symptoms: Inadvertent injection air bubble
Clinical narrative: Bexsero (GSK) vaccine - Lot #: 52N4S - product consistently contains air bubble that is not able to be dislodged through manual manipulation. Air bubble is therefore injected into patient with every dose, or significant volume loss occurs. This has happened with all lots for several months.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic aneurysm, Atrioventricular block, COVID-19, Death, Laboratory test abnormal
Clinical narrative: Resident admitted to facility for rehab. He had significant fall and was hospitalized where they found possible cancer, heart block, sepsis and AAA. He was given the covid vaccine on 02/08/2025. On 02/11/2025, he tested positive for covid. While doing rounds, he was found sitting in his chair. He passed away.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary mass, SARS-CoV-2 test positive, Sepsis
Clinical narrative: Resident admitted to facility for rehab. He had significant fall and was hospitalized where they found possible cancer, heart block, sepsis and AAA. He was given the covid vaccine on 02/08/2025. On 02/11/2025, he tested positive for covid. While doing rounds, he was found sitting in his chair. He passed away.
Age: 106.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Feeling abnormal, Oxygen saturation decreased, SARS-CoV-2 test negative
Clinical narrative: Resident was given the covid vaccine on 02/08/2025. On 02/09/2025, she developed SOB, "not feeling good" and POX dropped to 78% on RA. She was placed on oxygen and POX came back up to 93%. CXR was refused by family, but aerosol treatments were given with some relief. She was on hospice for heart failure, and she passed away on 02/12/2025. She had no s/s of covid and tested negative on 02/09/2025. Manufacturer/Lot#: Comirnaty LN0591 with exp date of 04/24/2025.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Pain, Pyrexia
Clinical narrative: Received first dose of Shingrix, 26 Nov 2025 with little to no side effects. Received second dose of Shingrix 17 Feb 2025 at approximately 3pm. Body aches began at approximately 10pm the day of the vaccination. At 9am on 18 Feb 2025 have 101F fever, body aches and diarrhea.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: While Reconstituting product syringe broke off cleanly from vial adaptor. Unable to determine if vaccine was still safe to give.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported AE on behalf of a patient who was administered improperly stored PEDVAXHIB on 2/4/2025 that experienced a TE on 1/31/2025. No symptoms reported. No additional AE details reported. Obtained consent to contact HCP. TE Filed (Case #02749; This spontaneous report has been received from a nurse, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 04-FEB-2025, the patient was vaccinated with an improperly stored dose of with improperly storage dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) at a dose of 0.5 milliliter (ml), lot number Y006392 which was determined to be valid, with an expiration date on 08-NOV-2026) as prophylaxis (vaccination scheme, route of administration, and anatomical site of injection were not reported).  Administered doses were stored at a temperature of 10.22 degrees Celsius (C), during a time frame of 22 hours and 50 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported in the patient.
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: a 45 year old female received a pediatric/adolescent dose of VAQTA.; No additional AE reported; This spontaneous report was received from a medical assistant and refers to a 45-year-old female patient. The patient's medical history, concurrent conditions and Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with a pediatric/adolescent dose of Hepatitis A Vaccine, Inactivated (VAQTA), suspension for injection (dose, route, strength, lot # and expiration date were not reported) for prophylaxis (underdose). No additional adverse event reported (no adverse event).  Lot# is being requested and will be submitted if received.
Age: 18.0
Sex: U
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: The office mistakenly administered a 3rd dose of Bexsero January 8, 2025; This non-serious case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a 18-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (a patient received two Bexsero doses (one month apart) in 2023) and Bexsero (a patient received two Bexsero doses (one month apart) in 2023).   On 08-JAN-2025, the patient received the 3rd dose of Bexsero. On 08-JAN-2025, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: The office mistakenly administered a 3rd dose of Bexsero January 8, 2025). The outcome of the extra dose administered 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: 20-JAN-2025 Nurse reported that a patient received two Bexsero doses (one month apart) in 2023.  The office mistakenly administered a 3rd dose of Bexsero January 8, 2025 which led to extra dose administered.
Sex: F
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: Pain seems to be in the patient's left bicep; This non-serious case was reported by a other health professional and described the occurrence of localized muscle pain in a 76-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number M77CC, expiry date 19-MAR-2027) for prophylaxis.   On 30-DEC-2024, the patient received Boostrix (intramuscular) .5 ml. On 30-DEC-2024, an unknown time after receiving Boostrix, the patient experienced localized muscle pain (Verbatim: Pain seems to be in the patient's left bicep). The outcome of the localized muscle pain was not resolved.   It was unknown if the reporter considered the localized muscle pain to be related to Boostrix.     It was unknown if the company considered the localized muscle pain to be related to Boostrix.   Additional Information: GSK receipt date: 13-JAN-2025 Other HCP reported that a patient had muscle pain which seem to be in the patient's left bicep.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Severe joint pain was reported as worsened; This non-serious case was reported by a nurse via sales rep and described the occurrence of joint pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced joint pain (Verbatim: Severe joint pain was reported as worsened). The outcome of the joint pain was not resolved.   The reporter considered the joint pain to be related to Shingrix.     The company considered the joint pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JAN-2025 Severe joint pain was reported as worsened. Patient was otherwise healthy before first dose was administered.  A week later, the patient complained of severe joint pain.  They were referred to rheumatologist, and the labs were all normal according to the provider.
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: injected arm still hurts/ pain; injected arm has limited mobility; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: injected arm still hurts/ pain) and injected limb mobility decreased (Verbatim: injected arm has limited mobility). The outcome of the pain in arm and injected limb mobility decreased were not resolved.   It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Shingrix.     It was unknown if the company considered the pain in arm and injected limb mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-JAN-2025 Patient was the reporter. Patient had the Shingrix vaccine in October 2024, and his/her injected arm still hurt and had limited mobility.  He/she read that he/she was supposed to take pain relievers, but patient was asking whether they need to take it forever. He/she did not want to take the second dose because the pain continued.  Patient never had any reaction to any other vaccine, although he/she vaccinated on a recommended schedule for any and all other vaccines.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult female patient received pediatric dose of Engerix B; adult female patient received pediatric dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 39-year-old female patient who received HBV (Engerix B 10 mcg) for prophylaxis.   On 17-JAN-2025, the patient received the 3rd dose of Engerix B 10 mcg. On 17-JAN-2025, an unknown time after receiving Engerix B 10 mcg, the patient experienced adult use of a child product (Verbatim: adult female patient received pediatric dose of Engerix B) and underdose (Verbatim: adult female patient received pediatric dose). The outcome of the adult use of a child product and underdose were not applicable.   Additional Information: GSK Receipt date: 22-JAN-2025 The registered nurse reported that an adult female patient received pediatric dose of Engerix B 10 mcg as a third dose which led to underdose and adult use of a child product.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, Product preparation error
Clinical narrative: The patient received a prior dose of Shingrix back on September 26th 2023 (unknown lot number and expiration date), and the second dose was given on January 8th 2025.; Second dose was the one who was mixed with a different diluent,; Second dose was the one who was mixed with a different diluent,; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26-SEP-2023).   On 08-JAN-2025, the patient received the 2nd dose of Shingrix. On 08-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: The patient received a prior dose of Shingrix back on September 26th 2023 (unknown lot number and expiration date), and the second dose was given on January 8th 2025.), wrong solution used in drug reconstitution (Verbatim: Second dose was the one who was mixed with a different diluent,) and inappropriate dose of vaccine administered (Verbatim: Second dose was the one who was mixed with a different diluent,). The outcome of the drug dose administration interval too long, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-JAN-2025 The medical assistant reported that  a patient received prior dose of Shingrix back on September 26th 2023 (unknown lot number and expiration date), and the second dose was given on January 8th 2025, which led to drug dose administration interval too long. Second dose was the one who was mixed with a different diluent, and the diluent pertains to an MMR vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: it hurt like hell/ sore arm; barely move his/her arm for a day; 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.   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 pain in arm (Verbatim: it hurt like hell/ sore arm) and mobility decreased (Verbatim: barely move his/her arm for a day). The outcome of the pain in arm was not reported and the outcome of the mobility decreased was resolved.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and mobility decreased to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2025AMR010517   Additional Information: GSK Receipt Date: 25-JAN-2025 This case was reported by a patient via interactive digital media. Patient was the reporter. It was fine for him/her.  But of course everyone was different. It was 2 shots and it hurt like hell. Especially the 2nd shot.  If he/she recalled, he/she could barely move his/her arm for a day or so.  He/she had been vaccinated for shingles for 7 years with no problems other than a sore arm when he/she got the shots. For tolerance to 2nd dose, refer case US2025AMR010517.; Sender's Comments:  US-GSK-US2025AMR010517:same patient, second dose
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient didn't get the 2nd dose (of Twinrix), it's been 2 months since the 1st dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix and an unknown time after receiving TWINRIX, the patient experienced incomplete course of vaccination (Verbatim: patient didn't get the 2nd dose (of Twinrix), it's been 2 months since the 1st dose). The outcome of the incomplete course of vaccination 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: 22-JAN-2025 A pharmacist called to inform that a patient did not get the 2nd dose of Twinrix, it's been 2 months since the 1st dose. According to reporter, the 1st dose of Twinrix was administered back on 26th November 2024. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination.
Sex: U
Vaccine: RSV
Symptoms: Intercepted product storage error
Clinical narrative: the products were received by the warehouse at below freezing temperature; This non-serious case was reported by a consumer via sales rep and described the occurrence of intercepted product storage error in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted product storage error (Verbatim: the products were received by the warehouse at below freezing temperature). The outcome of the intercepted product storage error was not applicable.   Additional Information: GSK receipt date: 22-JAN-2025 Reporter stated that a delivery truck that was involved in inclement weather and the products were received by the warehouse at below freezing temperature. Reporter had an invoice detailing the medication on the delivery truck. One of those products was Arexvy, however, quantity was unknown. No further information was known including names of medication on the delivery truck, quantity, or lot numbers. Products were received by the warehouse at below freezing temperature, which led to intercepted product storage error.
Age: 0.33
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient was 4 months old at that time), and was administered a FluLaval vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 79K45, expiry date 01-JUN-2025) for prophylaxis.   On 13-NOV-2024, the patient received FluLaval 2024-2025 season. On 13-NOV-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: patient was 4 months old at that time), and was administered a FluLaval vaccine). 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: 24-JAN-2025 The medical assistant reported that a patient who was currently 6 months old was seen in clinic on 13-Nov-2024 (patient was 4 months old at that time), and was administered a FluLaval vaccine, which led to inappropriate age at vaccine administration. At that time no one caught that the patient was too young for the vaccine, now the patient was back in clinic for 6 month visit and the error was discovered.  The medical assistant reports the patient was fine and had no reactions.  The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a one-year-old patient received a dose of Kinrix.; Kinrix administered instead of Infanrix.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   On 21-JAN-2025, the patient received Kinrix. On an unknown date, the patient did not receive Infanrix. On 21-JAN-2025, an unknown time after receiving Kinrix and not applicable after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a one-year-old patient received a dose of Kinrix.) and wrong vaccine administered (Verbatim: Kinrix administered instead of Infanrix.). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 24-JAN-2025 The nurse reported that a one-year-old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration. Reporter mentioned that the intention was to give Infanrix to that patient instead, which led to wrong vaccine administered.
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Mistaken administration of a FLULAVAL instead of a FLUZONE High Dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 71-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number J5T9Z, expiry date 06-JUN-2025) for prophylaxis.   Co-suspect products included Influenza vaccine inact split 3v (Fluzone high dose) for prophylaxis.   On 29-JAN-2025, the patient received FluLaval 2024-2025 season. On an unknown date, the patient received Fluzone high dose. On 29-JAN-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced wrong vaccine administered (Verbatim: Mistaken administration of a FLULAVAL instead of a FLUZONE High Dose). The outcome of the wrong vaccine 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: 30-JAN-2025 The reporter reported that a patient mistaken administration of a Flulaval instead of a fluzone high dose in a seventy one year old patient which led to wrong vaccine administered. Vaccination date, vaccine detail and patient demographics were provided from the registered nurse end.  No further information was obtained in this call.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not get the second dose at two to six months; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not get the second dose at two to six months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-FEB-2025 The physician reported that the patient received her first Shingles vaccine and did not get the second dose at two to six months. The reporter did not have a lot number or NDC number and states she does not remember which arm dose was given.   She had no side effects from the first dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient should be revaccinated after receiving an expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 52X45, expiry date 31-DEC-2024) for prophylaxis.   On 17-FEB-2025, the patient received Menveo. On 17-FEB-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: patient should be revaccinated after receiving an expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 17-FEB-2025 The health care provider called to ask if a patient should be revaccinated after receiving an expired dose of Menveo (1 vial) on the day of reporting. The patient recived expired dose of Menveo which led to, expired vaccine used. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: interval between first dose and second dose of Shingrix was too long; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11-NOV-2022).   On 05-NOV-2024, the patient received the 2nd dose of Shingrix. On 05-NOV-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: interval between first dose and second dose of Shingrix was too long). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 17-FEB-2025 The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not have lot number or expiration dates for any of the 2 vaccines administered.
Age: 75.0
Sex: M
Vaccine: CHIK
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: Fever; The following information was received from a nurse on 31 Dec 2024.  A 75-year-old male received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number 24B011) on 13 Dec 2024.   Two days later, on 15 Dec 2024, he experineced fever, fatigue and malaise.   The outcome of the events was reported as not resolved.  Case is linked to case US-INTERCELLP-6625 (wife with same events).; Sender's Comments: Causality assessed as possibly related, as time to onset is plausible (2 days past vaccination) and as Fever and Fatigue are well known for IXCHIQ and Malaise can be seen in the same context as abnormal/ill feeling. All reactions are indicative of a systemic vaccination reaction.