chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: On Saturday night, June 14, 2025, 30 hours after receiving the vaccine, I had terrible stomach cramps, vomiting, diarrhea and the most violent shivering that lasted 30 minutes.  I almost called the emergency room.  The shivering was like a seizure in that I could not control my limbs (arms and legs) which were moving very quickly and violently.  I also had difficulty breathing in that my throat seized up and I could breathe only shallowly and rapidly in an effort to control the violet shivering.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events pt just had already received vaccine in 2023
Age: 50.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Fatigue, Paraesthesia
Clinical narrative: PATIENT COMPAINT OF TINGLING WITHOUT ANY RESPIRATORY DISTRESS. PT CAN'T DESCRIBE SYMPTOMS BUT SAYS TIRED AND TINGLING FEELING
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Feeling jittery, Nasopharyngitis
Clinical narrative: PT CAME BACK IN 5 MINUTES LATER AFTER VACCINATION.  PT EXPERIENCE JITTERY, COLD SYMPTOMS, DIZZINESS. 5 MINUTES LATER, PT  TOLD ME THAT SHE COULDN'T BREATH. CALL 911 . PT HAD TAKEN TO  THE ER
Age: 76.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injection site dryness, Pain in extremity
Clinical narrative: per patient, the day after immunization, her arms were sore and then a small area of dry, patchy skin appeared in the same spot she got the two immunizations on each arm. She described it as having a raised, dry feeling when touched. She is dark skinned so the spot is not visible, can just tell by touch. It is not painful to the touch. The spots are still present 2 months after administration. She uses non-scented soap. She applies moisturizing lotion to the places every night after taking a bath. Patient has an upcoming appointment with her provider for routine check up, advised her to get her provider to look at those areas of skin.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Rheumatic disorder
Clinical narrative: Patient described the symptoms similar to rheumatic flares with extreme total body involvement.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dizziness, Fatigue, Heart rate increased, Laboratory test
Clinical narrative: Dizziness/faint, racing heart, fatigue, got covid 2 days after the event.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Syncope
Clinical narrative: Dizziness/faint, racing heart, fatigue, got covid 2 days after the event.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: Death due to Cardiac arrest
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Condition aggravated, Vertigo
Clinical narrative: Symptoms of vertigo after getting the booster shot. Not sure it was related to the vaccine since I?ve had vertigo before and it can recur I think.!
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the 6 month window for second dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (received 1st dose of vaccine on an unknown date).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: missed the 6 month window for second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 13-JUN-2025 This case was reported by a patient via interactive digital media. It had been 8 months since he/she had received his/her first shingles vaccine; he/she had missed the 6-month window for the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Infanrix expired (less than 30 days) dose administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-month-old female patient who received DTPa (Infanrix) (batch number GG39D, expiry date 05-JUN-2025) for prophylaxis.   On 12-JUN-2025, the patient received the 4th dose of Infanrix. On 12-JUN-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Infanrix expired (less than 30 days) dose administration). The outcome of the expired vaccine used 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: 13-JUN-2025 A Licensed Practical Nurse wanted to know how to proceed after administering an expired dose of Infanrix on 12th June 2025 to a patient, which led to Expired vaccine used. It was intended to be the fourth dose in the immunization schedule.
Age: 33.0
Vaccine: UNK
Symptoms: Off label use
Clinical narrative: Intentional Off Label Prescription by HCP: Imovax prescribed with off labe ldiagnosis Bitten by dog, initial encounter, with no reported adverse event; Initial information received on 18-Jun-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 33-year-old and unknown gender patient who was intentionally prescribed with IPV (VERO) [Imovax] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a intentional prescription of 1ml  dose of suspect IPV (VERO) Suspension for injection, frequency-4 times (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for bitten by dog, initial encounter (Animal bite) with no reported adverse event (off label use).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Pain in extremity, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: My arm began to experience pain, swelling from shoulder to wrist, hives, itching, & bruising. The pain started short after the injection, however, I didn?t realize my arm was in hives until around  4 or 5 hours because the itching wouldn?t stop. I took an antihistamine of Claritin, hydrocortisone ointment, I applied aloe, cold cloth thru out the day.  Today is 6/22/25 and my arm still has a bruise, slight pain on the bruise, & minor swelling.  It?s much better, but not 100%.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Agitation, Amnesia, Computerised tomogram head normal, Delusion, Dizziness
Clinical narrative: My daughter had numbness go down her riight ring finger, then middle, then index and thumb.  She felt like she had an explosion on the right side of her head.  The headache intensified until she felt nauseous.  Then she had trouble visually focusing , she repeatedly stated she couldn't think, asked what happened, had short-term memory loss. I took her to the ER.  She had a CT scan done to her head which revealed no skull fractures or issues with any veins.  As she was in the ER she became increasingly agitated and irritable.  She started slurring her speech.  She had trouble staying awake.  She was given Tylenol and Zofran and sent home with me.  She vomited 5 times after she got home.  She called her face a foot, her glasses contacts, her shoes she called glasses.  Eventually she fell asleep. (the doctor said it was ok to let her sleep). She slept for 17 hours. Woke up with headache and dizziness.  She has had a headache ever since and today is 6/22/25.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dysarthria, Headache, Hypersomnia, Hypoaesthesia, Irritability
Clinical narrative: My daughter had numbness go down her riight ring finger, then middle, then index and thumb.  She felt like she had an explosion on the right side of her head.  The headache intensified until she felt nauseous.  Then she had trouble visually focusing , she repeatedly stated she couldn't think, asked what happened, had short-term memory loss. I took her to the ER.  She had a CT scan done to her head which revealed no skull fractures or issues with any veins.  As she was in the ER she became increasingly agitated and irritable.  She started slurring her speech.  She had trouble staying awake.  She was given Tylenol and Zofran and sent home with me.  She vomited 5 times after she got home.  She called her face a foot, her glasses contacts, her shoes she called glasses.  Eventually she fell asleep. (the doctor said it was ok to let her sleep). She slept for 17 hours. Woke up with headache and dizziness.  She has had a headache ever since and today is 6/22/25.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Mental impairment, Nausea, Somnolence, Vision blurred, Vomiting
Clinical narrative: My daughter had numbness go down her riight ring finger, then middle, then index and thumb.  She felt like she had an explosion on the right side of her head.  The headache intensified until she felt nauseous.  Then she had trouble visually focusing , she repeatedly stated she couldn't think, asked what happened, had short-term memory loss. I took her to the ER.  She had a CT scan done to her head which revealed no skull fractures or issues with any veins.  As she was in the ER she became increasingly agitated and irritable.  She started slurring her speech.  She had trouble staying awake.  She was given Tylenol and Zofran and sent home with me.  She vomited 5 times after she got home.  She called her face a foot, her glasses contacts, her shoes she called glasses.  Eventually she fell asleep. (the doctor said it was ok to let her sleep). She slept for 17 hours. Woke up with headache and dizziness.  She has had a headache ever since and today is 6/22/25.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine, Cardiac disorder, Cardiac stress test, Cardiomyopathy, Computerised tomogram heart
Clinical narrative: Initially, sore arm, fatigue, no major illness detected. Within 3 months, I developed a heart condition. I assumed it would go away or get better. Combine that with my career (Pilot), I can't have medical tests that will show adversely against my medical. I didn't test anything until March 2024 when I was diagnosed with cardiomyopathy, low ejection fraction.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Ejection fraction decreased, Electrocardiogram, Fatigue, Haematocrit
Clinical narrative: Initially, sore arm, fatigue, no major illness detected. Within 3 months, I developed a heart condition. I assumed it would go away or get better. Combine that with my career (Pilot), I can't have medical tests that will show adversely against my medical. I didn't test anything until March 2024 when I was diagnosed with cardiomyopathy, low ejection fraction.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Pain in extremity, Scan with contrast
Clinical narrative: Initially, sore arm, fatigue, no major illness detected. Within 3 months, I developed a heart condition. I assumed it would go away or get better. Combine that with my career (Pilot), I can't have medical tests that will show adversely against my medical. I didn't test anything until March 2024 when I was diagnosed with cardiomyopathy, low ejection fraction.
Age: 64.0
Sex: F
Vaccine: HEP, PNC21
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at injection site
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: duplicate
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chromosomal analysis, Computerised tomogram head, Flow cytometry, Full blood count, Headache
Clinical narrative: Bedridden x2 days, headache, tinnitus, Mantel Cell Lymphoma.  Headache began immediately after, tinnitus soon after, Mantel Cell Lymphoma diagnosis 1/2025
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Laboratory test, Mantle cell lymphoma, Mobility decreased, Next-generation sequencing
Clinical narrative: Bedridden x2 days, headache, tinnitus, Mantel Cell Lymphoma.  Headache began immediately after, tinnitus soon after, Mantel Cell Lymphoma diagnosis 1/2025
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Positron emission tomogram, Tinnitus
Clinical narrative: Bedridden x2 days, headache, tinnitus, Mantel Cell Lymphoma.  Headache began immediately after, tinnitus soon after, Mantel Cell Lymphoma diagnosis 1/2025
Age: 36.0
Sex: F
Vaccine: IPV, YF
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash/swelling/tenderness/itching @ site of yellow fever injection 4.5 x 5.5 cm area of erythema.
Vaccine: COVID19
Symptoms: Blood test, Blood test abnormal
Clinical narrative: Took blood test and it is just so in there; The initial case was missing the following minimum criteria: specific adverse event. Upon receipt of follow-up information on 22Jun2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a consumer.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: BLOOD TEST ABNORMAL (non-serious), outcome "unknown", described as "Took blood test and it is just so in there". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It is about the Pfizer COVID-19 vaccine, just the side effects. When asked about the side effect, the patient did not know, they did the test and they were quiet about it. The patient took blood test and it is just so in there, the patient was not saying, it's according to them. The patient took all the shots from number one to last one (COVID-19 vaccine) and did not know. The patient just worries about it, the patient just wants some to relax the settlement. When clarified if patient needed settlement, the patient said not really, and was doing all right. The patient did not want it, but was just complaining about it.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 31.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Burning sensation, Chest X-ray normal, Chest discomfort, Chest pain, Dizziness
Clinical narrative: 1st dose of Anthrax vaccine (AVA) to his left arm at 1100 on 29 October 2024.  He was feeling well on the day of immunization, and received no other vaccines that day. Immediately following the injection, he reports feeling a burning sensation at the injection site which extended down his arm and into to his fingers. He then began feeling very lightheaded and nauseated. He felt better after drinking some water and was able to leave the clinic after 15 minutes. He denies any rash, flushing, vomiting, wheezing, or angioedema. While driving from the clinic he began to feel mild left sided arm and chest tightness (about 20-25 mins after the injection). The chest tightness increased over the next few hours, and he began having difficulty taking a deep breath. He also experienced soreness/pain to his teeth and tingling to his left hand and fingers. His reports that his left arm appeared red and itchy around the injection site for several days, but he never developed a diffuse rash.  His symptoms improved, however he still had lingering left arm soreness and mild left sided chest tightness, and mild SOB both with and without exertion. He received the second dose on 12/5/2024 and had a similar reaction. He has a normal EKG and CXR a few days later. He continues with continued to experiences chronic chest pain and is undergoing Cardiology eval (ECHO and EKD are normal so far, pending CT angio). Allergy and Immunology workup stating "non-IgE" rection.
Age: 31.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Dyspnoea, Dyspnoea exertional, Echocardiogram normal, Electrocardiogram normal, Immediate post-injection reaction
Clinical narrative: 1st dose of Anthrax vaccine (AVA) to his left arm at 1100 on 29 October 2024.  He was feeling well on the day of immunization, and received no other vaccines that day. Immediately following the injection, he reports feeling a burning sensation at the injection site which extended down his arm and into to his fingers. He then began feeling very lightheaded and nauseated. He felt better after drinking some water and was able to leave the clinic after 15 minutes. He denies any rash, flushing, vomiting, wheezing, or angioedema. While driving from the clinic he began to feel mild left sided arm and chest tightness (about 20-25 mins after the injection). The chest tightness increased over the next few hours, and he began having difficulty taking a deep breath. He also experienced soreness/pain to his teeth and tingling to his left hand and fingers. His reports that his left arm appeared red and itchy around the injection site for several days, but he never developed a diffuse rash.  His symptoms improved, however he still had lingering left arm soreness and mild left sided chest tightness, and mild SOB both with and without exertion. He received the second dose on 12/5/2024 and had a similar reaction. He has a normal EKG and CXR a few days later. He continues with continued to experiences chronic chest pain and is undergoing Cardiology eval (ECHO and EKD are normal so far, pending CT angio). Allergy and Immunology workup stating "non-IgE" rection.
Age: 31.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Nausea, Pain in extremity
Clinical narrative: 1st dose of Anthrax vaccine (AVA) to his left arm at 1100 on 29 October 2024.  He was feeling well on the day of immunization, and received no other vaccines that day. Immediately following the injection, he reports feeling a burning sensation at the injection site which extended down his arm and into to his fingers. He then began feeling very lightheaded and nauseated. He felt better after drinking some water and was able to leave the clinic after 15 minutes. He denies any rash, flushing, vomiting, wheezing, or angioedema. While driving from the clinic he began to feel mild left sided arm and chest tightness (about 20-25 mins after the injection). The chest tightness increased over the next few hours, and he began having difficulty taking a deep breath. He also experienced soreness/pain to his teeth and tingling to his left hand and fingers. His reports that his left arm appeared red and itchy around the injection site for several days, but he never developed a diffuse rash.  His symptoms improved, however he still had lingering left arm soreness and mild left sided chest tightness, and mild SOB both with and without exertion. He received the second dose on 12/5/2024 and had a similar reaction. He has a normal EKG and CXR a few days later. He continues with continued to experiences chronic chest pain and is undergoing Cardiology eval (ECHO and EKD are normal so far, pending CT angio). Allergy and Immunology workup stating "non-IgE" rection.
Age: 31.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Paraesthesia, Skin tightness, Toothache
Clinical narrative: 1st dose of Anthrax vaccine (AVA) to his left arm at 1100 on 29 October 2024.  He was feeling well on the day of immunization, and received no other vaccines that day. Immediately following the injection, he reports feeling a burning sensation at the injection site which extended down his arm and into to his fingers. He then began feeling very lightheaded and nauseated. He felt better after drinking some water and was able to leave the clinic after 15 minutes. He denies any rash, flushing, vomiting, wheezing, or angioedema. While driving from the clinic he began to feel mild left sided arm and chest tightness (about 20-25 mins after the injection). The chest tightness increased over the next few hours, and he began having difficulty taking a deep breath. He also experienced soreness/pain to his teeth and tingling to his left hand and fingers. His reports that his left arm appeared red and itchy around the injection site for several days, but he never developed a diffuse rash.  His symptoms improved, however he still had lingering left arm soreness and mild left sided chest tightness, and mild SOB both with and without exertion. He received the second dose on 12/5/2024 and had a similar reaction. He has a normal EKG and CXR a few days later. He continues with continued to experiences chronic chest pain and is undergoing Cardiology eval (ECHO and EKD are normal so far, pending CT angio). Allergy and Immunology workup stating "non-IgE" rection.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Wrong technique in product usage process
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Headache-Medium
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Headache-Medium
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Rash, Rash erythematous
Clinical narrative: Rash; Muscle soreness; red rash on arm;  This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart rate irregular (Irregular heart beat). Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included blood pressure high (Blood pressure high), blood cholesterol increased (High cholesterol), diabetes (Diabetes), crohn's disease (Crohn's disease) and hidradenitis (Hidradenitis). Concomitant products included amlodipine, apixaban, clindamycin, dulaglutide (Trulicity), esomeprazole sodium (Nexium), furosemide (Lasix), gabapentin, hydrochlorothiazide, losartan, metformin, simvastatin, ustekinumab (Stelara) and colecalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, vitamin b1 nos (Multivitamin).   In MAY-2025, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Rash), muscle soreness (Verbatim: Muscle soreness) and red rash (Verbatim: red rash on arm). The outcome of the rash, muscle soreness and red rash were not resolved.   It was unknown if the reporter considered the rash, muscle soreness and red rash to be related to Shingrix.     It was unknown if the company considered the rash, muscle soreness and red rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUN-2025 The case was self reported by patient. The patient received Shingrix vaccine 3.5 weeks ago after that he experienced muscle soreness in his right arm which has not gone away. This now extends down to his right wrist and to the back of his arm.  He had a red rash on this arm as well as on his waist.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Injection site rash; Injection site redness; Injection site swelling;  This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included gastric bypass (Gastric Bypass 20 years ago) and breast cancer (history of Breast cancer). Concomitant products included anastrozole, folic acid, escitalopram oxalate (Lexapro), ubidecarenone (Co Q-10), vitamin c and vitamin b12.   On 11-JUN-2025, the patient received Arexvy (left arm). On 12-JUN-2025, 1 days after receiving Arexvy, the patient experienced injection site rash (Verbatim: Injection site rash), injection site erythema (Verbatim: Injection site redness) and injection site swelling (Verbatim: Injection site swelling). The outcome of the injection site rash, injection site erythema and injection site swelling were not resolved.   It was unknown if the reporter considered the injection site rash, injection site erythema and injection site swelling to be related to Arexvy.     It was unknown if the company considered the injection site rash, injection site erythema and injection site swelling to be related to Arexvy.   Additional Information: GSK receipt date:  The reporter was the husband of the patient. The patient received Arexvy on Wednesday 11 June 2025 in the left arm. The next day, the patient noticed a rash, redness and swelling at the injection site. The reporter had very limited contact information for the HCP.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Injection site erythema
Clinical narrative: redness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included supraventricular tachycardia (History of SVT - had ablation done to treat). Concomitant products included Multivitamin.   On 11-JUN-2025, the patient received Arexvy (right arm). On 11-JUN-2025, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness at the injection site). On 12-JUN-2025, the outcome of the injection site erythema was resolved (duration 1 day).   It was unknown if the reporter considered the injection site erythema to be related to Arexvy.     It was unknown if the company considered the injection site erythema to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-JUN-2025 The reporter was the patient.  The patient received Arexvy on Wednesday 11 June 2025 in the right arm.  The patient noticed redness at the injection site the day of the vaccination, and it was gone the next day.
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: With the Menveo vaccine if we only gave the liquid part and did not mix with the other vial .; With the Menveo vaccine if we only gave the liquid part and did not mix with the other vial .; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: With the Menveo vaccine if we only gave the liquid part and did not mix with the other vial .) and inappropriate dose of vaccine administered (Verbatim: With the Menveo vaccine if we only gave the liquid part and did not mix with the other vial .). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 12-JUN-2025 This case was reported by a consumer via interactive digital media. The reporter reported that with the Menveo vaccine if they only gave the liquid part and did not mix with the other vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: maladministration of Infanrix after the expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received DTPa (Infanrix) (batch number GG39D, expiry date 07-JUN-2025) for prophylaxis.   On 13-JUN-2025, the patient received Infanrix. On 13-JUN-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: maladministration of Infanrix after the expiration date). The outcome of the expired vaccine used 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: 13-JUN-2025 Registered Nurse called to ask if they had to revaccinate after the maladministration of Infanrix after the expiration date which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter.
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Incomplete dose/They have no way of knowing if patients just got the diluent; Incomplete dose/They have no way of knowing if patients just got the diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Incomplete dose/They have no way of knowing if patients just got the diluent) and inappropriate dose of vaccine administered (Verbatim: Incomplete dose/They have no way of knowing if patients just got the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were 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: 16-JUN-2025 and 17-JUN-2025 The other health professional reported that they had several patients who may not have received full doses of Priorix vaccine. The other health professional asked what the recommendation regarding revaccination was. The other health professional stated that they bag the 2 components of Priorix  together and put them in the box protected from light.  They have no way of knowing if patients just got the diluent which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. She stated they bag them and band them together because this was an ongoing issue with the 2 component vaccines.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Delaying second dose of shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose five years ago).   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: Delaying second dose of shingrix). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 16-JUN-2025  The Vaccine Administration Facility was the same as Primary Reporter The reporter mentioned that a patient had first dose of Shingrix vaccine 5 years ago. The reporter asked how long after delaying second dose of Shingrix would the patient need to restart the series.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Oral herpes
Clinical narrative: Fever 1p1.7°f , headache, diarrhea. Will wait out at home and call dr if condition worsens.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Back pain, Chills, Decreased appetite, Fatigue
Clinical narrative: Sweating & chills; fatigue; leg and back pain; headache; upset stomach; loss of appetite; extreme fatigue; itching & rosacea (about 10 days post-vaccine); tingling in 3 fingers on left hand + left forearm + left shoulder + 2 fingers on right hand (about 11 days post-vaccine)
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Pain in extremity, Paraesthesia, Pruritus
Clinical narrative: Sweating & chills; fatigue; leg and back pain; headache; upset stomach; loss of appetite; extreme fatigue; itching & rosacea (about 10 days post-vaccine); tingling in 3 fingers on left hand + left forearm + left shoulder + 2 fingers on right hand (about 11 days post-vaccine)
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rosacea
Clinical narrative: Sweating & chills; fatigue; leg and back pain; headache; upset stomach; loss of appetite; extreme fatigue; itching & rosacea (about 10 days post-vaccine); tingling in 3 fingers on left hand + left forearm + left shoulder + 2 fingers on right hand (about 11 days post-vaccine)
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms or side effects; HCP called to report an expired dose of VARIVAX was administered to a patient on 6/18/2025.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-JAN-2023, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) with sterile diluent (MERCK STERILE DILUENT) administered for prophylaxis (strength, lot number, expiration date, route and anatomical site of administration were not provided). On 18-JUN-2025, the patient was vaccinated with a second expired dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection, 0.5 mL, lot #X012268 [which has been verified go be valid lot number for Varicella Virus Vaccine Live (Oka-Merck)], expiration date reported and upon internal validation establish as 30-APR-2025. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), lot #Y016370, expiration date: 13-MAY-2027 upon internal validation. Both were administered for prophylaxis (strength, route and anatomical site of administration were not provided). Expired dose supported by post expiry memo (Expired product administered).  Despite multiple reiterations of the supported outcome, customer not comprehending outcome and hung up despite offer to look into further resources if unclear. No symptoms or side effects (No adverse event). No previous temperature excursion.
Age: 2.0
Sex: M
Vaccine: COVID19, HEPA
Symptoms: Product storage error
Clinical narrative: None reported symptoms- COVID vaccine given over 10 weeks after thawed and storage.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Dyskinesia, Hypotonia, Infant irritability, Nystagmus
Clinical narrative: After receiving vaccine -IRRITBILITY/ Not himself x 2 wks - Not as expressive Also noted what sounds like nystagmus/and random jerking movement of extremity
Age: 1.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; E-mail received in the MNSC Contact Center mailbox on 03JUN2025 at 9:14 PM with RMPDS after hours case MRK-2025-0063 reporting an AE for VAQTA. Verbatim: "This medical assistant reported that a "15 month old" patient received his first dose of VAQTA; This spontaneous report was received from a Medical Assistant and refers to a 16-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 28-Feb-2025 (conflicting information as it was also reported as 28-Jan-2025), the patient was vaccinated with the first dose of Hepatitis A Vaccine, Inactivated (VAQTA),, dose number 1, 0.5 mL (0.5 mL), administered by Intramuscular route (lot # and expiration date were not reported). On 23-May-2025, the patient was vaccinated with the second dose of Hepatitis A Vaccine, Inactivated (VAQTA), (lot #Y013274, expiration date: 26-Dec-2025), dose number 2, 0.5 mL (0.5 mL), administered by Intramuscular route, both administered for prophylaxis, which was too early (inappropriate schedule of product administration). No adverse event was reported.   Lot # for the first dose is being requested and will be submitted if received.
Vaccine: HPV9, HPV9, HPV9, HPV9
Symptoms: Extra dose administered
Clinical narrative: patient reported no symptoms; Inadvertently administering a 4th dose of GARDASIL 9 to a 20 year old patient; This spontaneous report was received from a Nurse and refers to a(n) patient of unknown age and gender.   The patient's medical history, concurrent conditions AND Concomitant therapies were not reported.    On 30-Jan-2017, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 1, on 03-Apr-2017, dose number 2, and in August 2017, dose number 3, administered by Unknown route (lot # and expiration date were not reported).  On 10-Jun-2025, the patient was inadvertently administered a fourth dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y015599, expiration date: 10-Feb-2027), administered by Unknown route (Extra dose administered). All doses administered for prophylaxis. The patient reported no symptoms or adverse events.
Vaccine: PNC15, PNC15
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; extra dose of VAXNEUVANCE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On unknown dates, the patient was vaccinated with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) Suspension for injection (dose, route of administration, lot # and expiration date were not reported) as prophylaxis and completed 4-dose series. Then, on 13-Jun-2025, the patient was inadvertently administered an extra dose of this vaccine (lot #Z003633, expiration date: 24-May-2027) (dose and route of administration were not reported) also as prophylaxis (Extra dose administered). The patient did not report any symptoms (No adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: the second was postponed twice due to surgeries; This spontaneous report was received from a 44-year-old female patient, referring to herself.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 29-DEC-2024, the patient was vaccinated with 1st dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) suspension for injection, administered for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported).  The 2nd dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) was postponed twice due to unspecified surgeries (performed on unspecified dates). The outcome of the event was not reported.  Causality assessment was not provided.  Additional information is not expected.
Vaccine: DTPPVHBHPB, RVX
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP called to report inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion that occurred on 07MAY2025. ROTATEQ and VAXELIS were administered to a patient on 21MAY2025. Limited demographics provided. HCP originally called on; This spontaneous report was received from a nurse practitioner and refers to a 5-month-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 21-MAY-2025, the patient was inadvertently vaccinated with improper stored dose of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis b [recombinant] vaccine (VAXELIS) suspension for injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral solution administered by oral route (dose, lot # and expiration date were not reported); both administered as prophylaxis after a temperature excursion (that occurred on 07-MAY-2025) reported as 1.4 degree Celsius for 18 minutes. There was no previous temperature excursions.  No additional adverse events reported.  Lot# is being requested and will be submitted if received.  This is one of the several reports received form the same reporter.; Reporter's Comments
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was accidentally given to 11-year-old; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis.   On 11-JUN-2025, the patient received Kinrix. On 11-JUN-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was accidentally given to 11-year-old). The outcome of the inappropriate age at vaccine administration 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: 12-JUN-2025 Other HCP reported that Kinrix was accidentally given to 11-year-old, no symptoms were reported.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Gait disturbance, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Limping; administered a dose of Kinrix into the left thigh; Swollen Thigh; This non-serious case was reported by a physician via call center representative and described the occurrence of swelling of legs in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 4L454) for prophylaxis.   Concomitant products included Mmr ii and Varicella zoster vaccine live (Oka/Merck) (Varivax).   On 12-JUN-2025, the patient received Kinrix (left thigh). On 12-JUN-2025, less than a week after receiving Kinrix, the patient experienced limping (Verbatim: Limping) and vaccine administered at inappropriate site (Verbatim: administered a dose of Kinrix into the left thigh). In JUN-2025, the patient experienced swelling of legs (Verbatim: Swollen Thigh). The outcome of the swelling of legs was not resolved and the outcome of the limping was unknown and the outcome of the vaccine administered at inappropriate site was not applicable.   It was unknown if the reporter considered the swelling of legs and limping to be related to Kinrix and Kinrix Pre-Filled Syringe Device. The reporter considered the vaccine administered at inappropriate site to be unrelated to Kinrix.     It was unknown if the company considered the swelling of legs and limping to be related to Kinrix and Kinrix Pre-Filled Syringe Device. The company considered the vaccine administered at inappropriate site to be unrelated to Kinrix.   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: 13-JUN-2025 Physician stated that on 12th June 2025, she administered a dose of Kinrix into the left thigh of a pediatric patient, and mom noticed the patient was limping and complaining last night on 12th June 2025. The reporter stated that the patient did not let mom see the left thigh until today, 13th June 2025, and mom stated the left thigh was very, very big or swollen. Reporter stated that's all that was provided about these adverse events.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Rash
Clinical narrative: Diarrhea; Rash over torso, arms, face; This non-serious case was reported by a consumer and described the occurrence of diarrhea in a 57-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30-MAY-2025, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced diarrhea (Verbatim: Diarrhea) and rash (Verbatim: Rash over torso, arms, face). The outcome of the diarrhea was resolved and the outcome of the rash was not resolved.   It was unknown if the reporter considered the diarrhea and rash to be related to Shingles vaccine.     It was unknown if the company considered the diarrhea and rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-JUN-2025 The patient self-reported this case for herself. The patient had diarrhea and rash over torso, arms, face. The symptoms were not treated.
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Excruciating Pain for 6 weeks; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Excruciating Pain for 6 weeks). The outcome of the pain was resolved (duration 6 weeks).   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-JUN-2025 This case was reported by a patient via interactive digital media. The patient had the most excruciating pain for 6 weeks, not letting up pain pills, did not help at all. The patient's family thought that he/she was going to die, and he/she had the shot maybe that's why the patient never got the cash.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had the shot, but I am getting the shingles as often as before; 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.   The patient's past medical history included shingles.   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: had the shot, but I am getting the shingles as often as before). 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: 16-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported that it was a personal choice he/she had received the shot, but he/she kept getting shingles as often as before. The patient reported that he/she just kept going back for the antiviral. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of 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, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine