chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Expired product administered
Clinical narrative: Vaccine was completed by technician, the correct product was taken out of fridge before vaccine was given to the patient. After the vaccine was given, the technician came to the pharmacist and saw that he had mistyped the expiration date in database and had given an expired product. Patient was left a voicemail to call us back. Patient called back and was told he was given an expired vaccine. He was notified that it was recommended that he could talk with his provider about repeating the dose, or the recommendation is to repeat the dose. He said he would contact his provider.
Age: 6.0
Sex: M
Vaccine: YF
Symptoms: Contraindication to vaccination, Rash erythematous, Throat irritation
Clinical narrative: I administered the Yellow Fever vaccine to  and patient on Friday afternoon 07/18/2025.  Patient, 6 years old, had an allergic reaction to the YF vaccine and complained to mom of irritated throat and a redness/rash. Symptoms presented 5 minutes after the injection.  Mom gave the patient liquid Benadryl, which she had on hand. Patient felt better after Benadryl was given to him by mom. There wasn't a need for us to implement emergency treatment at the pharmacy.   Dad later reviewed to me patient is allergic to eggs , which is a contraindication to the Yellow Fever vaccine. Parents were aware of it and had discussed with a specialist prior to consulting travel health. The specialist had approved patient to get the vaccine despite the egg allergy. However, that when they filled out the live consent form, parents did not list egg as an allergy for patient. I followed up with patient that night and next day . Per dad, patient is fine, no concerns stated.
Age: 16.0
Sex: M
Vaccine: MNP
Symptoms: Arthralgia, Fatigue, Injection site pain
Clinical narrative: joint pain, fatigue, pain at injection site
Age: 62.0
Sex: M
Vaccine: PNC21
Symptoms: Fatigue
Clinical narrative: Fatigue onset 5 hours after vaccine administration. Fatigue persists, but is improving.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Nausea, Pallor, Syncope, Vomiting
Clinical narrative: After administration of the TB test and MenQuadfi (MCV4) vaccine, the patient reported feeling dizzy, appeared pale, and experienced a brief syncopal episode lasting approximately 30 seconds while seated in a chair with armrests down. The nurse immediately called for assistance and initiated assessment and supportive care. The patient was provided with juice, which she tolerated well. She reported feeling slightly better. Shortly afterward, the patient experienced nausea and was provided with an emesis bag. One episode of emesis occurred, estimated at approximately 100 mL of fluid.  Initial vital signs were as follows:  Blood Pressure: 89/50 mmHg  Pulse: 68 bpm  The patient reported feeling improved. A second set of vital signs was taken:  Blood Pressure: 90/57 mmHg  Pulse: 70 bpm  A snack was offered twice but declined; the patient accepted a bottle of water and continued to drink both juice and water. She reported feeling significantly better.  Final set of vital signs prior to discharge:  Blood Pressure: 95/60 mmHg  Pulse: 71 bpm  The nurse accompanied the patient and her partner to their vehicle. A steady gait was observed with no signs of instability upon standing or walking. The patient s partner confirmed he would be driving the patient home.  Discharge instructions were provided, including advice to eat a meal as soon as possible and to seek immediate medical attention at the nearest emergency clinic if any further symptoms arise. The patient verbalized understanding.
Age: 18.0
Sex: F
Vaccine: HEPA, HIBV, HPV9, IPV, MENB, MNQ, TDAP, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Hib administered to 18 year old patient. Patient reports she is fine. Patient should return to clinic for Hep B once she discusses it with mother.
Age: 30.0
Sex: M
Vaccine: HEPA, SMALLMNK, TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Jynneos vaccination was incorrectly administered intramuscularly. Patient has not reported other adversely related effects yet.
Age: 73.0
Sex: M
Vaccine: PNC21, VARZOS
Symptoms: Arthralgia, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Patient says that there was pain in both shoulders after vaccination. The right arm was swollen on the following day (7/20/25) all the way down to the wrist and hand. Swelling has continued to today (7/22/25) patient says it is painful. Also says it could be a gout attack.
Age: 51.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Blood glucose normal, Dizziness
Clinical narrative: CLIENT STATES HAD AN EPISODE OF DIZZINESS STARTING BETWEEN 2:00PM-3:00PM ON 7/16/2025 AND WAS OFF AND ON UNTIL 10:30PM.  REPORTED BLOOD SUGAR OF 102.  7/17/2025 HAD AN EPISODE OF DIZZINESS THAT STARTED BETWEEN 3:00PM-3:15PM AND LASTED FOR 60-90 MINUTES.  REPORTED BLOOD SUGAR IN AM 98
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Goitre, Menstruation irregular, Ovarian failure
Clinical narrative: Goiter  within a year of vaccination, and  irregular period within two years and now POI  at 17
Age: 66.0
Sex: F
Vaccine: PNC21
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccine ordered by PCP. Vaccine was given by me, checked vaccine administration record after, patient had already received vaccine in March of 2025. Extra dose was not indicated/needed at this time. Provider notified. Patient left clinic with no difficulties and did not exhibit signs of adverse reaction. Patient was called and notified of vaccination error.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix; Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix; Inappropriate schedule of vaccine administered;  This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   Previously administered products included Dtap vaccine (received 3 doses of DTap vaccine on an unknown date) and IPV vaccine (received 3 doses of IPV vaccine on an unknown date).   On 07-JUL-2025, the patient received Kinrix. The patient did not receive Infanrix. On 07-JUL-2025, an unknown time after receiving Kinrix, the patient had wrong vaccine administered (Verbatim: Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix), inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix) and inappropriate schedule of vaccine administered (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule 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: 09-JUL-2025 The medical assistant called to report on 07th July 2025 a dose of Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix which led to wrong vaccine administered and inappropriate age at vaccine administration. The patient had 3 doses of Dtap and IPV before Kinrix administration, which led to inappropriate schedule of vaccine administered. The healthcare professional mentioned that the patients were twin sisters. This case is 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2025087840:Same reporter/Diffrent patient
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a dose of Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix; before recommended age; Inappropriate schedule of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   Previously administered products included Dtap vaccine (received 3 doses of Dtap vaccine on an unknown date) and IPV vaccine (received 3 doses of IPV vaccine on an unknown date).   On 07-JUL-2025, the patient received Kinrix. The patient did not receive Infanrix. On 07-JUL-2025, an unknown time after receiving Kinrix, the patient had wrong vaccine administered (Verbatim: a dose of Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix), inappropriate age at vaccine administration (Verbatim: before recommended age) and inappropriate schedule of vaccine administered (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule 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: 09-JUL-2025 The medical assistant called to report on 07th July 2025 a dose of Kinrix was administered to a 15-month-old patient that was intended to receive Infanrix which led to wrong vaccine administered and inappropriate age at vaccine administration. The patient had 3 doses of Dtap and IPV before Kinrix administration, which led to inappropriate schedule of vaccine administered. The healthcare professional mentioned that the patients were twin sisters. This case is 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2025088165:Same reporter/Diffrent patient
Vaccine: TDAP
Symptoms: Intercepted product storage error
Clinical narrative: they were planning on administering Boostrix/possible administration after temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of intercepted product storage error in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 14-JUL-2025, the patient did not receive Boostrix. The patient had intercepted product storage error (Verbatim: they were planning on administering Boostrix/possible administration after temperature excursion). The outcome of the intercepted product storage error 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: 14-JUL-2025 A nurse practitioner called in to request data about the stability of boostrix and Infanrix after an excursion, stated that they were planning on administering boostrix which led to intercepted product storage error. During the call, it was incredibly difficult to understand the conversation due to technical issues. The possible event was filed with the limited data that was able to be collected, although it was important to clarify that the dose was not administered, but being planned on being administered. The vaccine administration facility was the same as primary reporter.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis on their arms where they had to administer; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 02Jul2025 as dose number unknown, single (Lot number: LN4929, Expiration Date: 31Jul2026) at the age of 59 years intramuscular, in arm for immunisation, Device Lot Number: LN4929, Device Expiration Date: 31Jul2026. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION SITE CELLULITIS (medically significant) with onset Jul2025, outcome "unknown", described as "Cellulitis on their arms where they had to administer". The event "cellulitis on their arms where they had to administer" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (30Jun2025) unknown result, notes: 2 days before the vaccine was given. Therapeutic measures were taken as a result of vaccination site cellulitis.  Causality for "cellulitis on their arms where they had to administer" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Clinical course: This was in regard to an adverse reaction that two patients had when they were vaccinated with Prevnar 20. What happened was the patients when they were vaccinated, they experience with what caller described as Cellulitis on their arms where they had to administer. The patients came back with an adverse reaction in their arm, they had what the caller describe as cellulitis on their arm. The reaction was severe enough, there were two people that were vaccinated with those Prevnar 20, they had to be administered antibiotic and or steroid treatment to prevent the infection on their arm. This was an adverse reaction because of the vaccine, the customer or rather caller would like to report that to know how to proceed with those patients. The reporter was a medical assistant at the doctor's office where the vaccine was administered. Site of administration was reported as Left right. Concomitant products, other medication and lab works: The patient was taking medication on a daily basis, and she did get blood work done 2 days before the vaccine was given. No further details about the medication. There was a treatment. After it was administrated, the vaccine she was seen 7 days letter. They prescribed Prednisone, a steroid medication. The indication was provided as pneumonia.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500144744 Same reporter/vaccine/event, different patients;
Sex: M
Vaccine: PNC13
Symptoms: Death, Leukaemia, Transfusion
Clinical narrative: leukemia; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2015 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: LEUKAEMIA (death, hospitalization, medically significant), 1 month after the suspect product(s) administration, outcome "fatal", described as "leukemia". The patient underwent the following laboratory tests and procedures: complete physical: was fine. Therapeutic measures were taken as a result of leukaemia. The patient date of death was unknown. Reported cause of death: "leukemia". It was not reported if an autopsy was performed. Clinical course: The wife informed that the doctor asked if the patient wanted the Prevnar 13 shot and he said yes he would take it and it threw him into leukemia. In 2015, her husband took Prevnar 13, and it killed him. The patient got leukemia about a month later after the shot. Her husband had been to the hospital and he had a complete physical and was fine. She was just told he was in great shape. They told him that he could get transfusions, and he did for about a month and then they told him after a while it wouldn't do any good and he would have not very long to live so he wanted to quit, and he did quit and was dead within 3 months of the shot. The cause of death was leukemia. The wife wanted to know what the company will do about it.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Reported Cause(s) of Death: leukemia
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia
Clinical narrative: persistent fever; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 19Jul2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 55 years, in right arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SHINGRIX taken for immunisation, in Jun2025 as dose number unknown, single. The following information was reported: PYREXIA (non-serious) with onset 19Jul2025, outcome "not recovered", described as "persistent fever". Therapeutic measures were not taken as a result of pyrexia.  Additional Information: No known allergy. The patient did not received any other vaccine on the same date as the vaccines. The patient was taking other medications within 2 weeks of event starting.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis
Clinical narrative: lymph nodes remained inflamed for weeks after the vaccine; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An adult female patient (unknown if pregnant) 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 included: "drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENITIS (non-serious), outcome "recovered", described as "lymph nodes remained inflamed for weeks after the vaccine". It was unknown if therapeutic measures were taken as a result of lymphadenitis.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizures; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 2021, 1 week after the suspect product(s) administration, outcome "unknown", described as "seizures". Clinical course: the patient took the "2021 vaccine" for work, and the week after, he ended up with seizures.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: they gave me the COVID; they gave me the COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "they gave me the COVID". The event "they gave me the covid" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient stated, "They made her call from (redacted) to get her prescription for Paxlovid, after asking if her physician had prescribed Paxlovid, patient advised, "The emergency room last night." Later advised, "Her daughter-in-law is the one who got sick first, and they took her to the physical therapy, and it was funny because she didn't feel no symptoms at all. Not even when they went with them last night to the ER because her son and the baby got sick, and it's funny they gave her the COVID, and that's when it turns out suppose she have a fever she didn't even feel it, and she had high blood pressure real high. Today she has been feeling it. Her nose because she couldn't, she was congested, guess she was not congested, she was breathing. and everything. Now, yeah." Later, (Withheld) stated, "I had taken the Pfizer COVID shot before." After confirming that she had taken the Pfizer vaccination in the past, patient stated, "Yes" how well it worked out for her, (Withheld) stated, "Well, it didn't, you know, cause what, 2,3 years, I guess, when it first started, we're already getting it right now. I didn't got it back then." (Withheld) also advised, "Back then, I had that COVID Vaccine, I didn't have the COVID, I was okay. It helped me big time." After confirming if the patient had taken Paxlovid in the past, (Withheld) advised, "No, I didn't have no COVID at all, I was safe I had got the Pfizer vaccine, both of them, and I didn't got sick." Towards the end of the call, (Withheld) advised, "I was just no, I guess I'm ask the pharmacy because they got me on Ozempic and Humira to take."
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient looking to finish her imovax pre-exposure course. however, her first and only dose was on 6/13/2023 with no reported adverse event.; Initial information received on 18-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient with unknown age and gender who looked to finish her i Rabies (Hdc) Vaccine [Imovax Rabies] pre-exposure course. however, her first and only dose was on 6/13/2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Jun-2023, the patient received an unknown dose (dose 1) of suspect Rabies (Hdc) Vaccine, Powder and solvent for suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) and patient was looking to finish her imovax pre-exposure course. however, her first and only dose was on 6/13/2023 with no reported ae (routine immunisation schedule not administered).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, they wanted to know what was recommended that the patient still received one dose to complete of her series, or did she need two doses 7 days apart to be considered fully vaccinated.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECEIVED A 2ND DOSE OF PREVNAR 20 ON 7/21/25. PATIENT SHOULD HAVE ONLY GOTTEN ONE DOSE, WHICH THEY GOT ON 6/9/22. PATIENT HAS NOT HAD ANY TYPE OF REACTION YET AND IS STILL FEELING GOOD AFTER I SPOKE TO HER.
Age: 88.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling at site & extending down left upper arm wrapping around to under side, onset was 1-2 days after vaccine and came to facility seeking treatment on 7/22/2025, Was given course of antibiotics, & monitor sx to ensure resolution, or seek further care if not resolving or if worsening
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Mobility decreased, Paraesthesia
Clinical narrative: Extreme pain in left shoulder joint, impaired mobility (unable to raise arm), tingling in fingers of left hand
Age: 28.0
Sex: F
Vaccine: MENB
Symptoms: Incorrect dose administered
Clinical narrative: INCORRECT DOSING SCHEDULE
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Asthma, Brain fog, Dyspnoea, Fatigue
Clinical narrative: Second dose October, 2021. Immediate effects, winded, weakness, fatigue. Strip throat and Asthma. Heart palpitations, brain fog, forgetfulness.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Memory impairment, Palpitations, Pharyngitis streptococcal
Clinical narrative: Second dose October, 2021. Immediate effects, winded, weakness, fatigue. Strip throat and Asthma. Heart palpitations, brain fog, forgetfulness.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Pustule, Tenderness, Tissue rupture
Clinical narrative: Pustules in different parts of the body (foot, torso, back, face, leg) that start with a small bubble and then breaks resulting in itching, and open sore that stings to the touch.
Age: 57.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Day after  injection patients arm became swollen and red, painful  and hot to the touch. This was from just below shoulder to about 2 inches above elbow.  Day 2 and 3 also had high fever (103.)  Pt used Tylenol and fever seems better.  When Patient came in today, arm was not swollen but still quite red and warm. Although patient seems to be getting better, they are still very concerned. Patient will continue Tylenol and ice pack as needed as it continues to resolve itself.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram abnormal, Deafness neurosensory, Tinnitus
Clinical narrative: Tinnitus.  Symptoms began one hour and 20 minutes after the vaccine and has continued since then.  I mentioned it to my PCP at my annual exam and she recommended that I make an appointment with an Ear/Nose/Throat specialist for testing. The ENT doctor recommended that I file a report of my symptoms.
Age: 71.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient had already received prevnar20 vaccination on 07/13/2022 at different facility. Vaccination was not reported to state data base and patient did not recall having it previously.
Age: 10.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Eye movement disorder, Hunger, Pallor
Clinical narrative: Pt was going to receive 2 vaccines Tdap Booster and HPV # 2 to complete series. Pt was a bit nervous and requested both vaccines to be administered on Left arm, while he held his mother's hand with his right hand. Tdap was the first vaccine administered on Left Arm. Pt tolerated well and was surprised how well he did. I had asked pt to tell me about what he had done for summer break to allow him to distract himself from the next vaccine. HPV # 2 was administered on Left Arm. Both vaccines were completed by 0933. Pt was surprised how well he tolerated both vaccines. I was informing MOC that pt would need to wait 15 minutes after the vaccine to rule out any adverse reaction. Shortly after mentioning post vaccine instructions. At 0934 MOC noticed pt looking pale and eye rolling up. Pt leaned towards me and and MOC to notify any nursing staff in our nursing station. I also verbally called a code Blue in rrom 3, while exam room door was open. 0934 Dr entered the exam room and assisted in laying pt on the exam table. Vitals were obtained at 0934. Pt was responsive and still a little out of it, but was able to answer all questions to provider. MOC was informed by provider that pt was ok, but would recommend to wait the 15 minutes. Apple juice was offered to pt. 0936 Pt was alert, skin color was back to normal and was conversing. Vitals were obtained at 0937. Pt was very cooperative with vitals. Vitals were obtained at 0941. Pt communicated was feeling better and hungry. Pt was discharged at 0953
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: First Dose of HEPLISAV-B in February 2025 Has Not Received Next Dose; Initial report received on 07-Jul-2025.  A pharmacist reported that a 58-year-old female received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Feb-2023 and has not received another dose yet.   No medical history or concomitant medications were reported.  In Feb-2023, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available).   On 07-Jul-2025, approximately 2 years and 5 months after receiving the first dose HEPLISAV-B, the reporter contacted medical information to inquire if the HEPLISAV-B series needed to be restarted. No adverse reactions were reported.  The reporter declined to provide further information.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete course of vaccination; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who did not receive HBV (Engerix B) for prophylaxis.   Previously administered products included RECOMBIVAX (received on 14th June 2014). Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. The patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). 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: 27-JUN-2025 The reporter called to ask they had a worker that received a Hepatitis B vaccine on twenty-fourteen (with a non-GlaxoSmithKline vaccine), and recently a ENGERIX-B on May twenty twenty-five.  The reporter asked if they must administer a complete series for GlaxoSmithKline vaccine or when could they administer the third required dose for this patient. The reporter asked was there any advice on this. The vaccination date, vaccine detail and patient demographics were obtained in this call.  No further information was obtained in this call. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. Till the time of reporting, the patient did not receive the 2nd dose of Engerix B, which led to incomplete course of vaccination.
Vaccine: DTAP, HEPA, PNC13
Symptoms: Abnormal behaviour, Hyporesponsive to stimuli, Somnolence
Clinical narrative: July 1, 2025 (Morning): Baby received routine vaccinations at facility Approximately 1 hour after vaccination: Baby became unusually sleepy and took a nap. Next 12 hours: - Baby was very difficult to wake - Did not fully open eyes or respond normally - Pupils were observed changing size ? dilating and constricting  - Baby did not engage in normal feeding behavior - At one point, baby drank through a straw and ate a popsicle with eyes closed - Never fully woke or responded to voices or touch during this time - No fever, rash, or vomiting was noted at the time and all vital signs were normal After approximately 12 hours: Baby slowly returned to normal alertness and began acting more like himself. Current Status (as of today): Baby has returned to normal behavior. No known lasting effects, but concern remains about possible neurological involvement due to: - Prolonged unresponsiveness - Pupil changes - Feeding with eyes closed - Lack of normal arousal for 12 hours
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had a horrendous case of them; I had all 3 shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had a horrendous case of them) and extra dose administered (Verbatim: I had all 3 shots). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUL-2025 This case was reported by a patient via interactive digital media. The patient had all 3 shots and had a horrendous case of them. The patient received 3 shots of Shingles vaccine, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles (Dose 1, 2 & 3)
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: presented problems with her arm/ lifting her arm, locked to a certain point; Locked arm (tightness) after Shingrix first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2025, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injected limb mobility decreased (Verbatim: presented problems with her arm/ lifting her arm, locked to a certain point) and muscle tightness (Verbatim: Locked arm (tightness) after Shingrix first dose). The outcome of the injected limb mobility decreased was not reported and the outcome of the muscle tightness was unknown.   It was unknown if the reporter considered the injected limb mobility decreased and muscle tightness to be related to Shingrix.     It was unknown if the company considered the injected limb mobility decreased and muscle tightness to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-JUL-2025 A pharmacist wanted to know if Shingrix second dose could be administered anywhere else than the arm, given that with the first dose the patient presented problems with her arm, lifting her arm, locked to a certain point in 2025. No AE (adverse event) shared by the HCP (health care professional) other than patient's gender because that first dose was given in another facility of which he did not know the zip code.
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose was given January 22, 2025.; This non-serious case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (The patient received their first dose of bexsero September 10th 2024).   On 22-JAN-2025, the patient received the 2nd dose of Bexsero. On 22-JAN-2025, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: second dose was given January 22, 2025.). The outcome of the drug dose administration interval too short 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: 15-JUL-2025 Registered nurse reported that the patient received their first dose of Bexsero September 10th, 2024, and the second dose was given January 22, 2025, which led to drug dose administration interval too short. Reporter questioned that did the patient need a third dose. Ongoing, did patients who receive a second dose before the 6th month timeframe, should they get a 3rd dose.
Age: 8.0
Sex: M
Vaccine: PPV, RSV
Symptoms: Blood test, Cellulitis, Respiratory syncytial virus infection
Clinical narrative: Yes, he was hospitalized on June 15-17th. Vaccine reactions (pneumococcal) with cellulitis and RSV. They are concerned he has CVID. He has had bloodwork. Waiting to see immunologist and for vaccine titers.
Age: 91.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Dizziness postural, Dysarthria, Fatigue, Frequent bowel movements, Injected limb mobility decreased
Clinical narrative: Received Capvaxive and Covid Vaccinations. Pain in left arm during administration, which worsened through the night and could not lift arm next morning. Upon awaking, stood to go to the bathroom and felt dizzy and almost passed out. Has excessive bowel movement, but not diarrhea. Went to sit in living area, speech was slow and slurred, unable to think or process thoughts. Moaning due to nausea. Tried to speak with Daughter on the phone, who thought a stroke and called EMS. Fire Department arrived and vital signs were normal. neurological assessment for stroke was done and no symptoms of stroke were noted. Fire Department cleared the on route Ambulance and family transported to local ER. Upon arrival, vital signs again were taken and normal. ER Physician assessed and treated with Zofran for nausea and Tylenol. Released and sent home. Upon returning home, slept most of the day and through the night. Since having had worsening leg weakness and fatigue.
Age: 91.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Injection site pain, Mental impairment, Moaning, Muscular weakness, Nausea
Clinical narrative: Received Capvaxive and Covid Vaccinations. Pain in left arm during administration, which worsened through the night and could not lift arm next morning. Upon awaking, stood to go to the bathroom and felt dizzy and almost passed out. Has excessive bowel movement, but not diarrhea. Went to sit in living area, speech was slow and slurred, unable to think or process thoughts. Moaning due to nausea. Tried to speak with Daughter on the phone, who thought a stroke and called EMS. Fire Department arrived and vital signs were normal. neurological assessment for stroke was done and no symptoms of stroke were noted. Fire Department cleared the on route Ambulance and family transported to local ER. Upon arrival, vital signs again were taken and normal. ER Physician assessed and treated with Zofran for nausea and Tylenol. Released and sent home. Upon returning home, slept most of the day and through the night. Since having had worsening leg weakness and fatigue.
Age: 91.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Presyncope, Slow speech
Clinical narrative: Received Capvaxive and Covid Vaccinations. Pain in left arm during administration, which worsened through the night and could not lift arm next morning. Upon awaking, stood to go to the bathroom and felt dizzy and almost passed out. Has excessive bowel movement, but not diarrhea. Went to sit in living area, speech was slow and slurred, unable to think or process thoughts. Moaning due to nausea. Tried to speak with Daughter on the phone, who thought a stroke and called EMS. Fire Department arrived and vital signs were normal. neurological assessment for stroke was done and no symptoms of stroke were noted. Fire Department cleared the on route Ambulance and family transported to local ER. Upon arrival, vital signs again were taken and normal. ER Physician assessed and treated with Zofran for nausea and Tylenol. Released and sent home. Upon returning home, slept most of the day and through the night. Since having had worsening leg weakness and fatigue.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Coordination abnormal, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: I received a shingles vaccine on 5/21/25. I had the expected vaccine site soreness, fatigue, and muscle aches for several days. Then I developed tachycardia, fever, and shortness of breath, intense pain in my joints, stiffness and weakness in my upper back, knees and elbows, extreme difficulty walking/mobilizing/coordinating, searing intense neuropathy in my hands and feet extending above the wrist and ankle. It is 7/4/25 and the neuropathy is still present and excruciating.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness, Musculoskeletal stiffness, Myalgia, Neuropathy peripheral, Pyrexia
Clinical narrative: I received a shingles vaccine on 5/21/25. I had the expected vaccine site soreness, fatigue, and muscle aches for several days. Then I developed tachycardia, fever, and shortness of breath, intense pain in my joints, stiffness and weakness in my upper back, knees and elbows, extreme difficulty walking/mobilizing/coordinating, searing intense neuropathy in my hands and feet extending above the wrist and ankle. It is 7/4/25 and the neuropathy is still present and excruciating.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tachycardia, Vaccination site pain
Clinical narrative: I received a shingles vaccine on 5/21/25. I had the expected vaccine site soreness, fatigue, and muscle aches for several days. Then I developed tachycardia, fever, and shortness of breath, intense pain in my joints, stiffness and weakness in my upper back, knees and elbows, extreme difficulty walking/mobilizing/coordinating, searing intense neuropathy in my hands and feet extending above the wrist and ankle. It is 7/4/25 and the neuropathy is still present and excruciating.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Feeling of despair, Insomnia, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: I received a shingles vaccine on 5/21/25. I had the expected vaccine site soreness, fatigue, and muscle aches for several days. Then I developed tachycardia, fever, and shortness of breath, intense pain in my joints, stiffness and weakness in my upper back, knees and elbows, extreme difficulty walking/mobilizing/coordinating, searing intense neuropathy in my hands and feet extending above the wrist and ankle. It is 7/4/25 and the neuropathy is still present and excruciating.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuropathy peripheral, Pain, Pyrexia, Tachycardia
Clinical narrative: I received a shingles vaccine on 5/21/25. I had the expected vaccine site soreness, fatigue, and muscle aches for several days. Then I developed tachycardia, fever, and shortness of breath, intense pain in my joints, stiffness and weakness in my upper back, knees and elbows, extreme difficulty walking/mobilizing/coordinating, searing intense neuropathy in my hands and feet extending above the wrist and ankle. It is 7/4/25 and the neuropathy is still present and excruciating.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Eustachian tube disorder, Skin hypopigmentation
Clinical narrative: Started losing pigment in my right ankle. Has now spread to my right foot and left ankle.
Vaccine: MMRV
Symptoms: Syringe issue, Underdose
Clinical narrative: AE was filed since she stated that a patient missed a dose.; PFS leaked while injecting diluent into the PROQUAD vial; PFS leaked while injecting diluent into the PROQUAD vial; This spontaneous report was received from a medical assistant and a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 14-Jul-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose, route of administration, lot #Y018154, expiration date: 29-Apr-2026) as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # 2050911, expiration date: 11-Feb-2027) pre-filled syringe (PFS). It was reported that PFS leaked while injecting diluent into the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) vial (Syringe issue, Poor quality device used). She wasn't completely sure but she thought that leaking was at the Luerlock area. When she pulled out the reconstituted solution using a different syringe and needle, she only got 0.2ml so she put the solution back into the vial. She stated that a patient missed a dose (Product dose omission issue). No further information was available. It was also reported that the needle was not supplied by Company and it was used to instill the diluent. different syringe and needle were used between adding the diluent to the vial and withdrawing the reconstituted product from the vial. No damage or issues with the shipping container, carton that contained the syringe undamaged on receipt, plastic syringe tray. N injury as a result of the breakage. The syringe or it parts was not exposed to the patient's bodily fluids.
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain, Rash
Clinical narrative: Suspected vaccination failure; I got the vaccine and currently have the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (mild case in 20s).   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: I got the vaccine and currently have the shingles). The patient was treated with calamine. The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     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-JUL-2025 The case was received from a patient via interactive digital media.  The patient got the vaccine and currently had the shingles. It was only on the patient's right upper arm in 3 areas and only hurt for 2 days once the areas started to blister. The patient put calamine lotion on it several times a day. It was starting to dry up now. The patient woke up Wednesday saw bumps and red areas thinking he/she was bitten by a bugs. Then it started looking like a rash the next day and the reporter realized it was the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.