chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Does the series have to be restarted; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who did not receive Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14-MAR-2023 with batch number YA493 and lot expiry 13-APR-2026).   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: Does the series have to be restarted). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 20-JUN-2025 The pharmacist reported that the patient received Shingrix first dose back on 14-MAR-2024. The reporter was ask did the series have to be restarted if patient receives first dose more than 6 months. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Shingrix - Redness close to injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Shingrix - Redness close to injection site). The outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JUN-2025 A pharmacist mentioned that a patient reported redness close to the injection site. The pharmacist said that redness was few inches down to the injection site. This patient received the first dose of Shingrix between 21-28 days ago (did not provide specific date of administration). The pharmacist mentioned that patient was in her early 70s (not specific age provided). No further details provided.  The reporter consented to follow up.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Shingles; This serious case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 01-JUL-2025 The pharmacist reported that the patient was fully vaccinated with Shingrix and a year later patient had a breakthrough shingles case.  The reporter asked should the patient get another series of Shingrix. This case was considered as suspected vaccination failure since the details regarding the 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, details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chronic obstructive pulmonary disease
Clinical narrative: currently has COVID-19; also has COPD; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (currently has COVID-19) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (also has COPD) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (currently has COVID-19) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (also has COPD). At the time of the report, COVID-19 (currently has COVID-19) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (also has COPD) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported. Patient currently had COVID-19 and also COPD. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-787946 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787946:Patient 1 (Master case)
Vaccine: PNC20
Symptoms: Device breakage, Device leakage
Clinical narrative: Cap and like the little piece that you put the needle on, it come completely off and the medication leaked out; Cap and like the little piece that you put the needle on, it come completely off and the medication leaked out; The initial case was missing the following minimum criteria: This case has been considered invalid as Info not qualifying for AE reporting - Product Complaint: no indication that the consumer experienced an event under Product Prevnar 20. Upon receipt of follow-up information, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Nurse from product quality group.  No patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown (Lot number: LN4929, Expiration Date: Jul2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE LEAKAGE (non-serious), outcome "unknown" and all described as "Cap and like the little piece that you put the needle on, it come completely off and the medication leaked out".  The reporter considered "cap and like the little piece that you put the needle on, it come completely off and the medication leaked out" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "cap and like the little piece that you put the needle on, it come completely off and the medication leaked out" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Additional information: NDC Number: 0005200001. While taking the cap off, unscrewing the cap, the cap and like the little piece that you put the needle on, it come completely off and the medication leaked out. It was like the top of the glass vial broke in half. Packaging was sealed and intact.  Follow-up (26Jun2025): This is a spontaneous follow-up report received from product quality group. Updated information: device reportability assessment; case has been considered valid.
Age: 74.0
Sex: M
Vaccine: PNC20
Symptoms: Cellulitis, Injection site pain
Clinical narrative: Cellulitis in the elbow; Severe pain upon administration of Prevnar 20; This is a spontaneous report received from a Nurse.  A 74-year-old male patient received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), on 24Jun2025 as dose number unknown, single (Lot number: LN4930, Expiration Date: 24Jul2026) at the age of 74 years intramuscular, in left deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CELLULITIS (non-serious), outcome "unknown", described as "Cellulitis in the elbow"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Severe pain upon administration of Prevnar 20". The events "cellulitis in the elbow" and "severe pain upon administration of prevnar 20" required physician office visit.  Additional information: The reporting nurse stated, "I am calling because we have had 3 patients complaint of severe pain upon administration of Prevnar 20. Two of which have seen the doctor for cellulitis and cellulitis in the elbow. They both have been assessed by the doctor." Causality was reported as "Yes".  Causality for "cellulitis in the elbow" and "severe pain upon administration of prevnar 20" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (malfunction).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Magnetic resonance imaging, Transient ischaemic attack
Clinical narrative: TIA; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28May2025 as dose 1, single (Lot number: MD3414) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic", start date: 2006 (ongoing), notes: Diabetic, Stated that she was diagnosed around 2006 or somewhere around there.; "Hypertension" (ongoing), notes: Hypertension. There were no concomitant medications. Vaccination history included: COVID-19 vaccine (Primary immunization series completed,, Manufacturer: Pfizer , Dose number in series: Dose 1, Vaccination batch/lot number: FH8028, Location of injection/shot: Believes in was the Left Arm, First Hospitalization was 12Dec2021 and was discharged on 13Dec2021.), administration date: 11Dec2021, for Covid-19 Immunization, reaction(s): "TIA". The following information was reported: TRANSIENT ISCHAEMIC ATTACK (hospitalization) with onset 02Jun2025, outcome "recovering", described as "TIA". The patient was hospitalized for transient ischaemic attack (start date: 02Jun2025, discharge date: 04Jun2025, hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: lot of testing: showed the TIA,but there was no damage toher brain, notes: Did a lot of testing and MRI's and a whole lot of other tests. The tests that she had showed the TIA, but there was no damage to her brain; Magnetic resonance imaging: showed the TIA,but there was no damage toher brain.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500135136 same patient/event, different vaccine dose;
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Multiple sclerosis
Clinical narrative: Dose 1: Oct2020, Dose 2: Apr2021; slurred speech and eye issues/eventually diagnosed as Multiple Sclerosis; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown if the patient has known allergies. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Oct2020, for COVID-19 immunization. The following information was reported: MULTIPLE SCLEROSIS (disability, medically significant) with onset Apr2021, outcome "not recovered", described as "slurred speech and eye issues/eventually diagnosed as Multiple Sclerosis"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Dose 1: Oct2020, Dose 2: Apr2021". It was unknown if therapeutic measures were taken as a result of multiple sclerosis.  Clinical course: After the 2nd Covid shot, the patient began having a slurred speech and eye issues. This was eventually diagnosed as Multiple Sclerosis. The event Multiple Sclerosis resulted to disability or permanent damage.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had covid once before; I had covid once before; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An 81-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 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: COMIRNATY OMICRON XBB.1.5 (Dose 1, single, lot number unknown), administration date: Mar2024, for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had covid once before".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  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. The following information was reported: DEATH (death), outcome "fatal", described as "died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: 3 of reporter's good friends died, after getting the so called mRNA covid shot (Covid vaccine).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500081194 same product/event, different patient; US-PFIZER INC-PV202500081195 same product/event, different patient;; Reported Cause(s) of Death: died
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  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. The following information was reported: DEATH (death), outcome "fatal", described as "died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: 3 of reporter's good friends died, after getting the so called mRNA covid shot (Covid vaccine).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500081193 same product/event, different patient;US-PFIZER INC-PV202500081195 same product/event, different patient;; Reported Cause(s) of Death: died
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: severe and persistent nosebleeds; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EPISTAXIS (medically significant), outcome "unknown", described as "severe and persistent nosebleeds".  Additional information: The patient reported experiencing severe and persistent nosebleeds after receiving a Pfizer COVID-19 vaccine. The patient inquired about related studies and side effects.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received a dose of Kinrix out of the recommended age/ patient is less than 4 years old; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   On 08-AUG-2024, the patient received Kinrix. On 08-AUG-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient received a dose of Kinrix out of the recommended age/ patient is less than 4 years 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: 18-JUN-2025 The RN (registered nurse) called to report that they administered a dose of Kinrix to 6 different patients under the age of 4 years old, which led to an inappropriate age at vaccine administration. The reporter wanted to know did they need to continue with the same schedule as recommended in the PI (package insert). This was 1 of 6 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2025076584:Same reporter/Diffrent patient US-GSK-US2025076587:Same reporter/Diffrent patient US-GSK-US2025076583:Same reporter/Diffrent patient US-GSK-US2025076592:Same reporter/Diffrent patient US-GSK-US2025076595:Same reporter/Diffrent patient
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Extra dose administered
Clinical narrative: Administered an extra dose of Bexsero, not knowing second dose was completed already in previous year.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Mass, Pruritus
Clinical narrative: Patient presented to clinic for evaluation of spider bite (painful itchy spot on back).  Zoster vaccine administered.  Small red bumps noted on back but also on abdomen.  Provider diagnosed patient with active shingles at that visit.
Age: 1.0
Sex: M
Vaccine: PNC20, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Urticaria all over. Fever 100-101.5F Benadryl given. Claritin given. Fever lasted x24 hours. Urticaria abated in 2 days.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Blood test, Burning sensation, Chest X-ray, Chest pain
Clinical narrative: Burning feeling in arms, legs, head, neck, chest
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prostate cancer, Prostatic specific antigen increased
Clinical narrative: Prostate Cancer - Adenocarcinoma of the prostate
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Right after administration of vaccine, pt states she feels dizzy. She was instructed to stay in the clinic, I asked her to lay down. I checked her VS and are within normal. She was monitored for approx 25-30mins, symptoms resolved on it's own. She called her parent to take her home, I did not allow her to drive in case dizziness came back. I instructed if symptoms return or more symptoms occur should go to ER.
Age: 54.0
Sex: M
Vaccine: PNC21
Symptoms: Arthralgia, Chills, Fatigue, Injection site erythema, Injection site warmth
Clinical narrative: 6 Hours Post Vaccination: onset chills; fever of upwards of 101 degrees for 3 days; 6 Hours Post Vaccination: fatigue, malaise, joint pain felt all over the body (symptoms current); 24 Hours Post Vaccination Injection Site: red and warm to touch (~5"x5")  and continues to grow in size
Age: 54.0
Sex: M
Vaccine: PNC21
Symptoms: Malaise, Pyrexia
Clinical narrative: 6 Hours Post Vaccination: onset chills; fever of upwards of 101 degrees for 3 days; 6 Hours Post Vaccination: fatigue, malaise, joint pain felt all over the body (symptoms current); 24 Hours Post Vaccination Injection Site: red and warm to touch (~5"x5")  and continues to grow in size
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Bundle branch block right, Computerised tomogram, Electrocardiogram abnormal, Influenza like illness
Clinical narrative: Initially felt flue like symptoms and then pain in heart area next day
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart abnormal, Myocardial fibrosis, Myopericarditis, Sinus bradycardia, Supraventricular tachycardia
Clinical narrative: Initially felt flue like symptoms and then pain in heart area next day
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Pain, Peripheral swelling, Swelling
Clinical narrative: Post injection, nothing happened initially to at least 2AM next day, when the patient went to sleep. Only symptom was slight swelling as expected.  On  wake up 8AM the patient ,(a Ph.D. neuroscientist) reported a mild horizontal vertigo that persisted for at least 6 hours. The injected left forearm was swollen but not edematous.  Some body aches. Chills were experience but no temperature was taken. Fan used. The patient was basically unable to ambulate safely down stairs and went back to bed where vertigo declined. Slept 5 hours.  Upon rising around 4PM 7/8/25 symptoms had declined, and patient could ambulate normally with good balance. The patient has had no previous reported  history of vertigo or Menniers.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo positional
Clinical narrative: Post injection, nothing happened initially to at least 2AM next day, when the patient went to sleep. Only symptom was slight swelling as expected.  On  wake up 8AM the patient ,(a Ph.D. neuroscientist) reported a mild horizontal vertigo that persisted for at least 6 hours. The injected left forearm was swollen but not edematous.  Some body aches. Chills were experience but no temperature was taken. Fan used. The patient was basically unable to ambulate safely down stairs and went back to bed where vertigo declined. Slept 5 hours.  Upon rising around 4PM 7/8/25 symptoms had declined, and patient could ambulate normally with good balance. The patient has had no previous reported  history of vertigo or Menniers.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient reports pain in left arm and inability to raise arm
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Pain, Seizure
Clinical narrative: Seizures, memory loss, pain, years of treatments
Age: 51.0
Sex: M
Vaccine: PNC21, VARZOS, PNC21, VARZOS
Symptoms: Dizziness, Hypersensitivity, Rash, Rash erythematous, Vision blurred
Clinical narrative: Rash/rashes behind his ears, and on his neck on the right side/entire face, forehead and cheeks; Redness/redness spread to his other side, entire face, forehead and cheeks; Swelling; Tiredness; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for prophylaxis.   On 27-JUN-2025, the patient received Shingrix and Capvaxive. On 28-JUN-2025, 1 days after receiving Shingrix and Capvaxive, the patient experienced rash (Verbatim: Rash/rashes behind his ears, and on his neck on the right side/entire face, forehead and cheeks), erythema (Verbatim: Redness/redness spread to his other side, entire face, forehead and cheeks), swelling (Verbatim: Swelling) and tiredness (Verbatim: Tiredness). The outcome of the rash, erythema, swelling and tiredness were unknown.   It was unknown if the reporter considered the rash, erythema, swelling and tiredness to be related to Shingrix and Capvaxive.     It was unknown if the company considered the rash, erythema, swelling and tiredness to be related to Shingrix and Capvaxive.   Additional Information: GSK Receipt Date: 30-JUN-2025 The patient who received his first dose of Shingrix and Capvaxive last Friday on 27 Jun 2025. He stated that the next day on 28 Jun 2025, he had rashes behind his ears, and on his neck on the right side. It was also swollen and red. The rash and redness spread to his other side, entire face, forehead and cheeks. His pharmacy instructed him to take Benadryl.
Age: 51.0
Sex: M
Vaccine: PNC21, VARZOS, PNC21, VARZOS
Symptoms: Fatigue, Rash, Rash erythematous, Rash papular
Clinical narrative: Rash/rashes behind his ears, and on his neck on the right side/entire face, forehead and cheeks; Redness/redness spread to his other side, entire face, forehead and cheeks; Swelling; Tiredness; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for prophylaxis.   On 27-JUN-2025, the patient received Shingrix and Capvaxive. On 28-JUN-2025, 1 days after receiving Shingrix and Capvaxive, the patient experienced rash (Verbatim: Rash/rashes behind his ears, and on his neck on the right side/entire face, forehead and cheeks), erythema (Verbatim: Redness/redness spread to his other side, entire face, forehead and cheeks), swelling (Verbatim: Swelling) and tiredness (Verbatim: Tiredness). The outcome of the rash, erythema, swelling and tiredness were unknown.   It was unknown if the reporter considered the rash, erythema, swelling and tiredness to be related to Shingrix and Capvaxive.     It was unknown if the company considered the rash, erythema, swelling and tiredness to be related to Shingrix and Capvaxive.   Additional Information: GSK Receipt Date: 30-JUN-2025 The patient who received his first dose of Shingrix and Capvaxive last Friday on 27 Jun 2025. He stated that the next day on 28 Jun 2025, he had rashes behind his ears, and on his neck on the right side. It was also swollen and red. The rash and redness spread to his other side, entire face, forehead and cheeks. His pharmacy instructed him to take Benadryl.
Age: 1.0
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects were reported; HCP called to report inadvertent administration of GARDASIL 9 to a 12 month old infant on 6/17/2025.; HCP stated it wasn't product confusion, the nurse just grabbed the wrong vaccine; This spontaneous report was received from other health professional and refers to an 1-year-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 17-Jun-2025, the patient was inadvertent vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection, 0.5 ml (route of administration, vaccination scheme, and vaccination site were not provided; lot #Z005055 which has been verified to be a valid number, expiration date reported and validated as 27-Feb-2026) as a prophylaxis (inappropriate age at vaccine administration). It was not a product confusion; the nurse just grabbed the wrong vaccine (wrong vaccine administrated). No adverse effects were reported.
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: HCP noted that there was a patient that had pain, soreness on the injection side; redness on the injection site; with a nodule measuring 4x2cm in size, which has lasted for a month; This spontaneous report was received from a Physician and refers to a 32-year-old female patient (also reported as gender queer, biologically female).   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were unknown by the reporter.    On 10-JUN-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection, administered as Prophylaxis (dose, vaccination scheme frequency, anatomical site of injection, route of administration, lot number and expiration date were not reported).  On that same date (10-JUN-2025) the patient experienced pain, soreness and redness on the injection site with a nodule measuring 4x2cm in size, which has lasted for a month (Vaccination site pain, Vaccination site erythema, Vaccination site nodule). The reporter inquired about additional data regarding extended side effects with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9).   At the reporting time, the patient had not recovered from Vaccination site nodule, while the outcome for Vaccination site pain and Vaccination site erythema was not provided.    The causal relationship between Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and the events was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received in 2024, for tolerance refer linked case US2025079195).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Linked case(s) involving the same patient: US2025079195   Additional Information: GSK Receipt Date: 24-JUN-2025 This case was reported by the parent of the patient. The reporter mentioned that her daughter (patient) had a reaction to Shingrix.  When questioned about the event, she was reluctant to provide any information, only saying that her daughter received both doses of Shingrix a few months ago in 2024 and the 2nd shot made her a little sicker in 2024. She did not wish to provide any further information on behalf of her daughter without her daughter's consent.; Sender's Comments:  US-GSK-US2025079195:Same patinet dose 1st/ same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patient was inadvertently administered just the diluent without the powder; the patient received twice the amount of diluent; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-JUL-2025, the patient received Shingrix. On 01-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient was inadvertently administered just the diluent without the powder) and inappropriate dose of vaccine administered (Verbatim: the patient received twice the amount of diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date:01-JUL-2025 This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media. A patient was inadvertently administered just the diluent without the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. When the error was identified, the provider than correctly reconstituted the vaccine and administered it. essentially, the patient received twice the amount of diluent. are there any risks or concerned they should look out for. The reporter did not currently have much information, but he/she could reach out to the health center if it was absolutely necessary. The reporter knew it was an unexpired lot and this occurred.
Age: 5.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Allergy to vaccine, Anaphylactic reaction, Anaphylaxis treatment, Crying, Drooling
Clinical narrative: Patient received 3 immunization on 12/07/2017. Before we left the office he said his face was tingling. I thought it was because he was crying. When we got home, which is about 5 minutes from the office, his face, ears, neck, chest and back were red. His lips and eyes were swollen and he started he was itchy all over. I rushed him to the emergency room for his anaphylaxtic reaction. The hospital is right next to the doctors office. By the time we got to the emergency room he was drooling and was having a hard time swallowing. Hospital rushed him back started an IV within minutes and administered IV Epi along with other medications. After a while his swelling went down and we took home steroid medication for continued treatment. We were told never to give him any of those vaccines administered that day.
Age: 5.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Dysphagia, Erythema, Eye swelling, Lip swelling, Paraesthesia
Clinical narrative: Patient received 3 immunization on 12/07/2017. Before we left the office he said his face was tingling. I thought it was because he was crying. When we got home, which is about 5 minutes from the office, his face, ears, neck, chest and back were red. His lips and eyes were swollen and he started he was itchy all over. I rushed him to the emergency room for his anaphylaxtic reaction. The hospital is right next to the doctors office. By the time we got to the emergency room he was drooling and was having a hard time swallowing. Hospital rushed him back started an IV within minutes and administered IV Epi along with other medications. After a while his swelling went down and we took home steroid medication for continued treatment. We were told never to give him any of those vaccines administered that day.
Age: 5.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Pruritus
Clinical narrative: Patient received 3 immunization on 12/07/2017. Before we left the office he said his face was tingling. I thought it was because he was crying. When we got home, which is about 5 minutes from the office, his face, ears, neck, chest and back were red. His lips and eyes were swollen and he started he was itchy all over. I rushed him to the emergency room for his anaphylaxtic reaction. The hospital is right next to the doctors office. By the time we got to the emergency room he was drooling and was having a hard time swallowing. Hospital rushed him back started an IV within minutes and administered IV Epi along with other medications. After a while his swelling went down and we took home steroid medication for continued treatment. We were told never to give him any of those vaccines administered that day.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: rash/ developed a blotchy rash on her chest, left arm, back and left breast;  This non-serious case was reported by a consumer via call center representative and described the occurrence of blotchy rash in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number 3J2S2, expiry date 27-MAR-2027) for prophylaxis.   The patient's past medical history included hip replacement (left hip in 2019) and shingles (3 dots on her forehead in 2009). Previously administered products included Valtrex (treated with Valtrex in 2009). Concurrent medical conditions included penicillin allergy (in 2019, her physician recommended that she could take oral penicillin but not injected penicillin).   On 04-JUN-2025, the patient received the 1st dose of Shingrix (left arm) .5 ml. On 06-JUN-2025, 2 days after receiving Shingrix, the patient experienced blotchy rash (Verbatim: rash/ developed a blotchy rash on her chest, left arm, back and left breast). On 20-JUN-2025, the outcome of the blotchy rash was resolved (duration 14 days).   It was unknown if the reporter considered the blotchy rash to be related to Shingrix.     It was unknown if the company considered the blotchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JUN-2025 The patient self-reported this case for herself. The patient developed a blotchy rash on her chest, left arm, back and left breast. The patient stated that the rash resolved in 2 weeks.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: first dose taken in 2008 and 2nd dose on 16 Jun 2025; An 18 years old male patient received an adult dose of Engerix-B; An 18 years old male patient received an adult dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 18-year-old male patient who received HBV (Engerix B adult) (batch number 4BX39, expiry date 29-JUL-2027) for prophylaxis.   Previously administered products included Engerix B (received first dose in 2008).   On 16-JUN-2025, the patient received the 2nd dose of Engerix B adult. On 16-JUN-2025, an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: first dose taken in 2008 and 2nd dose on 16 Jun 2025), adult product administered to child (Verbatim: An 18 years old male patient received an adult dose of Engerix-B) and overdose (Verbatim: An 18 years old male patient received an adult dose of Engerix-B). The outcome of the drug dose administration interval too long, adult product administered to child and overdose 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 On 16 Jun 2025 they administered an adult dose of Engerix-B to a male patient who was 18 years old which led to Adult product administered to child and overdose. The patient received 1 dose in 2008, that was his first dose but did not complete the series. The adult dose of Engerix-B that the patient received today was his second dose which led to Drug dose administration interval too long.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Extra dose suggested by Physician not yet given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted medication error in a elderly male patient who did not receive Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received second dose on 30 Aug 2022 with lot 5H29X and FA95N) and Shingrix (first one on July 5th, 2022).   On an unknown date, the patient did not receive the 3rd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced intercepted medication error (Verbatim: Extra dose suggested by Physician not yet given). The outcome of the intercepted medication error was not applicable.   Additional Information: GSK Receipt Date: 26-JUN-2025 Pharmacist mentioned that an immunocompetent patient already got 2 doses of Shingrix in another facility, first one on July 5th, 2022, and the second one on August 30th 2022. Physician of the patient noticed that the doses are too close together and suggested to give a third dose but caller did not administer it yet which led to Intercepted medication error, since they wanted to confirm with Glaxo Smith Kline what recommendations they have.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: a patient was given only the diluent portion of the Shingrix vaccine; a patient was given only the diluent portion of the Shingrix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 5Y4TL, expiry date 31-JAN-2027) for prophylaxis.   On 27-JUN-2025, the patient received Shingrix. On 27-JUN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: a patient was given only the diluent portion of the Shingrix vaccine) and inappropriate dose of vaccine administered (Verbatim: a patient was given only the diluent portion of the Shingrix vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 30-JUN-2025 Nurse called today June 30, 2025 to report on June 27, 2025 a patient was given only the diluent portion of the Shingrix vaccine, situation was discovered and right after a correctly reconstituted dose was administered to the patient on the same arm which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Vaccine: COVID19
Symptoms: Device issue, No adverse event
Clinical narrative: white plunger part were disconnected from the rubber part of the plunger; No adverse effect; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE ISSUE (white plunger part were disconnected from the rubber part of the plunger) and NO ADVERSE EVENT (No adverse effect) in a  patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046734) for COVID-19 prophylaxis.    Suspect product included Pre-filled Syringe injection (batch no. 3046734) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (white plunger part were disconnected from the rubber part of the plunger) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (white plunger part were disconnected from the rubber part of the plunger) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.            No concomitant medication was reported.  It was mentioned that the white plunger part was disconnected from the rubber part of the plunger (this happened when their customer was getting a syringe from the box and plunger fell off and was disconnected).   it was reported that filed an adverse event as a possible occupational exposure of the product to the HCP while preparing for administration. The Device problem code for pre-filled syringe include FDA code 1670, IMDRF code A23 which included Use of Device Problem.  No treatment information was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site reaction, Pain in extremity
Clinical narrative: Injection site breakout; Pain in arm; Diarrhea; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On 25-JUN-2025, an unknown time after receiving Shingrix, the patient experienced injection site reaction (Verbatim: Injection site breakout), pain in arm (Verbatim: Pain in arm) and diarrhea (Verbatim: Diarrhea). The outcome of the injection site reaction, pain in arm and diarrhea were not resolved.   It was unknown if the reporter considered the injection site reaction, pain in arm and diarrhea to be related to Shingrix.     It was unknown if the company considered the injection site reaction, pain in arm and diarrhea to be related to Shingrix.   Additional Information: GSK receipt date: 30-JUN-2025 The patient reported that he had experienced diarrhea, arm pain, and a breakout at the injection site after receiving the second shot of Shingrix.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 5 days).   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: 25-JUN-2025 This case was reported by a patient via interactive digital media. The patient had shingles after the vaccine, but it lasted five days and had no rash or blisters. It was not a fun five days. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In JUN-2025, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 02-JUL-2025 This case was reported by a patient via interactive digital media. The patient had both shots 4 years ago and now got shingles 4 days ago. This case was considered as suspected vaccination failure since the details regarding 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 and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2).